Representatives of medical device manufacturers can play an important role in patient safety and quality of care by providing information about the proper use of their companies’ devices or equipment and by offering technical assistance to physicians. However, allowing industry representatives to be present in clinical settings while care is being given also raises concerns. Their presence can pose challenges for patient autonomy, privacy, and confidentiality as well as safety and professionalism in care-giving.
Physicians have a responsibility to protect patient interests and thus have a corresponding obligation to exercise good professional judgment in inviting industry representatives into the clinical setting. Physicians should recognize that in this setting appropriately trained industry representatives function as consultants. Participation by industry representatives should not be allowed to substitute for training physicians to use devices and equipment safely themselves.
Physicians who invite industry representatives into the clinical setting should ensure that:
- The representative’s participation will improve the safety and effectiveness of patient care.
- The representative’s qualifications to provide the desired assistance have been appropriately screened.
- The patient is aware that an industry representative will facilitate care, has been informed about the scope and nature of the representative’s role in care, and has agreed to the representative’s participation.
- The representative understands and is committed to upholding medical standards of respect for patient privacy and confidentiality.
- The representative has agreed to abide by the policies of the health care institution governing his or her presence and clinical activities.
- The representative does not exceed the bounds of his or her training, is adequately supervised, and does not engage in the practice of medicine.
AMA Principles of Medical Ethics: I, IV, V
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