Cardinal Health plans to discontinue its Kangaroo Joey enteral feeding pump (pictured) and the rest of the Kangaroo Joey and Kangaroo ePump portfolio. [Photo courtesy of Cardinal Health]
The FDA also added five product codes to its discontinuance list, mostly due to the closure of Fremont, California-based Intuity Medical and the wind-down of Cardinal Health’s Kangaroo portfolio.
The oxygenator devices are 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 now estimated to remain in short supply through the fourth quarter of 2024, with the agency citing a component, part or accessory shortage or discontinuance.
Two other previously reported shortages remain on the list: blood culturing systems (product code MDB) and intra-aortic balloon and control systems (product code DSP). The agency said it expects those shortages to also persist through the end of the year. Intra-aortic balloon and control systems were added to the the list in December 2022 due to an increase in demand and component, part or accessory shortage or discontinuance.
The number of product codes on the FDA’s medical device shortages list remains at four, down from five in February but unchanged since the more recent update in July.
The device shortage list does not include IV bags, domestic production of which was disrupted by Hurricanes Helene and Milton. However, the agency added Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to its Drug Shortages Database, saying it considers those products “to not be commercially available in adequate supply to meet national demand.” To help deal with those shortages, the agency has published guidance on temporary policies for compounding certain parenteral drug products.
Medical device discontinuances
Intuity Medical has discontinued its POGO automatic blood glucose monitoring system. [Photo courtesy of Intuity Medical]
- NBW (over-the-counter blood glucose test system): These include POGO products made by Intuity Medical, which shut down this year despite securing Medicare coverage, and Abbott’s OptiumEZ Blood Glucose Monitoring System.
- JJX (single specified analyte controls, Assayed And unassayed): These include two more POGO products made by Intuity Medical and discontinued due to its closure.
- JQP (Calculator/data processing module for clinical use): Another Intuity Medical product, Patterns for POGO Automatic patients, was also discontinued due to the closure.
- LZH (enteral infusion pump): These include 18 SKUS from Cardinal Health, which told customers this year that it would discontinue its Kangaroo ePump and Kangaroo Joey portfolio due to “global supply chain challenges, including aging componentry and discontinued materials.” However, the device manufacturer launched the next-generation Kangaroo OMNI enteral feeding pump portfolio in 2023.
- FOX (infusion stand): These include eight Cardinal Health SKUs in the Kangaroo Joey portfolio.
The FDA says it publishes the device shortage list “to provide transparency to the American public, particularly those who use or purchase medical devices.” 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. Instead, the agency encourages voluntary reporting of device production interruptions or permanent discontinuations.
Related: 5 steps to help medical device makers deal with semiconductor shortages
