Sterilization and disinfection of medical devices

In today's thematic review, we focus on the requirements for organizing and conducting the decontamination of medical devices.

Classification of medical devices

Medical equipment and medical devices ("MDs") are divided into three groups, depending on the degree of contact with the human body and the risk of infection of the patient:

·         Critical MDs - instruments and equipment that are in direct contact with tissues, cavities, or bloodstream of a person;

·         Semi-critical MDs - tools and equipment in contact with intact mucous membranes;

·         Non-critical MDs - instruments, equipment, and care items in contact with intact skin.

Requirements for the decontamination of medical devices

At the same time, each group of MDs has its requirements for sterilization and disinfection. Thus, according to the Sanitary and Epidemiological Requirements for the organization and conduct of disinfection, disinsection, and deratization ("Sanitary Rules"), MDs, depending on their relevance to a group, are subject to the following treatment:

•      Critical MDs – to sterilization;

•      Semi-critical MDs – to disinfection of high and medium levels;

•      Non-critical MDs – to disinfection of medium and low levels.

Obviously, the quality of decontamination of MDs depends on the type and level of sterilization/disinfection operations.

For example, in the process of sterilization, all types of pathogens, including spores, are completely destroyed.

Whereas during high-level disinfection, all pathogenic and opportunistic microorganisms are destroyed, and the number of spores decreases.

When disinfecting of the average level, bacteria (including Mycobacterium tuberculosis), viruses (including polioviruses), fungi are destroyed, but spores are not destroyed.

And with low-level disinfection, bacteria, some fungi, viruses are destroyed, but it is not effective against resistant bacteria such as Mycobacterium tuberculosis.

Sanitary Rules contain both methods and detailed requirements for sterilization, pre-sterilization treatment and disinfection of MDs, as well as information on the types of MDs to which one or another method of decontamination is applied.

For example, the Sanitary Rules provide for the following methods of sterilization/disinfection of MDs:

·         chemical method (by immersion in disinfectant solutions);

·         plasma method (based on hydrogen peroxide);

·         steam method (by exposure to water-saturated steam under excess pressure);

·         air method (by exposure to dry hot air);

·         infrared method (using infrared light);

·         gas method (using ethylene oxide, formaldehyde, ozone);

·         glasperlene method (by injecting high temperature and, accordingly, high pressure).

Requirements for instructions for use for medical devices

Apparently, the Sanitary Rules cannot cover all the nuances of sterilization, pre-sterilization treatment, and disinfection of MDs and therefore contain the most general requirements.

In this regard, the legislation also establishes that the instructions for the use for MDs must contain the following mandatory information:

·         information on the method of sterilization of MDs (if the MD is supplied non-sterile - indicating the need to sterilize it before use);

·         information on the proper processing of MDs for their reuse, including cleaning, disinfection, packaging, and, if necessary, the method of resterilization (if the MD is intended for reusable use).

Information contained in this Review is of general nature and cannot be used as legal advice or recommendation. Please note that Kazakhstan is an emerging economy, and its legislation and legal system are in constant development. Should you have any questions or want to discuss matters addressed in this Review, please contact us.