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Should medical device manufacturers' representatives be "credentialed?"

Credentialing Resource Center Connection, September 21, 2006

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It is common for the representatives of medical device or system manufacturers to be present in the operating room (OR), endoscopy suite, catheter lab, or other rooms in which special procedures are being performed. Typically, they are there to train practitioners and provide general advice on how to use a piece of equipment or device, sell a new device or technology, or instruct physicians on how to perform a new procedure. 

Until just a few years ago, these individuals may have been allowed to simply show up and begin assisting the surgical team. However, due to heightened focus on patient safety initiatives, hospitals, ORs, medical staff leaders, and credentialing specialists are increasingly aware of the need to credential all individuals who work in the hospital setting.

The first time that a facility has a discussion about how medical device company representatives are to be handled and whether they are to be allowed into the OR should happen before one of these individuals appears at the hospital. Policy established and developed by the surgical department should provide guidance and structure for the requirements and procedure by which these individuals will be allowed to provide assistance to the surgical team.

The American College of Surgeons' "Statement on Health Care Industry Representatives in the Operating Room" (revised September 2005) provides guidelines for the development of such a policy to include the requirements, roles, and limitations of these individuals. In addition to researching the appropriate medical society recommendations, be aware of and follow all state laws and regulations and hospital policies related to OR orientation, health status, background checks, supervision, and patient consent.

Qualifications established by the hospital for monitoring medical device representatives should include verification of education and training, liability coverage, government-issued photo identification, and letters of reference.

Note: The CRC's Clinical Privilege White Papers also addressed this topic in "Special Report 1010 - Healthcare industry representatives in the operating room," published in January 2005.

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