Hospital officials in California reported the death of two patients and the illness of five others after contaminated duodenoscopes were used in surgical procedures. Such incidents often give rise to medical malpractice lawsuits against medical facilities, doctors and the manufacturers of medical devices. By inserting these devices down a patient’s throat, the duodenum area can be reached via the stomach and problems in the pancreas, liver and bile ducts can be diagnosed and treated. Following these incidents, the Food and Drug Administration announced that it will be beefing up the procedures whereby manufacturers test reusable medical devices.
It was reported that the device poses no danger, but the microscopic crevices included in the design of the duodenoscope makes it almost impossible to disinfect. It was determined that deadly bacteria originating from unsterilized devices caused the illnesses and deaths of the California patients. While firmer guidelines may save many lives, the tougher testing procedures will only be carried out on new devices presented for approval, and devices already in use may continue to expose patients to high risks.
The FDA said the new guidelines would apply to an assortment of reusable devices, and the manufacturers of hard-to-clean devices will have to provide data to prove that proper disinfection is possible. This is not a new problem, as the FDA reportedly looked at risks posed by unsterile duodenoscopes as far back as 2009. Bacterial infections that were linked to duodenoscopes from Jan. 2013 through Dec. 2014 totaled an alarming number of 75 nationwide.
California victims of such medical negligence retain the right to obtain the services of an experienced medical malpractice attorney to pursue recovery of losses incurred. There is no reason why persons who undergo medical procedures should be exposed to unnecessary risks that may further jeopardize their health. A lawyer can help in gathering the evidence required to identify potential defendants and to determine what legal steps may be appropriate.
Source: The New York Times, “New Rules Are Issued for Testing of Medical Devices“, Sabrina Tavernise, March 12, 2015