FDA removes dialysis-related products from device shortage list

The FDA has removed two dialysis-related product codes from its device shortage list. The products […]

The FDA has removed two dialysis-related product codes from its device shortage list.

The products — kidney perfusion system (product code KDN) and disposable kidney perfusion set (product code KDL) — had been on the FDA’s shortage list since January 2022.

The agency attributed the shortages to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays.

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.

The medical device shortages list now only includes five product codes, including automated external defibrillators (AEDs) and two types of oxygenator devices intended for extracorporeal circulation:

  • BYS: Oxygenators for long-term support (greater than 6 hours), added to the list in November 2023
  • DTZ: Cardiopulmonary bypass oxygenators, added to the list in November 2023
  • DSP: Intra-aortic balloon and control systems, added to the list in December 2022
  • MKJ: Non-wearable automated external defibrillators, added to the list in July  2022
  • MVK: Wearable automated external defibrillators, added to the list in July 2022

The FDA said it expects these shortages to last through summer 2024 with the exception of the intra-aortic balloon and control systems, for which no estimate is available. The agency said it is “still compiling and evaluating data on manufacturing and production capacity and will update the list when more data are available.”

Increased demand was a factor for all of the shortages except the oxygenator devices.

AEDs have been on the shortage list due to the global semiconductor shortage and an increase in demand for the cardiac devices. Some manufacturers discontinued AED production and support in recent years after the FDA required premarket approval for new and existing AEDs and necessary accessories.

Original Article: (https://www.medicaldesignandoutsourcing.com/fda-device-shortage-list-kidney-dialysis-perfusion/)