California state lawmakers are currently considering legislation that would severely undermine the quality and safety standards which ensure life-saving medical devices are properly serviced and maintained.
Senate Bill 605, dubbed euphemistically as the “Medical Device Right to Repair Act,” passed the Senate Judiciary Committee on April 27, after winning approval from the Senate Health Committee earlier in the month.
The bill would force the manufacturers of complex medical devices—including MRI machines, ultrasound, CT scanners, and PET systems—to hand over confidential training materials and other service tools to unregulated third-party servicing businesses.
If this bill becomes law, the result would likely be a confusing regulatory environment that would hamper the Food and Drug Administration (FDA)’s line of sight into all activities undertaken by third-party service businesses—all the while leaving California patients and healthcare professionals wondering if critical medical equipment was serviced properly or not.
Instead of further loosening government oversight and intellectual property right protections, California state lawmakers should work to ensure independent servicing organizations are held to the same quality and regulatory standards as original equipment manufacturers. More broadly, these independent servicing outfits should also be required to register with the FDA and follow federal regulations that ensure devices are maintained in a way that supports continued safety and efficacy.
But that’s not what these state lawmakers have in mind. Their willingness to disregard innovator intellectual property rights and keep third-party servicing activities in the shadows isn’t in the best interests of their constituents or the state’s public health. By refusing to make themselves known to the FDA and commit to using quality management systems, third-party service businesses increase the risk that a poor repair job goes unrecognized and unreported. When a repair job goes awry and unreported, risks increase and opportunities to correct the malfunction diminish.
The risk for California’s hospitals and physician practices which use third-party servicers is also amplified by the lack of accountability for these independent servicing organizations. With cyber threats to hospitals on the rise and hospital hardware and software systems increasingly integrated throughout a health system’s technology infrastructure, the responsibility to keep the bad guys out is a burden which should be shared between healthcare providers and their equipment and software vendors. As long as third-party service businesses rebuff FDA-approved quality and safety controls, they’ll break the chain of responsibility needed to protect hospital equipment and software.
Maintaining and repairing complex medical devices requires precision and expertise. Original manufacturer service technicians are highly skilled and deeply trained individuals who follow strict federal guidelines and answer to appropriate oversight. That level of competency is what patients everywhere deserve when receiving medical services. Protection of intellectual property rights is important for a strong healthcare sector. California patients deserve more transparency when it comes to medical device servicing, not less.