Medical Device that Skipped the FDA Approval Process Being Blamed for Deaths

Patients who undergo standard diagnostic procedures like colonoscopies or endoscopies rarely spend much time worrying about the safety of their procedure, and if they do, their worries concern things like the physician’s skill or the amount of anesthesia that will be used. But now comes word that several people have died as a result of negligence on the part of a medical device manufacturer, Olympus, that skipped the FDA approval process for their TJF-Q180V duodenoscope. The tool is used in a procedure done on over 500,000 patients per year.

All medical devices – defined as instruments, implants and the like – that are used to diagnose, prevent or treat a disease or condition are required to undergo a strict approval process to ensure that they are safe for use in humans. The process is very similar to the one that is required for drugs, and includes clinical testing. Valid scientific evidence is needed for approval to be granted, and this process takes time.

In the case of the Olympus TJF-Q180V duodenoscope, its manufacturer first introduced the product onto the market in 2010, selling it to the medical community for over three years. But when seven patients were sickened and two died at the UCLA Ronald Reagan Medical Center after undergoing endoscopies using the tool, an investigation followed. It determined that the problem was with the numerous nooks and crannies that are part of the scope’s design, and which made it difficult to clean. These allowed a deadly type of bacteria called carbapenem-resistant Enterobacteriaceae, or CRE, to be transferred from patient to patient. It was only then that it became known that the scope was not in the FDA database of approved devices.

The only reason that the failure to seek approval was discovered was that there were multiple cases of illness and deaths in one hospital, leading to an exhaustive inquiry. There is a very good chance that patients treated at other hospitals have also become ill without the cause of their illness having been detected. Since news has spread of the problem with the scope there have been reports of superbug infections at hospitals in Los Angeles and in Connecticut.

The FDA has requested that Olympus submit to the approval process now, and have given no indication as to whether they will be fining the company, which claims that they were unaware of their requirement to submit it for approval. It is also not known whether the agency will be advising that use of the device be discontinued. They have indicated that following the manufacturer’s cleaning directions is not sufficient to eliminate bacteria and microorganisms that can hide in its tiny crevices.

Though the FDA may choose not to take action, the legal system provides remedies for those who have been harmed by negligence of this type, and it is expected that there will be several lawsuits filed against the company. One patient has already filed suit after suffering a CRE infection following a procedure at UCLA.

If You’re An Injured Patient, Don’t Wait

For products liability or medical malpractice claims in which the patient is injured by a medical device, it is important to take action right away. Seek counsel from a qualified products liability and medical malpractice attorney. The attorneys at Eisenberg Rothweiler Winkler Eisenberg & Jeck, P.C. are here to help—a firm with experienced products liability and medical malpractice attorneys who will fight to get you the recovery you deserve. They will look at the total picture including medical bills, wage loss, physical therapy, rehabilitation, adaptive equipment, living quarters and pain and suffering to calculate the compensation to which you are entitled.

 



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