FDA adds oxygenators to medical devices shortage list

The FDA removed continuous ventilators — for both facility and home use — from its medical device shortage list today as Covid-19 pandemic-related manufacturing challenges continue to improve.

However, the agency also recently added two new product codes to the list (more on that in a bit).

The two ventilator product codes were the only products removed by the FDA in its latest update to the shortage list: facility-use continuous ventilators (product code CBK) and home-use continuous ventilators (product code NOU).

Those continuous ventilators were among the first products on the FDA’s list in August 2020. The FDA launched the list in response to pandemic supply chain shocks and a surge in demand for devices related to Covid-19.

Before the list’s latest update, the FDA expected shortages of continuous ventilators to persist through the end of 2023. Increased demand was cited as causing the shortage in at-home ventilators. Facility-use continuous ventilators, meanwhile, were in short supply not only due to increased demand, but also good manufacturing practices requirements and the global shortage of semiconductor chips.

The FDA offered support for ventilator shortage mitigations and alternatives to help deal with the shortages.

Recent device shortage list additions and removals
In September, the FDA added two circulatory support products to the shortage list: long-term (more than six hours) support oxygenators (product code BYS) and cardiopulmonary bypass oxygenators (product code DTZ).

Those shortages are expected to last through summer 2024, due to a “shortage or discontinuance of a component, part or accessory of the device,” the FDA said. Earlier this year, Getinge/Maquet recalled oxygenators due to compromised packaging sterility that posed an infection risk to patients.

In July, the FDA removed devices spanning 17 different product codes, including non-continuous ventilators (product code BZD), non-life-supporting continuous ventilators (product code MNS) and continuous ventilators with minimal ventilatory support for facility use (product code MNT).

Due to a variety of factors as of October 2023 — including increase in demand and continued shortages of semiconductors and other components — the medical device shortages list still contains 11 products across seven categories:

• Cardiovascular: circulatory support, structural and vascular devices
• Cardiac diagnostic and monitoring products
• Dialysis-related products
• General hospital and plastic surgery devices
• Radiological devices
• Certain ventilation-related products

As of the May 2023 expiration of the Covid-19 public health emergency, the FDA no longer requires medical device manufacturers to report product shortages, though the agency encourages voluntary reporting of device production interruptions or permanent discontinuations. Medical Design & Outsourcing