Medical devices are coming under closer regulatory scrutiny, with U.S. health insurers calling for more stringent control over how reusable devices are approved, monitored and maintained.
The most recent waves come from a Wall Street Journal series detailing the demise of the morcellator, a laparoscopic device used in hysterectomies. It has been found to spread uterine cancer within a patient – worsening the prognosis. As the morcellator gets withdrawn from general use, it’s serving as grounds for insurers and other stakeholders to call for toughening regulations.
But this comes on top of that UCLA superbug scare – in which a reusable duodenoscope that was difficult to clean wound up being the root cause of a CRE outbreak. As a result, the Food and Drug Administration recently issued guidance that calls for makers of reusable medical devices to thoroughly test and label their devices, and outline appropriate methods to clean them.
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As far as the morcellator goes, the FDA said in November that it shouldn’t be used in the vast majority of women. Trade group America’s Health Insurance Plans wrote to Sen. Bob Casey (D-Penn) that the dangers of the morcellator are indicative of the many weaknesses in how devices are approved and regulated once they’re on the market, the WSJ reports:
America’s Health Insurance Plans called for strengthening the 510(k) system and efforts to track devices.
The 510(k) system has drawn criticism over the years, including a 2011 report from a panel at the influential Institute of Medicine, which called for scrapping the process. But the medical-device industry and FDA have defended it.
Steve Ubl, president and chief executive of the Advanced Medical Technology Association, a device trade group, called the 510(k) system “overwhelmingly safe.”
“FDA’s 510(k) review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical advancements,” Mr. Ubl said in a statement responding to the letter from America’s Health Insurance Plans.
The FDA, which has said the device-approval process balances innovation and safety, declined to comment on the letter.
Despite these concerns, the FDA is launching a new, expedited market access program for certain high-risk devices that treat life-threatening disease, Mass Device points out. It’s an ROI thing, perhaps – what’s the risk of disease spread versus lives saved?
