The Principles of Medical Device Decontamination

Terminology and Definitions

Preparation of medical devices. Activity to prepare a new or used health care product for its intended use. Organisation and/or individual with the responsibility of carrying out actions necessary to prepare a new or reusable health care product for its intended use. Activities undertaken to demonstrate that utilities, equipment, and methods or modes are suitable for their intended use and perform properly. Process for verification that the proposed specification for the facility, equipment, or system meets the expectation for the intended use. Process of establishing by objective evidence that all key aspects of the process equipment and ancillary system installation comply with the approved specification. Process of obtaining and documenting evidence that installed equipment operates within predetermined limits when used in accordance with its operational procedures. Process of establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements. Those working in decontamination/reprocessing who are responsible for ensuring reusable medical devices are cleaned, disinfected, function tested, packaged and sterilised in accordance with extant guidance, ready for use.

Processing

Processor

Qualification

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Provider

176

@ 2025 Central Sterilising Club. All rights reserved. Do Not duplicate