by
Gus Iversen, Editor in Chief | August 10, 2018
From the August 2018 issue of HealthCare Business News magazine
I was one of the OEM representatives at the hearing and advocated for the passing of the Medical Device Servicing Safety and Accountability Act in an effort to ensure that all medical device servicers are held to the same quality, safety, and regulatory requirements. During my presentation I spoke to the fact that there is no basic requirement for third-party service companies to register with the FDA, creating a gap that makes it impossible for the agency to ensure devices are correctly serviced.
Other speakers included:
• Vy Tran, Varian; senior vice president, Regulatory Affairs and Compliance
• Miguel Machuca, Medical Outfitters
• Toni Mattoch, America’s Blood Centers; director, Quality Services,
HCB News: Why do you feel there is a need for Congressional action with regard to third-party service? What might the right legislation entail?
DD: Although the FDA’s report addresses important issues, there is still work to be done to understand the patient safety impact associated with unregulated servicing. Currently, service activities are only regulated by the FDA when they are performed by the medical device’s OEM. Service activities performed by non-OEM parties are not held to any quality, safety or regulatory requirements, including FDA oversight. As a patient, who is most likely seeing a physician because of some worrisome health problem, the last thing they should have to also worry about is who performed service on hospital equipment, are they qualified to do that work, and is the product that is going to be used on me safe. At a minimum, there are minimum requirements I believe the FDA should be ensuring across all providers that will significantly improve patient safety with little to no cost to the healthcare system.
It’s important to note that many third parties are following FDA guidelines in demonstrating best practices. These companies appear not to be concerned with FDA registration and minimal reporting and equipment in the proposal.
The FDA noted in its report the evidence available to date is not sufficient to conclude whether or not a public health concern is warranted. As such, legislation is needed to ensure third-party servicers of medical devices register with the FDA and report adverse events. The Medical Device Servicing and Accountability Act would require third-party servicers to register with the FDA, report deaths and serious injuries, and maintain complaint handling systems. We are encouraged to see leaders in Congress like Rep. Ryan Costello (R-Penn.) and Scott Peters (D-Calif.) champion consistency in the regulation of medical device servicing, which is critical to ensure patient safety and the effectiveness of life-saving medical technologies.
