How The US And FDA Can Reduce Medical Device Shortages
June 8th, 2022 // 8:00 pm @ jmpickett
During the pandemic in 2020, FDA got new authority from Congress under the CARES Act to prevent shortages of medical devices. The CARES Act has language requiring medical device companies to give FDA information on device availability and when there may be possible disruptions of device availability during an emergency.
Because of this new agency authority, FDA is now better able to get a handle on the many parts of the supply chain that supply medical devices to the country and the world. FDA has made several recommendations that have helped the medical device industry and the country reduce damage from medical device shortages.
However, while the agency’s authority has been a welcome shift, it doesn’t address every situation that can cause a device shortage. Shortages can happen during a public health emergency, such as during a natural disaster or a large recall.
the COVID-19 emergency will expire at the end of 2022, but it’s important to extend medical device shortage rules as they exist in the CARES Act.
Experts contend that to reduce medical device shortages over the long term, there need to be three major strategies.
First, we should learn from current models that don’t work as well as they should. The healthcare industry has two methods to address shortages. One is for drugs, with that one being around for more than 10 years. The other is for devices that was put into place with the CARES Act.
Efforts backed by FDA and Congress have been effective to reduce drug shortages. New language in the CARES ACT will give the agency more tools to encourage drug company incentives and requirements for notifications when some products are in limited supply.
There are still challenges in the drug supply chain, but there were only 115 drug shortages reported in 20121, which is the fewest in a decade.
But when it comes to devices, you can’t use the same strategies that you do for drugs.
Second, a one-size-fits-all solution won’t work. For instance, if there is an API shortage, it’s a lot different than if there is a shortage of a medical device. After all, the device can have 1,000 or more parts!
Device shortages need to be addressed by accounting for the unique aspects of these products. There needs to be coordination between the FDA and device companies to:
- Reduce FDA notification rules for the most important medical devices.
- Decide the criteria for vital device components and raw materials for some devices.
- Improve flexibility as device technology gets better and allow for better policy through the agency guidance process.
- Set up the most efficient shortage notification process to reduce burdens on manufacturers.
