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 issues two serious patient safety alerts
The notices are unrelated, but both require that clinicians adhere to a set of updated use instructions. One patient died as a result of injury.
FDA announces Class I recall on defective ports used for vein access
There have been two reported injuries linked to the Smiths Medical ProPort Plastic Implantable Ports, many of which are subject to an immediate recall.
FDA issues Class I recall on newborn resuscitation devices
The recall impacts products from ROi, supplied by Mercury Medical. A defective spring can cause a controller to malfunction, resulting in poor ventilation.
FDA announces recall of endoscope sheaths after 26 injuries
While there have been no reported deaths, certain lots of Olympus single-use guide sheath kits are to be quarantined immediately.
FDA approves first therapy for very rare lipid storage disorder
Ctexli (chenodiol) can now be prescribed to patients with cerebrotendinous xanthomatosis, a condition caused by a genetic mutation that leads to cholesterol buildup around vital organs.

CVS Health announces $10.6B acquisition of Oak Street Health

DOJ sues CVS over unlawful opioid prescriptions and reimbursement

The U.S. Department of Justice said policies at CVS Health forbade pharmacists from discussing patients and providers who may be prescribing opiates in violation of the Controlled Substance Act.

Video of SNMMI President Cathy Cutler explaining the efforts to get U.S. production started for Mo-99 for a domestic supply of nuclear imaging isotopes. #RSNA #SNMMI #RSNA24 #RSNA2024 #isotopeshortage

U.S. moves closer to establishing domestic supply of Mo-99 for nuclear imaging

Society of Nuclear Medicine and Molecular Imaging President, Cathy Cutler, explains the long road to jump-starting a new U.S. domestic supply of imaging isotopes.

Bipartisan bills in Congress would force insurance companies, PBMs to sell pharmacies

The Patients Before Monopolies Act, introduced in both the House and Senate, gives parent companies of PBMs three years to divest from pharmacies or face penalties.

FDA recalls 233K bottles of antidepressants due to cancer risk

Bottles of duloxetine manufactured by Rising Pharmaceuticals are being recalled due to higher-than-normal levels of nitrosamine contaminants. The recall is classified as Class II, the second most serious type.

FDA issues Class I recall on insulin syringes due to risk of death

A line of syringes manufactured by Cardinal Health may fail to properly inject insulin when used with needleless IV connectors.

doctor in handcuffs after being arrested

Anesthesiologist gets 190 years for injecting drugs into IV bags

The IV bags caused multiple patients to experience severe cardiac distress. The judge who sentenced former doctor Raynaldo Rivera Ortiz Jr. said his actions were “tantamount to attempted murder."

FDA issues Class I recall on insertion tubes after manufacturing error

Specific FHC-branded insertion tubes used in brain surgery are 20mm longer than expected and could pose a serious risk to patients.

FDA recalls brain biopsy needles due to stainless steel debris

There have been no reported injuries. However, due to the risk of death or paralysis associated with metal debris entering brain tissue, the recall is designated Class I, the most serious of its type.

Supply Chain

FDA issues two serious patient safety alerts

FDA announces Class I recall on defective ports used for vein access

FDA issues Class I recall on newborn resuscitation devices

FDA announces recall of endoscope sheaths after 26 injuries

FDA approves first therapy for very rare lipid storage disorder