**Wrong Patient, Wrong Drug: An Unfortunate Confluence of Events**

Anna Njarlangattil Thomas, Danielle Belser, Stephanie Rabenold, Omalara Olabisi Bamgbelu, Amaravani Mandalapu, Michael Pipestone, Alaa‐Eldin A Mira and Ric Baxter

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.69168

#### **Abstract**

[121] Lavan AH, Gallagher PF, O'Mahony D. Methods to reduce prescribing errors in elderly patients with multimorbidity. Clinical Interventions in Aging. 2016;**11**:857‐866

[122] Benjamin. Medication Adherence: Helping patients take their medicines as directed. U.S. Department of Health and Human Services Surgeon General's Perspectives Volume 127, 2012. Retrieved from: http://www.publichealthreports.org/issueopen.

[123] Unni EJ, Farris KB. Unintentional non‐adherence and belief in medicines in older

[124] Gadkari AS, McHorney CA. Unintentional non‐adherence to chronic prescription med‐ ications: How unintentional is it really? BMC Health Services Research. 2012;**12**:98 [125] Costa E, et al. Interventional tools to improve medication adherence: Review of litera‐

[126] Zullig LL, et al. A health literacy pilot intervention to improve medication adherence using Meducation(R) technology. Patient Education and Counseling. 2014;**95**(2):288‐291

adults. Patient Education and Counseling. 2011;**83**(2):265‐268

ture. Patient Preference and Adherence. 2015;**9**:1303‐1314

cfm?articleID=2800 [1 March 2017]

70 Vignettes in Patient Safety - Volume 1

Older adults, aged 65 years or older, represent 14.9% of U.S. population, and are projected to increase to 22% by 2050. It is estimated that almost half of hospitalized patients are older adults and is expected to increase as the population ages. Hospitalized older adults are most vulnerable to adverse events because of aging‐related conditions, physiological changes, and multiple comorbidities as well as fragmented care. The primary goal of health care providers is to improve patient safety and decrease adverse events. This chapter will use a complex clinical scenario with numerous potential overlapping risks to address the many active and latent factors that lead to patient safety‐related adverse events. Factors involved, as well as preventive strategies, will be discussed in detail.

**Keywords:** patient safety, medication dosing, elderly, delirium prevention, falls, restraints, culture of safety, clinical informatics, same or similar name, handoffs, disclosing error

#### **1. Introduction**

Patient safety events are unfortunately a common occurrence in healthcare systems across the United States [1, 2]. Medication errors, hospital acquired infections, wrong site surgery, and other types of errors contribute to increased morbidity and mortality in hospitalized patients [3, 4]. The question, of course, is how do such errors occur and how can they be prevented? James Reason's 1990 book, "Human Error" created a conceptual framework, commonly known

© 2017 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

as the Swiss Cheese Model to understand how such errors take place [5]. While not specifically aimed at healthcare, it instead seeks to explore how failures could occur in any system where holes in each defensive layer can lead to a potential for error. The availability of multiple defensive layers provide protection against a major hazardous event, but eventually, the holes line up and the system fails [5]. Some of the holes are related to active or proximal causes of failure–these are directly linked to how the patient, in the case of healthcare systems, is cared for. Other holes are due to latent causes that are hidden problems involving the entire health system. By dissecting a patient safety event into its active and latent causes, one can take a root‐ cause analysis approach to understanding, and ultimately preventing error [3]. In this chapter, we will investigate some of the active and latent causes that could have led to an error in the unfortunate clinical scenario outlined below.

his fevers had not abated. The decision was made to avoid any further benzodiazepines and request a urology consultation for the hematuria. Antibiotics were not changed at this time,

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The team finished rounds on their patients and the residents dispersed to complete tasks and follow up on orders. One of the residents who was covering both Mr. Pearse and Mr. Pierce, had a clinic that afternoon and signed out to his co‐resident prior to leaving the hospital for the day. While the covering resident was inputting the order for Mr. Pearse's heparin, he received a call from the nurse regarding culture results for Mr. Pierce. Mr. Pierce's urine culture revealed a resistant gram‐negative bacterium. The resident discussed the finding with the infectious disease consultant who recommends a change in antibiotic including a dose of gentamycin for synergy. He also placed the orders and informed his attending of the changes. A few hours later, the resident receives a phone call from the consulting urologist who is confused as to why heparin was ordered for a patient with active hematuria. Horrified, the resident realized that heparin had been ordered incorrectly for Mr. Pierce and gentamycin ordered incorrectly for Mr. Pearse. The resident immediately contacted nurses caring for both patients and is able to prevent the heparin from being started, but unfortunately, the gentamycin had already been administered. The resident and the attending return to Mr. Pearse's bedside to reassess him and then speak to him and his family about the medication error.

pending culture results which were expected to return within a few hours.

Unfortunately, his renal failure worsens and his hospital stay becomes prolonged.

As previously mentioned, causes of patient safety events can be understood easily when categorized by active vs. latent causes. The case above has several active causes that contributed to medical errors and ultimately to a patient safety adverse event. In the following section, we will explore the importance of appropriate medication dosing in the elderly, prevention and management of delirium in the elderly, fall prevention, and use of restraints in the hospital

In the elderly, changes in pharmacodynamics and pharmacokinetics result in prolonged effects of medications, making them more prone to toxicity. For most medications, absorption is slower and peak serum concentrations may be lower and delayed [6–8]. On the other hand, metabolic clearance of drugs by the liver may be decreased due to reduced blood flow, size or

The kidneys play a vital role, as they excrete many drugs. With aging, there is a decrease in renal blood flow, kidney size, number of functioning nephrons, tubular secretion and estimated glomerular filtration rate (EGFR) [3–7]. In addition, due to decreased lean body mass, serum creatinine may stay in normal range, masking changes in creatinine clearance and renal function [3–8]. Estimating Creatinine clearance (CrCl) is often complicated in the

**3. Active causes**

**3.1. Appropriate medication dosing in the elderly**

mass, and changes in intrinsic pathways or reactions [6–8].

setting.

### **2. Clinical vignette**

The following is a hypothetical case used to illustrate several key patient safety issues: Mr. Timothy Pearse is an 85‐year‐old male admitted to the hospital for progressive symptoms of shortness of breath for the past 3 days. He has a past medical history of paroxysmal atrial fibrillation, coronary artery disease, systolic congestive heart failure, osteoarthritis of bilateral knees, and benign prostate hypertrophy. He has had three admissions in the past year for congestive heart failure exacerbations. His home medications include carvedilol, aspirin, furosemide, metolazone, atorvastatin, naproxen, and tamsulosin. Today, he is notably dyspneic and is experiencing oxygen desaturations to 87% on room air. His lung examination reveals bilateral crackles and he is in rapid atrial fibrillation with a rate of 144. He is given intravenous diuretics for his heart failure and beta‐blockers for his atrial fibrillation and is admitted to the internal medicine service overnight.

The same night Mr. Thomas Pierce is admitted to the same internal medicine service with fever, confusion, and lethargy. Mr. Pierce is 87‐years‐old and has a history of Alzheimer's dementia, hypercholesterolemia, hypothyroidism, and neurogenic bladder from a prior back injury. He uses a chronic foley catheter. His initial workup is significant for sepsis secondary to pyelonephritis with acute delirium. He is started on empiric antibiotics and admitted to the hospital overnight.

Both patients are examined during rounds by the residents and attending physician at the bedside. Mr. Pearse had improvement in his atrial fibrillation and symptoms of heart failure but required further diuresis. Unfortunately, he developed acute renal failure from the combination of diuretics and naproxen. The decision was made to cautiously stop diuretics, stop naproxen, and to start intravenous heparin for his atrial fibrillation. The team next reviewed Mr. Pierce who was a few rooms down. Mr. Pierce received an "as needed" dose of lorazepam overnight for agitation and unfortunately experienced an unwitnessed fall in early morning hours, in addition to inadvertently pulling on his foley. This morning he was examined at the bedside where he was in soft hand restraints, with no improvement in his symptoms. His foley catheter had notable blood in the bag. His urine culture results were still pending, but his fevers had not abated. The decision was made to avoid any further benzodiazepines and request a urology consultation for the hematuria. Antibiotics were not changed at this time, pending culture results which were expected to return within a few hours.

The team finished rounds on their patients and the residents dispersed to complete tasks and follow up on orders. One of the residents who was covering both Mr. Pearse and Mr. Pierce, had a clinic that afternoon and signed out to his co‐resident prior to leaving the hospital for the day. While the covering resident was inputting the order for Mr. Pearse's heparin, he received a call from the nurse regarding culture results for Mr. Pierce. Mr. Pierce's urine culture revealed a resistant gram‐negative bacterium. The resident discussed the finding with the infectious disease consultant who recommends a change in antibiotic including a dose of gentamycin for synergy. He also placed the orders and informed his attending of the changes.

A few hours later, the resident receives a phone call from the consulting urologist who is confused as to why heparin was ordered for a patient with active hematuria. Horrified, the resident realized that heparin had been ordered incorrectly for Mr. Pierce and gentamycin ordered incorrectly for Mr. Pearse. The resident immediately contacted nurses caring for both patients and is able to prevent the heparin from being started, but unfortunately, the gentamycin had already been administered. The resident and the attending return to Mr. Pearse's bedside to reassess him and then speak to him and his family about the medication error. Unfortunately, his renal failure worsens and his hospital stay becomes prolonged.

#### **3. Active causes**

as the Swiss Cheese Model to understand how such errors take place [5]. While not specifically aimed at healthcare, it instead seeks to explore how failures could occur in any system where holes in each defensive layer can lead to a potential for error. The availability of multiple defensive layers provide protection against a major hazardous event, but eventually, the holes line up and the system fails [5]. Some of the holes are related to active or proximal causes of failure–these are directly linked to how the patient, in the case of healthcare systems, is cared for. Other holes are due to latent causes that are hidden problems involving the entire health system. By dissecting a patient safety event into its active and latent causes, one can take a root‐ cause analysis approach to understanding, and ultimately preventing error [3]. In this chapter, we will investigate some of the active and latent causes that could have led to an error in the

The following is a hypothetical case used to illustrate several key patient safety issues: Mr. Timothy Pearse is an 85‐year‐old male admitted to the hospital for progressive symptoms of shortness of breath for the past 3 days. He has a past medical history of paroxysmal atrial fibrillation, coronary artery disease, systolic congestive heart failure, osteoarthritis of bilateral knees, and benign prostate hypertrophy. He has had three admissions in the past year for congestive heart failure exacerbations. His home medications include carvedilol, aspirin, furosemide, metolazone, atorvastatin, naproxen, and tamsulosin. Today, he is notably dyspneic and is experiencing oxygen desaturations to 87% on room air. His lung examination reveals bilateral crackles and he is in rapid atrial fibrillation with a rate of 144. He is given intravenous diuretics for his heart failure and beta‐blockers for his atrial fibrillation and is admitted to the

The same night Mr. Thomas Pierce is admitted to the same internal medicine service with fever, confusion, and lethargy. Mr. Pierce is 87‐years‐old and has a history of Alzheimer's dementia, hypercholesterolemia, hypothyroidism, and neurogenic bladder from a prior back injury. He uses a chronic foley catheter. His initial workup is significant for sepsis secondary to pyelonephritis with acute delirium. He is started on empiric antibiotics and admitted to the

Both patients are examined during rounds by the residents and attending physician at the bedside. Mr. Pearse had improvement in his atrial fibrillation and symptoms of heart failure but required further diuresis. Unfortunately, he developed acute renal failure from the combination of diuretics and naproxen. The decision was made to cautiously stop diuretics, stop naproxen, and to start intravenous heparin for his atrial fibrillation. The team next reviewed Mr. Pierce who was a few rooms down. Mr. Pierce received an "as needed" dose of lorazepam overnight for agitation and unfortunately experienced an unwitnessed fall in early morning hours, in addition to inadvertently pulling on his foley. This morning he was examined at the bedside where he was in soft hand restraints, with no improvement in his symptoms. His foley catheter had notable blood in the bag. His urine culture results were still pending, but

unfortunate clinical scenario outlined below.

internal medicine service overnight.

hospital overnight.

**2. Clinical vignette**

72 Vignettes in Patient Safety - Volume 1

As previously mentioned, causes of patient safety events can be understood easily when categorized by active vs. latent causes. The case above has several active causes that contributed to medical errors and ultimately to a patient safety adverse event. In the following section, we will explore the importance of appropriate medication dosing in the elderly, prevention and management of delirium in the elderly, fall prevention, and use of restraints in the hospital setting.

#### **3.1. Appropriate medication dosing in the elderly**

In the elderly, changes in pharmacodynamics and pharmacokinetics result in prolonged effects of medications, making them more prone to toxicity. For most medications, absorption is slower and peak serum concentrations may be lower and delayed [6–8]. On the other hand, metabolic clearance of drugs by the liver may be decreased due to reduced blood flow, size or mass, and changes in intrinsic pathways or reactions [6–8].

The kidneys play a vital role, as they excrete many drugs. With aging, there is a decrease in renal blood flow, kidney size, number of functioning nephrons, tubular secretion and estimated glomerular filtration rate (EGFR) [3–7]. In addition, due to decreased lean body mass, serum creatinine may stay in normal range, masking changes in creatinine clearance and renal function [3–8]. Estimating Creatinine clearance (CrCl) is often complicated in the elderly due to such fluctuations, for example, the Cockroft–Gault calculation estimates EGFR based on weight, age, serum creatinine levels and gender; it requires, however, a stable serum creatinine level for accurate results [9]. This calculation may underestimate CrCl in those without significant age‐related renal decline and may overestimate CrCl in those with renal mass reduction beyond normal aging [8].

care in elderly patients [12]. This can be achieved by addressing predisposing factors such as using frequent reorientation, noise reduction, adequate hydration and early mobilization [11, 12]. In addition, identifying and treating reversible contributors such as pain, constipation, and drug withdrawal can assist in preventing the development of delirium. When delirium is present, early recognition and early non‐pharmacological intervention along with patient and

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Pharmacological interventions can also be used in the treatment and management of acute delirium. Haloperidol has the highest clinical evidence amongst pharmacological agents for use in agitated delirium refractory to non‐pharmacologic measures [13–15]. Using the lowest effective dose of this high potency antipsychotic is recommended, and as this medication may cause multiple adverse effects (including QT prolongation, torsades de pointes, withdrawal dyskinesias, etc), patients started on this medication should be closely monitored [13–15]. Other pharmacological agents that have been studied in the management of in‐hospital delirium include Gabapentin, second‐generation antipsychotics such as Risperidone, Olanzapine, as well as other medications like Cholinesterase Inhibitors, Statins, Corticosteroids, Tryptophan, and Melatonin; however, current data for such pharmacological treatment remains controversial [13]. It is important to remember that certain medications can also result in adverse events. High‐potency antipsychotics are contraindicated in Parkinson's disease and Lewy body dementia [14]. Benzodiazepines, such as lorazepam, are not recommended as first‐line agents in the treatment of delirium because

In summary, acute delirium in the hospital setting should be managed using a combination of non‐pharmacological and pharmacological methods. Had the patient in the case scenario outlined above been approached with the mindset of delirium prevention, some of the patient

Among older adults, the incidence of in‐hospital falls ranges from 6 to 15.9 per 1000 patient days, and a single fall could lead to an approximate increase of \$4000 per hospitalization [16, 17]. As such, all providers should conduct a careful history and physical examination aimed at identifying those at increased fall risk in order to reduce in‐hospital fall events. Historical clues include a history of previous falls at home, use of an assistive device and any underlying visual or hearing impairment [18, 19]. During the initial examination, a patient's gait, balance, strength, cognition, and mood should also be assessed [18, 19]. Once at‐risk patients are identified, several interventions can be started to reduce fall risk including: (1) encourage early mobility, (2) avoid use of restraints, (3) minimize use of medications that contribute to falls, (4) use assistive devices like walkers or canes as indicated, (5) address sensory impairments like vision difficulties with patients home equipment, and (6) provide early inpatient

Supplementation with Vitamin D3 has also been shown to be effective in fall reduction in nursing facilities [22]. Multifactorial interventions, increasing patients' awareness of their fall risk through bedside teaching, and careful medication review by clinical pharmacists may also decrease the occurrence of falls; however, continued research is needed in this area [20, 21].

they often exacerbate mental status changes and can cause over‐sedation [13].

safety‐related adverse events might have been avoided.

**3.3. Fall prevention in the elderly**

physical therapy [20, 21].

family support are very important [11, 12].

Given the above, medication dosing in the elderly can be quite complicated! When prescribing medications in the elderly, the aim is to achieve a balance between over and under‐ prescribing. Some steps are outlined in **Table 1**.

It is important to note that the elderly are more prone to adverse drug effects and reactions including acute kidney injury, hypotension, delirium, and falls. Aging and illnesses which impair kidney function can lead to drug accumulation and toxicity. Additional risk factors include a CrCl less than 50 ml/min, multiple chronic medical comorbidities and polypharmacy [6–8]. It is important to decide on appropriate medication administration routes, medication forms and suitable times of administration to ensure effectiveness and compliance while minimizing adverse events. An additional tool is the American Geriatric Society's Beers Criteria, which identifies many common medications that cause adverse drug events in older adults and are meant to assist clinical judgment in prescribing medications for this population [10].

In summary, when prescribing in the elderly, it is essential to perform a complete medication review which should include all prescribed and over the counter drugs. Medications should be started at low doses and titrated upwards slowly. Therapeutic endpoints should be clearly defined and reviewed periodically. Close follow‐up in this especially vulnerable population is essential.

#### **3.2. Management of delirium in the elderly**

Delirium is often multifactorial in origin and is caused by a sum of predisposing factors including advanced age, medical comorbidities, functional impairment and dementia; and precipitating factors which include acute medical problems, bed rest and the use of restraints [11]. Delirium is associated with substantial morbidity and mortality in older people and prevention is the best management. The Hospital Elder Life Program (HELP) is an innovative tool that uses tested delirium prevention strategies to improve the overall quality of hospital

**Table 1.** Recommendations for prescribing medications in the elderly [6, 8].

<sup>1.</sup> Consider non‐pharmacological methods for managing the condition in question if possible.

<sup>2.</sup> Review the benefits vs. risks associated with the medication. Is it truly appropriate?

<sup>3.</sup> Avoid starting more than one medication at any given time.

<sup>4.</sup> Consider using a single medication to address multiple conditions if possible.

<sup>5.</sup> Consider drug‐drug interactions (including consideration of over the counter medications) and drug elimination (half‐life and clearance) profiles of the medications prior to prescribing.

<sup>6.</sup> Periodically review medications and discontinue inappropriate medications as soon as possible.

care in elderly patients [12]. This can be achieved by addressing predisposing factors such as using frequent reorientation, noise reduction, adequate hydration and early mobilization [11, 12]. In addition, identifying and treating reversible contributors such as pain, constipation, and drug withdrawal can assist in preventing the development of delirium. When delirium is present, early recognition and early non‐pharmacological intervention along with patient and family support are very important [11, 12].

Pharmacological interventions can also be used in the treatment and management of acute delirium. Haloperidol has the highest clinical evidence amongst pharmacological agents for use in agitated delirium refractory to non‐pharmacologic measures [13–15]. Using the lowest effective dose of this high potency antipsychotic is recommended, and as this medication may cause multiple adverse effects (including QT prolongation, torsades de pointes, withdrawal dyskinesias, etc), patients started on this medication should be closely monitored [13–15]. Other pharmacological agents that have been studied in the management of in‐hospital delirium include Gabapentin, second‐generation antipsychotics such as Risperidone, Olanzapine, as well as other medications like Cholinesterase Inhibitors, Statins, Corticosteroids, Tryptophan, and Melatonin; however, current data for such pharmacological treatment remains controversial [13]. It is important to remember that certain medications can also result in adverse events. High‐potency antipsychotics are contraindicated in Parkinson's disease and Lewy body dementia [14]. Benzodiazepines, such as lorazepam, are not recommended as first‐line agents in the treatment of delirium because they often exacerbate mental status changes and can cause over‐sedation [13].

In summary, acute delirium in the hospital setting should be managed using a combination of non‐pharmacological and pharmacological methods. Had the patient in the case scenario outlined above been approached with the mindset of delirium prevention, some of the patient safety‐related adverse events might have been avoided.

#### **3.3. Fall prevention in the elderly**

elderly due to such fluctuations, for example, the Cockroft–Gault calculation estimates EGFR based on weight, age, serum creatinine levels and gender; it requires, however, a stable serum creatinine level for accurate results [9]. This calculation may underestimate CrCl in those without significant age‐related renal decline and may overestimate CrCl in those with renal

Given the above, medication dosing in the elderly can be quite complicated! When prescribing medications in the elderly, the aim is to achieve a balance between over and under‐

It is important to note that the elderly are more prone to adverse drug effects and reactions including acute kidney injury, hypotension, delirium, and falls. Aging and illnesses which impair kidney function can lead to drug accumulation and toxicity. Additional risk factors include a CrCl less than 50 ml/min, multiple chronic medical comorbidities and polypharmacy [6–8]. It is important to decide on appropriate medication administration routes, medication forms and suitable times of administration to ensure effectiveness and compliance while minimizing adverse events. An additional tool is the American Geriatric Society's Beers Criteria, which identifies many common medications that cause adverse drug events in older adults and are meant to assist clinical judgment in prescribing medications for this population [10]. In summary, when prescribing in the elderly, it is essential to perform a complete medication review which should include all prescribed and over the counter drugs. Medications should be started at low doses and titrated upwards slowly. Therapeutic endpoints should be clearly defined and reviewed periodically. Close follow‐up in this especially vulnerable population

Delirium is often multifactorial in origin and is caused by a sum of predisposing factors including advanced age, medical comorbidities, functional impairment and dementia; and precipitating factors which include acute medical problems, bed rest and the use of restraints [11]. Delirium is associated with substantial morbidity and mortality in older people and prevention is the best management. The Hospital Elder Life Program (HELP) is an innovative tool that uses tested delirium prevention strategies to improve the overall quality of hospital

5. Consider drug‐drug interactions (including consideration of over the counter medications) and drug elimination

1. Consider non‐pharmacological methods for managing the condition in question if possible.

6. Periodically review medications and discontinue inappropriate medications as soon as possible.

2. Review the benefits vs. risks associated with the medication. Is it truly appropriate?

4. Consider using a single medication to address multiple conditions if possible.

(half‐life and clearance) profiles of the medications prior to prescribing.

**Table 1.** Recommendations for prescribing medications in the elderly [6, 8].

mass reduction beyond normal aging [8].

74 Vignettes in Patient Safety - Volume 1

is essential.

prescribing. Some steps are outlined in **Table 1**.

**3.2. Management of delirium in the elderly**

3. Avoid starting more than one medication at any given time.

Among older adults, the incidence of in‐hospital falls ranges from 6 to 15.9 per 1000 patient days, and a single fall could lead to an approximate increase of \$4000 per hospitalization [16, 17]. As such, all providers should conduct a careful history and physical examination aimed at identifying those at increased fall risk in order to reduce in‐hospital fall events. Historical clues include a history of previous falls at home, use of an assistive device and any underlying visual or hearing impairment [18, 19]. During the initial examination, a patient's gait, balance, strength, cognition, and mood should also be assessed [18, 19]. Once at‐risk patients are identified, several interventions can be started to reduce fall risk including: (1) encourage early mobility, (2) avoid use of restraints, (3) minimize use of medications that contribute to falls, (4) use assistive devices like walkers or canes as indicated, (5) address sensory impairments like vision difficulties with patients home equipment, and (6) provide early inpatient physical therapy [20, 21].

Supplementation with Vitamin D3 has also been shown to be effective in fall reduction in nursing facilities [22]. Multifactorial interventions, increasing patients' awareness of their fall risk through bedside teaching, and careful medication review by clinical pharmacists may also decrease the occurrence of falls; however, continued research is needed in this area [20, 21].

#### **3.4. Use of restraints in the hospital setting**

The use of restraints in the elderly is sometimes necessary, such as when the patient poses a threat to themselves, to staff members, or to other caregivers and family. The goal of restraint use is to limit a patient's movement, and should only be used after other methods to calm or redirect the patient have failed. Specific instances were restraints may be necessary include violent behaviors (hitting, biting, scratching, etc) as well as non‐violent behaviors (pulling on lines or tubes, interfering with medical care resulting in self‐injury, etc). Types of restraints can range from physical (such as waist belts, wrist restraints, mittens or side‐rails) to the use of chemical restraints (such as medications like lorazepam or haloperidol) to sedate the individual [23].

health information technology, and training in a blame free error reporting and error disclosure [24–27]. Improving team dynamics can reduce error by allowing teammates to coordinate their care, improve efficiency, and reduce stress and fatigue. Given that each team member brings different skills to the care of the patient, creating an environment where all team members share responsibility allows each to safely question and escalate issues that could potentially impact patient safety without fear of backlash [24]. In addition, safety huddles and multidisciplinary team based rounding enables all members of the team to provide input into the plan of care and identify potential obstacles and errors earlier on during the course of a patient's stay [24–27].

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In our case above, several team members correctly identified patient safety events and brought it to relevant provider's attention to be addressed, and all quickly responded to reduce the severity of the error. In addition, while the resident in the case appeared horrified at the magnitude of the error, the calm and team‐oriented approach taken by the attending physician serves as an example of a positive culture of safety. Key components of a culture of safety are

Due to the impact that medication errors have on healthcare outcomes, the use of clinical informatics to prevent such errors has emerged in recent years and can potentially result in significant costs savings [28]. Medication management and clinical decision support systems can reduce errors in prescribing, transcribing, dispensing, and administration of medications [29]. For example, an electronic medical record system that utilizes computerized physician order entry may allow for automatic checking of drug interactions and allergy contraindications, or even appropriate dosing based on renal function [30]. Alert functions can be utilized by the physician or provider to reduce medication dosing errors as well. It is estimated that such systems could reduce errors by greater than 50% [30]. Similarly, drug dispensing systems

outlined in **Figure 1**.

**4.2. Using clinical informatics to reduce error**

**Figure 1.** Schematic representation of key components of a culture of safety.

The use of restraints in the hospital, however, could potentially lead to adverse events including falls, injury, and even at times death. As such, the use of restraints in the hospital setting is controlled by the specific state and federal regulations, such as those described by the Joint Commission, in addition to individual hospital guidelines [23]. The Joint Commission outlines several items related to restraint use in hospitals, including (1) when restraints are clinically justified, (2) how a physician is to order restraint use, (3) how to safely implement restraint use to a patient's plan of care, (4) how to evaluate/care for the patient properly while under restraints, and (5) how to report death and injury as a result of restraint use [23].

In the clinical case outlined above, while soft restraints might have initially felt to be appropriate to manage an unsafe situation, its use was involved in a chain of patient safety events including a fall, traumatic pulling off a foley catheter and resulting hematuria, and worsening of delirium symptoms.

#### **4. Latent causes**

After having reviewed a few specific active causes related to patient safety in this clinical scenario, let us investigate further the latent causes or systemic factors that may have contributed to patient safety events for the hypothetical patients in this case.

#### **4.1. Culture of safety**

The broadest category for systemic or latent causes of adverse events in a health system is the 'culture of safety' practiced by the individuals within it. A 'culture of safety' can be described as all of the characteristics, attitudes, behaviors and perceptions of individual health care professionals who consciously play an active role in promoting the patient's health and safety [24, 25]. Given the high‐cost burden that anyone adverse event can have, most healthcare systems have now adopted various strategies to improve teamwork and embrace a philosophy where the best patient outcomes become a shared goal. High‐Reliability Organizations aim for an ultimate goal of no errors and has been promoted by the Agency for Healthcare Research and Quality as an aim all healthcare systems should strive for [4, 25].

A few methods through which a culture of safety can be achieved within the healthcare setting include safe transitions and handovers between team members, efficient and accurate use of health information technology, and training in a blame free error reporting and error disclosure [24–27]. Improving team dynamics can reduce error by allowing teammates to coordinate their care, improve efficiency, and reduce stress and fatigue. Given that each team member brings different skills to the care of the patient, creating an environment where all team members share responsibility allows each to safely question and escalate issues that could potentially impact patient safety without fear of backlash [24]. In addition, safety huddles and multidisciplinary team based rounding enables all members of the team to provide input into the plan of care and identify potential obstacles and errors earlier on during the course of a patient's stay [24–27].

In our case above, several team members correctly identified patient safety events and brought it to relevant provider's attention to be addressed, and all quickly responded to reduce the severity of the error. In addition, while the resident in the case appeared horrified at the magnitude of the error, the calm and team‐oriented approach taken by the attending physician serves as an example of a positive culture of safety. Key components of a culture of safety are outlined in **Figure 1**.

#### **4.2. Using clinical informatics to reduce error**

**3.4. Use of restraints in the hospital setting**

76 Vignettes in Patient Safety - Volume 1

of delirium symptoms.

**4. Latent causes**

**4.1. Culture of safety**

The use of restraints in the elderly is sometimes necessary, such as when the patient poses a threat to themselves, to staff members, or to other caregivers and family. The goal of restraint use is to limit a patient's movement, and should only be used after other methods to calm or redirect the patient have failed. Specific instances were restraints may be necessary include violent behaviors (hitting, biting, scratching, etc) as well as non‐violent behaviors (pulling on lines or tubes, interfering with medical care resulting in self‐injury, etc). Types of restraints can range from physical (such as waist belts, wrist restraints, mittens or side‐rails) to the use of chemical restraints (such as medications like lorazepam or haloperidol) to sedate the individual [23].

The use of restraints in the hospital, however, could potentially lead to adverse events including falls, injury, and even at times death. As such, the use of restraints in the hospital setting is controlled by the specific state and federal regulations, such as those described by the Joint Commission, in addition to individual hospital guidelines [23]. The Joint Commission outlines several items related to restraint use in hospitals, including (1) when restraints are clinically justified, (2) how a physician is to order restraint use, (3) how to safely implement restraint use to a patient's plan of care, (4) how to evaluate/care for the patient properly while under restraints, and (5) how to report death and injury as a result of restraint use [23].

In the clinical case outlined above, while soft restraints might have initially felt to be appropriate to manage an unsafe situation, its use was involved in a chain of patient safety events including a fall, traumatic pulling off a foley catheter and resulting hematuria, and worsening

After having reviewed a few specific active causes related to patient safety in this clinical scenario, let us investigate further the latent causes or systemic factors that may have contributed

The broadest category for systemic or latent causes of adverse events in a health system is the 'culture of safety' practiced by the individuals within it. A 'culture of safety' can be described as all of the characteristics, attitudes, behaviors and perceptions of individual health care professionals who consciously play an active role in promoting the patient's health and safety [24, 25]. Given the high‐cost burden that anyone adverse event can have, most healthcare systems have now adopted various strategies to improve teamwork and embrace a philosophy where the best patient outcomes become a shared goal. High‐Reliability Organizations aim for an ultimate goal of no errors and has been promoted by the Agency for Healthcare

A few methods through which a culture of safety can be achieved within the healthcare setting include safe transitions and handovers between team members, efficient and accurate use of

Research and Quality as an aim all healthcare systems should strive for [4, 25].

to patient safety events for the hypothetical patients in this case.

Due to the impact that medication errors have on healthcare outcomes, the use of clinical informatics to prevent such errors has emerged in recent years and can potentially result in significant costs savings [28]. Medication management and clinical decision support systems can reduce errors in prescribing, transcribing, dispensing, and administration of medications [29]. For example, an electronic medical record system that utilizes computerized physician order entry may allow for automatic checking of drug interactions and allergy contraindications, or even appropriate dosing based on renal function [30]. Alert functions can be utilized by the physician or provider to reduce medication dosing errors as well. It is estimated that such systems could reduce errors by greater than 50% [30]. Similarly, drug dispensing systems


**Figure 1.** Schematic representation of key components of a culture of safety.

using automated cabinets, bar coding, packaging, etc, can also significantly reduce errors in medication dispensing and ultimately, administration of medications to the patient [31].

In this clinical scenario, there are several latent causes of patient safety adverse events due to similar sounding names. The patients were both admitted to the same team and were placed on the same hospital floor just a few rooms apart. In addition, as the resident was attempting to multitask, he very easily placed orders on the wrong patient which ultimately led to the medication administration error. Had some of the steps outlined above been in place, the

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79

Handoffs are the transfer of information during transitions in care and can occur at multiple points during the course of a patient's hospital stay. The handoff is a complex mechanism of communication between care providers and includes transferring of critical information, records and responsibility, all of which impacts patient safety [41]. Ineffective or fumbled handoffs can lead to critical patient safety related events including wrong site procedures, medication administration errors, and even death [41]. As a result, an effective handoff is largely dependent on the interpersonal communication skills of the caregivers involved.

The Joint Commission introduced a national patient safety goal on handoffs to reduce communication‐related errors [42]. This patient safety goal requires health care organizations to implement a standardized approach to all handoff communications by emphasizing the transfer of critical patient information [40]. One common approach is the use of sign‐out sheets for communication and is often utilized by physicians. The SBAR (Situation, Background, Assessment, and Recommendation) model is being used to bridge the gap between the different communication styles of nurses and physicians to enhance handoff communication [43]. In addition, the use of electronic medical records may be utilized to improve the handoff

In the clinical case above, safe handoff between the resident team members is a critical component of ensuring patient's safety. A safe handoff might have included a reminder about similar sounding names, relevant cautions about medication dosing based on age, renal function or allergies, as well as a succinct yet thorough description of the patients' history and

Medical errors occur; of this, there can be no doubt. A common dilemma for physicians is how–or if–to disclose the error to patients or families. The central ethical tension in this dilemma hinges on the interplay between the four Western biomedical ethical tenets. The unavoidable pragmatic conflict is the legal or financial risks the provider may incur either by

Professional societies generally agree that patients have a right to know about their care, including errors that may or may not be directly related to adverse outcomes [44, 45]. These may be good ethical standards, but we believe that no guideline can substitute for a provider's personal sense of ethics. Furthermore, the application of any guideline should be refined by

openly identifying an error, or knowingly choosing not to disclose one.

the cross‐cultural interactions between a provider, a patient, and family.

process by eliminating difficulties with data access or illegible documentation [43].

potential for error due to the similarity in names might have been reduced.

**4.4. Safe handoffs**

plan of care.

**4.5. Disclosing error**

While the use of information technology to reduce medication error is quite promising, it is not without its own limitations. The ability of the software to detect error is a function of the underlying man‐made program, which is also susceptible to error. For example, poor system design can increase provider workload, leading to inefficiency and alert fatigue, and can ultimately contribute to other types of downstream medical errors [32]. Multitasking can lead to medication errors, as in the case described, as physicians may jump through charts while ordering medications and inadvertently enter orders into the wrong patient's chart. As such, it is critical that providers continue to stay vigilant to mistakes even when using information technology. One simple tool utilized by High‐Reliability Organizations is the STAR (Stop, Think, Act and Review) acronym which can be utilized in multiple settings to reduce errors in settings where patient safety (such as when medications are being ordered) is vital [4, 25]. This simple acronym should remind providers to take a conscious effort to focus on the task at hand to ensure that the correct order is assigned to the right patient [4].

#### **4.3. Same or similar sounding names**

A common patient safety risk occurs when hospitalized patients have the same or similar sounding names, which causes confusion in identifying and treating the intended patient. Patient identification errors can occur at any point throughout the course of a patient's hospitalization from meal delivery to procedures and interventions. However, there is an incredible potential for harm and even death, when patient misidentification occurs. It is, however, difficult to determine the true incidence of patient misidentification due to underreporting [33–35]. One study, for example, did identify that over 70% of transfusion errors in New York State occurred as a result of patient misidentification [36]. Likewise, the UK Patient Safety Agency identified 236 errors within 2 years which were related to missing or incorrect patient name bands [37]. Although correct patient identification may seem intuitive, there are several steps that hospital systems should take to prevent identification errors, as outlined in **Table 2**:

<sup>1.</sup> Identify charts of patients with same or similar sounding names with the name in bold or italics [33]

<sup>2.</sup> Use two or more separate identifiers (Name, Date of Birth, Medical Record Number, etc) to identify a patient prior to any intervention or care delivery [33, 37, 38]

<sup>3.</sup> Utilize a barcode system for drug dispensation and for patient identification [35, 37, 39]

<sup>4.</sup> Patient identity wristbands could also include a picture of the patient to provide an additional level of protection [35, 37, 39]

<sup>5.</sup> Patient identity should be verified by all providers at the time of charting, order entry, and medication administration [40]

<sup>6.</sup> Use alerts in the electronic medical record that require the provider to acknowledge and verify that they are in the correct chart if a similarly named patient is also admitted to the hospital [40]

<sup>7.</sup> Empower patients to become actively involved in the self‐identification process prior to any intervention, particularly when a similarly named patient is on the same floor

In this clinical scenario, there are several latent causes of patient safety adverse events due to similar sounding names. The patients were both admitted to the same team and were placed on the same hospital floor just a few rooms apart. In addition, as the resident was attempting to multitask, he very easily placed orders on the wrong patient which ultimately led to the medication administration error. Had some of the steps outlined above been in place, the potential for error due to the similarity in names might have been reduced.

#### **4.4. Safe handoffs**

using automated cabinets, bar coding, packaging, etc, can also significantly reduce errors in medication dispensing and ultimately, administration of medications to the patient [31].

While the use of information technology to reduce medication error is quite promising, it is not without its own limitations. The ability of the software to detect error is a function of the underlying man‐made program, which is also susceptible to error. For example, poor system design can increase provider workload, leading to inefficiency and alert fatigue, and can ultimately contribute to other types of downstream medical errors [32]. Multitasking can lead to medication errors, as in the case described, as physicians may jump through charts while ordering medications and inadvertently enter orders into the wrong patient's chart. As such, it is critical that providers continue to stay vigilant to mistakes even when using information technology. One simple tool utilized by High‐Reliability Organizations is the STAR (Stop, Think, Act and Review) acronym which can be utilized in multiple settings to reduce errors in settings where patient safety (such as when medications are being ordered) is vital [4, 25]. This simple acronym should remind providers to take a conscious effort to focus on the task

A common patient safety risk occurs when hospitalized patients have the same or similar sounding names, which causes confusion in identifying and treating the intended patient. Patient identification errors can occur at any point throughout the course of a patient's hospitalization from meal delivery to procedures and interventions. However, there is an incredible potential for harm and even death, when patient misidentification occurs. It is, however, difficult to determine the true incidence of patient misidentification due to underreporting [33–35]. One study, for example, did identify that over 70% of transfusion errors in New York State occurred as a result of patient misidentification [36]. Likewise, the UK Patient Safety Agency identified 236 errors within 2 years which were related to missing or incorrect patient name bands [37]. Although correct patient identification may seem intuitive, there are several steps that hospital systems should take to prevent identification errors, as outlined in **Table 2**:

at hand to ensure that the correct order is assigned to the right patient [4].

1. Identify charts of patients with same or similar sounding names with the name in bold or italics [33]

5. Patient identity should be verified by all providers at the time of charting, order entry, and medication

7. Empower patients to become actively involved in the self‐identification process prior to any intervention,

3. Utilize a barcode system for drug dispensation and for patient identification [35, 37, 39]

correct chart if a similarly named patient is also admitted to the hospital [40]

particularly when a similarly named patient is on the same floor

**Table 2.** Methods to reduce patient identification errors.

2. Use two or more separate identifiers (Name, Date of Birth, Medical Record Number, etc) to identify a patient prior

4. Patient identity wristbands could also include a picture of the patient to provide an additional level of protection

6. Use alerts in the electronic medical record that require the provider to acknowledge and verify that they are in the

**4.3. Same or similar sounding names**

78 Vignettes in Patient Safety - Volume 1

to any intervention or care delivery [33, 37, 38]

[35, 37, 39]

administration [40]

Handoffs are the transfer of information during transitions in care and can occur at multiple points during the course of a patient's hospital stay. The handoff is a complex mechanism of communication between care providers and includes transferring of critical information, records and responsibility, all of which impacts patient safety [41]. Ineffective or fumbled handoffs can lead to critical patient safety related events including wrong site procedures, medication administration errors, and even death [41]. As a result, an effective handoff is largely dependent on the interpersonal communication skills of the caregivers involved.

The Joint Commission introduced a national patient safety goal on handoffs to reduce communication‐related errors [42]. This patient safety goal requires health care organizations to implement a standardized approach to all handoff communications by emphasizing the transfer of critical patient information [40]. One common approach is the use of sign‐out sheets for communication and is often utilized by physicians. The SBAR (Situation, Background, Assessment, and Recommendation) model is being used to bridge the gap between the different communication styles of nurses and physicians to enhance handoff communication [43]. In addition, the use of electronic medical records may be utilized to improve the handoff process by eliminating difficulties with data access or illegible documentation [43].

In the clinical case above, safe handoff between the resident team members is a critical component of ensuring patient's safety. A safe handoff might have included a reminder about similar sounding names, relevant cautions about medication dosing based on age, renal function or allergies, as well as a succinct yet thorough description of the patients' history and plan of care.

#### **4.5. Disclosing error**

Medical errors occur; of this, there can be no doubt. A common dilemma for physicians is how–or if–to disclose the error to patients or families. The central ethical tension in this dilemma hinges on the interplay between the four Western biomedical ethical tenets. The unavoidable pragmatic conflict is the legal or financial risks the provider may incur either by openly identifying an error, or knowingly choosing not to disclose one.

Professional societies generally agree that patients have a right to know about their care, including errors that may or may not be directly related to adverse outcomes [44, 45]. These may be good ethical standards, but we believe that no guideline can substitute for a provider's personal sense of ethics. Furthermore, the application of any guideline should be refined by the cross‐cultural interactions between a provider, a patient, and family.

In any therapeutic interaction (keeping in mind that all interactions are potentially cross‐ cultural!), an important first step is identifying how information of any nature should be disclosed. For example, a traditional Latino family may seek multiple familial inputs before making an important medical decision for an elder. In certain Chinese families, the eldest son may hold cultural power; and family members will defer decisions to that son. Identifying dynamics ahead of time is best practice.

**References**

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Lastly, when encountering a disclosure dilemma, the use of 'therapeutic privilege' should be exercised with caution. According to the ACP Ethics Manual, therapeutic privilege is "is the withholding of relevant health information from the patient if disclosure is believed to be medically contraindicated" [44]. Ultimately, it will be for the provider to decide 1) what information about an error may be medically indicated to disclose, and 2) how that information may be shared therapeutically with the decisional apparatus in the most culturally appropriate way.

#### **5. Summary and conclusion**

These two cases highlight multiple patient safety issues, errors and causes for concern– particularly in the relative ease with which such errors occur. While each case on its own presents a patient safety event, the co‐mingling of these patients created additional stress points opening the system up to failure. In both cases, a simple error caused or potentially caused significant patient harm and prolongation of the hospital stay. Name similarity, service proximity, and multi‐tasking all contributed to the preventable errors. We have discussed the multiple active causes contributing to error as well as contributing conditions such as medication use and dosing in an elderly patient.

Creating a safe space for all team members to be able to pose safety related questions in a blame‐free environment and encouraging the disclosure of error whenever it occurs, along with the creation of layers of defense mechanisms (such as the use of computer based technology; simple pictures on wristbands and color coded alerts on handoff/sign‐out materials) will all help to foster a true culture of safety within the Healthcare system. Additionally, the cultivation of an Anticipation, Prevention, and Treatment approach to each patient's plan of care, that includes patient safety and the prevention of errors, will move us toward improved care and improved patient satisfaction with the care delivered.

#### **Author details**

Anna Njarlangattil Thomas\*, Danielle Belser, Stephanie Rabenold, Omalara Olabisi Bamgbelu, Amaravani Mandalapu, Michael Pipestone, Alaa‐Eldin A Mira and Ric Baxter

\*Address all correspondence to: anna.thomas@sluhn.org

St. Luke's Hospital Network, Bethlehem, USA

#### **References**

In any therapeutic interaction (keeping in mind that all interactions are potentially cross‐ cultural!), an important first step is identifying how information of any nature should be disclosed. For example, a traditional Latino family may seek multiple familial inputs before making an important medical decision for an elder. In certain Chinese families, the eldest son may hold cultural power; and family members will defer decisions to that son. Identifying

Lastly, when encountering a disclosure dilemma, the use of 'therapeutic privilege' should be exercised with caution. According to the ACP Ethics Manual, therapeutic privilege is "is the withholding of relevant health information from the patient if disclosure is believed to be medically contraindicated" [44]. Ultimately, it will be for the provider to decide 1) what information about an error may be medically indicated to disclose, and 2) how that information may be shared therapeutically with the decisional apparatus in the most culturally

These two cases highlight multiple patient safety issues, errors and causes for concern– particularly in the relative ease with which such errors occur. While each case on its own presents a patient safety event, the co‐mingling of these patients created additional stress points opening the system up to failure. In both cases, a simple error caused or potentially caused significant patient harm and prolongation of the hospital stay. Name similarity, service proximity, and multi‐tasking all contributed to the preventable errors. We have discussed the multiple active causes contributing to error as well as contributing conditions such as medication use and

Creating a safe space for all team members to be able to pose safety related questions in a blame‐free environment and encouraging the disclosure of error whenever it occurs, along with the creation of layers of defense mechanisms (such as the use of computer based technology; simple pictures on wristbands and color coded alerts on handoff/sign‐out materials) will all help to foster a true culture of safety within the Healthcare system. Additionally, the cultivation of an Anticipation, Prevention, and Treatment approach to each patient's plan of care, that includes patient safety and the prevention of errors, will move us toward improved

Anna Njarlangattil Thomas\*, Danielle Belser, Stephanie Rabenold, Omalara Olabisi Bamgbelu,

Amaravani Mandalapu, Michael Pipestone, Alaa‐Eldin A Mira and Ric Baxter

care and improved patient satisfaction with the care delivered.

\*Address all correspondence to: anna.thomas@sluhn.org

St. Luke's Hospital Network, Bethlehem, USA

dynamics ahead of time is best practice.

80 Vignettes in Patient Safety - Volume 1

**5. Summary and conclusion**

dosing in an elderly patient.

**Author details**

appropriate way.


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**Chapter 6**

**Provisional chapter**

**Inadequate Decontamination Procedures: Sepsis**

**Inadequate Decontamination Procedures: Sepsis** 

DOI: 10.5772/intechopen.69465

Exogenous infection following endoscopy remains rare, however, recent attention in the media and the rise of antibacterial resistant strains of bacteria have emphasized the importance of proper sterilization techniques involved in the reprocessing of endoscopes and accessory devices. This chapter serves as comprehensive review into the epidemiology of exogenous infections as well as basic reprocessing techniques and guidelines for

A 51 year old Caucasian female, with a past medical history of hypertension, was admitted to the hospital with the diagnosis of gallstone pancreatitis. At the time of admission, the patient had an elevated lipase at 14,528, an abdominal ultrasound demonstrating gallstones with a common bile duct measuring 7 mm without choledocholithiasis. In addition, she was noted to have an elevated total bilirubin, without leukocytosis or fever. Patient was admitted with

The next hospital day, the patient underwent endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and sludge removal. Post procedure her pain was improved and she was tolerating a clear liquid diet. Forty-eight hours after the procedure, the patient was noted to have a temperature of 101.8°F, and a leukocytosis of 15,600 per mcL. Two blood cultures drawn at the time of fever resulted in carbapenem-resistant Enterobacteriaceae (CRE). Infectious disease consultation was obtained and the patient was treated with tigecycline plus gentamicin.

all medical professionals that treat patients that would benefit from endoscopy.

**Keywords:** endoscopy, reprocessing, exogenous infection, sterilization

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution,

© 2017 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

and reproduction in any medium, provided the original work is properly cited.

**Following Uneventful Endoscopy**

**Following Uneventful Endoscopy**

Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

Ellyn A. Smith, Kimberly J. Chaput and

Ellyn A. Smith, Kimberly J. Chaput and

http://dx.doi.org/10.5772/intechopen.69465

Berhanu M. Geme

**Abstract**

**1. Clinical vignette**

gastroenterology consultation.

Berhanu M. Geme


**Provisional chapter**

#### **Inadequate Decontamination Procedures: Sepsis Following Uneventful Endoscopy Following Uneventful Endoscopy**

**Inadequate Decontamination Procedures: Sepsis** 

DOI: 10.5772/intechopen.69465

Ellyn A. Smith, Kimberly J. Chaput and Berhanu M. Geme Berhanu M. Geme

Ellyn A. Smith, Kimberly J. Chaput and

Additional information is available at the end of the chapter Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.69465

#### **Abstract**

[36] Linden JV, Paul B, Dressler KP. A report of 104 transfusion errors in New York State. Transfusion. Sep 1992;**32**(7):601‐606. DOI: 10.1046/j.1537‐2995.1992.32792391030.x [37] National patient safety agency [Internet]. United Kingdom: National patient safety agency; c2005. Wristbands for hospital inpatients improves patient safety;22 Nov 2005 [cited 27 Feb 2017]. Available from: http://www.nrls.npsa.nhs.uk/EasySiteWeb/getre-

[38] The Joint Commission Center for Transforming Healthcare [Internet]. [place unknown]: Joint Commission Center for Transforming Healthcare; c2017. High Reliability in Health Care; 2017 [cited 27 Feb 2017]. Available from: http://www.centerfortransforminghealth-

[39] Murphy MF, Kay JD. Barcode identification for transfusion safety. Current Opinion in

[40] Adelman JS, Kalkut GE, Schechter CB, Weiss JM, Berger MA, Reissman SH, et al. Understanding and preventing wrong patient electronic orders: A randomized controlled trial. Journal of the American Medical Informatics Association. Mar‐Apr 2013;**20**(2):

[41] Friesen MA, White SV, Byers JF. Chapter 34 Handoffs: Implications for Nurses. In: Hughes RG, editor. Patient safety and quality: An evidence‐based handbook for nurses.

[42] The Joint Commission Center for Transforming Healthcare [Internet]. [place unknown]: Joint Commission Center for Transforming Healthcare; c2017. Targeted Solutions Tool for Hand‐off Communications; 2017 [cited 27 Feb 2017]. Available from: http://www.

[43] Fleming D, Hubner U. How to improve change of shift handovers and collaborative grounding and what role does the electronic patient record system play? Results of a systemic literature review. International Journal of Medical Informatics. Jul 2013;**82**(7):580‐

[44] Snyder L, editor. American College of Physician's Ethics Manuel 6th Edition [Internet]. Philadelphia (PA): American College of Physicians; 2012 [cited 27 Feb 2017]. Available from: https://www.acponline.org/clinical‐information/ethics‐and‐professionalism/acp‐ ethics‐manual‐sixth‐edition‐a‐comprehensive‐medical‐ethics‐resource/acp‐ethics‐

[45] The AMA Code of medical ethics' opinions on informing patients. AMA The Journal of

Rockville: Agency for Healthcare Research and Quality; 2008.pp. 285‐332

source.axd?AssetID=60032

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care.org/hro\_portal\_main.aspx

Hematology. Sep 2004;**11**(5):334‐338

305‐310. DOI: 10.1136/amiajnl‐2012‐001055

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592. DOI: 10.1016/j.ijmedinf.2013.03.004

manual‐sixth‐edition

Ethics. Jul 2012;**14**(7):555‐556

Exogenous infection following endoscopy remains rare, however, recent attention in the media and the rise of antibacterial resistant strains of bacteria have emphasized the importance of proper sterilization techniques involved in the reprocessing of endoscopes and accessory devices. This chapter serves as comprehensive review into the epidemiology of exogenous infections as well as basic reprocessing techniques and guidelines for all medical professionals that treat patients that would benefit from endoscopy.

**Keywords:** endoscopy, reprocessing, exogenous infection, sterilization

#### **1. Clinical vignette**

A 51 year old Caucasian female, with a past medical history of hypertension, was admitted to the hospital with the diagnosis of gallstone pancreatitis. At the time of admission, the patient had an elevated lipase at 14,528, an abdominal ultrasound demonstrating gallstones with a common bile duct measuring 7 mm without choledocholithiasis. In addition, she was noted to have an elevated total bilirubin, without leukocytosis or fever. Patient was admitted with gastroenterology consultation.

The next hospital day, the patient underwent endoscopic retrograde cholangiopancreatography (ERCP) with sphincterotomy and sludge removal. Post procedure her pain was improved and she was tolerating a clear liquid diet. Forty-eight hours after the procedure, the patient was noted to have a temperature of 101.8°F, and a leukocytosis of 15,600 per mcL. Two blood cultures drawn at the time of fever resulted in carbapenem-resistant Enterobacteriaceae (CRE). Infectious disease consultation was obtained and the patient was treated with tigecycline plus gentamicin.

Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2017 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons

Within two weeks another patient at the same facility was diagnosed with CRE bacteremia following ERCP, prompting investigation into the technique involved in endoscopy sterilization.

The majority of modern day endoscopes are video-endoscopes. These, although technically similar to the original fiber-endoscopes, which utilized fiber optical viewing bundles, conversely utilize a charged couple device (CCD) "chip" and electronics at the tip of the scope to generate an image that can be viewed upon a screen [8]. This advancement in technology has allowed for changes in instrument design, and limited the need for the endoscopist to place their eye close to the instrument. This has obvious hygienic advantages and minimizes the

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Endoscopes are divided into several sections. In general, the scope has a light source, a "universal cord" which is plugged into the light source and the video processor, a the head of the instrument which contains a variety of switches and valves that control many scope functions and positions, and the "insertion tube" which includes the objective lens and the light guide lens. It is just behind the objective lens that the charge-coupled device (CCD) is located. An understanding of the basic equipment as well as the portion of the scopes which may be removed is important to ensure the adequate cleaning and reprocessing of the endoscope (**Figure 1**).

**3. Terminology: critical, semi-critical, noncritical, cleaning, disinfection,** 

A variety of terms exist to describe the different processes and levels of sterilization involved in reprocessing endoscopes. An understanding of these terms is imperative. In general, there are three levels of disinfection of medical equipment. These include sterilization, high-level

**and sterilization**

**Figure 1.** Structure of flexible endoscope.

risk of infection transmitted between patient and endoscopy personnel.

#### **2. Introduction**

Although the overall risk of exogenous infection from endoscopy and flexible bronchoscopy remains rare, increased concern and awareness has recently been stimulated by outbreaks reported in the literature and newspapers. In 2015, the United States Food and Drug Administration (FDA) released a safety communication about duodenoscopes, after an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) infections were diagnosed following procedural intervention with duodenoscopes. The communication outlined the close monitoring the association between reprocessed endoscopes and multidrug-resistant bacterial infections caused by CRE, such as *Klebsiella* species and *Escherichia coli* [1]. Subsequently, the increased awareness as well as the emergence of "super-bugs" and anti-bacterial resistant strains of bacteria has emphasized the importance of proper sterilization techniques involved in the reprocessing of endoscopes and accessory devices.

#### **2.1. Epidemiology**

Infection following endoscopy can be divided into three broad categories: exogenous infection, endogenous infection, and infection transmitted between patient and endoscopy personnel or vice versa [2]. Exogenous infection involves the spread of bacteria via contaminated equipment between one patient and another. Endogenous infection is not due to contaminated equipment, but rather, the translocation of bacteria from the gastrointestinal tract as a result of the endoscopic procedure. An example of an endogenous infection would be a patient that develops bacteremia secondary to traumatic tissue injury during the endoscopy. Lastly, infection may be transmitted from the patient to the endoscopy personnel and vice versa if proper technique and personal protective equipment are not utilized.

The benefit of endoscopy when compared to the risks has been clearly demonstrated throughout literature [3]. Despite the large number of GI endoscopic procedures performed, estimated at over 24 million procedures in 2004 in the United States alone, instances of infectious complications remain rare [4, 5]. Infectious complications are estimated at frequency of 1 in 1.8 million procedures [6]. The majority of infections following endoscopy are endogenous infections, with exogenous infections occurring even less frequently [7].

#### **2.2. Equipment**

Endoscopies are performed in a variety of facilities throughout the United States, including the hospital, ambulatory surgical center as well as physician offices. The term endoscope is a broad term encompassing any instrument used to visualize a hollow viscus. Endoscopes can be used to perform a variety of procedures including bronchoscopy, esophagogastroduodenoscopy, sigmoidoscopy, and colonoscopy as well as a variety of others. The equipment of the endoscope is similar, although slight variations exist to facilitate the performance of one procedure over another.

The majority of modern day endoscopes are video-endoscopes. These, although technically similar to the original fiber-endoscopes, which utilized fiber optical viewing bundles, conversely utilize a charged couple device (CCD) "chip" and electronics at the tip of the scope to generate an image that can be viewed upon a screen [8]. This advancement in technology has allowed for changes in instrument design, and limited the need for the endoscopist to place their eye close to the instrument. This has obvious hygienic advantages and minimizes the risk of infection transmitted between patient and endoscopy personnel.

Endoscopes are divided into several sections. In general, the scope has a light source, a "universal cord" which is plugged into the light source and the video processor, a the head of the instrument which contains a variety of switches and valves that control many scope functions and positions, and the "insertion tube" which includes the objective lens and the light guide lens. It is just behind the objective lens that the charge-coupled device (CCD) is located. An understanding of the basic equipment as well as the portion of the scopes which may be removed is important to ensure the adequate cleaning and reprocessing of the endoscope (**Figure 1**).

**Figure 1.** Structure of flexible endoscope.

Within two weeks another patient at the same facility was diagnosed with CRE bacteremia following ERCP, prompting investigation into the technique involved in endoscopy sterilization.

Although the overall risk of exogenous infection from endoscopy and flexible bronchoscopy remains rare, increased concern and awareness has recently been stimulated by outbreaks reported in the literature and newspapers. In 2015, the United States Food and Drug Administration (FDA) released a safety communication about duodenoscopes, after an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) infections were diagnosed following procedural intervention with duodenoscopes. The communication outlined the close monitoring the association between reprocessed endoscopes and multidrug-resistant bacterial infections caused by CRE, such as *Klebsiella* species and *Escherichia coli* [1]. Subsequently, the increased awareness as well as the emergence of "super-bugs" and anti-bacterial resistant strains of bacteria has emphasized the importance of proper sterilization techniques involved

Infection following endoscopy can be divided into three broad categories: exogenous infection, endogenous infection, and infection transmitted between patient and endoscopy personnel or vice versa [2]. Exogenous infection involves the spread of bacteria via contaminated equipment between one patient and another. Endogenous infection is not due to contaminated equipment, but rather, the translocation of bacteria from the gastrointestinal tract as a result of the endoscopic procedure. An example of an endogenous infection would be a patient that develops bacteremia secondary to traumatic tissue injury during the endoscopy. Lastly, infection may be transmitted from the patient to the endoscopy personnel and vice versa if proper technique and personal protective equipment are not utilized. The benefit of endoscopy when compared to the risks has been clearly demonstrated throughout literature [3]. Despite the large number of GI endoscopic procedures performed, estimated at over 24 million procedures in 2004 in the United States alone, instances of infectious complications remain rare [4, 5]. Infectious complications are estimated at frequency of 1 in 1.8 million procedures [6]. The majority of infections following endoscopy are endogenous

Endoscopies are performed in a variety of facilities throughout the United States, including the hospital, ambulatory surgical center as well as physician offices. The term endoscope is a broad term encompassing any instrument used to visualize a hollow viscus. Endoscopes can be used to perform a variety of procedures including bronchoscopy, esophagogastroduodenoscopy, sigmoidoscopy, and colonoscopy as well as a variety of others. The equipment of the endoscope is similar, although slight variations exist to facilitate the performance of one

in the reprocessing of endoscopes and accessory devices.

infections, with exogenous infections occurring even less frequently [7].

**2. Introduction**

86 Vignettes in Patient Safety - Volume 1

**2.1. Epidemiology**

**2.2. Equipment**

procedure over another.

### **3. Terminology: critical, semi-critical, noncritical, cleaning, disinfection, and sterilization**

A variety of terms exist to describe the different processes and levels of sterilization involved in reprocessing endoscopes. An understanding of these terms is imperative. In general, there are three levels of disinfection of medical equipment. These include sterilization, high-level disinfection and low-level disinfection, and are based upon the whether the equipment is labeled as critical, semi-critical, or noncritical [2, 9, 10]. A definition of each team, an example and the associated level of sterilization is displayed in **Table 1**.

**3.3. Leakage test**

removed the water and reprocessed [13].

**3.4. Mechanical cleaning**

brush.

**3.5. Alcohol flushing**

**3.6. Endoscope storage**

through each port with air from a syringe [13].

sible avoiding contact with other instruments.

Prior to immersing an endoscope in any fluid, a leakage test should be completed to ensure that the device is air and fluid tight. This is important in the maintenance of the equipment as well as infection control. Begin by ensuring that the water resistant cap is properly attached then, remove the suction valve, air-water channel, cleaning channel, biopsy valve and auxiliary water tube if present. The scope should then be emerged in clean water, with the leakage test device on. Any evidence of continuous bubbles coming from the scope or while moving the control dials indicates a leak and should not be immersed in detergent and reprocessed. The endoscope should be repaired at this point. If no leaks are observed the scope may be

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Mechanical cleaning is a multistep process that utilizes equipment such as tubes, brushes and additional flushing devices to reduce bioburden and reduce the risk of cross contamination [14]. Effective cleaning will remove more than 99.9% of the bioburden from the endoscope [15]. For specific details regarding endoscope mechanical cleaning protocols please see the manufacturing guidelines for cleaning. In general, a basin of detergent solution should be prepared. It is important to ensure that this detergent is freshly prepared at the specific concentration and temperature recommended. Never re-use a solution. The endoscope should be completely immersed within the solution and using a soft sponge or brush to clean the endoscope all working channels, valves and portions of the endoscope should be cleaned. Ensure that any brush that is utilized to facilitate the cleaning process is not damaged. Replace any damaged

The use of flushing the endoscope channel with alcohol promotes drying and inhibits the growth of water born microorganisms. Utilizing 70% Ethyl or Isopropyl alcohol, immerse the injection tube within the beaker of solution. Then flush the solution through the air/water channel as well as the suction port. Complete this step by flushing copious amounts of air

Once the endoscope has been reprocessed and it is dry, it should be stored vertically, in a well ventilated cabinet. The scope should be labeled or sealed with a date of when it was reprocessed. Ensure that all valves have been removed prior to storage. Angulation locks should also be placed in the "free" position. The distal tip should hang freely, and as straight as pos-

The interval of storage between reprocessing and use has been an area of debate and investigation. According to the "American Society of Gastrointestinal Endoscopy Multi-society guideline for reprocessing flexible gastrointestinal endoscopes" it remains an issue requiring

The classification and terminology involved in the associated level of sterilization and disinfection is based on the ability to eliminate microbial life. Sterilization refers to the process of complete elimination of all microbial life. Conversely, high-level disinfection destroys all vegetative bacteria, mycobacteria, fungi, enveloped and nonenveloped viruses. High-level disinfection, however, does not necessarily eliminate bacterial spores. Low-level disinfection kills most vegetative bacteria, some fungi, and enveloped viruses (e.g., HIV, and hepatitis B, C) but does not kill mycobacteria or bacterial spores [11]. Cleaning is often the first step in removing the microbial burden from a device. It refers to the physical removal of debris.

#### **3.1. Established protocols**

All endoscopy units and facilities should have strict procedural guidelines that exist to ensure the correct reprocessing of equipment. Unit personnel should be proficient with the guidelines and methods unique to that institution and procedural monitoring should also be in place to ensure the method is being carried out effectively. Adherence to guidelines is a critical component of reducing infection.

#### **3.2. Pre-cleaning**

Following an endoscopy, biomaterial and microorganisms are present on the endoscope. The first step in endoscope reprocessing is an attempt to eliminate as much of the biomaterial as possible. Begin by wiping the insertion tube from the control section to the distal tube with a moist cloth or sponge. Then, all channels and working sites must be cleaned and flushed with detergent/and or water as recommended by the manufacture. This includes channels that are not used, due to the distal end being exposed to material and fluid. We recommend removing the material immediately after the procedure to minimize the risk of the material becoming dry, adherent and hard on the scope. If a delay of over an hour occurs between the endoscopy and pre-cleaning the scope should be soaked within the manufacture recommended detergent [12].


**Table 1.** Terminology of endoscope reprocessing.

#### **3.3. Leakage test**

disinfection and low-level disinfection, and are based upon the whether the equipment is labeled as critical, semi-critical, or noncritical [2, 9, 10]. A definition of each team, an example

The classification and terminology involved in the associated level of sterilization and disinfection is based on the ability to eliminate microbial life. Sterilization refers to the process of complete elimination of all microbial life. Conversely, high-level disinfection destroys all vegetative bacteria, mycobacteria, fungi, enveloped and nonenveloped viruses. High-level disinfection, however, does not necessarily eliminate bacterial spores. Low-level disinfection kills most vegetative bacteria, some fungi, and enveloped viruses (e.g., HIV, and hepatitis B, C) but does not kill mycobacteria or bacterial spores [11]. Cleaning is often the first step in removing the microbial burden from a device. It refers to the physical removal of debris.

All endoscopy units and facilities should have strict procedural guidelines that exist to ensure the correct reprocessing of equipment. Unit personnel should be proficient with the guidelines and methods unique to that institution and procedural monitoring should also be in place to ensure the method is being carried out effectively. Adherence to guidelines is a criti-

Following an endoscopy, biomaterial and microorganisms are present on the endoscope. The first step in endoscope reprocessing is an attempt to eliminate as much of the biomaterial as possible. Begin by wiping the insertion tube from the control section to the distal tube with a moist cloth or sponge. Then, all channels and working sites must be cleaned and flushed with detergent/and or water as recommended by the manufacture. This includes channels that are not used, due to the distal end being exposed to material and fluid. We recommend removing the material immediately after the procedure to minimize the risk of the material becoming dry, adherent and hard on the scope. If a delay of over an hour occurs between the endoscopy and pre-cleaning the scope should be soaked within the manufacture recommended detergent [12].

**Definition Example Associated level of** 

• Biopsy forceps • Sphincterotomes

• Snares

• Endoscopes • Dilators

**sterilization and disinfection**

High-level disinfection

Sterilization

• Endoscopy control cart Low-level disinfection

and the associated level of sterilization is displayed in **Table 1**.

**3.1. Established protocols**

88 Vignettes in Patient Safety - Volume 1

**3.2. Pre-cleaning**

cal component of reducing infection.

Critical A device that *penetrates*

Semi-critical A device that comes in

**Table 1.** Terminology of endoscope reprocessing.

Noncritical Objects that *do not come into* 

mucus membranes, blood vessels or body cavities

*contact, but does not penetrate* mucus membranes

*contact* with patients

Prior to immersing an endoscope in any fluid, a leakage test should be completed to ensure that the device is air and fluid tight. This is important in the maintenance of the equipment as well as infection control. Begin by ensuring that the water resistant cap is properly attached then, remove the suction valve, air-water channel, cleaning channel, biopsy valve and auxiliary water tube if present. The scope should then be emerged in clean water, with the leakage test device on. Any evidence of continuous bubbles coming from the scope or while moving the control dials indicates a leak and should not be immersed in detergent and reprocessed. The endoscope should be repaired at this point. If no leaks are observed the scope may be removed the water and reprocessed [13].

#### **3.4. Mechanical cleaning**

Mechanical cleaning is a multistep process that utilizes equipment such as tubes, brushes and additional flushing devices to reduce bioburden and reduce the risk of cross contamination [14]. Effective cleaning will remove more than 99.9% of the bioburden from the endoscope [15]. For specific details regarding endoscope mechanical cleaning protocols please see the manufacturing guidelines for cleaning. In general, a basin of detergent solution should be prepared. It is important to ensure that this detergent is freshly prepared at the specific concentration and temperature recommended. Never re-use a solution. The endoscope should be completely immersed within the solution and using a soft sponge or brush to clean the endoscope all working channels, valves and portions of the endoscope should be cleaned. Ensure that any brush that is utilized to facilitate the cleaning process is not damaged. Replace any damaged brush.

#### **3.5. Alcohol flushing**

The use of flushing the endoscope channel with alcohol promotes drying and inhibits the growth of water born microorganisms. Utilizing 70% Ethyl or Isopropyl alcohol, immerse the injection tube within the beaker of solution. Then flush the solution through the air/water channel as well as the suction port. Complete this step by flushing copious amounts of air through each port with air from a syringe [13].

#### **3.6. Endoscope storage**

Once the endoscope has been reprocessed and it is dry, it should be stored vertically, in a well ventilated cabinet. The scope should be labeled or sealed with a date of when it was reprocessed. Ensure that all valves have been removed prior to storage. Angulation locks should also be placed in the "free" position. The distal tip should hang freely, and as straight as possible avoiding contact with other instruments.

The interval of storage between reprocessing and use has been an area of debate and investigation. According to the "American Society of Gastrointestinal Endoscopy Multi-society guideline for reprocessing flexible gastrointestinal endoscopes" it remains an issue requiring further studies [10]. Data suggests that intervals of 7 to 14 days have negligible contamination and is typically related to skin organisms rather than pathogenic bacterial growth [16–18]. The data for maximal duration of re-use is currently undetermined.

and 2005 revealed only 70 outbreaks of infection reported within 64 articles [22]. This number may underestimate the amount of infections, due to under-reporting. The recognition of exogenous infection risk and adequate reprocessing techniques is imperative to all personnel and staff involved in endoscopy. Proper reprocessing could reduce the number of infections.

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• The three main types of infection following endoscopy include exogenous infections, endogenous infections and infection spread between patient and medical personnel.

• Sterilization, high-level disinfection and low-level disinfection are distinct terms used to clarify the level of sterilization based on the ability to eliminate microbial life. Sterilization refers to the process of complete elimination of all microbial life for critical pieces of equipment. • All personnel should understand the decontamination and reprocessing protocols within their institution. Protocols should be based off specific equipment protocols by the manufacturer.

• The main steps of endoscope reprocessing include; pre-cleaning, performing leak test, me-

• Exogenous infections, though rare, have increased clinical significance given the rise of antibiotic strains of bacteria. All efforts should be made to prevent the exogenous infections

Increased concern and awareness of infections after endoscopies has gained much attention in the literature in recent times. The rise of superbugs and transmission of potentially lethal microbes has led to an increased awareness of the necessity for proper reprocessing of all endoscopes. An understanding of the specific equipment, protocols within each institution and each manufacture guidelines is essential. Also as important, is the implementation of system of periodic and random review of policies and methods, to ensure that all protocols are being followed as intended. In the future, automated endoscope reprocessors, AERs, which are beginning to emerge from a variety of manufacturers have been proposed to enhance the efficiency, consistency and reliability of endoscope reprocessing and may reduce the potential

This chapter is meant to provide education in the form of a comprehensive review and act as a guideline all medical professionals that treat patients that would benefit from endoscopy. This guideline should not be mistaken for a legal standard of care. Clinical judgment should

be considered in all circumstances, and may vary based on endoscopist and facility.

chanical cleaning, alcohol flushing and proper storage.

**4. Key points**

from endoscopes.

human error associated reprocessing [23].

**Acknowledgements**

**5. Conclusions**

#### **3.7. Precautionary measures and occupational exposure**

All personnel involved in handling of endoscopy equipment that has been used is in danger of transmission of bacterial infections to themselves. Personal protective equipment should be worn at all times while handling soiled equipment for reprocessing. This includes gowns, gloves and eye protection [10]. Occupational Safety and Health Administration (OSHA), and manufacture guidelines should be observed while handling any specific detergents, with an importance placed on diluting detergents per protocol. The proper disposal of all products that is not reprocessed is also recommended to decrease the risk of infection among personnel.

#### **3.8. Exogenous infection after endoscopy**

With more than 19 million gastrointestinal endoscopies and bronchoscopies performed each year within the United States [19], the overall risk of exogenous infections, or infections involving the spread of bacteria from one patient to another, remain relatively low. However, the importance of proper reprocessing remains fundamental in reducing the transmission risk, particularly in the time of bacterial resistance and the emersion of "superbugs." The variability of endoscopy cleanliness and reprocessing protocols has been shown to be significant. In a study published in 2013 approximately 15% of hospitals within the United States failed to achieve an acceptable level of cleanliness [20]. The specific type or endoscopy impacted the results with a higher level of duodenoscopes being unacceptable than other gastrointestinal endoscopes [20]. The suspected rationale for the inadequate reprocessing of endoscopies has been outlined in a study published in 2003, **Figure 2** [21]. A systemic review of published literature between 1966


**Figure 2.** Causes of exogenous infection.

and 2005 revealed only 70 outbreaks of infection reported within 64 articles [22]. This number may underestimate the amount of infections, due to under-reporting. The recognition of exogenous infection risk and adequate reprocessing techniques is imperative to all personnel and staff involved in endoscopy. Proper reprocessing could reduce the number of infections.

### **4. Key points**

further studies [10]. Data suggests that intervals of 7 to 14 days have negligible contamination and is typically related to skin organisms rather than pathogenic bacterial growth [16–18].

All personnel involved in handling of endoscopy equipment that has been used is in danger of transmission of bacterial infections to themselves. Personal protective equipment should be worn at all times while handling soiled equipment for reprocessing. This includes gowns, gloves and eye protection [10]. Occupational Safety and Health Administration (OSHA), and manufacture guidelines should be observed while handling any specific detergents, with an importance placed on diluting detergents per protocol. The proper disposal of all products that is not reprocessed is also recommended to decrease the risk of infection among personnel.

With more than 19 million gastrointestinal endoscopies and bronchoscopies performed each year within the United States [19], the overall risk of exogenous infections, or infections involving the spread of bacteria from one patient to another, remain relatively low. However, the importance of proper reprocessing remains fundamental in reducing the transmission risk, particularly in the time of bacterial resistance and the emersion of "superbugs." The variability of endoscopy cleanliness and reprocessing protocols has been shown to be significant. In a study published in 2013 approximately 15% of hospitals within the United States failed to achieve an acceptable level of cleanliness [20]. The specific type or endoscopy impacted the results with a higher level of duodenoscopes being unacceptable than other gastrointestinal endoscopes [20]. The suspected rationale for the inadequate reprocessing of endoscopies has been outlined in a study published in 2003, **Figure 2** [21]. A systemic review of published literature between 1966

The data for maximal duration of re-use is currently undetermined.

**3.7. Precautionary measures and occupational exposure**

**3.8. Exogenous infection after endoscopy**

90 Vignettes in Patient Safety - Volume 1

**Figure 2.** Causes of exogenous infection.


#### **5. Conclusions**

Increased concern and awareness of infections after endoscopies has gained much attention in the literature in recent times. The rise of superbugs and transmission of potentially lethal microbes has led to an increased awareness of the necessity for proper reprocessing of all endoscopes. An understanding of the specific equipment, protocols within each institution and each manufacture guidelines is essential. Also as important, is the implementation of system of periodic and random review of policies and methods, to ensure that all protocols are being followed as intended. In the future, automated endoscope reprocessors, AERs, which are beginning to emerge from a variety of manufacturers have been proposed to enhance the efficiency, consistency and reliability of endoscope reprocessing and may reduce the potential human error associated reprocessing [23].

#### **Acknowledgements**

This chapter is meant to provide education in the form of a comprehensive review and act as a guideline all medical professionals that treat patients that would benefit from endoscopy. This guideline should not be mistaken for a legal standard of care. Clinical judgment should be considered in all circumstances, and may vary based on endoscopist and facility.

#### **Author details**

Ellyn A. Smith\*, Kimberly J. Chaput and Berhanu M. Geme \*Address all correspondence to: ellyn.smith@sluhn.org St. Luke's University Health Network, Bethlehem, PA, USA

#### **References**

[1] U.S. Food and Drug Administration. Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. March 4, 2015. Available from: http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm434871.htm

[12] Catalone, B, Koos G. Reprocessing flexible endoscopes: Avoiding reprocessing errors critical for infection prevention and control. Managing Infection Control. 2005 June: 74-80. Available from: http://www.olympusamerica.com/msg\_section/files/mic0605p74.

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[13] Olympus America. Video Instruction on GI Endoscope Reprocessing. Available from: http://medical.olympusamerica.com/customer-resources/cleaning-disinfection-steril-

[14] American Society for Gastrointestinal Endoscopy. Multi-society guideline for reprocessing flexible gastrointestinal endoscopes. Gastrointestinal Endoscopy. 2003;**58**:1-8 [15] Rutala WA, Weber DJ. Reprocessing endoscopes: United States perspective. Journal of

[16] Osborne S, Reynolds S, Goerge N, et al. Challenging endoscopy reprocessing guidelines: A prospective study investigating the safe shelf life of flexible endoscopes in a tertiary

[17] Rejchrt S, Cermak P, Pavlatova L, et al. Bacteriologic testign of endoscopes after high-

[18] Vergis AS, Thomson D, Pieroni P, et al. Reprocessing flexible gastrointestinal endosco-

[19] Peery AF, Dellon ES, Lund J, et al. Burden of gastrointestinal disease in the United States:

[20] Bommarito M, Stahl J, Morse D, Reuter H. Monitoring the efficacy of the cleaning and disinfection process for flexible endoscopes by quantification of multiple biological

[21] Nelson DB. Infectious disease complications of GI endoscopy: Part II, exogenous infec-

[22] Seoane-Vazquez E, Rodriguez-Monguio R, Visaria J, Carlson A. Exogenous endoscopyrelated infections, pseudo-infections, and toxic reactions: Clinical and economic burden.

[23] Parsi M, Sullivan S, Goodman A, et al. Automated endoscope reprocessors. Gastrointestinal

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[12] Catalone, B, Koos G. Reprocessing flexible endoscopes: Avoiding reprocessing errors critical for infection prevention and control. Managing Infection Control. 2005 June: 74-80. Available from: http://www.olympusamerica.com/msg\_section/files/mic0605p74. pdf

**Author details**

92 Vignettes in Patient Safety - Volume 1

**References**

Ellyn A. Smith\*, Kimberly J. Chaput and Berhanu M. Geme

St. Luke's University Health Network, Bethlehem, PA, USA

[1] U.S. Food and Drug Administration. Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication. March 4, 2015. Available from: http://www.fda.gov/MedicalDevices/

[2] Banerjee S, Shen B, Nelson DB, et al. Infection control during GI endoscopy. Gastrointestinal

[3] Seoane-Vazquez E, Rodriguez-Monguio R. Endoscopy-related infection: Relic of the

[4] Hing E, Cherry DK, Woodwell DA. National Ambulatory Medical Care Survey: 2004 summary. Advance Data. 2006;**374**;1-33. Available from: http://www.cdc.gov/nchs/data/

[5] DeFrances CJ, Podgornik MN. 2004 National Hospital Discharge Survey. Advance Data. 2006;**371**;1-19. Available from: http://www.cdc.gov/nchs/data/ad/ad371.pdf [Accessed:

[6] Kimmey MB, Burnett DA, Carr-Locke DL, et al. Transmission of infection by gastrointes-

[7] Shaukat A, Nelson DB. Risks of infection from gastrointestinal endoscopy. Techniques in

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[9] Cotton PB, Williams CB. Practical Gastrointestinal Endoscopy the Fundamentals. 5th ed.

[10] ASGE Quality Assurance In Endoscopy Committee, Petersen, Bret, MD, et al. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011. Gastrointestinal

[11] Rutala WA, Weber DJ. Sterilization, high-level disinfection, and environmental cleaning.

past? Current Opinion in Infectious Diseases. 2008;**21**:362-366

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\*Address all correspondence to: ellyn.smith@sluhn.org

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March 5, 2008]


**Chapter 7**

**Unnecessary Complications: The Forgotten Indwelling**

Complications of indwelling urinary catheters (IUCs) are common, with the infectious one accounting for 40% of all reported healthcare-associated infections. Myths and rituals exist among healthcare professionals in the application of the urinary catheter, and the catheter is often forgotten after the placement, resulting in a potentially significant impact on patient outcomes and healthcare cost. The implementation of institutional protocols through a bundled approach can significantly reduce forgotten IUCs and dramati-

**Keywords:** urinary tract infection, indwelling urinary catheter, bacteremia, sepsis, risk

Indwelling urinary catheters (IUC) are among the oldest of medical devices that continue to be used in therapy today. The earliest known documentation of transurethral catheterization is found in an Egyptian papyrus dating to 1500 BC. The report describes catheterization performed primarily to treat male urinary retention utilizing a variety of materials, including bronze tubes, reeds, straws and curled palm leaves [1]. Over the ensuing centuries, the catheterization process underwent several modifications, including the use of various manufacture materials, contours and fixation methods. Eventually, Dr. Frederic Foley developed a selfretaining, balloon-based latex catheter in 1929 while seeking a treatment of post-prostatectomy hemorrhage. With the invention and broad commercial production of the Foley catheter, the accepted indications for catheterization rapidly expanded to include post-surgical care

> © 2017 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

**Urinary Catheter**

**Abstract**

factors

**1. Introduction**

Kathleen A. Hromatka and Weidun Alan Guo

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.69467

cally improve patient safety.
