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Groups urge White House to conclude safety review

Interest groups were putting pressure on the White House to compete its final safety review on medical device identifiers. Premier healthcare alliance, which represents purchasers of devices, and The Pew Charitable Trusts, a research organization, were asking the White House Office of Management and Budget, or OMB, to make a final decision concerning the Food and Drug Administration rule. The groups claim that the FDA missed a statutory deadline; they insist that the decision is necessary in order to provide safety and quality improvements regarding patient care in Ohio and all over the United States.

In a July 8 letter directed towards OMB's director, the two groups explained that the unique device identifier, or UDI, system would serve as a foundation in order to improve the quality and safety of medical devices. Three days later, the FDA sent its final rule to OMB.

According to Premier and Pew, recalls and medical device failures indicate the necessity to identify potential problems with them before a large number of patients in the United States begin to use them. Additionally, the Government Accountability Office discovered that over 50 percent of medical device recalls conclude without fully fixing the problems or removing the products from the market. This would increase the likelihood of pharmaceutical litigation. According to the two groups, implementing an improved device identification system for such products will help address the issues.

Health care providers and patients assume that when medical devices and new medications receive FDA approval that they are safe. However, if healthcare products are defective, patients may suffer from serious side effects, permanent injury or even death. In such cases, a pharmaceutical liability attorney may be able to aid in filing suit to pursue compensation for damages.

Source: Bloomberg BNA, "Groups keep up pressure, ask OMB to release Final Device identifier Rule", Brian Broderick, July 10, 2013

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