Single-use Medical Devices: To Reuse or Toss?
Reduce. Reuse. Recycle. That is the EPA’s motto for protecting our environment, but this adage doesn’t always apply to the medical waste field.
Medical waste, and more specifically, regulated medical waste (RMW), has a different set of rules when it comes to disposal and reusing because of the very nature of this type of waste. The Medical Waste Tracking Act of 1988 clearly defines items that fall under this category, including potentially infectious materials. One of the more debated topics in the medical waste removal field, however, is how to process single-use medical devices.
The term itself is a bit of a misnomer; to label a device as single-use is at the sole discretion of the manufacturer. The FDA doesn’t exactly make it much clearer what constitutes a single-use device. An institution that reuses a single-use device should be able to prove that the device can be properly cleaned and sterilized, that the physical characteristics or quality of the device will not be compromised, and that the device remains safe and effective for the intended clinical use.
What, specifically, is considered a single-use device? The FDA has an exhaustive list of items, each broken out into different classes. Each class represents a risk, I being low risk and II being medium risk. The U.S. FDA Class I non-invasive devices include sequential compression sleeves, tourniquet cuffs, and pulse oximeter sensors, whereas Class II includes surgical devices including Ear, Nose and Throat microdebriders and cautery electrodes. Class III is not currently recommended for reprocessing due to the nature of the risk.
Reprocessing is strictly an economic choice, but we’ve come a long way since one-use devices came to be in the 1970s. With the advent of HIV, newer materials, and other communicable diseases, many hospitals have switched to the idea that certain devices should only be single-use.
The takeaway here is that the kind of device will determine whether it’s reprocessed or treated as medical waste and disposed of.
Fast Facts
- All evidence shows that single-use devices reprocessed in accordance with FDA’s requirements are safe and effective.
- FDA rigorously regulates the reprocessing industry.
- Besides being just as safe as original equipment, reprocessing keeps tons of medical waste from filling community landfills, and saves money for local hospitals.
MedXwaste can help your facility understand the ins and outs of single-use devices and how to properly deal with them. We can help you maintain compliance by controlling potential infection caused by reprocessed SUDs. Our OSHA training program will give you the tools to manage every aspect of OSHA compliance. With our reduced costs, there is not a more complete & affordable program for your facility.
Contact MedXwaste today to speak to a representative about our services and programs.
