Right to Repair

 

Medical devices are highly complex and sensitive, so even small repairs and service require extensive training and expertise. If improperly repaired, the equipment can pose a range of serious risks to patients and operators.

For this reason, quality service is dependent on more than just the possession of manuals and materials. Expertise, adherence to a quality system, and compliance with regulatory requirements set by the Food & Drug Administration (FDA) are essential to ensuring medical devices are serviced properly and safely.

Medical device service activities performed by the original equipment manufacturer (OEM) are regulated by the FDA. These companies and their servicers meet rigorous quality, safety, and regulatory requirements, including proper training, adverse event reporting, and registration. In contrast, very little is currently known about unregulated third-party medical device servicing businesses. Nonmanufacturer, third-party servicer businesses do not even have to register with the FDA, and they are not held to any quality, safety, and regulatory requirements.

“Right to Repair” policies, which have been proposed as legislation in multiple states, would create new and unnecessary risks to patients, hospitals, and innovators by allowing any unregulated third-party business to service and access proprietary information about medical imaging devices.

To further their business interests, independent service businesses have made expansive demands for proprietary servicing materials, but safe and effective servicing does not come from a book and is not merely the acquisition of specific documentation or materials. Proper servicing is the implementation of and adherence to a set of policies, practices, and procedures undertaken by properly qualified and credentialed individuals that consistently return the device to a state of safe and effective operation. These principles and practices should apply to all medical device servicers, including those from independent service businesses.

“Right to repair” policies pose the following risks:

Risk to Patients and Health Providers: If medical imaging equipment is improperly serviced, it could put technicians and patients at risk for serious injury or result in poor image quality, leading to a delayed or missed diagnosis or repeated imaging procedures and increased healthcare costs.

Cybersecurity Risks: Improper servicing using uncontrolled use of proprietary, highly technical service materials by entities that are not required to have appropriate safety and quality processes and controls in place increases hospital cybersecurity risk. In 2020 alone, 92 individual ransomware attacks cost an estimated $20 billion, affected over 600 separate clinics, hospitals, and organizations, and jeopardized more than 18 million patient records. By relying on unregulated third- party service, hospitals and other providers are giving access to network-integrated devices to unknown actors, which could further jeopardize the integrity of these medical devices and healthcare networks.

Limit and Discourage Medical Innovations: Proponents of “right to repair” policies have made expansive demands for proprietary servicing materials OEMs - such as service manuals, software keys, schematics, and tools. The wide release of proprietary servicing materials, and the investment they represent, will create an irreversible loss of trade secret protection for innovators, damaging competition and innovation.

Learn more about this issue from Todd Lajiness, a field service engineer for HITACHI Medical Systems America, who knows first-hand the training and dedication that goes into regulated medical imaging service: