How To Confirm The Effectiveness Of The Sterilization Process For Reusable Medical Devices?

Reusable medical devices refer to medical equipment that can be reused to provide diagnosis and treatment for patients. Common reusable medical devices include surgical instruments, puncture needles, laparoscopes, etc.

When in use, reusable medical devices may be contaminated by blood, human tissue, and microorganisms. To avoid the risk of patient allergies and infections caused by contamination, reusable medical devices undergo a "reprocessing" process, which is a detailed multi-step process that typically includes cleaning, disinfection, and/or sterilization.

In this article, we will talk about the sterilization process of reusable medical devices. If the "reprocessing" process of reusable instruments involves sterilization, then in order to ensure the safety of product use, it is necessary to ensure the effectiveness of the sterilization process, usually determined by analyzing the comparison of recovered bacterial count and process testing cycle results. In general, the conduct of sterilization tests should meet the following basic requirements:

The amount of recovered bacteria should be greater than or equal to 10 ^ 6 CFU/piece.

Residual bacterial spores are recovered by washing, wiping, or rinsing with eluent. The recovery rate can be improved through methods such as mechanical shaking, ultrasound, and repeated washing with eluent.

After a complete sterilization process, the sample should be treated with specific elution techniques to recover all residual bacterial spores on the instrument.

At least 5 instruments should be used for one process testing cycle, or one instrument should be used for at least 5 consecutive process testing cycles. If all pass, it proves that the sterilization process is effective.

Personnel engaged in this standard testing should have an educational background in microbiology or related professional knowledge.

Aseptic testing and microbiological limit testing should comply with the corresponding requirements of Part IV of the Pharmacopoeia of the People's Republic of China (2015 edition).