MITA: Now is the time for clarification on device refurbishment
Medical imaging devices group, MITA, has expressed support for legislation that calls for clarity on what activities fall under the remanufacturing of medical devices. Currently, the definition of refurbished could be misinterpreted and could result in some devices being modified incorrectly without supervision. The definition of medical device remanufacturing would be a collaborative effort with the FDA and Congress. The bill, HR 7253, The Clarifying Remanufacturing to Protect Patient Safety Act of 2022, was introduced earlier this month.
“We believe the time is right to really bring that clarity to the medical device industry,” said Peter Weems, director of policy and strategy at MITA, or Medical Imaging & Technology Alliance. “This has been an issue with growing visibility and one that we believe requires the attention of the FDA and Congress.”
Maintenance vs Refurbishment
Medical device systems are complex and require maintenance and updates throughout their use. However, improper maintenance that alters the action or effectiveness of devices falls within the scope of device manufacturing, an activity regulated by the FDA. Significant changes to devices or power generation could harm operators, patients, and reduce diagnostic accuracy, according to MITA.
Other medical device groups welcomed efforts to clarify refurbishment and reduce risk, noting that there are many aspects to consider. “The industry is increasingly concerned about the impact of service changes on a device’s known risks if the manufacturer is not the provider providing the service,” said Joby Semmler, vice president of the marketing and business development at Regulatory Compliance Associates.
“For example, how are third-party service companies formed? Are there any new certifications they need to undergo based on servicing medical devices? All of this is intended to maintain and increase patient safety. Post-market surveillance of medical devices is also becoming increasingly important globally. It is essential for the industry to understand this type of scenario in more detail and to determine whether the safety or performance of devices is indeed changed due to refurbishment. Any type of significant change that impacts patient safety will not be taken lightly by the FDA. »
Tracking trends that go beyond service
MITA, which represents manufacturers of ultrasound, CT, MRI, X-ray and nuclear imaging systems, said companies have witnessed devices that have been improperly modified by third-party repairers . “[Medical device imaging systems] are large pieces of medical equipment that remain in service, have an operational life of several years and during that life cycle any equipment will need to be serviced, repaired or serviced,” Weems said. “And what our member companies have increasingly seen are cases where devices have been improperly repaired by someone other than the manufacturer in a way that has created real patient safety issues and performance of the device.”
MITA began sharing information about improperly remanufactured devices with the FDA several years ago. The agency released a 2018 report that cited devices that had been improperly modified in some way were more likely to cause harm to the patient or caregiver. These changes were made during servicing but should have been classified as rebuilt.
Definition is key
Changes made during attempted maintenance could turn into a refurbishment, as the line between the two is currently unclear, according to MITA. “The reason that had escaped scrutiny was that the definition of remanufacturing as currently stated is vague and not very applicable,” Weems said. “The current definition of refurbishment is an activity that significantly alters the safety, performance or intended use of a device. This definition really lacks the clarity that manufacturers, servicers, and the FDA need to understand the distinctions between maintenance and refurbishment of garden varieties, which has [a] significant influence on the operation of the device.
Weems provided an example of an ultrasound transducer that was serviced and improperly sealed, leaving the device open to fluid buildup, potentially transferring an electric shock to the patient or ultrasound operator. The change would also not offer the same diagnostic quality to patients.
Concern has grown in recent years about the potential problems when maintenance extends to refurbishment and the risks that could result. “Currently, third parties servicing medical devices are not subject to the same level of scrutiny as manufacturers. This can become a serious issue if there is a change in the intended use of the device during servicing. “Semmler said. “The updated guidance provides more clarity on what the FDA is looking for now.”
The proposed legislation provides a clearly defined distinction between the two activities, including definitions and a list of activities that would be considered refurbishment. Standard activities such as installing a required software update, replacing a validated part, or performing preventive maintenance are part of normal maintenance activities.
“It wouldn’t change anything in terms of the service, how it’s regulated or what it includes. [The legislation] only applies to activities that fall outside of this,” said Weems, who explained that there are between 16,000 and 20,000 third-party medical device repairers who play a critical role in keeping devices in good working order. functioning.