AAMI Offers Guidance for Submitting Comments on Third-Party Repair, Refurbishment of Medical Devices

Earlier this month, the Food and Drug Administration (FDA) announced it was gathering information from original equipment manufacturers (OEMs), third-party companies, and the healthcare community about the service, repair, refurbishment, reconditioning, rebuilding, remarketing, and remanufacturing of medical devices. To help realize the agency’s stated goal of receiving comments “from the widest range of interested persons” possible and to help healthcare technology professionals consider how they could inform this discussion, the Association for the Advancement of Medical Instrumentation (AAMI) has developed a series of talking points and outlined an approach organizations can take when formulating their responses.

“The FDA needs to hear from a broad cross section of stakeholders in order to gain a balanced perspective on the issues,” said AAMI president Mary Logan. “AAMI is a neutral and multidisciplinary organization. We believe that the best decisions in healthcare are made when all stakeholders are at the table. We will be filing comments to provide objective information to the FDA, but our focus will be on the entire industry, not any one specific domain.”

AAMI is encouraging all stakeholders to take the time to understand this issue and prepare informative comments. To help individuals talk with their colleagues and supervisors about the importance of responding to the FDA’s request, AAMI has prepared a list of talking points:
•Comments are due to the FDA by May 3, 2016. It is important for your organization to submit comments because the FDA needs to hear from as many people in your segment of the industry as possible.
•AAMI is the national association that knows the entire industry best from a big picture perspective, and AAMI will be submitting comments and information that helps the FDA understand the entire industry from a 30,000-foot level.
•The FDA needs much more than that big picture perspective, and AAMI has recommended that it would be very helpful for as many organizations as possible to submit comments, especially concrete, detailed answers to the specific questions that the FDA has asked. If the FDA doesn’t hear from organizations like yours, it will be missing an important piece of the overall story about servicing of medical devices.
•The FDA may – or may not – believe there is a problem with service that needs to be “fixed” through regulation. At the moment, the FDA is simply asking for information.
•If the information that the FDA receives is incomplete (because not enough organizations respond or because one or more segments of the industry do not provide detailed information), then it will make decisions using incomplete information. The FDA can only base its decisions on the information it receives or already have on hand.

AAMI has also outlined which organizations are best suited to respond to various portions of the FDA’s request, as well as some “food for thought” guidance to consider when answering each of the agency’s questions. This outline, as well as the complete list of talking points, is available as a PDF from www.aami.org/AAMI_FDA_Talking_Points/.