scope:

General

This technical information report (TIR) is a compilation of available information regarding test protocols, materials, test soils, and acceptance criteria that can be used by medical device manufacturers to validate cleaning processes for reusable medical devices.

Inclusions

This TIR covers the validation of cleaning processes for medical devices that are intended and labeled by the manufacturer for reprocessing and reuse. Such devices include those that are intended for routine reprocessing and reuse (e.g., surgical instruments) and certain implant accessories (e.g., orthopedic screws) that are provided as parts of sets and that are intended and labeled by the manufacturer for reprocessing if not used during a particular procedure.

The scope of this TIR Includes the following topics:

a) Device design and material considerations

b) Available cleaning processes

c) Test soils

d) Test methods

e) Test equipment

f) Acceptance criteria

g) Regulatory considerations

This TIR also provides numerous literature references and a sample cleaning validation outline.

Exclusions

This TIR does not cover the performance of procedures for cleaning reusable medical devices in health care facilities (see ANSI/AAMI ST79), nor does it cover procedures for reprocessing single-use medical devices and hemodialyzers in health care facilities (see FDA, 2000b; and ANSI/AAMI RD47).

The test protocols, test soils, and acceptance criteria described in this TIR do not necessarily apply to the validation of cleaning processes for medical devices contaminated with prions, such as the prion that causes Creutzfeldt-Jakob disease (CJD); such devices could require specialized processing steps. For information regarding the decontamination of devices exposed to prions, see ANSI/AAMI ST79, AORN (2011a), Favero and Bond (2001), and Rutala and Weber (2010), as well as the recommendations of the Centers for Disease Control and Prevention (http://www.cdc.gov/ncidod/dvrd/cjd/qa_cjd_infection_control.htm#reprocessed).