Sponsored by AUE
By Jim Carr
Unless you are a lawyer or work for a regulatory consulting company, the FDA announcement in the May report FDARA 710 that they do not intend to place additional regulations on “third-party servicers” was undoubtedly good news. Some hospital executives and HTM professionals may not realize how adversely the budgets of imaging departments might have been affected had the decision gone the other way. And, the general public has little or no idea that such a huge change was being proposed, one that even the FDA believes would have contributed to higher health care costs.
There is a reason many of the OEMs were lobbying hard and using NEMA to push for stronger oversight. Based on my 45 years of experience working for both OEMs and ISOs, it has almost nothing to do with safety. It is part of ongoing attempts by some manufacturers to burden independent service organizations (ISOs) with more regulations and the added costs that come with them, in the hopes of creating virtual monopolies for their service businesses. Don’t expect the OEMs and special interests to stop that pursuit, which means we need to pay heed to the FDA report.
The primary reason the FDA stated for their decision is that there is not sufficient evidence to conclude there is any real threat to public safety as a result of servicers, including servicing by third-parties. They found that most valid complaints regarding service would actually fall under the category of remanufacturing, based on the FDA definitions for those activities. They also stated that the continued availability of third-party entities to service and repair medical devices is critical to the U.S. health care system. Thank you to the folks from the FTC, AAMI and all the hospital executives and clinical engineering directors who provided comments and attended the workshop to help the FDA understand that!
However, the FDA report does not mean ISOs have gotten off scot-free, without any cost or responsibility. The existing regulations and costs for third parties will continue, such as the existing federal and state regulations regarding X-ray systems. And all ISOs that claim to sell or repair scanners need to understand that they can be inspected by the FDA at any time, whether registered with FDA or not.
It is important for ISOs to consider what the FDA report says about the actions they intend to take as a result of their findings. Their number one action is to “promote the adoption of quality management principles.” Many of the comments received by FDA from third-party entities and OEMs talked about the importance of having a quality system that meets one of the international standards. In March, an FDA director stated that the FDA is interested in further harmonization of the Quality System Regulation and ISO 13485:2016. I doubt that 21 CFR Part 820 (QSR) will ever be completely dropped, but that is a big hint as to what the FDA expects from third parties. It is hard to disagree. If done correctly, having a quality management system leads to higher customer satisfaction and increases profits. Plus, if your company can’t pass an ISO 13485 certification audit, your chances of surviving an FDA inspection are pretty slim!
Another action that FDARA 710 states the FDA intends to take is to clarify the difference between remanufacturing and servicing. That would be very helpful, especially since the regulatory requirements for a remanufacturer are much more onerous. The FDA report says they also will encourage the strengthening of cybersecurity practices.
Another point to take note of in the FDA report is how they monitor the safety of service activities. One of the main methods the FDA uses to monitor potential safety issues are MedWatch reports by hospitals and Medical Device Reporting (MDRs) by OEMs. The report says their reasoning behind not requiring tighter regulation in this area is that most reports lack detailed information that is needed to analyze the complaint, and also because the FDA knows there is “potential under reporting of events.” Even though MDR reporting is not required, there are good reasons for a third-party company to have a formal complaint reporting and investigation procedure. It is a key process in an ISO 13485 certified quality system, and it gives a service engineer a way to document a potentially dangerous situation. Imaging techs might encounter a potentially dangerous situation caused by a bad design, poor quality parts or an inability to repair the system because of a lack of AIAT information from the OEM. It can also be very helpful to have a documented investigation in the event of a lawsuit against your company or a “for cause” FDA investigation.
Rather than being seen as a reprieve from further regulatory requirements, the FDA report should be used as a roadmap for MVS and ISO companies to follow in order to avoid unnecessary and burdensome regulatory oversight. If you have not read the entire report, at least read section 6, the summary of key issues and ongoing activities. The key action FDA identified for third-party entities is to develop or improve a quality management system. And make your quality system legit; get it certified by a medical device auditor. Make sure your company is trained and compliant with HIPAA, and be cautious when making network connections to scanners, especially if you use them for servicing. Doing the right things and having good processes and documentation does not guarantee that there won’t be regulatory problems, but not doing it puts yourself, your company and, more importantly, patient safety at risk.
Jim Carr is Director of Service and International Operations for AUE. He may be contacted via email at JCarr@auetulsa.com.