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After Years of Unfixed Problems, FDA Says Medtronic Must Stop Selling Synchromed Drug Pumps

Medtronic Must Stop Selling Synchromed Drug Pumps

Medtronic Must Stop Selling Synchromed Drug Pumps


Medtronic must stop selling the majority of its implantable drug pumps due to years of unfixed problems, the U.S. Food and Drug Administration (FDA) said. Star Tribune reports that the agency has filed a court order stating that Medtronic must stop distributing and producing its Synchromed II drug pumps. The devices are surgically implanted to delivery a drug solution in the area surrounding the spine in patients with cancer, chronic pain and severe muscle spasms. The pumps were recalled because they may lose battery power and fail, causing harm to patients. The devices were also problematic in cases where they delivered the wrong amount of medication. Even though Medtronic has been aware of problems since 2006, they have failed to act; this lack of compliance has prompted to the FDA more aggressively assert its authority. More After Years of Unfixed Problems, FDA Says Medtronic Must Stop Selling Synchromed Drug Pumps

Contaminated Duodenoscopes also Linked to Drug-Resistant E. Coli Outbreak

Contaminated Duodenoscopes also Linked to E. Coli Outbreak

Contaminated Duodenoscopes also Linked to E. Coli Outbreak

Tainted duodenoscopes, which have come under scrutiny in light of a series of superbug outbreaks, are also associated with an outbreak of drug-resistant Escherichia coli (E. coli) in a Washington state hospital. According to a study published in Infection Control & Hospital Epidemiology, patients can still be infected even when following manufacturers’ cleaning instructions.

An investigation revealed that between November 2012 and August 2013,32 patients were infected with an antibiotic-resistant strain of E. coli at Seattle Virginia Mason Medical Center. The hospital had followed the manufacturer’s cleaning protocol, but these procedures were apparently insufficient.

Recent evidence suggests that manufacturers’ cleaning instructions alone are not enough to sterilize duodenoscopes, a specialized type of endoscope. Recently, the devices were implicated in recent outbreaks of Carbapenem-resistant Enterobacteriaceae (CRE) at two Los Angeles Hospitals: UCLA’s Ronald Reagan Medical Center and Cedars-Sinai hospital. A total of 11 patients were infected with CRE at the two hospitals and 246 more were potentially exposed.
More Contaminated Duodenoscopes also Linked to Drug-Resistant E. Coli Outbreak

Settlement Deadline Extended for Patients Injured by Defective Stryker Hip Systems

Settlement Deadline Extended for Patients Injured by Stryker

Settlement Deadline Extended for Patients Injured by Stryker


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

FDA Hopes new Rules will Make Endoscopes Cleaner and Safer

FDA Hopes new Rules will Make Endoscopes 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

FDA Issues Stricter Guidelines to Endoscope Manufacturers

FDA Issues Stricter Guidelines to Endoscope Manufacturers


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

Ethicon Settles Transvaginal Mesh Lawsuit

Ethicon Settles Transvaginal Mesh Lawsuit


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