Published By : 23 Mar 2016 | Published By : QYRESEARCH
Most medical devices that are meant for reprocessing are intended for single-use reprocessing. Very few devices are enabled for multiple-use reprocessing. Single-use devices involves cleaning, disinfection, sterilization, and testing. After the testing process, the device is remanufactured and packaged. This stage may or may not involve re-labelling. The reprocessed device is then moved back into the distribution stream for use. There are a number of rather high standards that a medical device must meet after being reprocessed, in order to be used again. These guidelines are set by major bodies such as the United States FDA. According to the FDA, a medical device has to meet extremely tight specification when it comes to being cleaned and kept functional. Reprocessing of single-use medical devices is currently a global practice that involves regional and international governing bodies from North America, Asia Pacific, Europe, and Africa. In the United States, only 2.0% of the single-use medical devices are actually deemed worthy of reprocessing, which is usually performed by a highly qualified third-party vendor.
FDA Control on Third-party Reprocessing Intensifies
According to the Association for the Advancement of Medical Instrumentation, the USFDA is currently trying to get more data on all the third-party vendors that are concerned with medical devices and their remanufacturing, refurbishment, reprocessing, reconditioning, and remarketing. A public meeting will be held on the same later in 2016. The motive of the FDA is to pinpoint the safety concerns regarding the reprocessing of medical devices such as radiation-emitting devices and endoscopes. Additionally, the FDA is interested in finding out what obstacles the third-party vendors are experiencing in the reprocessing of medical devices.
Reprocessing Training Pushed for Mandatory Use
Healthcare professionals are pushing for a stronger hand towards training more individuals for reprocessing of medical devices. They are stressing on the fact that the costs incurred for the manufacture of most medical devices is becoming too high to maintain medical expenditure within acceptable levels. The experts are also not restricting the reprocessing of medical devices to simple devices such as duodenoscopes, they also want to extend the processes to more sophisticated devices.