Many people spend a significant amount of time vetting their doctors, via the good old- fashioned research or asking family and friends for referrals. The time spent getting to know your doctor is important, since it is your doctor who will provide recommendations for vital health decisions. However, we generally fail to account for the lab facilities that doctors rely on to process their tests.
Doctors generally source out diagnostic tests to laboratories which they depend on to be quick, but more importantly, accurate. The field of medical tests has seen significant developments in the past decade, and now there are exams for a myriad of conditions that can give results within minutes. Unfortunately, with faster results, there is also a noticeable increase in errors, which lead to misdiagnosis by even the best doctors.
The Federal Drug Administration has limitations as to which diagnostic tests they regulate. As it currently stands, the FDA reviews only tests that are manufactured and sold commercially to several labs, not the ones that are manufactured for a single lab. They have strict guidelines that manufacturers must follow, including informing the FDA of any deaths or serious injuries caused by these tests. This only covers a small portion of the tests being used for diagnosis, since many labs started developing tests for their own use. The latter are not regulated by the FDA, and some of these tests are so complex that even trained personnel perform them incorrectly. Since many doctors are unaware of the origins of the tests used or of the inaccuracies of these waved tests, they continue to make treatment decisions based on false information.
Why aren’t exams more heavily regulated?
As often happens with law, the current regulations, passed by Congress in 1988, are now outdated. At that time, technology only allowed for simpler tests to be developed, so they were not likely to cause any detrimental mistakes.
Congress is currently working on gaining more control over labs creating their own exams, but many of the manufacturers are not keen on the idea. They argue that increased FDA involvement will hinder progress. Nevertheless, they will need to come to an agreement that supports innovation and keeps people safe.
At Graham Legal, the team is dedicated to looking out for the interest of the community. This includes defending personal injury cases in Miami caused by medical malpractice. If you feel that your doctor or healthcare provider did not take due diligence, and it resulted in a serious injury or death of a loved one, do not hesitate to contact Graham Legal today.