As I write this there is a bill, H.R. 2118, in the subcommittee on health in the U.S. Congress that is called the “Medical Device Servicing Safety and Accountability Act.” If passed and signed by the president, the law would amend the FDA laws to require all persons and companies that service medical devices in the United States to register with the Food and Drug Administration. It also would require those companies to comply with 21 CFR Part 820.198 on Complaint Handling. At first glance the only concern most service companies probably have is the additional cost of registration, especially small ones which have to pay the same annual registration fee as all other companies (that fee is $3,382 for 2017). And it is hard to argue with the idea that a servicer should report a potential safety issue with a medical device. But the 500 or so words contained in this proposed legislation have implications far beyond that.
The FDA law regarding complaint reporting requires a documented process be in place for receiving, reviewing, and evaluating written or oral reports regarding the possible failure of a device, or its labeling or packaging. A record of the complaint needs to be kept, and each complaint needs to be evaluated to determine if there is a potential risk to patient safety. If there was a potential safety risk, it needs to be reported to the FDA as a MDR (Medical Device Report, 21 CFR Part 803). This administrative and reporting requirement would be additional work and cost for almost all service companies, and that is basically everyone except hospitals and the manufacturers. A service company is defined in the bill as any person or company other than the OEM that is involved with “refurbishing, reconditioning, rebuilding, remarketing, repairing, or other servicing of the device.”
I believe there are larger issues than complaint reporting to be considered by service companies, many of which up to now have had no other regulatory concerns beyond registering with state radiation boards and filing a 2579 form after changing an X-ray tube. Companies or individuals that are registered with the FDA are subject to regular inspection. They will also be at risk of having a “for cause” inspection due to a MDR or MedWatch report being filed that claims the company performed service activities that could have resulted in injury or death. I know from personal experience that an OEM can file a completely bogus MedWatch report with the FDA that triggers a “for cause” inspection. The FDA has no easy way of telling if the reported problem is real, and there is little or no risk for the company or person that filed the false report. An FDA inspection will use resources of time and money, and since an auditor or inspector can always find something that doesn’t exactly conform to requirements, it usually results in ongoing additional costs.
Servicing imaging systems could be done more safely and effectively if the FDA would enforce the existing laws and ensure OEMs provide the information and tools needed to perform AIAT activities (assemble, install, adjust, and test). The most specific and stringent requirements are for systems that emit radiation, such as CT scanners, which is covered in Part 1000 of 21 CFR. Part 1000 has some valuable benefits for those working on X-ray systems, primarily because in section 1020.40 (9) it requires the manufacturers to provide the AIAT information at a reasonable cost. Unfortunately for those working on MRI, endoscopes and ultrasound scanners, there is not such specific verbiage. But even in X-ray we see manufacturers getting away with inadequate service manuals and not providing passwords needed to perform preventive maintenance or repairs. That type of behavior, like the legislation to regulate third-party servicers, has the effect of reducing choices and increasing costs for health care organizations.
Jim Carr is Director of Service and International Operations for AUE. He may be contacted via email at JCarr@auetulsa.com.