ANSI/AAMI PB70: Closing the Gap

Discussion during the recent AAMI meeting included the use of correct wording for these products. For example, there was general consensus to include head and boot covers, which are meant to provide liquid barrier protection, and to exclude head caps meant to contain hair and foot covers meant to keep the environment free of contamination. After the October 16 AAMI meeting, the task groups will be working on better clarifying the purpose, definitions, barrier level requirements, and critical areas throughout the entire document. Many agreed diagrams for each product type should be included in the informative section similar to the diagram that already exists for surgical and isolations gowns. In addition, AAMI TIR11:2005/(R)2015 “Selection and use of protective apparel and surgical drapes in health care facilities” will soon be under revision to guide healthcare personnel on the appropriate selection and use of the products added to PB70. The revision of PB70 and TIR 11 should publish around the same time. Since the standard is currently under revision and has not gone through the balloting process, the information presented here may change once the standard revises.
Source: MDDI - Category: Medical Devices Authors: Tags: Regulatory and Compliance Source Type: news