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 production capacity and will update the list when more data are available.”
Philips notified customers of the shortage in September, blaming “several factors” without specifying them.
For now, the FDA is recommending health care providers discuss alternatives with patients if they can not perform MRI-guided breast biopsy procedures due to the Philips shortage.
A shortage of wearable and non-wearable automated external defibrillators (AEDs) will likely continue through the end of 2023, the FDA said.
AEDs have been on the shortage list since July 2022 due to an increase in demand for the devices while semiconductor supplies remain tight.
Home-use continuous ventilators remain on the list with no end in sight. They’ve been on the list since August 2020, when the agency first released its medical device shortages list in response to the COVID-19 pandemic.
“While there is currently limited supply available, public and private mitigations appear to be reducing constraints on the supply chain,” the FDA said.
Testing supplies and equipment
Blood collection tubes remain on the shortage list, with the FDA now estimating they’ll be in short supply through the first half of 2023. They’ve been on the list since June 2021 due to increased demand and good manufacturing practices-related requirements. The FDA has offered conservation strategies to help.
The FDA also extended its shortage duration estimate through the first half of the year for micropipettes, pipette tips and other testing supplies for which demand has increased due to the COVID-19 pandemic.
Medtech product discontinuations
The FDA also reported new medical device manufacturing discontinuations.
Invacare discontinued a host of portable oxygen generator products including the Platinum 5NXG, Platinum 10 Concentrator with SensO2, Platinum Mobile Portable Concentrator (with and without extra battery) and Perfecto2 V Oxygen Concentrator with SensO2. Invacare also discontinued HomeFill products including the HomeFill Compressor, HomeFill Ambulatory Systems (D, M2, M9 — IOH200PPC9, IOH200PV9 — ML4 and ML6 — IOH200PPC, IOH200PV6) and HomeFill Cylinders with Integrated Conservers M2 (with carrying Bag) M9, ML4 and ML6.
Cardinal Health has discontinued its white 25-in. bouffant designer surgical caps (product No. 3276), but said alternatives are available
And Inno Foods will stop making its surgical 3D mask and LIfeCare face mask.