Ethical Standards for Medical Device Companies:
The Newly Revised AdvaMed Code of Ethics

         On December 18, 2008, the Advanced Medical Technology Association (AdvaMed) released a revised "Code on Ethics on Interactions with Health Care Professionals," which is a voluntary code focusing on the industry's interactions with health care professionals as they related to the marketing of products.  The revised code will become effective on July 1, 2009. 

         The "updated and more rigorous Code of Ethics reflects the medical technology industry's ongoing commitment to openness, transparency, and high ethical standards," AdvaMed chairman Michael Mussallem, who is the chairman and CEO of Edwards Lifesciences, stated in a press release.  The revised code is more restrictive than the 2005 version and includes some of the new restrictions incorporated in the recently revised Pharmaceutical Research and Manufacturers of America (PhRMA) Code on Interactions with Health Care Professionals (effective January 1, 2009), including a prohibition on the distribution of promotional non-educational items (i.e., pens with a company or product logo) and a complete prohibition on entertainment and recreational activities.

         Additionally, the revised code includes new or expanded provisions related to evaluation and demonstration products, consulting agreements and royalties as compensation, compliance certification, support for third-party educational conferences, company-conducted training and education for health care professionals, research and education grants, and reimbursement assistance.

         While not all medical device manufacturers are members of AdvaMed, all device manufacturers should follow the revised code as a minimum standard as the revised code was reviewed by the Office of the Inspector General of the U.S. Department of Health and Human Services and is considered by the Department of Justice to be the industry standard for ethical behavior.

         The revised code is available on AdvaMed's Web site.

         If you have questions about the revised AdvaMed code or would like to further review its implications on your company, please contact Sarah Dansker Cotterill.