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FDA Issues Safety Warning About Contaminated Bronchoscopes

The U.S. Food and Drug Administration (FDA) recently issued a warning about a new class of medical devices that is prone to contamination and may pose risks to patients. According to the FDA, it is currently investigating infections linked to flexible bronchoscopes.

As we have previously discussed on this blog, the inability to thoroughly sterilize specialty endoscopes known as duodenoscopes was linked to a drug-resistant “superbug” that claimed the lives of three California patients in 2013. While the FDA stated that the risk of infection from bronchoscopes “appears to be lower” than the risk posed by duodenoscopes, at least 14 patients have been infected with the same deadly bacteria.

Approximately 500,000 bronchoscopy procedures are performed in the United States each year. The reusable scope is a thin, lighted tube that is threaded through the nose or the mouth to allow a physician to examine a patient’s throat, larynx, trachea, and lower airways. After each procedure, the scope must be reprocessed, a multi-step process that is supposed to clean and sanitize the device.

As part of its ongoing, comprehensive investigation into infections associated with reprocessed reusable medical devices, the FDA is examining 109 reports received from January 2010 to June 2015 concerning infections or device contamination related to bronchoscopes. In some cases, the FDA found “persistent device contamination despite following the manufacturer's reprocessing instructions.” However, in other situations, it found that hospitals failed to meticulously follow manufacturer instructions for reprocessing and/or continued to use the devices despite integrity, maintenance and mechanical issues.

To lower the risk of a serious infection, the FDA warned healthcare providers to strictly adhere to the manufacturer’s reprocessing instructions and specifically not to skip steps. The agency also reminded facilities to immediately stop using any bronchoscope that fails a leak test or shows visible signs of damage, such as loose parts, damaged channel walls, kinks or bends in tubing, or holes.

The FDA also advises that patients undergoing bronchoscopy procedures should ask their doctors what to expect following the procedure and when to seek medical attention. The FDA alert states that symptoms such as fever, pain, nausea and vomiting may be a sign of a more serious problem.

If you or someone you love has suffered serious harm due to a contaminated or otherwise defective medical device, don’t hesitate to contact a San Diego product liability attorney at the Law Offices of Robert Vaage for a free consultation.