Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers
|Publication Date:||1 January 2010|
The scope of this TIR includes the following topics:
a) Design considerations: Assurance that a device can be safely and effectively reprocessed begins with the design of the device. Section 3 of the TIR describes categories of medical devices and the materials and other design characteristics that affect the ability of health care personnel to clean, disinfect, and/or sterilize devices adequately.
b) Decontamination: A device cannot be disinfected adequately or sterilized to an adequate sterility assurance level (SAL) if it cannot be cleaned thoroughly. Section 4 addresses variables associated with cleaning and other decontamination processes used in health care facilities, as well as the minimum information that the device manufacturer should supply to health care personnel.
c) Disinfection: Section 5 describes the levels of disinfection, the criteria for selecting chemical disinfectants, and the testing that device manufacturers should perform to establish the effectiveness of the disinfection processes recommended for their products.
d) Sterilization: Section 6 describes the sterilization processes commonly used in health care facilities, the minimum information that device manufacturers should provide with their products, and the procedures that device manufacturers should use to qualify the sterilization parameters that they recommend for their products.
This TIR also includes definitions of terms, a list of references, and annexes providing supplementary information.
This TIR does not cover the following topics:
a) the design, testing, and labeling of reusable textiles (see ANSI/AAMI PB70),
b) the design, testing, and labeling of devices intended and labeled for single use, or
c) the design, testing, and labeling of containment devices for reusable medical devices (see ANSI/AAMI ST77).
Although this TIR refers to water quality for cleaning and other elements of reprocessing, it does not address methods of producing or ensuring adequate water quality (see AAMI TIR34).