Making sense of it all: sterilization, high-level disinfection and disposable medical devices

Community-based physicians rely on and commonly use critical medical devices in their practices, such as surgical instruments, biopsy forceps, suture scissors and staple removal instruments. Any instrument that punctures the skin, enters a sterile tissue or the vascular system, is considered a critical medical device.

While physicians are familiar with the use of these instruments, many may not be aware that they must be sterile at point of use. In other words, physicians must ensure that the item has not been contaminated or handled in any way to compromise its sterility. Taking the item directly out of a sterile package right before use is the only way to ensure the item hasn’t been contaminated. 

  1. Disposable medical devices: Single-use disposable items are packaged sterile by the manufacturer, and remain sterile until the package is opened at point of use. Once the item is used, it is discarded.
  2. Steam-sterilized reusable medical devices: Reusable medical devices are appropriately steam sterilized in an autoclave. Appropriate use of an autoclave means that all of the required parameters as described in the BC Ministry of Health’s best practice document must be met to ensure sterility of the item. For a complete description of the required parameters for steam sterilization, refer to the BC Ministry of Health’s Best Practice Guidelines for Cleaning, Disinfection and Sterilization of Critical and Semi-critical Medical Devices (December 2011). 

A common misunderstanding that peer assessors with the Physician Practice Enhancement Program encounter when working with physicians is around the practise of chemical sterilization for reusable medical devices, otherwise known as “the cold sterilant method.” Typically with this method, surgical instruments are submerged in a sterilant solution for a certain amount of time, removed with tongs and stored away in a drawer or wrapped in linen. 

Please note: This is not an acceptable practice for sterilizing reusable critical medical devices, because once the item is removed from the cold sterilant solution, it is no longer sterile and therefore cannot be sterile at point of use. 

When it comes to reusable critical medical devices and patient safety, all community-based physicians have a responsibility to review their current practices and ensure that they are meeting the requirements.