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STERILIZATION PRACTICES
JULY 1994, VOL 60, NO I
believe it is important for readers to be aware of the advantages and benefits of these two standards. No one can deny the increased importance that surgical gowns serve in protecting health care professionals. Even before the advent of the Occupational Safety and Health Administration (OSHA) bloodbome pathogens standard, the health care community was looking for ways to accurately demonstrate how well gown materials prevent passage of blood and body fluids that contain potentially infectious viruses. In the past, the industry relied upon outdated testing techniques that were incapable of measuring resistance to viral penetration. Essentially, medical practitioners were dependent on apparel manufacturers’claims when judging gown barrier efficacy. Previous attempts by other groups (eg, AAMI) to define a standard test methodology failed, primarily because vested manufacturer interests prevented a consensus from being achieved. The ASTM has addressed this need with its long-standing history as an effective developer of standard test methods. Recognizing the needs of the health care community, particularly in light of the OSHA rule, the protective clothing committee organized a well-represented subcommittee to develop test methods that would assist apparel manufacturers and health care professionals in testingbelecting surgical gowns and other medical apparel. The results of this effort are two new standard test methods: the ASTM ES 21, which measures the penetration resistance of protective clothing materials to synthetic blood and is intended to be used as a screening method for fluid barrier resistance, and the ASTM ES 22, which is a more
sophisticated test that measures viral penetration of protective clothing materials using a surrogate bacteriophage and sensitive assay procedure. In these tests, fabrics are exposed to pressures similar to those in the elbow lean test, long regarded as typical of OR pressures. The ASTM went to great lengths to show how well the standards correlate with actual OR pressures. These tests do not purport to recreate every stress that might occur in the OR; however, they do create a level playing field for comparing the protective baseline performance of fabrics. As such, it is up to the user to decide when to use this level of performance. The ASTM test methods have achieved recognition from several groups, including A M , the American Industrial Hygiene Association, and the National Fire Protection Association. The ASTM is in the process of improving these methods to make them more useful and to provide a more detailed description of the required procedures. We continue to welcome input from informed infection control experts during the refinement of these two test methods. JEFFREY 0. STULL PRESIDENT AUSTIN, TEX
reason for tracking the number of times the wrappers have been laundered, as this practice nomially is only required for quality assurance purposes for materials said to possess barrier capabilitie~.~ I do not believe that a wrapper made of 140-count muslin or any other readily permeable material can be considered appropriate for use as a barrier wrapper because the quality of this material does not satisfy the requirements delineated in the “Recommended practices for selection and use of packaging system~.’’~ It is not merely the number of layers used in wrapping that accounts for the barrier attributes, but rather the barrier capability of the material itself. A double wrapper is essential for packs destined for areas in the hospital in which asepsis is practiced. If the primary purpose of the outer wrapper is to protect the pack from dust before it is brought into the clean zone: how necessary is it that this outer wrapper be of a barrier quality? If barrier-quality packaging materials are used as the first (ie, single) layer, there is no reason the second or outer wrapper cannot be made of a readily permeable material. NATHAN 1. BELKIN PHD CLEARWATER, Fu
STERILIZA TlON PRACTICES egarding the “Clinical Issues” in the April 1994 issue of the Journal, I believe the answer to the question regarding double wrapping with double-layered, 140-count muslin warrants edification. Readily permeable, reusable material has been identified as an ineffective barrier even when multiple layers are used.’ I believe, therefore, that there is no
The Journal welcomes letters for its “Letters’column. Letters must refer to Journal arficles or columns pub/ished within the preceding two months. A// letters are subject to editing before publication. Authors may be given the opportunity to respond. Each letter must contain the reader’s name, credentials if applicable (eg, RN, SSN, CNOR), position or title, employer, ond employer’s address. Submit a// correspondence to AORN Journal, letters, 2 I70 S Parker Rd, Suite 300, Denver, CO 80231-571I .
lNTERNATlONAL PERSONNEL PROTECTION, INC
R
25 AORN JOURNAL
believe it is important for readers to be aware of the advantages and benefits of these two standards. No one can deny the increased importance that surgical gowns serve in protecting health care professionals. Even before the advent of the Occupational Safety and Health Administration (OSHA) bloodbome pathogens standard, the health care community was looking for ways to accurately demonstrate how well gown materials prevent passage of blood and body fluids that contain potentially infectious viruses. In the past, the industry relied upon outdated testing techniques that were incapable of measuring resistance to viral penetration. Essentially, medical practitioners were dependent on apparel manufacturers’claims when judging gown barrier efficacy. Previous attempts by other groups (eg, AAMI) to define a standard test methodology failed, primarily because vested manufacturer interests prevented a consensus from being achieved. The ASTM has addressed this need with its long-standing history as an effective developer of standard test methods. Recognizing the needs of the health care community, particularly in light of the OSHA rule, the protective clothing committee organized a well-represented subcommittee to develop test methods that would assist apparel manufacturers and health care professionals in testingbelecting surgical gowns and other medical apparel. The results of this effort are two new standard test methods: the ASTM ES 21, which measures the penetration resistance of protective clothing materials to synthetic blood and is intended to be used as a screening method for fluid barrier resistance, and the ASTM ES 22, which is a more
sophisticated test that measures viral penetration of protective clothing materials using a surrogate bacteriophage and sensitive assay procedure. In these tests, fabrics are exposed to pressures similar to those in the elbow lean test, long regarded as typical of OR pressures. The ASTM went to great lengths to show how well the standards correlate with actual OR pressures. These tests do not purport to recreate every stress that might occur in the OR; however, they do create a level playing field for comparing the protective baseline performance of fabrics. As such, it is up to the user to decide when to use this level of performance. The ASTM test methods have achieved recognition from several groups, including A M , the American Industrial Hygiene Association, and the National Fire Protection Association. The ASTM is in the process of improving these methods to make them more useful and to provide a more detailed description of the required procedures. We continue to welcome input from informed infection control experts during the refinement of these two test methods. JEFFREY 0. STULL PRESIDENT AUSTIN, TEX
reason for tracking the number of times the wrappers have been laundered, as this practice nomially is only required for quality assurance purposes for materials said to possess barrier capabilitie~.~ I do not believe that a wrapper made of 140-count muslin or any other readily permeable material can be considered appropriate for use as a barrier wrapper because the quality of this material does not satisfy the requirements delineated in the “Recommended practices for selection and use of packaging system~.’’~ It is not merely the number of layers used in wrapping that accounts for the barrier attributes, but rather the barrier capability of the material itself. A double wrapper is essential for packs destined for areas in the hospital in which asepsis is practiced. If the primary purpose of the outer wrapper is to protect the pack from dust before it is brought into the clean zone: how necessary is it that this outer wrapper be of a barrier quality? If barrier-quality packaging materials are used as the first (ie, single) layer, there is no reason the second or outer wrapper cannot be made of a readily permeable material. NATHAN 1. BELKIN PHD CLEARWATER, Fu
STERILIZA TlON PRACTICES egarding the “Clinical Issues” in the April 1994 issue of the Journal, I believe the answer to the question regarding double wrapping with double-layered, 140-count muslin warrants edification. Readily permeable, reusable material has been identified as an ineffective barrier even when multiple layers are used.’ I believe, therefore, that there is no
The Journal welcomes letters for its “Letters’column. Letters must refer to Journal arficles or columns pub/ished within the preceding two months. A// letters are subject to editing before publication. Authors may be given the opportunity to respond. Each letter must contain the reader’s name, credentials if applicable (eg, RN, SSN, CNOR), position or title, employer, ond employer’s address. Submit a// correspondence to AORN Journal, letters, 2 I70 S Parker Rd, Suite 300, Denver, CO 80231-571I .
lNTERNATlONAL PERSONNEL PROTECTION, INC
R
25 AORN JOURNAL