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.

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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. 

U.S. FDA Sign

Drugmaker’s stock tumbles 20% after FDA issues formal warning to executives

ImmunityBio, the developer of bladder cancer treatment Anktiva, is accused by the U.S. Food and Drug Administration of disseminating “false or misleading information” about the drug's efficacy in an advertisement and podcast. The FDA said it’s not the first time it's sent a warning letter to the company’s executives over allegedly inaccurate claims.

Foreign national accused of operating fake company that billed Medicare for $90M—and now he’s on the run

A federal grand jury indicted Anar Rustamov, 38, of Azerbaijan on 14 counts of healthcare fraud. The complex conspiracy allegedly involved billing Medicare Advantage for medical equipment that providers never ordered. Rustamov is currently a fugitive from justice. 

FDA issues recall of imaging systems

FDA issues emergency alert on surgical stapler reloads after 1 death, 4 injuries

The problem is limited to surgical stapler reloads used by the da Vinci robot, specifically those manufactured by Intuitive Surgical. The FDA said it’s currently investigating why the reloads are leaving incomplete line formations. For now, they need to be pulled from all patient care settings. 

U.S. FDA Sign

FDA merges all adverse event reporting systems into new AEMS platform

Adverse event reports for food, drugs, vaccines, dietary supplements and medical devices will soon be available in one place. The U.S. Food and Drug Administration said the change will simplify reporting for consumers and allow it to react in real-time to FOIA requests.

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Medical device manufacturer hit by cyberattack, possibly from Iranian-backed hackers

Stryker, a Michigan-based company that manufactures surgical implants, confirmed it was experiencing a global network outage. Employee devices reportedly displayed the logo of a pro-Iran cybercrime cell.

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FDA issues emergency alert after reports of 5 serious injuries connected to exploding cryoprobes

The devices are manufactured by Erbe USA. They’re used to deliver pressurized cold therapy to tumors, blood clots, and more. A manufacturing defect can cause a rupture, exposing anyone in the vicinity to a dangerous blast and deafening sound.

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$15M in medical device and cancer testing fraud earns chiropractor 43 months in prison

Teflyon Cameron’s sentence was announced on Monday. She pleaded guilty for her role in a scheme that sent kickbacks to doctors for medically unnecessary orders. The U.S. Department of Justice said the conspiracy went on for “several years.