In March, the Food and Drug Administration (FDA) announced it was accepting comments regarding medical device service, refurbishment, repair, reconditioning, and modification by OEMs, third parties, and healthcare organizations through May 3, 2016. Now, the Association for the Advancement of Medical Instrumentation (AAMI) has released guidance on its website aimed at helping individuals and organizations respond in the most comprehensive manner possible.
“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. “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 notes that the FDA may not necessarily believe a problem exists that needs to be fixed through regulation. But in order to make an accurate judgment, the agency needs a broad, thorough sampling of information from all parties involved. According to AAMI, that involves “OEMs; parts companies; third-party service and repair companies; ISOs; in-house HTM departments in hospitals and other healthcare delivery organizations; companies that sell used equipment; specialty organizations; group purchasing organizations; and anyone who is involved with or impacted by the refurbishing, reconditioning, rebuilding, remarketing, remanufacturing, servicing, and repair of medical devices.”
In its original statement, the FDA outlined seven questions it wants answered, including an overview of the stakeholders involved, evidence of specific safety issues, and potential risks associated with performing defined repair activities. AAMI says it will take the lead on addressing the industry overview, and it has prepared a number of follow-up questions for the remaining points.
For example, in response to evidence of actual problems with medical devices resulting from third-party repair and maintenance, AAMI provides the following “food for thought”:
…What data do you have about the percentage of “bad” service/repairs and what is the cause? If you have records/data showing that you service, for example, 10,000 devices a year and only 1 device a year has a problem with service, then that’s important information to share with the FDA. What can you say about the “causes” of those problems?…Education and training (are there more problems if an employee is not competent or well educated/trained); budget challenges (do budget challenges impact actual problems); bad parts (eg, if the original OEM or a replacement OEM or non-OEM battery in a device is not very good, what problems does that cause)…
AAMI also encourages respondents to include background information on themselves and their organizations (including CBET and ISO certifications), and any processes in place to ensure verification and validation.
In addition, 24×7 editorial board member Pat Lynch has supplied the following sample disclaimer language for biomeds submitting their responses to the FDA. HTM professionals who are worried about offering their comments can use this language to distinguish their views from those of their employer:
The statements and experiences expressed in this letter are my own, and are the results of my years of experience in the HTM field. They have not necessarily occurred at my present place of employment, nor do the opinions necessarily reflect those of my present employer.
The full list of AAMI talking points is available on AAMI’s website.