Maryland Medical Malpractice Lawyers: Superbug OutbreaksFebruary 15, 2016
Duodenoscopes have been linked to over 250 cases of antibiotic-resistant infections between 2012 and early 2015, several of which resulted in fatalities. These medical devices are difficult to clean and sterilize after being used on one patient and before being used on another. Although a dozen or more hospitals have had issues with unsterile duodenoscopes, they generally did not alert federal regulators to the problem.
When a medical device manufacturer learns that one of its devices may have contributed to death or injury, they have 30 days to report that information to the FDA. Despite the 250 known cases of infections originating with unsterile duodenoscopes, the FDA received only 75 reports. Even more disturbing, one manufacturer, Olympus, knew that its duodenoscopes could transmit bacteria after a thorough cleaning as early as 2013 yet failed to alert American hospitals or the FDA until February 2015.
The FDA has advised that any patients who experience the following symptoms after undergoing a duodenoscope procedure should seek medical attention immediately:
- Chest pain
- Severe abdominal pain
- Trouble swallowing or breathing
- Black or tarry stools
In her report, Senator Murray sharply criticized manufacturers, noting that it is their responsibility to alert patients, doctors, and hospitals when they know their medical device has a safety defect. According to the report, many of the major duodenoscope manufacturers failed to meet regulatory reporting obligations. Ultimately, according to the FDA, the benefits of duodenoscope procedures outweigh the risks because the procedure can diagnose serious life threatening health conditions.
Maryland Medical Malpractice Lawyers at LeViness, Tolzman & Hamilton Fight For Victims Injured by Defective Medical Devices
If you or someone you love has been injured by an unsterile or dangerous medical device, the experienced Maryland medical malpractice lawyers at LeViness, Tolzman & Hamilton can help you hold responsible parties accountable. To schedule a consultation, call us at 800-547-4LAW (4529) or fill out our online contact form. With offices located in Red Bank, Edison and Toms River, Maryland, we serve clients throughout the state.
Our offices are located in Baltimore, Columbia, Glen Burnie and Towson, allowing us to represent families harmed by medical malpractice in Anne Arundel County, Carroll County, Harford County, Howard County, Montgomery County, Maryland’s Western Counties, Southern Maryland and the Eastern Shore, as well as the communities of Catonsville, Essex, Halethorpe, Middle River, Rosedale, Gwynn Oak, Brooklandville, Dundalk, Pikesville, Parkville, Nottingham, Windsor Mill, Lutherville, Timonium, Sparrows Point, Ridgewood and Elkridge.