FDA removes products from medical device shortage list, reports AED discontinuation

The FDA removed several products from its medical device shortages list and expects the shortage of prefilled saline flush syringes to end soon.

The agency also said Stryker is discontinuing certain automatic external defibrillators (AEDs), a product category for which manufacturers have faced heightened regulatory scrutiny in recent years.

Previously: FDA’s mandatory medical device shortage reporting ends

Relief in sight for prefilled saline flush syringe shortage

Prefilled 0.9% sodium chloride intravenous lock/flush syringes have been in short supply since at least March 2022 due to increased demand. At the same time, supply chain challenges and manufacturing discontinuances have reduced product availability.

These single-use syringes help to prevent blockage of vascular access systems and remove residual medication from the catheter site.

The FDA estimates the prefilled saline flush syringe shortage will end in October 2023. Until then, the agency said it is working with manufacturers and has provided recommendations for healthcare providers to manage the shortage.

Devices recently removed from the FDA’s medical device shortage list

The FDA removed Philips magnetic resonance imaging (MRI) breast biopsy grid plates used with breast biopsy/localization trays, surgical guide needles and specialty magnetic resonance coils from its medical device shortages list.

Philips Invivo MRI breast biopsy grid plates had been on the shortage list since October 2022. Philips notified customers of the shortage that September, blaming “several factors” without specifying them.

AED shortage and discontinuations

The FDA said Stryker’s Physio-Control subsidiary will stop making certain catalog numbers of its Lifepak 20e defibrillator/monitor as of Jan. 12, 2023. Alternative products are available, the FDA said.

AEDs have been on the shortage list since July 2022 due to the global semiconductor shortage and an increase in demand for the cardiac devices. The FDA still projects a shortage of wearable and non-wearable automated external defibrillators (AEDs) to continue through the end of 2023.

Some manufacturers discontinued AED production and support in recent years after the FDA required premarket approval for new and existing AEDs and necessary accessories.