Quality of Steam Used in Medical Device Reprocessing

This publication was initially prepared in response to a number of complex steam support requests received by the CERDM. It is intended to provide a tool for consolidating and sharing expertise on the production and distribution of steam of acceptable quality and purity for MDR. The goal of sharing this knowledge is to reduce the recurrence of complex steam problems that generate significant costs, and to improve the quality of MDR.

This document supplements the information found in practice guides previously published by the INSPQ’s CERDM. It first presents the standards and reference documents on the quality and purity of steam used for MDR. It then provides a definition of steam and specifies the type sought for MDR. Lastly, the guide describes practical means for producing and distributing steam for MDR in medical device reprocessing units (MDRUs). It also presents a quality assurance program (QAP) for ensuring that the recommended steam purity and quality standards are met.

The present guide will help to harmonize and ensure the quality of MDR-related processes throughout Quebec’s HSSN institutions.

It reflects the knowledge of the INSPQ and the standards generally applicable to MDR at the time of publication. Given the development of knowledge in the field of MDR, stakeholders must continually update their knowledge through, for example, continuing education programs. They must also keep abreast of new applicable standards and guidelines.

To simplify the text, the term medical device (MD) always refers to a reusable critical medical device. Similarly, the term "water" refers to water in its liquid phase, and the term "steam", to water in its gas phase.