Opinion 8.047 - Industry representatives in Clinical Settings
Manufacturers of medical devices may facilitate their use through industry representatives who can play an important role in patient safety and quality of care by providing information about the proper use of the device or equipment as well as technical assistance to physicians.
Because of their obligation to protect their patients, physicians must strive to prevent industry representatives from breaching patient privacy and confidentiality, and seek to verify that they are properly credentialed and do not exceed the bounds of their training. Physicians may fulfill these obligations by satisfying themselves that the facility has suitable mechanisms in place to accomplish these functions.
Physicians or their designees must disclose to patients the anticipated presence and roles of industry representatives during clinical encounters, and obtain patients’ approval. This requires neither disclosure of the representative’s specific identity nor a formal informed consent process. (I, IV, V)