When reusable medical devices are not properly cleaned and sterilized, patients are at a high risk for serious infections, including:
These infections can lead to initial symptoms such as fever, cough, shortness of breath or chest pain. These symptoms often progress to dangerous and life-threatening conditions, including pneumonia or septicemia.
Reusable medical devices are used for numerous common medical procedures, including:
Due to faulty designs, many devices are never properly disassembled for cleaning and sterilization. Some devices also include components such as hinges, o-rings and valves that cause infectious materials to be left behind. Similarly, manufacturers’ instructions for proper cleaning often are too generic and not based on real-world testing.
The many problems associated with reusable medical devices have gained more attention in recent years, as the Veteran’s Administration issued warnings to more than 10,000 patients who were at risk of infection from improperly cleaned endoscopes.
Since 2007, the U.S. Food and Drug Administration (FDA) has received dozens of reports of improperly cleaned and sterilized medical devices that were directly to blame for hospital-acquired infections. In July 2009, the FDA warned hospitals and other health care providers of instances in which pieces of tissue and other contaminants remained even after devices were cleaned under the directions provided in the manufacturer's instructions. In May 2011, the FDA issued draft guidance on Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. The FDA also has established a website dedicated to the Reprocessing of Reusable Medical Devices.
Attorneys at The Lanier Law Firm represent patients who have experienced serious infections and other side effects of contaminated reusable medical devices. You can learn more about these infections caused by reusable medical devices here.
If you or a loved one has suffered an infection or any adverse side effects or reusable medical devices, please contact our office for a free evaluation.
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