By Diana Upton and Robert Kerwin
FDA issued today its long-awaited report on "Quality, Safety and Effectiveness of Servicing of Medical Devices". The report, mandated by Congress last year, is 27 pages in length.
Among the key FDA conclusions are the following:
- The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern relating to servicing of medical devices, including by third-party servicers, that would justify imposing additional/different burdensome regulatory requirements at this time.
- The FDA does not believe that additional formal regulatory action is warranted, based on available information and findings.
- The FDA nonetheless intends to pursue the adoption of quality management principals and clarify the difference between servicing and remanufacturing.
- The FDA intends to strengthen cybersecurity practices associated with servicing of medical devices; and
- The FDA intends to foster evidence development to assess the quality, safety and effectiveness of medical device servicing.
Citing the long-term analysis of the FDA MAUDE database by ECRI Institute, the FDA noted that ECRI had concluded they do not believe that a safety problem exists with the servicing, maintenance, and repair of medical devices by either third-party organizations or OEMs. The FDA also noted in its report that the FDA receives several hundred thousand MDRs of suspected device-associated deaths or serious injuries. From this information, the FDA determined that it was not able to establish a conclusive relationship between a device's third-party entity's servicing and subsequent adverse events.
The FDA did note their view that there was persistent underreporting of patient safety events and device malfunctions even when there are well established programs in place to encourage adverse event reporting. The FDA stated that there was a failure to recognize adverse events as related to the servicing of a medical device, and there was poor documentation of service histories, which impeded root-cause analysis.
The FDA further noted in a general way that it intended to foster evidence development to assess quality, safety and effectiveness of medical device servicing. However, the FDA specifically declined to use its authority to require registration of entities or persons performing servicing functions.
IAMERS encourages full review of the report, including those portions which address the FDA’s intention to clarify the difference between servicing and remanufacturing and its further intention to strengthen cybersecurity practices associated with servicing of medical devices.
The FDA has also opened a new docket where stakeholders can submit their comments on the new report until November 12. To view the docket on the FDA website or contribute comments to it, click here
and enter "FDA-2018-N-1794" into the search bar.
About the authors: Diana Upton is the president of IAMERS and Robert Kerwin is the general counsel.