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The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt. The decree will remain in force until regulators are convinced that the company has addressed and fixed the identified issues.

The SychroMed II Implantable Infusion Pump System is a device designed to deliver medication necessary for the treatment of cancer, chronic pain, and sever spasticity. Medtronic, the manufacturer of the device, says that more 230,000 patients have used a SynchroMed system since it was developed more than 25 years ago. However, inspections by the FDA in 2006 and 2013 identified “significant violations” of federal regulations, including issues related to handling complaints and corrective actions. A warning letter from the FDA in 2012 noted the devices' propensity to stall and subsequently fail to deliver the needed medication.

Finally, in 2013, Medtronic officially notified doctors of several potential problems with the device, revealing that 14 deaths had been associated with the pump. In response, Class 1 recalls were issued to correct the problems, along with promises from the maker to correct the problems. The FDA continued to pursue the action which was made official this week as “defendants are well aware that their practices violate the [Food, Drug, and Cosmetic] Act,” the filing stated. Despite numerous warnings, the administration was not convinced the manufacturer had taken the necessary corrective steps.

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Tagged in: Fda Recall

Every year, more than 7 million patients receive home health medical care under the direction of their medical providers. Many such cases require the use of medical devices in the home to treat or maintain a wide variety of conditions. The devices are put to use by the patient directly, or with the help of a caregiver or family member. While, to a certain extent, home health providers may be able to offer a degree of training in the proper utilization of a home-use medical device, federal regulators have expressed concern over the lack of a standardized labeling format for the devices.

Home-use medical devices include a wide range of equipment, including more simple things like canes and crutches, to more complicated items such as infusion pumps, glucose monitors, and continuous positive airway pressure (CPAP) machines. According to the U.S. Food and Drug Administration (FDA), there have increasing reports of adverse events related to medical devices used in the home, many of them related to the unavailability of the manufacturers instructions.

Over the course of time, and many devices are used in the home for years, the original packaging and documentation can easily be lost or separated from the equipment. This can create problems for a family member or new caregiver who may be unfamiliar with the proper use of the medical device. For a “lay user” without formal training, the device label and package insert may be his or her only possible resource to facilitate the device's proper use.

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Tagged in: Fda Medical device

An influential health insurer trade group has called for more stringent rules related to the approval and tracking of medical devices. The request follows revelations of gaps or loopholes in the federal regulatory procedures which allow potentially dangerous medical devices to be put on the market with minimal safety and performance testing. In particular, the group referenced a medical tool used in performing hysterectomies which, despite being widely available, has been found to contribute to the spread of cancer in patients.

This week, America's Health Insurance Plans, an organization representing nearly 1300 health insurers who provide coverage for over 200 million Americans, sent a letter to United States Senator Bob Casey, D-Pennsylvania, citing the dangers discovered regarding laparoscopic power morcellators. Since the 1990s, morcellators have been used to remove fibroids, or benign uterine growths, frequently during hysterectomies. Last year, the U.S. Food and Drug Administration (FDA) announced that women undergoing such procedures may be at higher risk for a certain type of malignant cancer, and use of the devices can potentially spread the cancerous tissue and worsen the condition.

While medical officials are reporting a significant drop in the use of power morcellators, they remain on the market. Johnson & Johnson, once the largest manufacturer of such devices, however, has withdrawn from the market.

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A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down.

Compounded Drug Recall

The NCBOP said in a news release that it was recalling all nonsterile and sterile products that were compounded, repackaged, and distributed by the pharmacy from September 10, 2014 to March 10, 2015. The listing of recalled products includes antidepressants, antibiotics, antiviral medications, immunosupressants, and others which were distributed to all 50 states and Canada. “This recall is due [to] the pharmacy's inability to ensure sterility, stability, and potency for these products,” the Board of Pharmacy said. While no complaints of injuries have been received by the board, the NCBOP and FDA are advising clinicians to quarantine any products from the Prescription Center and not to administer them to human or animal patients.

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Tagged in: Drugs Fda Recall

In an effort to increase safety and prevent disease, the United States Food and Drug Administration (FDA) released new recommendations regarding reusable medical devices. The announcement from the FDA was made following an outbreak of a bacterial superbug linked to the design of a specific piece of reusable medical equipment.

At least seven patients at Ronald Reagan UCLA Medical Center in Los Angeles were infected over the last several months with carbapanem-resistant enterobacteria, or CRE, while undergoing minor gastrointestinal diagnostic procedures. Two of patients later died from complications of the CRE infections, which antibiotics struggle to combat. The procedures at UCLA all involved a reusable medical device called a duodenoscope.

Hospital officials have determined that the device had been maintained and serviced in accordance with manufacturer guidelines, and claim that design flaws allowed the bacteria to be transmitted between patients despite the efforts of hospital staff. While the manufacturer continues to stand behind its products, the company is currently facing several lawsuits related to the outbreak.

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