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Many medical tests are not reviewed by the FDA

Dec 2, 2015 | Failure to Diagnose

New York patients may be dismayed to find out that many of the medical tests performed each year in the United States are not reviewed and approved by the Food and Drug Administration. A 1988 law gives the FDA authority to review only tests that are sold to multiple labs, which allows thousands of tests to be performed each year that have not been required to undergo any kind of official scrutiny. The FDA also points out that only about 1 percent of the nation’s approximately 180,000 medical labs have ever been inspected.

Numerous case studies have shown how inaccurate medical tests have led to unfortunate outcomes for patients, including unnecessary surgery or pregnancies being terminated for no reason. The results of these tests are sometimes inaccurate because lab staff or medical professionals have made minor procedural errors. Many tests provide unreliable results if the chemicals used are not stored correctly or the blood sample being tested is even one drop too large.

When Congress passed the law governing medical tests in 1988, there were only eight so-called "waived tests" that fell outside the rules. However, a boom in biotechnology has seen the number of waived tests increase to more than 3,000. In 1988, tests not covered by the regulations were straightforward and mistakes were uncommon, but many of today’s waived tests are highly sophisticated and difficult to perform correctly.

While any efforts to improve patient safety should be welcomed, no amount of regulations can hope to eliminate all human error. A mistaken or delayed diagnosis can have catastrophic consequences for a patient with cancer or a similar progressive disease, and an attorney with experience in this area may deem it advisable to file a medical malpractice lawsuit on behalf of a patient who has been harmed due to this form of medical error.