FDA predicts possible shortage of medical devices

Now that the Covid-19 public health emergency has ended, FDA officials are predicting a possible shortage of medical devices, saying in a new Health Affairs article that the supply chain may be threatened now that there will no longer be mandatory reporting.

For the duration of the PHE, medical device companies were required to notify the FDA of any shortages. Under the CARES Act, the FDA’s Center for Devices and Radiological Health had the authority to enforce manufacturers to issue 506J notifications indicating any possible supply chain disruptions.

Now, reporting supply chain issues will be voluntary, meaning the agency will likely have an incomplete picture of potential shortages. That, the FDA officials said, will make it more difficult to build resilience in the supply chain.

What’s the impact
During the PHE, patients and healthcare providers were impacted by shortages of medical devices ranging from ventilators to personal protective equipment and test supplies. But the CDRH was able to take prompt action.

In February 2021, for example, winter storm Uri shut down the oil and gas industry in Texas and Louisiana, halting the production of fresh resin, a raw material used in the manufacture of many medical devices. More than 30 manufacturers and 180 devices were impacted, but because it was alerted to the disruption, CDRH worked with suppliers, manufacturers, and U.S. government partners to ensure that the medical device industry was able to access resin.

That led to the issuance of priority access letters and use of the Defense Production Act-priority ratings for resins used in critical medical devices. That allowed manufacturers to receive allocations of resin that kept production going on catheters, syringes and other items that use resin.

Importantly, the FDA officials said that supply chain challenges won’t go away with the end of the PHE. Medical device supply chains have inherent vulnerabilities and risks that predate the Covid-19 pandemic and will certainly exist long after it, they said.

Weather alone remains a recurrent and growing threat to supply chains, including winter storms, hurricanes, extreme heat, and floods. Other potential triggers for supply chain disruptions include device recalls, regulatory pressures, geopolitical conflicts, raw materials shortages, labor shortages and disputes, energy crises and transportation bottlenecks.

“All these factors contribute to the persistent and growing threat of medical device shortages on patient safety and care,” officials said.

The larger trend
The FDA officials said catching the first signs of a supply chain disruption enable the best protections, including the development of risk management plans. Manufacturers are well-equipped to develop such plans, the FDA said, and should be required to share that information with CDRH through 506J notifications.

“The agency should not have to learn of critical device shortages from desperate clinicians and patients,” officials said. “By then it may very well be too late.” Healthcare Finance News