AdvaMed approves code of ethics self-certification

Medical-technology companies will soon be able to self-certify that they adhere to the highest ethical standards and have strong compliance mechanisms in place. At AdvaMed's 2006 Annual Meeting, the Board voted to further encourage industry adoption of the AdvaMed Code of Ethics for Interactions with Health Care Professionals by authorizing use of an “AdvaMed Code Logo.”

Under the program, companies that certify they meet the eight items outlined in a “Conditions of Use” agreement will be granted a license to display the logo on their corporate Web site, business cards, displays, and other marketing materials. The eight elements of the agreement outline specific programs and processes firms must maintain to ensure effective compliance, and align with the HHS Office of the Inspector General (OIG) Compliance Program Effectiveness Standards.

AdvaMed will require the Conditions of Use certification be signed by a high-ranking corporate executive to reinforce that a company's commitment to ethical practices must originate at the highest levels.

FDA and AdvaMed discuss postmarket safety of devices

A meeting between the FDA and AdvaMed, the Advanced Medical Technology Association, held in February, discussed the FDA's analysis of postmarket trends and industry's perspective of postmarket issues and regulations. In addition, they discussed new perspectives on product recalls, removals, and corrections, future trends in postmarket regulation, and industry/FDA collaboration.

“We established clear goals to promptly identify and analyze adverse events related to devices once they are on the market and to alert device users of potential risks,” says Daniel Schultz, M.D., Director, FDA Center of Devices and Radiological Health. “Specifically, we are strengthening the requirements for industry-sponsored studies once their devices are on the market and improving our targeted surveillance systems to identify adverse events. We are enhancing our risk-based approach to inspecting manufacturing sites, including implementing third-party inspections, and improving our communications of risk-benefit information to the public and health care providers. We are also increasing use of automated information systems.”

“The medical-technology industry is committed to providing safe and effective devices and recognizes the value of FDA's role in ensuring device safety both before and once a device is on the market,” says Steve Ubl, AdvaMed President. “We welcome opportunities to work with the FDA to find ways to improve and refine existing systems to ensure patient safety, and we offer our extensive expertise and commitment to working with FDA going forward.”

At the conclusion of the meeting, FDA and AdvaMed participants highlighted some possible areas of collaboration:

• Pre and Postmarket Regulation — Better coordination and integration within FDA and within companies of the pre and post-market processes to ensure consistency, quality, and safety throughout the product lifecycle.

• Training — Enhance training for industry and FDA staff on quality systems, conduct of post approval studies, device recall processes, and reporting of postmarket adverse events.

• Recalls — Increase industry's understanding of FDA's expectations for when a device should be recalled for a malfunction or adverse events, thresholds for when actions should be taken, and how the public should be informed.

• Good Manufacturing Practices — Greater collaboration between FDA and industry on how to become compliant with regulations.

• Postmarket Safety Initiative — Provide for industry input to implementing FDA's postmarket safety initiatives.

• Technology — Greater use of automated information systems to obtain and use data, including electronic submission of marketing applications.

• FDA activities with industry and other stakeholders — Working groups on recalls, annual reports, condition of approval studies, and unique device identifiers. Future workshops with stakeholders on communications associated with recalls, risk management, and human factors.