One of the early consequences of the COVID-19 pandemic was the overcrowding of hospitals and the shortage of medical equipment. As a result of this crisis, several states have developed a renewed interest in passing legislation that would require medical device manufacturers to provide third-party entities the tools, information, and training (among other things) the entities would need to repair the manufacturers’ medical devices. These statutes would prevent manufacturers from ensuring that companies that repair their medical devices are authorized and qualified.The long-term implications of state right-to-repair laws could have devastating consequences for health care providers and their patients. In fact, one such bill, SB-605, was recently rejected by the California Senate Appropriations Committee.
Are Repairs & Services Regulated?
The Food and Drug Administration (“FDA”) imposes strict regulations on original equipment manufacturers (“OEMs”). These regulations govern not only the design and manufacture of medical devices, but also the OEMs’ service of the devices. OEMs are required, for example, to verify that their servicing meets specified requirements, including maintenance of service records and training of service technicians. OEMs must also analyze and report information to the FDA on adverse events involving their devices and either initiate field corrective actions or remove devices when warranted. OEMs are subject to FDA inspection to ensure they are complying with these regulations. Strictly following these important regulations and procedures ensures safety and effectiveness of medical devices that patients, doctors and hospitals depend on.
In contrast, FDA has not applied federal regulations for repairs performed by third-party repairers and does not monitor the effectiveness of such repairs. In 2017, FDA explained that it is using enforcement discretion (i.e., not enforcing regulations) with third-party repairers. Third-party repairers are not required to receive, monitor, or report issues related to the devices they have serviced, including if a device has allegedly caused harm to a patient. This means that third-party repairers that perform sub-par repairs could go undetected, posing significant risks to patients, doctors and hospitals.
The patient safety concerns are not hypothetical.
AdvaMed is aware of at least 281 adverse events (also referred to as Medical Device Reports or MDRs) from 2012 to 2017 associated with third-party servicing.
The lack of FDA oversight of third-party repairers places not only patients, but also doctors and hospitals, at risk. Hospitals are generally viewed as providers of medical services, not medical equipment. As a result, hospitals are typically not liable for strict products liability.
As hospitals become more involved in the repair and servicing of medical equipment (including contracting with third-party repairers), they risk blurring the lines. Moving all repairs “in-house,” for example, would likely turn hospitals into providers of medical equipment, subjecting them to liability.
In addition, a patient injured by a device that was repaired by a third-party repairer would likely not file suit against the third-party repairer, but against the health care facility or doctor (and manufacturer). Because third-party repairers contract with hospitals, and not patients, the third-party repairers are not likely to be held responsible for injuries caused to patients by an inadequately-repaired device. And if they were, the costs of third-party repair services would inevitably increase to cover the costs of potential litigation, resulting in a substantial increase in costs to hospitals for the use of third-party repair services.
What’s Best for Patients?
In sum, placing patient safety in the hands of unregulated third-party repairers has serious implications for patients and hospitals. OEMs and their service technicians are highly skilled and trained and are subject to federal oversight. Their services are monitored, and they must maintain records on repairs of devices and report adverse events to FDA. This is the level of care all patients deserve when undergoing medical treatment.
Medical device manufacturers stand behind their devices and with the health care providers who use them for patients every day.
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