providers depend on the safe and effective operation of these devices, but if imaging systems are improperly serviced, patients and providers could be injured, downtime could result in delayed care, or poor images could be produced, leading to delayed or missed diagnosis or repeated imaging procedures, which increase healthcare costs. Patients deserve to know that medical device servicers don’t cut corners and take responsibility for quality and safety.

Unlike original equipment manufacturers (OEMs), non-manufacturer independent servicing organizations (ISOs) are unregulated by the FDA and largely escape any oversight or accountability. Little is known about how many ISOs are operating or what experience or qualifications ISO servicers typically have. Even the FDA has noted that the precise number of entities that perform servicing of medical devices in the U.S. is not known.

Qualified and responsible ISOs can play a key role in the post-market maintenance ecosystem. However, the Medical Imaging and Technology Alliance (MITA) opposes unregulated medical device service that presents significant risks to patients and providers. 

MITA advocates that any service business working on a sophisticated and expensive piece of medical device technology should be well-trained and properly qualified. And they should be required to demonstrate these qualifications in line with FDA requirements.

OUR SOLUTION

The FDA should hold all servicers to the same quality, safety and regulatory requirements, including:

• Registration: All servicers of medical devices should be required to register with the FDA.

• Quality Management System: All servicers of medical devices should be required to adopt and maintain a quality management system that ensures devices are returned to safe and effective condition. 

• Reporting of Adverse Events: All servicers should be required to report adverse events to the FDA when they encounter death, serious injury, or device malfunction. 

RIGHT TO REPAIR

“Right to Repair” policies affecting medical devices, would create new and unnecessary risks to patients, operators, and hospitals by allowing any unregulated third-party business to service and access proprietary information about medical imaging devices. Moreover, right to repair demands go well beyond what would be necessary to perform routine work on a medical device, including OEM trade secrets, patent, copyright, and other proprietary information.

These policies have been proposed at multiple levels of government, including in State and Federal legislation, but have consistently been rejected for medical devices.

To enhance patient safety and cybersecurity, policymakers should continue to support exempting medical devices from any “right to repair” legislation and hold all entities engaged in servicing medical devices to the same minimum quality, safety, and regulatory requirements. To ensure safe servicing and enhance patient safety, legislators should oppose right to repair legislation that applies to medical devices.