Description

AAMI TIR12 – Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers

This technical information report (TIR) provides guidance to medical device manufacturers, who are required to provide instructions that detail the processing steps from pre-treatment at the point of use through the terminal process and storage to accompany reusable and single-use medical devices that are processed by a health care facility prior to clinical use. In addition, greater detail is provided about the processes and resources that a health care facility can have for processing devices. This should provide further assistance to medical device manufacturers (MDMs) in developing their processing instructions.

Health care personnel have the responsibility to obtain and review manufacturers’ data and recommendations and to ensure that they have the necessary resources to follow manufacturers’ instructions thoroughly. This TIR can serve as a resource for identifying the questions health care personnel should ask manufacturers when considering a product for purchase or when devising a processing protocol for a product already being used.