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FDA Pushing for Stricter Standards on Medical Tests, Citing Potential Safety and Accuracy Issues

November 30, 2015  ·  By HM&M

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When Americans go to the doctor and are at risk for an illness, they are often administered a test. Some of them have tried and true results but the Food and Drug Administration (FDA) has recently pointed out just how inaccurate, unreliable, and even potentially dangerous to patients others may be. They are now calling for stricter standards to regulate the use and distribution of medical tests. Unfortunately, those new regulations may be too little too late those that have already suffered an error in diagnosis.

The Gap Problem in Reporting Adverse Events from Medical Tests

Before a test kit can be sold to multiple laboratories, it must be reviewed by the FDA. Once it is approved for distribution, the manufacturer is supposed to report any adverse effects, such as death or serious injury that may have resulted from the use of the test. They may also be required to report defects in their products. However, these same regulations do not apply to all medical tests.

For those that are manufactured and used in a single laboratory, no regulations exist. Yet, doctors from anywhere in the country may administer these tests and send samples to that lab for testing. As a result, there are patients who are receiving test results from a source that has not yet been tested for efficacy. And many of them are falling short.

FDA Highlights Seriousness of Problem

Unreliable or inaccurate tests could lead to undetected life-threatening diseases or unnecessary treatments for conditions they do not have. In fact, the FDA claims that tens of thousands of patients have been placed on medications they do not need, and many others have been subjected to unnecessary surgeries and procedures that could put their lives at risk. To investigate the matter further, they performed several case studies on medical tests currently used by physicians and laboratories. The following are just a few of their results:

  • A blood test designed to test for ovarian cancer was never proven effective but was widely used anyway. False-positives may have led to the unnecessary removal of healthy ovaries in women.
  • Pregnant women may have considered or had abortions after receiving inaccurate test results that indicated an abnormality in their fetus.
  • Genetic variants thought to increase heart disease risk have not been confirmed, yet several tests detecting this variant are frequently used. More than 150,000 patients have reportedly been given these tests, and many may be under- or overly treated with statin drugs.

The Push for Stricter Regulations

Although the FDA and the Obama administration have been pushing for stricter regulations on medical tests, the road has proven to be a difficult one. Rules have remained largely the same since 1988, and there is a great deal of resistance from non-supporters. Unfortunately, until reform happens, patients will continue to be placed at risk—sometimes unbeknownst even to their physicians—and may make important, life-altering medical decisions based on a lie.

Seek Help with Your Medical Malpractice Claim

If you or someone you love has been injured or has suffered through unnecessary treatment because of the negligence of a healthcare provider or facility, you may be entitled to compensation. However, medical malpractice cases are often complex, and they need proper investigation and supporting evidence. For this reason, victims are advised to seek the assistance of a skilled and professional medical malpractice attorney.

At Hurley, McKenna & Mertz, P.C., we are dedicated to protecting the rights of victims. Our knowledge and experience give us the skills and resources that are needed to investigate your case fully and aggressively pursue compensation for you and your family. To request your free initial consultation with our skilled Chicago medical malpractice attorneys, call our offices at 312-553-4900 today.


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