Calling for greater consistency in the medical device sector
The Medical Imaging & Technology Alliance (MITA), a division of the National Electrical Manufacturers Association, serves as the collective voice of medical imaging equipment manufacturers, innovators, and product developers. The association is also a major advocate for across-the-board device servicing requirements.
Peter Weems, MITA’s director of policy and strategy, sat down with 24×7 to clarify the association’s position regarding device regulation and argue why strengthening the FDA’s policies isn’t unreasonable. Don’t miss out.
24×7: MITA is very adamant about consistent regulation of device servicers. Can you please address MITA’s platform regarding this issue?
Peter Weems: Consistent regulation of device servicers matters to us for two main reasons: patient safety and device performance. After all, medical imaging equipment exists because of patient need. For this reason, the patient is the most important stakeholder in device servicing. Safe and effective operation of medical imaging equipment allows for views into anatomical structure and physiological function of the patient, which are otherwise impossible barring surgical intervention.
Patients and healthcare providers count on the safe, effective, and reliable operation of medical devices. If medical devices do not perform properly or do not perform at all due to improper servicing, patients may not be able to receive the care they need—and healthcare professionals are unable to do their job effectively. Furthermore, patients should be able to assume an equivalent level of safety and efficacy regardless of service provider.
24×7: What exactly is the problem that MITA is trying to solve?
Weems: Non-OEM service activities do not have the same oversight and are not held to the same quality, safety, and regulatory requirements. This is an important problem because performance of these activities within a quality system by properly trained personnel using qualified, properly sourced parts greatly reduces the risk of harm to the patient or operator and greatly improves the performance of the device.
24×7: Is there any evidence of problems with the servicing of medical imaging devices?
Weems: In a word: yes. MITA member companies routinely encounter improperly serviced devices, demonstrating issues with the safe and effective operation of these devices. And, unfortunately, improper servicing has led to a number of incidents. Through public comments, meetings with the U.S. FDA, Medical Device Reporting submission, and other means, the device industry has submitted numerous examples of improper servicing that posed serious problems for patient safety and device performance.
Unfortunately, though, every problem isn’t required to be reported. Until that requirement exists, there is no way that we can fully understand the scope of this issue. In general, there is a risk of delivering nonconforming devices if service activities are not properly performed.
A nonconforming device means that the device does not meet its specifications and poses a risk in regards to the safety and effectiveness of the device, and thus potentially also to the health and safety of patients and users.
24×7: Won’t additional oversight increase costs to service providers, hospitals, FDA, and patients?
Weems: We believe that adherence to a quality system, as well as appropriate oversight, are reasonable expectations that are not unduly burdensome. After all, the FDA’s Quality System Regulation/Medical Device Good Manufacturing Practices are scalable. This means that it applies equally well to large entities with considerable resources, as well as small entities with more limited resources. In all cases, however, the same principles apply.
Further, certain elements of the quality system record may or may not be applicable, depending on the nature of the activity. Many third parties and in-house service operations currently perform quality work. There is variability in this community, though, and greater consistency in quality can be achieved through consistent regulatory requirements.
24×7: What is the scope of what you’re looking for the FDA to do and how will this directly benefit patients?
Weems: All entities that service medical devices should be required to have an appropriately scaled quality system adequate to the activity being performed; meet minimum quality, safety, and regulatory requirements; and have proper oversight. We believe that the best and most efficient method for ensuring this would be for the FDA to extend currently existing regulation and oversight to all entities that service medical devices.