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.

overweight patient seeking health advice

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 recall medical device recall product recall

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.

Example of a RF burn from an MRI scan where a sedated patient's identification bracelet was touching their skin during an exam. Image courtesy of RSNA. https://pubs.rsna.org/doi/10.1148/radiol.09090637

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.

cannabis weed marijuana heart health doctor cardiologist

Healthcare agencies mellow on medical cannabis as CMS launches Medicare hemp pilot

The Centers for Medicare & Medicaid Services unveiled a new program for alternative payment model participants that would allow clinicians to use products containing CBD as part of patient care plans. In response, the Food and Drug Administration vowed not to further restrict the sale of oral hemp products.

doctor comparing the costs of different medical treatments

Helium prices spike as war rages on—should MRI providers be worried?

The ramifications of the conflict in the Middle East may soon extend beyond the gas pump and into the healthcare sector, experts are cautioning.

Department of energy partners to bolster domestic radioisotope supply

Gadolinium-153, or Gd-153, is routinely used to calibrate nuclear imaging equipment. It has been in short supply since 2023 when global distribution of the radioisotope came to a halt.