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:
- The implementation of a medical device safety surveillance system, which would let the FDA access real-time information on adverse events, without relying on manufacturers and hospitals to report them. The system would also provide a larger pool of data, so the FDA could analyze adverse events in the context of total patients treated.
- The FDA should: 1) evaluate the design of closed-channel duodenoscopes and implement a recall; 2) update guidance to specify when manufacturers should request clearance after devices are modified; and 3) implement new guidance to offer providers information when it becomes aware that a medical device might compromise patient safety.
- Congress should require that unique device identifiers (UDIs) be used in insurance claims, electronic medical records, and device registries, and clarify the FDA’s authority to consider applications incomplete due to lack of sufficient data about whether a device can be safely cleaned and reused.
- Hospital compliance with adverse event reporting should be made a condition of being able to participate in Medicare.
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.