The Right to Repair Conversation Excludes the Medical Devices

Lars Thording eloquently lays out the issues for the Right to Repair movement in healthcare in his October 5 column, including patient safety, cybersecurity, and the need to stimulate more health care innovation. However, pushing the entire sector to submit to the lowest common denominator should not solve these problems. Instead, when making Repair on complicated and sensitive medical equipment, all service providers should fulfill the same safety, quality, and regulatory requirements.

These standards exist in some parts of the service industry and should be implemented across the board. Patient safety is, and should be, the first and foremost priority when it comes to mending medical devices, as Thording points out. The Food and Drug Administration (FDA) has already put systems to monitor and assure device safety when servicing this sophisticated equipment. The hitch is that these restrictions only apply to original equipment manufacturers at the moment (OEMs).

Non-OEM servicing businesses are unregulated by the FDA and are not held to any quality or safety standards. Rather than putting only a portion of the servicing industry to the same standards, all service businesses should be held to the same standards. This involves registering with the FDA so that the agency may better protect patient safety by determining when and how activities like remanufacturing and inappropriate servicing occur and who is responsible for them.

It also entails more control of Independent Service Organizations (ISOs) through quality management system requirements, inspections, and documentation audits mandated by remanufacturing recommendations and enhanced data collecting and public disclosure of findings concerning the servicing business. Thording also brings up the issue of cybersecurity. We concur. As we’ve seen, healthcare cybersecurity is a problem for organizations of all kinds.