The FDA has removed automated external defibrillators (AEDs) from its device shortage list in an update this month, but added blood culturing systems.
The agency also added six product codes to its discontinuance list.
AEDs — both wearable AEDs (product code MVK) and non-wearable AEDs (product code MKJ) — had been on the list since July 2022 due to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays.
The FDA previously cited the global semiconductor shortage and an increase in demand for the AEDs. Some manufacturers discontinued AED production and support in recent years after the FDA required premarket approval for new and existing AEDs and necessary accessories.
With the addition of the blood culturing systems (product code MDB), the medical device shortages list now totals four product codes, down from five earlier this year.
Devices with continued shortages include two types of oxygenator devices intended for extracorporeal circulation: oxygenators for long-term support (product code BYS) and cardiopulmonary bypass oxygenators (product code DTZ). Those were both added to the list in November 2023 and are estimated to remain in short supply through the summer, with the agency again citing a component, part or accessory shortage or discontinuance.
The FDA also for the first time estimated the previously reported shortage of intra-aortic balloon and control systems (product code DSP) will last through winter 2024. Those devices were added to the the list in December 2022 due to an increase in demand and component, part or accessory shortage or discontinuance.
The FDA’s latest additions to its list of permanently discontinued devices include:
- AEDs (product code MKJ) made by Philips Medical Systems: the HeartStart FR3 Defibrillator, FR3 Rechargeable Battery and FR3 Battery Charger.
- Infusion pumps (product code FRN) made by Fresenius Kabi AG, specifically the Agilia Infusion Pump (model: VOLUMAT MC AGILIA US, product code Z021135).
- Electrosurgical cutting and coagulation devices and accessories (product code: GEI) made by Pro Med Instruments GmbH: the DORO Non-Stick Bipolar Forceps and DORO Bipolar Reusable Cables.
- Colposcopes (product code HEX) made by DYSIS Medical: DYSIS Classic Digital Colposcope (SKU DYS302), DYSIS Ultra 2.0 Digital Colposcope (SKU DYS403), DYSIS Ultra 3.0 Digital Colposcope (SKU DYS404) and DYSIS View Digital Colposcope (SKU VIE001).
- Metal vaginal speculums (product code HDF) made by DYSIS Medical: DYSIS Reusable Speculum-small (SKU RSP001), DYSIS Reusable Speculum-large (SKU RSP003), DYSIS Reusable Speculum-large wide (SKU RSP004), DYSIS Reusable Speculum-large wide offset (SKU RSP005) and DYSIS Reusable Speculum-medium narrow (SKU RSP006).
- Nonnmetal vaginal speculums (product code HIB) made by DYSIS Medical: DYSIS Disposable Speculum-small (SKU DSP001), DYSIS Disposable Speculum-medium (SKU DSP002), DYSIS Disposable Speculum-large (SKU DSP003) and DYSIS Disposable Treatment Pipe (SKU TRP001).
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.
Related: 5 steps to help medical device makers deal with semiconductor shortages
