FDA removes more products from medical device shortages list

The FDA removed more products from its medical device shortages list as supply chain issues from the COVID-19 pandemic continue to improve.

The federal safety agency recently removed devices spanning 17 different product codes, including ventilator products

The products removed from the FDA medical device shortages lists in the latest update were:

Ventilation-related products

The FDA removed three ventilation-related devices from the list: 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).

All had been in short supply due to the global semiconductor shortage and good manufacturing practices requirement compliance. Increase in demand was another factor specific to non-continuous ventilators, which had been in short supply since at least August 2020. The shortage of the two continuous ventilators started as early as September 2021.

The FDA had not previously offered an expected end date for the ventilator shortages.

Prefilled 0.9% sodium chloride intravenous lock/flush syringes

These saline vascular access flush syringes are general ICU/hospital products, product code: NGT. They had been in short supply since at least March 2022 due to increased demand, supply chain challenges and manufacturing discontinuances. The FDA previously expected that shortage to last until October.

Testing supplies and equipment

The FDA removed 13 testing supplies and equipment product codes from its device shortages list, covering three categories:

Specimen Collection: Blood collection tubes, vials, systems and serum separators (product code: JKA), vacuum sample tubes with anticoagulant (product code: GIM) and absorbent tipped applicators (product code: KXG)
Laboratory reagents and testing supplies: Multi-target respiratory specimen nucleic acid test, including SARS-CoV-2 and other microbial agents (product code: QOF), micro pipettes (product code: JRC), pipette tips (product code: LXG), general purpose reagents for in vitro diagnostic tests, including pipette tips (product code: PPM), instrumentation for clinical multiplex test system (product code: NSU), real-time nucleic acid amplification systems (product code: OOI) and clinical sample concentrator (product code: JJH)
Transport media devices: microbiological specimen collection and transport device (product code: LIO), microbial nucleic acid storage and stabilization device (product code: QBD) and transport culture media (product code: JSM).

Most of these products had been in short supply due to increased demand since 2020, when the FDA launched the medical device shortages list in response to the COVID-19 pandemic.

Medical device shortages persist

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.

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

Anesthesiology
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