**4.1 Database**

*Bioethics in Medicine and Society*

port for the recovery of these patients.

**3.4 Medications and materials**

However, one should not offer to provide or perform operations beyond the scope of your practice at your home institution [11]. Moreover, one must also maintain a sense of what is actually possible not just in the operating theater but, in the intensive care unit as well. Although the surgical expertise may exist to perform a complex operation flawlessly in the operating theater there must be adequate sup-

Frequently the visiting team will provide donated products to carry out the surgery and care of the children. Several medical product and pharmaceutical companies in UIC support these efforts by providing product that may have a limited expiration date remaining. Additionally, hospitals in UIC often provide products which have had the external wrapping removed but remain in a secondary sterile packet and can be re-sterilized at the local site. Working in resource limited LMIC institutions one must be sure to understand the medical importation regulations before shipping nearly expired products. There are times when a nongovernmental organization (NGO) may be offered expired products and medications from hospitals and manufacturers, when is it ethical to use such products? Clearly the expiration dates for medications are arbitrarily set and publications on potency after expiration are available [12, 13]. One must ask is it ethical to use a product or medication in order to provide life-saving cardiac surgery, this is an answer that will vary by site, culture and country. Implicit in this decision is input from the local team. Consultation with the local team over this issue is both respect and autonomy for and of the local team. Moreover, the family should be involved

Regulations for the importation of medications vary by country and similarly drugs which are registered for use vary. One must balance the good for the patient in deciding whether to adhere to local regulations but, beware of the consequences of violating such regulations [14]. A drug as beneficial as milrinone is not registered in several countries that we travel too, but we and our local colleagues know the benefits of this drug in pediatric cardiac surgery. We receive requests routinely to bring milrinone to countries where it is not registered for use and hand-carry sufficient quantities to carry-out the operative list. Clearly one must consider the ethical position of beneficence versus local regulations installed by a slowly moving

Providing safe, beneficial patient care is the first priority of the visiting team and is an excellent starting point for teaching the local team how to organize a pediatric cardiac care program [15]. We are all aware that it is not unusual for the local team to prepare a list of complex operative interventions for the visitors. Operations that the locals have never seen and certainly never performed are frequently on the list of the patient management conference. Once again it is important not to operate outside of your boundaries because you are not at home. Trust is important in developing relationships and can be eroded by an unwanted outcome as a result of operating outside normal boundaries, whether for the surgeon, perfusionist or ICU team's capabilities. Moreover, the unethical performance of an operation outside the limits of your capabilities can bring unwanted and complicating legal issues to bare as well. Teaching and reinforcing a patient-centric non-maleficence philosophy will

in this decision, as patient autonomy clearly must be preserved.

lead to the development of a patient first approach by the locals.

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bureaucracy.

**3.5 Patient care**

Developing a truly equitable program in an LMIC requires the encouragement of a clinical database and research projects. The benefits of a database need to be clearly communicated to the local team and then they must be left to make the decision to proceed with the establishment of one or not. Again, this highlights the autonomy of the local team and provides them with the opportunity to display complete commitment to program development, rather than simply intermittent surgical mission trips by the visitors. Program growth cannot be judged, and corrective actions taken unless a clinical database of outcomes is implemented. Furthermore, the establishment of a database and routine review and presentation of results provides the Ministry of Health with a realistic view of program growth and development, thus justifying the continuation of Ministry level support. Ideally the site will enroll in an international database that serves LMIC, examples include the IQIC [16] and WSPCHS registries [17]. Databases which only enroll UIC programs can be discouraging when results are compared, and the site should seek to compare itself to similar programs in LMIC.
