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On Point – Two Wrongs Don’t Make a Right to Repair
“A major flaw of right to repair bills is their broad definition of “digital electronic equipment.” The model legislation defines such equipment as “any product that depends for its functioning, in whole or in part, on digital electronics embedded in or attached to the product.” The primary intention is to target everyday consumer electronics, like cell phones, tablets, and personal computers. Proponents of the model legislation may also be interested in regulating the repair of other home electronics, like televisions and smart home devices. However, distinctly different industries, like home appliances, medical devices, and agricultural equipment have also been at the focus of advocacy as traditional products become more digital.”
Competitive Enterprise Institute
’Right to Repair’ Legislation Opposition Letter Sent to the Honorable Michelle Mussman, Illinois House of Representatives
“Given the sophistication and technology powering these machines, it’s no surprise that medical device servicing and repair is complex. Repairs to any kind of modern technology brings its own complexities and training requirements and creates a variety of different risks when done incorrectly. For medical devices, if repairs are done incorrectly, patients can be directly endangered, care delayed, or diagnoses missed. That’s why the FDA regulates some servicers to follow quality-management processes, meet minimum training requirements and report incidents to enhance patient and user safety. ISOs, however, aren’t held to any regulatory standards or reporting requirements. An open-ended medical device “right to repair” law that forces the transfer of intellectual property to companies with little to no accountability makes this lack of oversight even more problematic.”
Patients Rising Now
Nixing the Fix: An FTC Report to Congress on Repair Restrictions
“When deciding the scope of expanded repair rights, policymakers should think about whether the rights should be limited to consumer goods or include capital items. Given the complexity and variation among products, it seems unlikely that there is a one-size fits all approach that will adequately address this issue.”
Federal Trade Commission
Remanufacturing and Servicing Medical Devices
“Poor quality servicing may lead to poor device performance, device malfunction, and adverse events. Cybersecurity is also an important consideration in the servicing of medical devices.”
U.S. Food and Drug Administration
MAUDE Reporting – Manufacturer and User Facility Device Experience
“The incidence or prevalence of an event cannot be determined from this reporting system alone due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about frequency of device use.”
U.S. Food and Drug Administration