Reprocessing of Reusable Medical Devices
What does it mean to reprocess a medical device? The Federal Food and Drug Administration defines reprocessing as a multi-step process that cleans and disinfects a device. Any medical products used on a patient will become contaminated with microorganisms. Single-use devices are disposed of after just one application. Some tools, however, are designed for multiple uses, so proper reprocessing is a vital part of patient safety.
What is a Reusable Device?
Reusable medical devices treat multiple patients. The FDA offers three classifications for reusable devices.
- Critical – come in contact with blood or sterile tissue like surgical forceps
- Semi-critical – come in contact with mucus membranes such as an endoscope
- Non-critical – come in contact with unbroken skin like a stethoscope
Each classification requires a different level of reprocessing and disinfection or sterilization. Some devices, such as critical surgical tools, require stringent cleaning and sterilization before reuse.
The Risk of Reusable Devices
Microorganisms need a medium to thrive. That is what makes multi-use devices like endoscopes such a risk. Biological debris like mucus, blood and tissue adhere to the surface of the tool. If not properly cleaned, the artifacts remain there, allowing bacteria and other pathogens to breed despite disinfection and sterilization.
When used again, that infectious agent transfers, causing cross-contamination and, potentially, leading to a healthcare-associated infection (HAI) or another type of adverse patient outcome.
Managing the Reprocessing
Healthcare facilities must take responsibility for managing the reprocessing of multi-use devices and reducing the risk of cross-contamination. Manufacturing companies, in turn, must provide evidence based instructions that these facilities can understand clearly and put into practice.
The FDA oversees both sides of the reprocessing formula. This agency reviews safety reports, looking for ways to improve the process. This includes reviewing the designs. The FDA has standards for device designs aimed to make the reprocessing more effective. For example:
- Devices must have smooth inner surfaces for lumens, the narrow inner channels
- They must disassemble and reassemble when there are multiple components
- They require clear identification of connecting accessories
The FDA also evaluates the premarket and postmarket information from manufacturers to help facilities find efficient ways to complete the reprocessing.
The goal of the Federal Food and Drug Administration is to create a collaborative network that improves patient safety and reduce the incidents of healthcare associated infections. Better reprocessing standards mean better patient outcomes and a healthy environment for the staff.