New FDA report warns inaccurate medical tests are harming patients

A new report from the FDA reveals that inaccurate or unvalidated medical tests may harm thousands of patients by causing missed or incorrect diagnoses.

Many patients and physicians in Lehigh Valley rely on medical tests to detect diseases and also rule out incorrect diagnoses. Unfortunately, according to a recent Food and Drug Administration report, many widely used medical tests may actually be unreliable. As The Boston Globe reports, these tests may put patients at risk for delayed or missed diagnoses, incorrect diagnoses and medically unnecessary treatments.

Unsubstantiated tests

Many people think that medical tests would not be professionally used if they had not been scientifically validated. This is the case for commercial test kits, which are kits designed for use in multiple laboratories. These kits must pass FDA review before they can be marketed. However, tests that will only be produced and used within one lab aren't subject to the same standards. Troublingly, these tests may be just as widely used as commercial tests.

The FDA report highlights the dangers of these inaccurate medical tests with 20 case studies. Each case study explores the serious potential impacts of medical tests that have never been proven effective. As an example, the report notes that one test for ovarian cancer may have generated false positives, leading to unnecessary oophorectomies. Another test for heart disease, which was used on over 150,000 people, may have led some patients to receive unnecessary intervention. After taking the same test, other patients may have gone without needed treatment.

Prevalent errors

Determining the overall number of diagnostic errors that occur each year in the U.S. has proven challenging, given the nature of these errors. Often, diagnostic mistakes are caught long after the diagnosis is made, so they may not be reported back to the responsible physician. Still, the available data suggests that these errors are all too common.

In 2014, a study published in BMJ Quality & Safety reported that about 12 million Americans are misdiagnosed in outpatient settings each year. According to CBS News, this translates to about one in 20 patients who may experience unnecessary medical treatments or delayed diagnoses of serious illnesses. With cases involving failure to diagnose factored in, the number of people who suffer harm from diagnostic errors may be even higher.

Proposed fixes

The Boston Globe reports that the Obama administration is now looking to establish greater regulatory control over these medical tests. However, critics worry that increased regulation could hinder future medical advances. Sadly, until lawmakers agree to implement new standards or regulations, these questionable tests may continue adversely affecting thousands of patients.

Malpractice claims

When patients suffer harm as a result of misdiagnosis, the medical professional, facility or healthcare provider may be liable. However, proving that a diagnostic error constitutes malpractice may be challenging. In Pennsylvania, victims must meet several legal criteria, such as showing that the diagnostic mistake deviated from the standard of care and increased the risk of harm. To improve the likelihood of a favorable outcome, victims may benefit from consulting with a malpractice attorney.