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How can faulty medical lab tests lead to diagnosis errors?

On Behalf of | Oct 31, 2023 | Medical Malpractice |

Medical malpractice claims often result from missed or mistaken diagnoses. The AARP says research shows that roughly 12 million Americans are misdiagnosed in outpatient settings each year. The Food and Drug Administration (FDA) says thousands of unreliable laboratory medical tests contribute to this problem. The agency is proposing a new rule forcing more tests to undergo FDA reviews.

The 10 most commonly missed or delayed diagnoses

The medical journal BMJ says research shows nearly 800,000 Americans die or suffer severe disabilities due to misdiagnosis annually. Another study published in JAMA says these are most often undiagnosed or misdiagnosed conditions:

  1. Colorectal cancer
  2. Lung cancer
  3. Breast cancer
  4. Heart attack
  5. Prostate cancer
  6. Stroke
  7. Sepsis
  8. Bladder cancer
  9. Pulmonary embolism
  10. Brain hemorrhage

Medical experts say several other conditions are routinely missed, such as pneumonia, kidney disease, heart disease and urinary tract infections.

Reigning in the multibillion-dollar testing industry

The FDA says oversight of laboratory medical tests has been sporadic, at best, for decades. Years ago, only a few companies developed tests, but the industry has mushroomed in recent years, with more laboratories offering tests without proof that they are reliable.

The agency says medical testing has become a multibillion-dollar industry that poses elevated risks to patients due to the possibility of inaccurate results. The FDA reviews many tests, such as those for detecting COVID-19, strep throat and other conditions.

The agency proposes enhanced scrutiny for tests typically developed at public and private hi-tech labs and universities. These tests screen for anything from complex diseases like cancer to less complicated conditions like high cholesterol and sexually transmitted infections. Some testing companies also claim their products can measure risks for developing autism or Alzheimer’s disease without any proof.

Faulty tests can lead to inaccurate diagnoses, unnecessary surgery or medication, or can delay treatment, which can lead to greater health risks later on. Changes protecting patients have been stalled for years. The FDA drafted stricter regulations over a decade ago but never implemented them. Congress considered legislation to regulate tests for high-risk conditions, but the measure failed. Critics say a majority of legislators were swayed by medical testing lobbyists who oppose the requirements.