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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

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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The Food and Drug Administration (FDA) recently announced that it is conducting a pilot program to expedite drug recall notifications in an effort to quickly and efficiently relay important information to the public. The Agency, according to the FDA, currently issues a weekly Enforcement Report for consumers to be informed about the risks posed by products on the market. And in April, the Agency released a report on how to increase public access to such enforcement reports to ensure public access.

To do this, the FDA appointed eight focus groups, as detailed in the 2014 Transparency Report, with each group representing a center of the Agency to ensure that no significant function was left unwatched. One such initiative to come out of the focus groups was the decision that all agency groups will now, and moving forward, submit information electronically, and keep all electronic information stored in one place. This thus establishes “a single authoritative source for facility identifying information” and ultimately makes it easier for consumers to know where to look to check on product recalls, and also where to submit information. The FDA relies on consumer reports to stay on top of all the different products and services it regulates. Ensuring that consumers know where to go, as well as an ease to report faulty products, makes it easier for the FDA to do its job.

The utilization of social media channels to make such announcements and to help increase consumer awareness of product recalls and defective devices is another initiative undertaken by the FDA. The Agency's centers and offices presently share “compliance and enforcement information with the public” through a variety of social media outlets, according to the 2014 Transparency Report.

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Crohn's disease is an inflammatory bowel disease and can affect any portion of the gastrointestinal tract from the mouth to the anus. If this is left untreated, a patient can suffer from diarrhea, vomiting, weight loss, skin rashes, abdominal pain, lack of concentration, tiredness, eye inflammation, and even arthritis. As a result of the pain and discomfort experienced by many Crohn's patients, the search for a medical treatment has been widespread. However, a new medical treatment is on the horizon.

A press release from the FDA has announced that the agency has approved a new treatment method for both Crohn's disease and ulcerative colitis. Ulcerative colitis is another type of inflammatory bowel disease that causes the formation of ulcers in the bowels and is common to Crohn's disease.

The new medical treatment method for Crohn's and ulcerative colitis is that of Entyvio, which is an injection for adults who have moderate to severe cases of these illnesses. This new treatment has been approved to treat cases where primary methods have not helped relieve symptoms in patients.

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