Hello readers! We are launching another blog series on reprocessing of reusable medical devices. The idea is to serve you with one-stop-shop contents on this topic.
Did you know that reprocessing usually involves more than one process? Did you know that each process also needs to be validated?
If you’ve already figured out the reprocessing mechanism for your products, then you’re one step closer to performing the validation; but, if you’re exploring the starting point, then you’ve arrived at the right platform. The intent of this blog is to introduce you to the main topic in a simplified manner. Let us begin with basics first!
- What is reprocessing?
As the name suggests, reprocessing means processing a used device with a series of activities to prepare it for reuse. Reprocessing is intended to remove blood stains or biological debris from tissues and to inactivate infectious microbes to prepare the devices for the next patient. This means that each medical device that is meant to be reused needs a reprocessing regimen of its own.
- What is a reusable medical device?
Reusable medical device is a device that healthcare providers can reprocess and reuse on multiple patients. Commonly used reusable medical devices include:
Reusable medical devices can be classified into three categories depending on the level of risk of infection:
- How are the medical devices re-processed?
Reprocessing medical devices is a daunting task in itself. It requires multiple resources, time and efforts to thoroughly reprocess a medical device for subsequent use. But the question is – What is the process to follow? Well, on a broader level, reprocessing involves three main steps:
Point-of-use cleaning normally starts in the operating room or nearby cleaning area to prevent the devices from drying. The devices receive initial decontamination and cleaning either by soaking, wiping, initial washing or wrapping in a damp cloth.
The devices are then transferred for thorough cleaning. Thorough cleaning can be manual, automated or both basis the recommendation of the original manufacturer.
After cleaning, the devices undergo disinfection and/or sterilization depending on the intended use, type of use and the materials used in their manufacturing.
- What is the role of a manufacturer?
Well, it all starts and ends with them!
First, the manufacturer needs to develop reprocessing instructions for the reusable devices, then they need to validate these instructions, and then they need to ensure that intended users follow these instructions correctly to protect the patient safety. The manufacturer must also continuously collect information from post-market activities for any issues that may occur from reprocessing of the devices.
Sounds quite a lot? The task list to set up this process correctly is endless, and it can overwhelm you at any point. That’s where we can help you! Reach us if you need help in figuring all this out. We can help you in strategizing the compliance activities, planning of the validation study, connecting with labs and managing the necessary documentation.
Drop an inquiry at contact@alceonconsulting.com or book a FREE consultation call from HERE.
In the next blog in this series will discuss worst-case selection.
