BY: Matthew Turner | IN: Medical Malpractice
Contaminated medical devices have sickened hundreds of hospital patients across the United States and elsewhere in recent years, leading to complications and sometimes death.
Duodenoscopes are the primary contamination culprit. These flexible, lighted tubes are threaded through the mouth, throat, and stomach into the top of the small intestine (duodenum) to drain fluids from pancreatic and biliary ducts blocked by tumors, gallstones or other conditions. Recent statistics indicate that duodenoscopes are used in more than 500,000 procedures each year in the U.S.
Increased illness caused by dirty duodenoscopes and other medical devices sparked an investigation by the U.S. Senate Health, Education, Labor, and Pensions Committee, which revealed both wrongdoing and mistakes on the part of medical device manufacturers, hospitals, and the U.S. Food & Drug Administration (FDA).
The Committee’s investigation was prompted by a September 2013 notification from the Centers for Disease Control and Prevention to the FDA, raising concerns over infections at a Chicago hospital. The infections were linked to a duodenoscope manufactured by Hoya Corporation PENTAX Life Care Division. Around the same time, a Seattle hospital also associated a series of infections to a duodenoscope manufactured by Olympus Medical Systems (Olympus). The hospitals had reportedly cleaned the duodenoscopes based on the manufacturer’s instructions.
According to the Committee, although the FDA looked into the concerns, it did not issue a safety alert to hospitals for at least 17 months. The Committee also found that it took two years for the FDA to provide hospitals with additional measures to supplement reprocessing of duodenoscopes for reuse, during which time at least another 68 patients were infected.
In a January 2016 report, the Committee issued several recommendations for preventing infections related to duodenoscopes and other medical devices. The suggestions include:
When the failure of medical device manufacturers and health care providers to avoid unnecessary risks results in patient injuries and death, they may be liable for damages caused by their negligence or medical malpractice. If you have been harmed due to the result of a contaminated medical instrument, a hospital’s negligence, or a doctor’s mistake, please contact the attorneys in Sommers Schwartz’s Medical Malpractice Group today to discuss your case.
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Matthew Turner is a shareholder with Sommers Schwartz, and focuses his practice on medical malpractice, legal malpractice, ERISA, and class action matters.