Current Events

Cook Medical this week released information on a select voluntary recall of its Bush DL and Bush SL ureteral illuminating catheter sets over issues with overheating.

The Bloomington, Ind.-based company said it has received an increased number of reports of the proximal black component that connects to the distal transparent component overheating and melting, which could potentially cause burns.

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Inspectors with the U.S. Food and Drug Administration on Wednesday slapped St. Jude Medical with a warning letter accusing the medical device maker of failing to properly investigate problems with the batteries in its implantable defibrillators and the cybersecurity of its at-home monitoring equipment.

The inspectors said that company officials systematically underestimated the true risks facing heart-device patients, even after one person died in 2014.
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Over the past several years, there have been multiple recalls involving implant devices because of the dangerous risks they pose to patients. These recalls have included devices use for hip replacement and for knee replacements. Recently, the Food and Drug Administration announced a new recall — this time for shoulder implant devices.

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Dublin-based Medtronic plc said this week that an increase in product complaints prompted a Feb. 22 recall of all unused units of the StrataMR adjustable valves and shunts.

Roughly 2,622 of the affected devices had been distributed worldwide, and the company said the product’s complaint rate as of April 1 was 2.75%.

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A Queens man who was severely burned and temporarily had to use a wheelchair when an e-cigarette battery exploded in his pocket is suing the company that distributed the device.

It’s been four months after Otis Gooding’s Wismec Reuleaux RC200 vape instrument blew up while he was at work at the Central Cellar wine shop in Grand Central. But he still feels the pain.

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Due to problems with oversight and contract issues, the Medicare Fee-for-Service Program wrongly made payments of $41.1 billion in 2016, according to a GAO report.

Following an HHS report that initially found the inappropriate payments in the program, GAO noted that Medicare administrative contractors (MACs) conduct provider education to ensure fee-for-service payments. GAO observed and examined MAC operational procedures as the focus of its report.

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Drugmaker Mylan NV failed to investigate why medications made at a factory in India didn’t meet quality standards and frequently didn’t report the substandard results from its tests, the U.S. drug regulator said.

The quality system at Mylan’s facility in Maharashtra, India, “does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture,” the Food and Drug Administration told the company in a warning letter dated April 3 that was posted Tuesday. The shares fell as much as 2.
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It’s bad enough for family members when a loved one dies.

Getting cheated by Uncle Sam afterward makes it worse.

He did that in cases involving more than 2,000 beneficiaries who didn’t get the full benefit of U.S. Postal Service life insurance policies.
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While a federal jury is still weeks away from deciding whether Palm Beach County retinal specialist Dr. Salomon Melgen bilked Medicare out of as much as $105 million, they learned on Monday that his far-flung practice was immensely lucrative.

Diagnosing and treating thousands of elderly patients for wet macular degeneration at four clinics from Delray Beach to Port St. Lucie, Melgen raked in millions more from Medicare for various tests and procedures than any other eye specialist in the nation, according to figures compiled by an FBI intelligence analyst.

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Hyundai Motor Co. and Kia Motors Corp. announced recalls to inspect and, if necessary, replace four-cylinder engine assemblies in as many as 1.2 million U.S.
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It's been more than two decades since President Bill Clinton signed the Health Insurance Portability and Accountability Act into law in 1996. Since then, the rule has arguably become far more synonymous with its privacy provisions than the health plan flexibility for which it's named.

And 20 years later, its rules – made all the more complex by the rise of health information technology and the electronic data exchange it enables – continue to confuse patients and providers alike, according to the American Health Information Management Association.

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