On June 9, 2017, the Food and Drug Administration determined that it was necessary for manufactures of certain reusable medical devices to provide instruction for cleaning, disinfection, and sterilization. Reusable medical devices include devices such as bronchoscopes, forceps, coloscopes, gastroscopes, and other reusable devices. The June 9th notice provided a list of certain reusable medical devices and design features. A reusable medical device is one intended for repeated use either on the same or different patients with appropriate cleaning and other reprocessing steps between uses. According to the Food and Drug Administration, manufacturers are to provide validation data regarding cleaning, disinfection, and sterilization to keep patients safe and protected.
Manufacturers of reusable medical devices are responsible for having labeling that bears adequate directions for use, including instructions on preparing a device for use under federal regulation. According to the FDA, in recent years, there has been significant changes in knowledge and technology involved in reprocessing reusable medical devices. There has been an evolution towards more complex reusable medical device designs that are more difficult to clean, disinfect, and sterilize. As such, the FDA believed that reusable medical devices must be designed for adequate reprocessing and safe reuse. The manufactures must provide comprehensive and clear instructions for infected reprocessing procedures for use by health care facilities that reprocess these devices.
In recent years, there have been a number of instances where patients have been exposed to contaminated and infected reusable medical devices. These procedures include colonoscopies, bronchoscopies, biopsies, and other operations. For example, there was a recent rash of cases in Western Pennsylvania regarding colonoscopies due to contaminated scopes. Patients must be safe and feel protected from infection when undergoing what are relatively simple procedures. The instruments must be sterilized to keep patients safe and protected from transmitted disease. These avoidable events must be brought to the light of day and, for those who are affected, compensation must follow. If you or a family member have suffered avoidable complications from surgery, including an infection due to the utilization of non-sterile medical devices, contact Rolf Patberg and the Patberg Law Firm at 412-232-3500 or email Attorney Patberg at email@example.com.