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Settlement Deadline Extended for Patients Injured by Defective Stryker Hip Systems

The deadline to enroll in the Stryker Orthopedics Rejuvenate Hip System settlement has been extended to March 30, 2015.

Patients who were implanted with one of the now-recalled ABG II Modular Hip Systems or Rejuvenate Modular Hip Systems still have time to register with the settlement, which was announced in late 2014. More Settlement Deadline Extended for Patients Injured by Defective Stryker Hip Systems

FDA Hopes new Rules will Make Endoscopes Blamed on a Superbug Outbreak Cleaner and Safer

Under new federal rules, endoscope manufacturers will need to prove to the U.S. Food and Drug Administration (FDA) that its devices can be thoroughly cleaned. The move comes on the heels of an outbreak of a superbug at two Los Angeles hospitals.

Duodenoscope manufacturers will now need to provide scientific evidence that duodenoscopes can be cleaned reliably, but the FDA cannot require manufacturers to change the design of the devices to make them easier to disinfect. The FDA said it was issuing new rules for cleaning the duodenscopes, along with a wide range of other reusable medical devices. The agency proposed the rules in draft form in 2011, but they were never finalized, the Los Angeles (LA Times) reported. More FDA Hopes new Rules will Make Endoscopes Blamed on a Superbug Outbreak Cleaner and Safer

FDA Issues Stricter Guidelines to Endoscope Manufacturers Following the Deaths of Two Patients Infected with Antibiotic-Resistant Bacteria

Outbreaks of a deadly superbug caused by lingering bacteria on duodenoscopes have triggered federal health officials to issue stricter guidelines for manufacturers that are intended to ensure the devices are sufficiently disinfected.

The guidelines not only apply to the scopes, but to reusable medical instruments, in general.  The U.S. Food and Drug Administration (FDA) will ask duodenoscope manufacturers to submit scientific data showing that their devices can be adequately disinfected. FDA officials have admitted that the agency’s previous guidelines from 1996 made no such request from manufacturers, according to the Associated Press (AP). More FDA Issues Stricter Guidelines to Endoscope Manufacturers Following the Deaths of Two Patients Infected with Antibiotic-Resistant Bacteria

Ethicon Settles Transvaginal Mesh Lawsuit Only a Day after Being Hit with a $5.7 Million Verdict

Johnson & Johnson subsidiary Ethicon settled a transvaginal mesh lawsuit five days into the trial, in the wake of a $5.7 million verdict in a related suit.

Ethicon spokesman Matthew Johnson confirmed to Law360 on Tuesday that the bellwether case had been settled, but declined to provide any details of the deal. Jurors were told on Friday, the fifth day of the trial, that the case had concluded. More Ethicon Settles Transvaginal Mesh Lawsuit Only a Day after Being Hit with a $5.7 Million Verdict

Maker of Medical Device that Started a Superbug Outbreak Started Selling the Devices Without FDA Clearance

Superbug Outbreak Device sold the w/o FDA Clearance

Superbug Outbreak Device sold the w/o FDA Clearance

The manufacturer of the endoscope that infected seven people at Ronald Regan UCLA Medical Center with a deadly superbug outbreak never obtained permission from the U.S. Food and Drug Administration (FDA) to sell the device.

CNN reported that it learned that Olympus never received FDA clearance before it began selling its TJF-Q180V duodenoscope in 2010, and the agency didn’t realize it until late 2013 or early 2014. More Maker of Medical Device that Started a Superbug Outbreak Started Selling the Devices Without FDA Clearance

First TVT-Abbrevo Trial Ends in $5.7 Verdict for the Plaintiff

First TVT-Abbrevo Trial Ends in $5.7 Verdict for Plaintiff

First TVT-Abbrevo Trial Ends in $5.7 Verdict for Plaintiff


A Bakersfield, California, jury awarded $5.7 million on Thursday to a woman who alleged she was implanted with a defective TVT-Abbrevo pelvic mesh sling made by Ethicon, a subsidiary of Johnson  & Johnson (J&J). It was the first trial centered on the device.

The TVT-Abbrevo device is intended for the treatment of urinary incontinence caused by sudden movements. The plaintiff in the case, who had the device implanted in 2011, alleged that her TVT-Abbrevo caused her pain and continued urinary incontinence, according to The National Law Journal (The Journal). More First TVT-Abbrevo Trial Ends in $5.7 Verdict for the Plaintiff

Cedars-Sinai Medical Center says Four Patients Contracted CRE Superbug Between August and January

Medical Center says 4 Patients Contracted CRE Superbug

Medical Center says 4 Patients Contracted CRE Superbug


Four patients have contracted a deadly, drug-resistant infection linked to a duodenoscope, officials from Cedars-Sinai Medical Center in Los Angeles announced on Wednesday.

Seven patients were infected with the superbug, known as carbapenem-resistant Enterobacteriaceae (CRE), at the University of California Los Angeles’ Ronald Reagan Medical Center recently. In 2013, 30 patients at Advocate Lutheran General Hospital in Park Ridge, Illinois, contracted CRE, as did 32 patients treated at Virginia Mason Hospital in Seattle, Washington, between 2012 and 2014. More Cedars-Sinai Medical Center says Four Patients Contracted CRE Superbug Between August and January

Health Officials Mull Better Sterilizing Techniques for Duodenoscopes After Outbreaks of Antibiotic-Resistant Infections Emerge

Health Officials Mull Better Sterilizing Techniques for Duodenoscopes

Health Officials Mull Better Sterilizing Techniques for Duodenoscopes


A U.S. Food and Drug Administration (FDA) never reviewed data from manufacturers concerning the procedures needed to clean duodenoscopes that infected seven patients with multidrug-resistant bacteria, and the agency has yet to offer any guidance.

Duodenoscopes are long, flexible tubes with a tiny camera at the tip. The devices are inserted into the throats of patients to examine the small ducts that drain the liver or gallbladder. The bacteria spread even after clinicians followed manufacturers’ concise instructions for disinfecting the duodenoscopes. Makers of the scopes have defended their recommended cleaning techniques, but the scopes are notoriously difficult to sanitize. The inner tubing is intricate and difficult to clean, and can allow for the growth of up to 10 billion individual bacteria, William A. Rutala, an infection control specialist at University of North Carolina Hospitals, told The New York Times (The Times.) More Health Officials Mull Better Sterilizing Techniques for Duodenoscopes After Outbreaks of Antibiotic-Resistant Infections Emerge

Ventricular Assist System Controllers Recalled due to Electric Shock Risk

Ventricular Assist System Controllers Recalled

Ventricular Assist System Controllers Recalled


HeartWare International Inc. has recalled its older HeartWare Ventricular Assist System Controllers in the United States because they are much more vulnerable to the risk of an electrostatic discharge (ESD) event, which could result in serious injury or death.

The company issued letters to clinicians and patients warning of the problem. The later commercial controllers are not affected by the recall, as the firm has made significant design improvements to them.  HeartWare first issued a Field Safety Corrective Action in April 2013. The medical device maker expects that the recall will affect about 120 patients in the U.S. Since the notice was issued, HeartWare has received one additional report of death and one injury due to ESD. The recalled Ventricular Assist System Controllers were distributed during the course of a clinical trial period, before the devices were approved by the U.S. Food and Drug Administration (FDA), according to ZACKS.com. More Ventricular Assist System Controllers Recalled due to Electric Shock Risk

Heart Monitor App Crashes, Prompting Recall

AliveCor has recalled one of its heart monitor apps due to the app crashing upon use.

More than 5,000 active iOS users are affected by the recall, the U.S. Food and Drug Administration (FDA) said in a recall notice. The AliveECG app works in tandem with the AliveCor Heart Monitor to record electrocardiograms and detect the presence of atrial fibrillation and normal sinus rhythm when prescribed by or under the guidance of a physician. The FDA has designated this as a Class III recall, according to HITConsultant.net More Heart Monitor App Crashes, Prompting Recall