This piece was originally published in the September/October 2019 issue of electroindustry.

Peter Weems, Senior Director of Policy & Strategy, MITA

Medical imaging devices allow healthcare providers to observe and analyze the anatomy and physiological functioning of patients without invasive surgery. MITA Member companies are responsible for the innovation, original design, manufacture, packaging, labeling, assembling, and upgrading of medical devices. Original equipment manufacturers also often provide servicing activities for installed devices— both their own and those initially manufactured by other companies.

Medical imaging device manufacturers are all heavily regulated by the U.S. Food and Drug Administration (FDA). The FDA has established strict pre- and post-market requirements for medical devices, including registration with the FDA, pre-market review of new devices by the agency, reporting of adverse events, and maintenance of a quality management system.

Non-manufacturer entities—such as independent servicing organizations—have no FDA oversight and do not have to follow FDA regulations. Currently, only servicing activities  performed by medical device manufacturers are held to any quality, safety, or regulatory requirements  by the FDA. This is an important problem because the performance of servicing activities within a quality system by properly trained personnel using qualified, properly sourced parts reduces the risk of harm to the patient, healthcare provider, and device operator and reduces the risk of a device performing poorly.

Whether or not the manufacturer is also the entity that services a device, it has a stake in all service activities for its devices. Improper servicing presents significant concerns to the manufacturerand creates challenges such as:

• difficulties in future manufacturer-provided servicing operations and the potential for significant periods of downtime if poorly performed repairs must be remedied
• lack of required regulatory reporting and incomplete device history does not allow for tracking of significant events, root cause investigation, or prevention of adverse events
• voided existing device certifications (e.g., UL certifications)
• difficulties in providing future field upgrades or field corrections to the device if improper parts have been used or if the device has otherwise been altered
• diminished brand value due to unsafe and ineffective operation of the device
• liability concerns for the manufacturer if the device directly or indirectly injures a patient or operator

Because our Member companies and their service departments regularly encounter these and other challenges, we have raised this issue with the  FDA several times over the past few years. In raising this issue, our goal has been to ensure the performance of servicing activities results in the safe and effective operation of medical devices.

Safety, quality, and regulatory controls should not be voluntary. All entities that service a medical device should have appropriate oversight and be held to consistent requirements. ei