Reprocessing of Reusable Medical Devices
A hospital in Pasadena released a statement this week that some of its patients contracted an antibiotic resistant “superbug” that has been linked to a medical scope that has infected dozens of people around the country. Huntington Memorial Hospital states that it notified health officials after several patients who had endoscopic retrograde cholangiopancreatogrophy procedures (“ERCP”) using Olympus Corp. duodenoscopes were found to have the resistant pseudomonas bacteria. A duodenoscope is a reusable medical device used to diagnose and treat gallstones, blockages, and digestive-tract cancers.
Reprocessed and Reusable Medical Devices Defined
Reusable medical devices are devices that health care providers can reprocess and reuse on multiple patients. Examples of reusable medical devices include stethoscopes or surgical forceps. Reusable medical devices are categorized according to the risk of infection. These devices are designed and labeled for multiple uses and are reprocessed by thorough cleaning followed by high-level disinfection or sterilization between patients. They are made of materials that can withstand repeated reprocessing, including manual brushing and the use of chemicals.
FDA and Scope Makers
In the current example, the U.S. Food and Drug Administration (“FDA”) is investigating a link between patients who contracted the superbug following an ERCP using the Olympus Corp. duodenoscope. The FDA regulates a broad range of medical devices like artificial hearts, tongue depressors, and sutures. They have the authority to regulate medical devices before and after they reach the marketplace. According to the FDA, Olympus Corp. holds an 85% share of the U.S. market for duodenoscopes and other specialty endoscopes.
In this region alone, a dozen infections were reported earlier this year at Cedars-Sinai and UCLA’s Ronald Reagan Medical Center in Los Angeles. Three patients died. The FDA posted an online warning letter to Olympus Corp. stating it waited three years to alert regulators to a cluster of 16 infections in patients who underwent procedures using the duodenoscope in 2012 and that the company has no standard procedure to promptly report serious problems with its devices, a requirement of medical device companies. Click here to access Olympus Corp. online warning letter. Hoya (Pentax) Corporation and Fujifilm Medical Systems USA, Inc. were also cited for problems with the testing, design, reporting, and quality control of their devices.
Obtaining Legal Help
Medical device companies have a responsibility to design, manufacture, and market safe, reliable products. When they fail to do so and those products cause serious injuries or death, you might have grounds to take legal action against the company for its negligence. These are known as “product liability” cases. Sometimes, a company issues a product recall, but often it is after several people have been injured or lost their lives that the affected product is recalled.
The Law Offices of Brian Brandt has successfully handled some of the largest, most complex product liability claims in California. That is why injury victims statewide routinely rely on us when they or a loved one has been injured by a defective or dangerous product. To schedule a consultation, click here or call 800.983.4467 today.