Earlier this week, the FDA released its report entitled, “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices in Accordance with Section 710 of the Food and Drug Administration Reauthorization Act of 2017 (FDARA).” This report has been eagerly anticipated in the medical device servicing and parts industry following a period of gathering public comment and objective evidence on the state of medical device service as provided by OEMs, third-party ISOs, and hospitals.
You can find our summary and response to the report below, or click here to read the full 32-page document.
Results of the Report
Upon review, the FDA report concluded that "The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third-party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time." The FDA's findings are cause for celebration among the ranks of third-party servicers, providing vindication (albeit indirect) of the workmanship and safety standards they've put in place.
In response to the FDA release, Jason Crawford, President of Block Imaging Parts and Service had this to say: "We are proud of the level of quality and safety the third-party service and parts market offers the medical imaging community. We believe Block Imaging and our industry partners provide tremendous value by being a safe and effective alternative to expensive OEM service and spare parts solutions."
The Future of the Regulatory Discussion
While the FDA has determined that it is not currently necessary to impose regulation on the medical device service industry, they have committed to taking steps that promote the ongoing development and continuous improvement of quality, safety, and effectiveness in medical device service. According to the report, these include:
• Promote the adoption of quality management principles
• Clarify the difference between servicing and remanufacturing
• Strengthen cybersecurity practices associated with servicing of medical devices
• Foster evidence development to assess the quality, safety and effectiveness of medical device servicing
The conversation surrounding regulation has been pushed forward, in part, by the efforts of the International Association of Medical Equipment Resellers and Servicers (IAMERS), namely President Diana Upton and General Counsel Rob Kerwin. Along with IAMERS leadership, member organizations, like Block Imaging, will have an important role in partnering with the FDA to see the steps above become an effective reality.
While we in the medical device service and parts world are glad to learn that this report doesn't suggest regulation, we can't afford to take the results as an opportunity to rest on our past successes. Ultimately, our future success depends on our ability to continuously improve the way we serve medical professionals and, in turn, the patients they serve. If that goal is always in front of us, foregone regulation will be just one hallmark of our industry.