AdvaMed Updates Code of Ethics

With federal investigators and healthcare industry watchdogs keeping a closer watch on the business practices of medtech companies than ever before, industry association AdvaMed (Washington, DC) may soon have trouble keeping up with requests for guidance on corporate ethics.

Earlier this month, the association released an updated version of its “Code of Ethics on Interactions with Healthcare Professionals,” the industry guidance document commonly known as the AdvaMed code of ethics. Intended for use by both AdvaMed members and nonmembers, the code provides “an ethical framework and guidelines for the medical technology industry within the context of federal law,” helping to ensure that companies follow consistent practices in working with healthcare professionals.

The voluntary code was initially adopted by AdvaMed’s board of directors in September 2003 and became effective on January 1, 2004. Members of the AdvaMed committee that framed the code expected that it would be a living document, subject to periodic revision and updating. But they may have underestimated the frequency with which such changes might be required.

According to AdvaMed, the revisions released earlier this month were issued in response to its members’ experience in implementing the guidelines. The updated version of the code includes several new items in the frequently asked questions (FAQs) portion of the document.

The new FAQs provide additional guidance to medtech manufacturers and answer specific questions about the propriety of giving gifts and other types of financial support to healthcare professionals. One of the new entries clarifies the application of the code beyond healthcare professionals to administrators and other healthcare business people.

The code uses the term healthcare professional as a term of art that applies to any person that is in the position to purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe a member’s medical technology in the United States. This means that the code applies both to licensed healthcare professionals and any other people in a position to make product-related decisions of the sort listed, such as hospital purchasing agents, physician’s practice managers, and management within a group purchasing organization.

Such guidance follows directly from AdvaMed’s stated purpose for the code of ethics, which is “to facilitate members’ ethical interactions with those individuals or entities that purchase, lease, recommend, use, arrange for the purchase or lease of, or prescribe members’ medical technology products in the United States.” The code addresses interactions among medtech manufacturers and healthcare professionals in the following areas.

• Member-sponsored product training and education.
• Supporting third-party educational conferences.
• Sales and promotional meetings.
• Arrangements with consultants.
• Gifts.
• Provision of reimbursement and other economic information.
• Grants and other charitable donations.

AdvaMed reports that it has made an extensive effort to educate the medical device industry and healthcare professionals about the code. The organization provides materials to its members so that they may communicate the code’s principles to their employees, agents, dealers, and distributors.

To encourage compliance with the code, AdvaMed has also developed a searchable on-line database that enables users to locate and communicate directly with healthcare compliance officers from individual member companies. The database is available at http://hcc.advamed.org/hcc.

New items in the FAQs section of AdvaMed’s guidance are clearly marked as updates in the downloadable version of the code. A complete version of the updated code of ethics and FAQs document is available via the AdvaMed Web site at www.advamed.org/publicdocs/coe_with_faqs_4-15-05.pdf.

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AdvaMed Updates Code of Ethics