Supply Chain

Managing supplies is a crucial part of moving medical products from the manufacturer to patient’s bedside. Efficient supply chains can reduce healthcare costs and make medical devices more affordable for patients and health systems. This news page includes content on supply shortages, inventory management, and procurement practices.

FDA moves to restrict compounded versions of popular GLP-1 weight loss drugs
The agency said it is seeking to exclude semaglutide, tirzepatide and liraglutide from the 503B program based on a lack of clinical evidence. Unless there’s a shortage, the pharmaceuticals would be barred from being compounded by third-parties for the purpose of treating diabetes or obesity. The FDA is seeking public comment on the proposal.
FDA announces recall on insulin pump pods after leaks cause 29 serious injuries
Some Omnipod 5 devices, manufactured by Insulet, are subject to the Class I recall. The products with the defect must be removed from where they are used or sold to ensure safety, as lower-than-expected insulin doses could have potentially lethal repercussions.
FDA: CVS and MediHoney wound gels recalled after 14 serious injuries
The wound and burn gels are manufactured by Integra LifeSciences. Defective packaging could cause the sterile barrier to fail, exposing the gels to pathogens. Due to the risk of severe infections, all recalled products must be removed from where they are used and sold.
FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices
Prior to the new “RAPID” program announced on Thursday, it could take a year or more for Breakthrough-designated medical devices to earn approval for Medicare coverage. Now regulators say that timeline could be reduced to as little as two months.
FDA announces recall on angiography syringes after 4 serious injuries to patients
The recall is officially an early alert, as the syringes are part of surgical convenience kits—the rest of which are safe to use. The defective syringes risk causing fatal injuries to patients and must be discarded.

FDA announces recall of Integra applicators due to sanitation risk

Multiple lots of extended tip applicators from Integra LifeSciences could put patients at risk of serious infection, prompting the FDA to designate the recall as Class I.

B. Braun recalls IV solutions over serious patient safety risks

Two lots of IV solution bags from the company were found to contain particulate matter that could cause blockages in blood vessels, killing a patient. To date, no serious adverse events have been reported.

Tandem Diabetes Care is recalling a recent update of the mobile app for its t:slim X2 insulin pump due to repeated software issues that may cause the pump to shut down unexpectedly. The FDA has said this is a Class I recall.

Error with Tandem insulin pumps causes 700 adverse events, 59 injuries

A malfunctioning speaker is being blamed for the error code, which effectively pauses infusions on t:slim X2 insulin pumps. Tandem Diabetes Care has promised to release a software patch to improve the safety of the devices.

FDA issues early alert on Baxter infusion pumps after 3 serious injuries

Some Baxter Novum IQ pumps have a software issue that can cause the “run” screen to go blank or trigger another system error, potentially resulting in inadequate infusion. The company has issued updated use instructions to ensure safe operation.

warning safety alert recall healthcare issue

FDA recalls breathing system filters after multiple injuries

Multiple lots of Draeger SafeStar and TwinStar filters—which are typically used during mechanical ventilation—are being removed from where they’re used and sold due to erroneous carbon dioxide readings.

Helene damage to bridge Baxter North Cove facility in North Carolina.

FDA confirms end to IV saline shortage caused by Hurricane Helene

Nearly 11 months after the hurricane flooded a Baxter manufacturing facility near Asheville, North Carolina, the resulting nationwide shortage of saline solution bags is officially over.

Assembly issue spurs FDA recall on manual resuscitators

A problem with the B/V filters on SunMed adult resuscitators can cause the devices to malfunction. Due to the high safety risk this poses to patients, the FDA has assigned this recall its most serious designation.

FDA recalls real-time glucose monitors after 56 injuries

Receivers on active glucose monitors manufactured by Dexcom are reportedly failing to send alerts when a patient’s blood sugar levels are dangerously high or low. There have been no deaths linked to the malfunction.

Supply Chain

FDA moves to restrict compounded versions of popular GLP-1 weight loss drugs

FDA announces recall on insulin pump pods after leaks cause 29 serious injuries

FDA: CVS and MediHoney wound gels recalled after 14 serious injuries

FDA, CMS unveil rapid Medicare coverage pathway for critical medical devices

FDA announces recall on angiography syringes after 4 serious injuries to patients