Matthew Sharp Argues that Recent Illnesses Show Why Device Market Needs More Oversight

A deadly superbug outbreak at a Los Angeles hospital in February has now popped up at another area medical center. The outbreak of CRE was caused by an infected duodenoscope that is used in endoscopic procedures. After first appearing at UCLA Medical Center, it's now shown up at Cedars-Sinai Medical Center. The manufacturers and regulators have known for many years that the manufacturer?s instructions for cleaning duodenoscope are inadequate and that the surgical instrument poses the risk of transmitting super bugs from patient to patient.

Matthew Sharp, a defective medical device lawyer in Reno, NV, argues that the recent outbreak shows why current oversight is inadequate and why the manufacturers of thes instrument should be held to account for the design and warnings. "The outbreak likely happened because these scopes are defective and the sanitizing steps dictated by the manufacturer were inadequate." Mr. Sharp explained. "That's a basic requirement that a medical device should not create a risk of disease transmission. The health care professionals rely upon the manufacturer and its instructions for cleaning the instrument."

Since the UCLA outbreak, the FDA issued a warning. New sterilization instructions for the scope. The FDA claims it will require manufacturers to show that surgical devices can be cleaned adequately. One of the problems is that the duodenscope has many intricate parts, which interferes with sterilization.

In 2013 and 2014, the FDA received 75 reports of adverse events of disease transmission related to the duodenscope. Yet manufacturers are not addressing the risk their devices pose to the patient.

"This just shows that it's not just enough for these devices to work," argued Mr. Sharp, a defective medical device lawyer in Reno. "They also have to be designed in manner that they can effectively be cleaned. I hope the manufacturers and the FDA takes steps to protect against future outbreaks"

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