The FDA Reauthorization Act of 2017 completed its passage through Congress on Aug. 3, and the bill will become law once signed by President Trump. Although a major focus of this legislation is FDA user fees that are paid by manufacturers, it also addresses a number of other topics, including a favorite of everyone involved in healthcare technology management (HTM)– the servicing of medical devices. In this case, the FDA has been directed by the legislation to produce a report within 270 days that addresses “the continued quality, safety, and effectiveness of devices … with respect to servicing.” Here servicing is defined as “refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.” Thus, servicing is part of servicing.
According to the legislation, the report will be posted online and is supposed to address eight topics:
- The status of, and findings to date, with respect to the “proposed rule” entitled “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers; Request for Comments” which was published in the Federal Register by the FDA in March 2016 (81 Fed. Reg. 11477). Of interest here is that the cited “proposed rule” was not actually a proposed rule but was instead a request for comments. This request generated 176 official comments and much discussion to date.
- Information presented during the October 2016 public workshop of the same title. This one is curious in that a webcast of that proceeding and a complete transcript is already available.What other information might there be?
- A description of the statutory and regulatory authority of the FDA with respect to the servicing of devices conducted by any entity. The FDA has addressed this issue at various times, and its basic position is that it does have the authority to regulate servicers but has chosen not to under its regulatory discretion.
- Details regarding how the FDA regulates servicing and how it could improve such regulation using existing or additional authority. This point seems to suggest that improvement is in fact necessary, with the further implication that improvement means more regulation. This topic has been central to much of the discussion to date, which has focused on whether there is an actual problem with service as currently conducted with little or no FDA oversight.
- Information on actions the FDA could take under its current authority to assess servicing, including the size, scope, location, and composition of third-party entities. The focus on third parties presumably excludes the manufacturer or the owner. This approach creates a curious situation in which a hospital-employee HTM department is perhaps not such a third party since it is part of the owner, but a contracted HTM provider presumably is a third party.
- Information on actions the FDA could take to track adverse events caused by servicing errors by anyone who performs such service. This may be a redundant question about authority, or it could mean specific actions that could be taken under general authority. It also disregards the fact that adverse events are already reportable regardless of whether they have anything to do with service.
- Information regarding the regulation by states, The Joint Commission, or other regulatory bodies of device servicing. Curiously, the Centers for Medicare & Medicaid Services (CMS) is not expressly mentioned here even though it has waded into matters involving routine service procedures.
- Other, as determined to be relevant to ensuring the quality, safety, and effectiveness of devices with respect to servicing. I like the inclusion of “other” in many lists of important things in that it at least reminds us that short lists are inherently incomplete.
Other than calling for this report and setting a corresponding deadline which the FDA may or may not meet, the FDA Reauthorization Act of 2017 may not result in anything new when it comes to the long-running service debate, but we will have to wait and see.
William Hyman, ScD, is an adjunct professor of biomedical engineering at The Cooper Union and a consultant in New York. He is also a professor emeritus of biomedical engineering at Texas A&M University.