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 — 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…
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  • February 27, 2024
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FDA updates medical device shortage list due to shipping delays and semiconductors

Medical device shortages persist due to shipping delays and semiconductor availability, the FDA said last week in an update to its medical device shortage list.

The updated medtech products in short supply include radiological devices, general plastic surgery devices, cardiac diagnostic and monitoring products, general ICU/ hospital products, specimen collection supplies and ventilators.

Philips Invivo MRI breast biopsy grid plates

Philips product shipping delays caused a shortage of magnetic resonance imaging (MRI) breast biopsy grid plates used with breast biopsy/localization trays, surgical guide needles and specialty magnetic resonance coils.

Those Philips Invivo MRI breast biopsy grid plates have been on the shortage list since October 2022 after imaging facilities notified the FDA of the shortage in July. The FDA said it does not know how long the shortage will last, but said it “is still compiling and evaluating data on manufacturing and pro…

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  • March 20, 2023
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