By Surabhi Dangi-Garimella, Ph.D.
Repair restrictions by equipment manufacturers remains a significant issue that spans industries and is relevant to consumer protection and antitrust issues related to repair restrictions—be it phone or car manufacturers or manufacturers of medical equipment. A recent report by the Federal Trade Commission (FTC) found that original equipment manufacturers (OEMs) raise a variety of barriers—complicated product design, lack of parts or repair information, enforcing trademarks or applying patent rights, among others—that prevent independent repair groups or consumers to proceed with repairs. This can prove detrimental to consumers, especially if those consumers are patients in need of medical equipment for diagnosis or treatment.
What’s Happening in California, and Its Implications
The Medical Device Right to Repair Act (SB 605), introduced in the 2021-2022 Legislative Session in California by Senator Susan Eggman (D-Stockton), was intended to allow hospitals and healthcare facilities to contract with independent third-party repair organizations, other than those that contract with the OEMs. While this legislation unanimously passed the California Senate Committees on Health and Judiciary in April 2021, it was stalled by the Senate Appropriations Committee in May 2021.
Intellectual property issues apart, forcing OEMs to share proprietary servicing information with independent repair organizations whose personnel may not be adequately trained can be harmful to patients. Consider critical equipment such as ventilators, computed tomography (CT) scanners, magnetic resonance imaging (MRI) machines, and electrocardiograms (ECGs). The FDA requires medical device manufacturers to adhere to strict standards of manufacture, repair, and maintenance. OEMs are also required to analyze and report on the functioning of their equipment to the FDA and are also subject to FDA inspections. Non-certified repair contractors can make a patient vulnerable to inaccuracies, missed diagnosis, poor health outcomes. The lack of regulatory oversight on these independent contractors can jeopardize patient safety.
Several instances of medical equipment malfunction due to unauthorized part replacement or repair have been reported.
Medical equipment, many of which are connected to the internet, are also highly prone to cybersecurity breaches, which can allow digital hackers to access highly confidential information or change equipment settings, thereby affecting device safety and putting patients at risk. In his OpEd piece for The Hill, Peter J. Pitts, former FDA Associate Commissioner, wrote that medical equipment can be kept secure from this threat by restricting their repair and maintenance to FDA-regulated manufacturers.
Delayed Access to Care
The other side of this conversation is the delay in patient care as a consequence of a malfunctioning device, which too can compromise patient safety. Consider ventilator breakdown during the current COVID-19 pandemic. Hospitals, especially those in remote areas, sometimes have to wait for several weeks for manufacturers to send their trained and qualified repair personnel, which can endanger patients. While the FDA has acknowledged this shortage of repair personnel in a 2018 report, there does not seem to be a regulatory remedy in site.
Is There a Middle Ground?
The need here is for accountability, which will keep patients safe and while ensuring timely repair and maintenance of critical medical equipment by well-trained and certified experts. What do we need to meet this middle ground?
- The FDA could establish a parallel regulatory pathway for oversight of third-party repair organizations
- Ensuring independent contractors comply with regulatory standards that are the same as OEMs
The FTC report, citing insufficient evidence to justify repair restrictions by OEMs, states that the Commission is ready to reinvigorate regulatory and law enforcement options in collaboration with legislators at the state and federal level to clear the path for consumers and independent repair shops to step up as needed.
Surabhi Dangi-Garimella, Ph.D. is a biologist with academic research experience, who brings her skills and knowledge to the health care communications world. She provides writing and strategic support to non-profit groups via her consultancy, SDG AdvoHealth, LLC.