3 AAMI Levels and Surgical Gowns: Know if You’re Protected

AAMI Levels and Surgical Gowns:
Know if You’re Protected
(An Online Continuing Education Activity)
OVERV IEW
Preventing disease transmission in patients and healthcare workers has taken on greater
significance in today’s healthcare environment with the emergence of new pathogens,
multi-drug resistant organisms, and increased economic pressures to reduce healthcareassociated
infections. During a surgical procedure, both the patient and members of the
surgical team are at risk for transmission of infectious agents, not only through direct
contact with blood and body fluids, but also through bacterial penetration of barrier fabrics.
Therefore, surgical barrier materials have two purposes: they must protect the patient
from exposure to microorganisms that may be present in the patient’s own microbial flora,
the operating Room (OR) environment, or on members of the surgical team; and they
must protect the surgical team from microorganisms that may be shed by the patient. The
selection and use of surgical gowns are essential components of an effective infection
prevention program; therefore, perioperative nurses must be knowledgeable about barrier
fabric qualities in order to select and use gowns appropriately in the OR practice setting.
This continuing education activity will provide a review of the key considerations for the
appropriate selection and use of surgical gowns as an infection prevention measure
for both patients and the surgical team. The rationale for the use of surgical gowns in
providing an effective barrier to disease transmission will be discussed. Standards and
guidelines pertaining to the selection and use of surgical gowns published by various
federal agencies and professional organizations will be reviewed. The Association for the
Advancement of Medical Instrumentation (AAMI) standard, Liquid Barrier Performance
and Classification of Protective Apparel and Drapes Intended for Use in Health Care
Facilities (AAMI/ANSI PB70), that provides an objective standard to select the proper
level of protection needed for specific procedures, will be highlighted. Key criteria in the
appropriate selection and use of surgical gowns will be outlined. Finally, a case study will
provide the participant with the opportunity to synthesize the information and evaluate a
workplace scenario related to surgical gown selection and use.
OBJECTIVES
After completing this continuing nursing education activity, the participant should be able
to:
1. Summarize the clinical rationale for the use of surgical gowns related to barrier
protection.
2. Discuss regulatory and professional standards and guidelines pertaining to the
selection and use of surgical gowns.
3. Describe standardized industry tests used to evaluate the effectiveness of barrier
materials, with emphasis on tests specified in the ANSI/AAMI PB70 standard.
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4. Identify key criteria used for the appropriate selection and use of surgical gowns.
5. Critique a clinical case study regarding the selection and use of surgical gowns.
INTENDED AUDIENCE
This continuing nursing education activity is intended for use by perioperative nurses and
surgical technologists who are interested in learning more about clinical implications of
barrier fabrics and how to appropriately select gowns for use in the OR, based on current
standards and selection criteria.
Credit/Credit Information
State Board Approval for Nurses
Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing,
Provider Number CEP14944, for 2.0 contact hours.
Obtaining full credit for this offering depends upon attendance, regardless of
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The certificate of course completion issued at the conclusion of this course
must be retained in the participant’s records for at least four (4) years as proof of
attendance.
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Association for Continuing Education and Training (IACET).
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programs that qualify under the ANSI/IACET Standard.
• Pfiedler Enterprises is authorized by IACET to offer 0.2 CEUs for this program.
Release and Expiration Date:
This continuing education activity was planned and provided in accordance with
accreditation criteria. This material was originally produced in August 2014 and can
no longer be used after August 2016 without being updated; therefore, this continuing
education activity expires August 2016.
Disclaimer
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Support
Funds to support this activity have been provided by Cardinal Health
Authors/Planning Committee/Reviewer
Rose Moss, RN, MN, CNOR                    C asa Grande, AZ
Nurse Consultant/Author/Planning Committee
Judith I. Pfister, RN, BSN, MBA Aurora, CO
Program Manager/Planning Committee
Pfiedler Enterprises
Julia A. Kneedler, RN, MS, EdD                Aurora, CO
Program Manager/Reviewer
Pfiedler Enterprises
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Disclosure includes relevant financial relationships with commercial interests related to
the subject matter that may be presented in this continuing education activity. “Relevant
financial relationships” are those in any amount, occurring within the past 12 months
that create a conflict of interest. A commercial interest is any entity producing,
marketing, reselling, or distributing health care goods or services consumed by, or used
on, patients.
Activity Authors/ Planning Committee/Reviewer
Rose Moss, RN, MN, CNOR
No conflict of interest
Judith I. Pfister, MBA, RN
Co-owner of company that receives grant funds from commercial entities
Julia A. Kneedler, EdD, RN
Co-owner of company that receives grant funds from commercial entities
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INTRODUCTION
Prevention of disease transmission in patients and personnel has taken on greater
significance today, as health-care professionals are continually challenged by new
pathogens and multi-drug resistant organisms, as well as increased economic pressures
to reduce healthcare-associated infections. The inherent nature of the perioperative
practice setting places both patients and members of the surgical team at greater risk for
exposure to infectious agents. For every surgical patient, one of the expected outcomes
is that he/she is free from signs and symptoms of infection.1 Today, the development of a
Surgical Site Infection (SSI) is a common complication and represents one of the leading
causes of postoperative morbidity and mortality; SSIs also may be associated with
enormous additional costs for hospitals and health-care systems.2 For members of the
surgical team, an exposure incident can result in morbidity, lost wages and productivity,
and increased costs of care. As a safety advocate, protecting patients and safeguarding
perioperative team members from transmission of potentially infectious agents continue
to be a primary focus of the perioperative nurse.3 The appropriate use of surgical barrier
materials plays a key role in reducing the risk for disease transmission. However,
because the barrier quality of surgical gowns varies, perioperative personnel must select
the appropriate gown based on its planned use and anticipated exposure to blood and
bodily fluids.
RATIONALE FOR THE USE OF SURGICAL GOWNS
Surgical gowns are an important link in the prevention of disease transmission for
patients and OR staff members because they serve a critically important dual purpose
in the operating room. Not only do they protect the patient from microorganisms that
may be shed by the patient’s own skin and by members of the surgical team, they
also protect members of the surgical team from potentially infectious microorganisms
that may be harbored by the patient. This is especially important in today’s era of
the hazards associated with the transmission of blood-borne pathogens (eg, Human
Immunodeficiency Virus (HIV), Hepatitis B and C Viruses (HBV and HCV), and Other
Potentially Infectious Materials (OPIM).
Wearing surgical gowns and other apparel (eg, surgical masks, gloves) is vital because
there will always be microorganisms on or in the human skin, even after conducting
strict hygienic and antiseptic procedures. Microorganisms are also found on the attire of
health-care workers. A study conducted on bacterial contamination of home-laundered
uniforms began by culturing uniforms worn at the beginning of the shift; 39% of the
uniforms identified as “clean” had one or more microorganisms (eg, vancomycin-resistant
enterococci, Methicillin-resistant Staphylococcus aureus, Clostridium difficile) identified.4
The uniforms were tested again at the end of the shift, at which time 54% had one or
more microorganisms; some that were positive at the beginning of the shift were negative
at the end of the shift. In one demonstration, bacillus spores were transferred from
health-care providers’ aprons and cotton uniforms to a mock patient.
The importance of barrier protection in minimizing the risk of disease transmission to the
patient and staff is widely accepted and is supported by various regulations, standards,
and guidelines.
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STANDARDS AND GUIDELINES
Federal agencies and several professional organizations that have published standards
and guidelines pertaining to the selection and use of surgical gowns, include:
• Occupational Safety and Health Administration (OSHA);
• Centers for Disease Control and Prevention (CDC);
• United States Food and Drug Administration (FDA);
• Association of periOperative Registered Nurses (AORN);
• ASTM International (formerly the American Society for Testing and Materials);
• American National Standards Institute (ANSI);
• Association for the Advancement of Medical Instrumentation (AAMI); and
• American Association of Textile Chemists and Colorists (AATCC).
Each of these guidelines is described in greater detail below, with an emphasis on the
AAMI/ANSI PB70 standard.
Occupational Safety and Health Administration (OSHA)
Because engineering and work practice controls cannot prevent all occupational
exposure to blood-borne pathogens, OSHA’s blood-borne pathogens standard also
requires employers to provide appropriate Personal Protective Equipment (PPE),
including gowns, to workers at risk of workplace exposure to blood-borne pathogens.
PPE is defined as “specialized clothing or equipment worn by an employee for protection
against infectious materials.” Under the OSHA standard, personal protective equipment
is considered “appropriate” only if it does not permit blood or other potentially infectious
materials to pass through to or reach the employee’s work clothes, street clothes,
undergarments, skin, eyes, mouth, or other mucous membranes under normal conditions
of use and for the duration of time for which the protective equipment will be used. The
type and characteristics of protective body clothing provided must be commensurate with
the “task and degree of exposure anticipated.” 5
Centers for Disease Control and Prevention (CDC)
The CDC has provided a number of recommendations and guidelines, based on current
clinical research, related to the appropriate use of protective clothing, including personal
protective equipment intended to decrease transmission of blood-borne pathogens
and other related infectious diseases: In the Guideline for Prevention of Surgical Site
Infection, 1999 the CDC’s Hospital Infection Control Practices Advisory Committee
(HICPAC) recommends, among other things, that sterile team members wear surgical
gowns that are effective barriers when wet (ie, materials that resist liquid penetration).6
Although gowns that are impermeable to liquids and viruses are preferred, HICPAC
recognizes that only gowns reinforced with films, coatings, or membranes appear to
meet ASTM standards for impermeability. In the 2007 Guideline for Isolation Precautions:
Preventing Transmission of Infectious Agents in Health-care Settings, the CDC defines
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Standard Precautions as a group of infection-prevention practices that apply to all patients,
regardless of suspected or confirmed infection status, in any setting in which health care
is delivered; it includes the use of gowns.7 The application of Standard Precautions during
patient care is determined by the nature of the health-care worker and patient interaction
and the extent of anticipated blood, body fluid, or pathogen exposure. For gowns, this
includes during procedures and patient-care activities when contact of clothing and/or
exposed skin with blood/body fluids, secretions, and excretions is anticipated.
United States Food and Drug Administration (FDA)
The FDA regulates surgical gowns as medical devices. Manufacturers of new or modified
surgical gowns must obtain FDA clearance to market their products. As part of the
premarket clearance 510(k) process, manufacturers provide data to the FDA regarding
the safety and efficacy of their products. (The FDA’s Guidance on Premarket Notification
[510(k)] Submissions for Surgical Gowns and Surgical Drapes8 details the information that
must be provided by manufacturers.) The FDA also mandates that Good Manufacturing
Practices (GMPs) must be employed in the manufacture and commercial reprocessing
of surgical barrier products, and that they must be labeled in accordance with FDA
requirements.
Surgical gowns also are subject to the FDA’s medical device reporting requirements. The
agency has ruled that strikethrough events are reportable under medical device reporting
regulations if strikethrough of a gown labeled as protective (eg, repellent, resistant, liquidproof,
or impervious) caused or may have contributed to a death or serious injury.
Association of periOperative Registered Nurses (AORN)
AORN’s mission is to support registered nurses in achieving optimal outcomes for
patients undergoing operative and other invasive procedures. Every year, the Association
publishes Perioperative Standards and Recommended Practices, which is a compilation
of recommendations based on the principles of microbiology, scientific literature, research,
and the opinions of experts. Each recommended practice is reviewed and revised
periodically. The current “Recommended Practices for Sterile Technique” emphasize
the need to evaluate product safety and performance based on the planned use (ie, the
resistance to penetration by blood and other body fluids, as well as wearer preferences
such as comfort) and its anticipated exposure to blood and body fluids.9 It elaborates on
the need to address barrier effectiveness, resistance to tears, punctures, and abrasions;
seam strength; linting; function, and flexibility, and sizing in the selection and use of
surgical gowns.
For surgical gowns, AORN’s current recommended practices include, but are not limited
to, the following recommendations and interpretive statements:
• Prior to purchase or use, surgical gowns to be used in the perioperative setting
should be evaluated for safety, efficacy, and cost.
o Surgical gowns should be evaluated and selected for use based on:
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 Compliance with federal, state, and local regulations as well
as standards-setting bodies;
 Environmental considerations;
 Product-specific requirements;
 Procedure-related requirements;
 Patient-related; and
 End-user requirements and preferences.
o Surgical gowns must provide a barrier and should be resistant to
punctures, and abrasions.
o The seams and points of attachments of surgical gowns should
minimize penetration of liquids and the passage of potential
contaminants.
o Surgical gowns should be non-abrasive and non-toxic.
o The barrier materials used for surgical gowns should be as lint free as
possible.
o Surgical gowns should be functional and flexible.
o Perioperative personnel should select and use surgical gowns for a
procedure according to the barrier performance class of the product as
indicated on the label and the anticipated degree of exposure to blood,
body fluids, and other potentially infectious materials.
 Surgical gowns are labeled by the manufacturer with the
level of performance as determined by the barrier properties
of the area of the gown where direct contact with blood, body
fluids, and other potentially infectious materials is most likely
to occur. (This is discussed in greater detail below.)
ASTM International (formerly the American Society for Testing and Materials)
ASTM International is globally recognized in the development of international voluntary
consensus standards.10 It establishes evaluative test methods for manufacturers as
a means of measuring critical parameters for health-care or consumer products. If
appropriate, limits are established and requirements are defined in product-specific
standards. ASTM has published a number of standards pertaining to the safety and
efficacy of barrier materials, many of which are described in the following pages.
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American National Standards Institute (ANSI)
ANSI has served in its role as administrator and coordinator of the United States private
sector voluntary standardization system for over 90 years. 11 ANSI was founded in 1918
by five engineering societies and three government agencies; it remains a private,
nonprofit membership organization supported by a diverse community of both public
and private sector organizations. ANSI facilitates the development of American National
Standards (ANS) by accrediting the procedures of standards developing organizations
(SDOs). These groups work cooperatively to develop voluntary national consensus
standards. Accreditation by ANSI signifies that the procedures used by the standards
body in connection with the development of American National Standards meet the
Institute’s essential requirements for openness, balance, consensus and due process.
Association for the Advancement of Medical Instrumentation (AAMI)
AAMI, a nonprofit organization founded in 1967, is a unique alliance of approximately
7,000 healthcare technology professionals united by one key mission: to support the
healthcare community in the development, management, and use of safe and effective
medical technology.12 AAMI fulfills this mission through continuing education activities;
certification of healthcare technical specialists; and publication of various technical
documents, periodicals, software, and books. AAMI continues to be the primary source
of consensus and timely information on medical instrumentation and technology and
this is the primary resource for the industry, professions, and government for both
national and international standards.
American Association of Textile Chemists and Colorists (AATCC)
The AATCC, founded in 1921,continues to evolve to meet the needs of personnel in
the ever-changing textile and materials industries.13 Today, the AATCC provides test
method development, quality control materials, education, and professional networking
for a global audience. AATCC is also recognized internationally for its standard methods
of testing fibers and fabrics, in order to measure and evaluate various performance
characteristics, including appearance, colorfastness, soil release, dimensional change,
and water resistance. New and updated test methods are published annually in its
technical manual.
AAMI STANDARD FOR CLASSIFICATION OF GOWNS
The ANSI/AAMIPB70: 2012 - Liquid Barrier Performance and Classification of Protective
Apparel and Drapes Intended for Use in Health Care Facilities establishes the minimum
barrier performance requirements, a classification system, and associated labeling
requirements for protective apparel intended for use in health care facilities.14 It provides
examples of expected use conditions and procedural applications for the selection of
materials for surgical gowns based on the required level of barrier protection. As noted
above, surgical gowns must be labeled from least protective to most protective by the
manufacturer with the gown’s level of performance, as determined by the barrier properties
of the area of the gown where direct contact with blood, body fluids, and other
potentially infectious materials is most likely to occur. For example, short procedures
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during which there is little or no anticipated exposure to blood or body fluids can be completed
successfully using a surgical gown with minimal barrier protection. As the complexity and
length of the planned procedure increases, there may be increased potential for exposure to
bloodborne pathogens, and it would be prudent to select a gown with greater barrier capability.
Table 1 outlines examples of surgical/invasive procedures and the barrier performance classification
levels based on the level of on the anticipated blood and body fluid exposure.
Table 1 – Relationships between Barrier Performance and Anticipated Risks of
Exposure*
ANSI/AAMI
PB70
Barrier
Risk of
Exposure:
Fluid Amount
Risk of
Exposure:
Fluid Spray
or Splash
Risk of
Exposure:
Pressure on
Gown
Examples of Procedures with Anticipated
Exposure Risks
Level 1 Minimal Minimal Minimal
 Simple excisional biopsies
 Excision of “lumps and bumps”
 Ophthalmological procedures
 Simple Ear, Nose, and Throat (ENT)
procedures
Level 2 Low Low Low  Tonsillectomies and adenoidectomies
 Endoscopic gastrointestinal procedures
 Simple orthopedic procedures during
which tourniquets are used
 Open hernia repair
 Minimally Invasive Surgery (MIS)
 Interventional radiology or catheter
laboratory procedures
Level 3 Moderate Moderate Moderate  Mastectomies
 Arthroscopic orthopedic procedures
 Endoscopic urological procedures (eg,
Transurethral Prostate Resections
[TURP])
 Open gastrointestinal and genitourinary
procedures
Level 4 High High High  Any procedure in which the surgeon’s
hands and arms are in a body cavity
 Orthopedic procedures during which
tourniquets are not used
 Open cardiovascular or thoracic
procedures
 Trauma procedures
 Cesarean sections
* NOTE: The examples listed in this table are not meant to be all-inclusive for every situation that may be
encountered in any health care facility; nor are they a substitute for professional judgment and experience.
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It should be noted that this standard does not cover:
• Protective apparel for the:
o Hands, such as surgical gloves, patient examination gloves, and other
medical gloves;
o Head, face, and eyes, such as goggles, face shields, surgical caps or
hoods, surgical masks, and respirators; or
o Feet, such as OR shoes, shoe covers, and surgical boots.
• Other types of protective clothing worn by health care personnel, ie,
o Apparel that is not intended or labeled as a barrier to liquid or
microorganisms (e.g., surgical scrub attire, cover coats) and
o Apparel or equipment that is used when handling hazardous chemicals,
chemotherapeutic agents, or hazardous wastes.
• Absorbent OR towels.
• All of the requirements needed to ensure the safety and effectiveness of the
products within the scope of the standard.
• The interfaces between products, eg, the gown/glove interface.
• All of the labeling or other information that a health care facility might consider
necessary or desirable in product selection.
• Protection from dry particulate and dry microbial penetration.
• Manufacturing, quality assurance, or purchasing specifications;
• Criteria for evaluating experimental products;
• Guidance on the proper handling, processing, or preparing products for reuse in
health care facilities.
• Evaluation of antimicrobial properties.
The updates to this standard are intended to tighten up what is acceptable and can be
taken to market and also gives manufactures greater latitude when testing their products.15
Although the standard is primarily for manufacturers, health care professionals also find
it helpful to understand what kind of protection they can expect to get from a particular
gown. The changes to the standard focus on the acceptance criteria for a product lot, by
adding what is called a rejectable quality level (RQL) to help determine if the test results
are acceptable and if the product can be released. The previous version of the standard
recommended that manufacturers use only an acceptable quality level (AQL) to set the
criteria; now it recommends manufacturers use both AQL and RQL. RQL is defined as
that level of quality that the sampling plan will accept 10% of the time; this means lots at
or worse than the RQL are accepted 10 % of the time at most, or alternatively stated, they
are rejected at least 90% of the time. The use of both AQL and RQL criteria provides a
high probability that the consumer will only receive an unacceptable product a very small
percentage of the time.
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Critical Zones
One key to understanding the significance of the ANSI/AAMI PB70 standard is defining the
critical zones of a surgical gown. The barrier requirements for surgical gowns are based
on the location and degree of liquid contact expected during use. The critical zones of a
surgical gown are those areas where direct contact with blood, body fluids, and OPIM is
most likely to occur.
The entire front of a gown (See areas A, B and C in Figure 1), including the seam and other
components, is required to meet the minimum level of barrier performance (Level 1). Since
the back of a gown (See area D in Figure 1) is expected to stay dry, there is no liquid barrier
performance requirement for that area. The critical zone of the surgical gown is comprised
of at least areas A and B. The classification of the surgical gown is based on the lower
performing component of the two.
Figure 1 – Critical Zones of Surgical Gown
Levels of Barrier Performance
As previously noted, ANSI/AAMI PB70 focuses on levels of barrier protection and the
impact that material construction has on barrier performance. The AAMI standard classifies
the barrier performance of surgical gowns through the use of four industry standard tests:
• AATCC 42-2007. Water Resistance: Impact Penetration Test.16 This test measures
resistance of fabrics to penetration of water by spray impact (at 1 pound per square
inch [psi]), as measured by weight gain of a blotter (in grams). The results obtained
with this test method depend on the water repellency of the fibers and yarns and on
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the construction of the fabric. A lower number represents higher resistance.
This test method has been in use for many years; however, the blotter paper
employed in this test is no longer being manufactured, although some test houses
still have a supply.17 The standard now allows manufacturers to use a test called
WSP80.3, which does not require the use of any specific paper, but instead
permits the use of any blotter paper that meets the specifications in PB70. It is a
similar test that should give equivalent results, while giving manufacturers some
degree of flexibility while maintaining the same standard.
• AATCC 127-2008. Water Resistance: Hydrostatic Pressure Test.18 This test
measures resistance of fabrics to penetration of water under constantly increasing
hydrostatic pressure (0.25 to 2.0 psi), measured as hydrostatic resistance (cm).
As in AATCC 42-2007, water resistance depends on the repellency of the fibers
and yarns as well as the fabric construction. A higher number represents higher
resistance.
• ASTM F1670-08. Standard Test Method for Resistance of Materials Used in
Protective Clothing to Penetration by Synthetic Blood.19 This test is used to
evaluate the resistance of materials used in protective clothing to penetration
by synthetic blood under conditions of continuous liquid contact. Pass/fail
determinations are based on visual detection of synthetic blood penetration. If a
fabric passes this test, it is considered impervious to blood.
• ASTM F1671-13. Standard Test Method for Resistance of Materials Used in
Protective Clothing to Penetration by Blood-Borne Pathogens Using Phi-X174
Bacteriophage Penetration as a Test System.20 This test measures the resistance
of materials used in protective clothing to penetration by blood-borne pathogens,
using a surrogate microbe under conditions of continuous liquid contact. Results
are reported on a pass/fail basis, and if a fabric passes this test, it is considered
impervious to viruses. The Phi-X174 bacteriophage was selected as the most
appropriate surrogate test material because it is similar in size to HCV (the
smallest blood-borne pathogen) and it has a nearly spherical morphology similar
to HIV, HBV, and HCV. It also is environmentally stable, is noninfectious to
humans, has a limit of detection that approaches a single virus particle, grows
very rapidly (assay results can be read within as little as 8 hours), and can be
cultivated to very high titers similar to HBV, the most concentrated blood-borne
pathogen discussed.21
The less stringent tests used for this standard–AATCC 42 and AATCC 127–
involve the use of indirect (splash or spray) and direct contact with water
according to time and pressure protocols. The more stringent tests - ASTM F1670
and F1671 - involve the use of body fluid and blood-borne pathogen simulants
according to time and pressure protocols that have been found to discriminate a
higher level barrier performance in the laboratory setting.
Based on the results of these standardized tests, four levels of barrier performance are
defined, with Level 1 being the lowest level of protection and Level 4 being the highest
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level of protection (see Figure 2), as described below and summarized in Table 2:
• Level 1 is the lowest level of protection. It describes surgical gowns and other
protective apparel that demonstrate the ability to resist liquid penetration in one
laboratory test (AATCC 42, Water Resistance: Impact Penetration Test).
• Level 2 provides a slightly higher barrier protection than does Level 1. It describes
surgical gowns and other protective apparel that demonstrate the ability to resist
liquid penetration in two laboratory tests: AATCC 42 and AATCC 127 (Water
Resistance: Hydrostatic Pressure Test).
• Level 3 provides good fluid barrier protection, but is not considered impervious. It
describes surgical gowns and other protective apparel that demonstrate the ability
to resist liquid penetration in two laboratory tests: AATCC 42 and AATCC 127. For
Level 3, the test criterion for AATCC 127 performance is set at a higher value than
for Level 2.
• Level 4 provides the highest level of barrier protection: an impervious barrier, in
the entire critical zone, including any seams or other attachments, such as the
front belt on a gown, that are in the critical zone. It describes surgical gowns and
protective apparel that demonstrate the ability to resist liquid and viral penetration
in the laboratory test ASTM F1671.
Figure 2 – AAMI Levels of Barrier Performance
Table 2 – Barrier Performance of Surgical Gowns
Level Test Criterion Acceptable
Quality Level
Rejectable Quality
Level
1 AATCC 42:2007 ≤4.5 g 4% 20%
2
AATCC 42:2007
AATCC 127:2008
≤1.0 g
≥20 cm
4%
4%
20%
3
AATCC 42:2007
AATCC 127:2008
≤1.0 g
≥50 cm
4%
4%
20%
4 ASTM F1671:2007 Pass 4% 20%
For a surgical gown (as depicted in Figure 1), the entire front of the gown (areas A, B and
C), including the seam and other components, is required to provide a minimum level of
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barrier performance (Level 1). Since the back of a gown (area D) intended for surgical
applications is expected to stay dry, there is no liquid barrier performance requirement for
that area. The critical zones of the surgical gown (areas A and B) can be constructed to
provide increased protection (Level 2, 3, or 4). The classification of the surgical gown is
based on the lower-performing component of the two.
Labeling
ANSI/AAMI PB70 requires that each surgical gown be prominently labeled with its
class of barrier performance. In addition, gowns having back panels that do not meet
at least Level 1 requirements must be prominently labeled with the warning, “Back is
Non-Protective.” (Users concerned about potential contact with blood, bodily fluids, or
OPIM from the back should not choose gowns with nonprotective backs.) Labeling the
device itself is particularly important because the original outer packaging is generally not
immediately available to the end-user.
The standard also calls for each package containing a barrier product with a barrier claim
to be prominently labeled with the class of barrier performance of each item contained in
the package that has a barrier claim. Manufacturers also are required to provide technical
literature upon request, including:
• Detailed information on the barrier performance of each critical zone component,
either as a graphical representation showing the class of barrier performance of
each component or a narrative description of the level of barrier performance of
each component, or both.
• Detailed information on the barrier performance of each area outside the critical
zone.
Education
Manufacturers must provide technical information and/or training for the staff on the
classification system and its implications for users, as follows:
• The manufacturer shall provide technical information and/or training explaining
the barrier performance classification system and its implications for the enduser.
Thereafter, the end-user is responsible for making judicious selections of
products according to (a) the barrier performance class of the product, and (b) the
anticipated degree of exposure of health-care personnel to blood, bodily fluids,
and OPIM during a given procedure or activity.22
In particular, it is important that users understand the significance of the standardized
test methods used to determine levels of protection (eg, that the tests are laboratory
tests, not in-use tests). In addition, professional organizations such as AORN support
the use of educational materials to aid in the adoption of products and medical devices.
According to AORN’s Recommended Practices for Sterile Technique, perioperative staff
members should receive initial and ongoing education, as well as competency validation
regarding their understanding of the principles of and performance of sterile technique
18
processes; this education may include a review of the policies and procedures related
to the selection and evaluation of surgical gowns.23 Reinforcement of the proper use of
medical devices can aid in the judicious use of surgical gowns.
SELECTION CRITERIA FOR SURGICAL GOWNS
All surgical gowns are not created equal; this is an important consideration when trying
to decide what level of gown is needed for a surgical or invasive procedure. The AAMI
standard addresses the barrier effectiveness of surgical gowns, but OR directors,
infection preventionists, safety officers, material managers, and other product committee
members should consider many other attributes related to the safety and efficacy of
surgical gowns, as well as other protective apparel, when choosing these products.
The safety and performance characteristics of protective materials identified by AAMI
in TIR11, Selection and Use of Protective Apparel and Surgical Drapes in Health Care
Facilities are:24
• Barrier effectiveness (includes resistance to liquid and microbial penetration and
resistance to penetration by airborne, aerosol-borne, or dry particles);
• Abrasion resistance;
• Strength, including breaking strength and tear strength;
• Drapeability;
• Comfort;
• Flammability;
• Lint generation; and
• Toxicity.
Other factors to be taken into consideration are compliance with regulatory guidelines,
efficiency, cost effectiveness, and environmental concerns. All of these considerations
are described in greater detail below.
Barrier Effectiveness
Barrier effectiveness means that, given the specific circumstances of the procedure,
the gown will minimize microbial penetration. As discussed, the barrier requirements for
the design and construction of surgical gowns and other protective apparel are based
on the anticipated location and degree of liquid contact, given the expected conditions
of use. The critical zones include those areas where direct contact with blood, bodily
fluids and OPIM is most likely to occur, although areas outside of the critical zones can
inadvertently be splashed or sprayed as well. This TIR covers the selection and use of
protective apparel. It includes information on types of protective materials, safety and
performance characteristics of protective materials, product evaluation and selection,
levels of barrier performance, and care of protective apparel. Definitions of terms and
informative annexes also are provided. AAMI’s TIR11 was revised to include new
19
information on the general relationships between barrier performance and anticipated
exposure risks to assist clinicians in choosing protective apparel that is labeled in
accordance with ANSI/AAMI PB70 and that is appropriate for the procedure and for the
level of protection required for both patient and staff.
In this regard, it may not be necessary for staff to wear an impervious AAMI Level 4 gown
on a laparoscopic procedure with a small amount of fluid exposure; in contrast, a surgical
gown rated at an AAMI Level 3 may not provide adequate protection during, for example,
colectomy procedures where the length of the procedure and fluid exposure exceeds the
barrier protection levels.25
Abrasion Resistance
Surgical barrier materials should not abrade significantly during normal use, under wet or
dry conditions. Abrasion may weaken the material, which may adversely affect its barrier
properties, cause it to tear, or cause it to generate more lint. Abrasion that occurs through
the rubbing of a material against itself or against another material is of primary concern
(eg, if the arm rubs against the chest area of a gown or if the stomach area of a gown
rubs against a drape on the OR table).
Strength
The strength of a material includes both breaking strength and tear strength. Surgical
barrier materials should be resistant to tears, punctures, and fiber strains over the
expected life of the product and under normal conditions of use. Three widely used tests
of fabric strength are:
• The Grab Test (ASTM D5034 – Standard Test Method for Breaking Strength
and Elongation of Textile Fabrics).26 The grab test determines the resistance (ie,
breaking force and elongation) of fabrics under an increased pulling stress. It
indicates the material’s resistance to breaking when there is no initial tear in the
material. A high rating on the Grab Test indicates superior performance.
• The Diaphragm Bursting Strength Tester Method (ASTM D3786 / D3786M
- 13) measures the resistance of fabrics to bursting using a hydraulic or
pneumatic diaphragm bursting tester.27 A high rating on this test indicates
superior performance.
• The Elmendorf Tear Test (IST 100.1) measures the resistance of fabrics to tear
under a controlled force.28 It indicates the material’s resistance to tearing when
there is an initial tear in the material. A high rating on the Elmendorf Tear Test
indicates superior performance.
Drapeability
Gowns should fit comfortably and allow freedom of movement. Drapeability can be
evaluated by tests that measure the softness of a material, such as the Handle-O-Meter
Test (IST 90.3),29 which measures the weight necessary to push a material through a
¼-in slit. The lighter the weight needed, the more drapeable the material. The Cantilever
Stiffness test is also used to measure drapeability.30
20
Comfort
Surgical gowns should be comfortable and should contribute to maintaining the wearer’s
body temperature. Taken in its broadest context, comfort includes psychological,
physical, physiological, and environmental elements. In practice, comfort is usually
defined primarily in terms of air permeability and water vapor transmission.
In the Air Permeability Test (ASTM D73731 and IST 70.132), the rate of airflow passing
perpendicularly through a known area of fabric is adjusted to obtain a prescribed air
pressure differential between the two fabric surfaces. Air permeability indicates the
material’s breathability and coolness during use.
Two types of Water Vapor Transmission Rate tests are used to evaluate the breathability
of a material: 1) the desiccant method, which measures the rate of water vapor
movement through the specimen into a desiccant; and 2) the water method, which
measures the rate of vapor movement through the specimen from a dish of distilled
water. These tests are described in ASTM E9633 and IST 70.4.34
These tests measure only the air or moisture vapor permeability of small samples of
barrier materials, not the thermal and evaporative resistance of multi-component clothing
systems under work and environmental conditions. After determining that the product’s
protective properties are appropriate for the intended application, the best assessment of
overall comfort can be made by wear-testing the product during use in surgery.
In addition to being breathable, comfortable barrier materials should be:
• Lightweight. The mass per unit area (ie, basis weight) of a fabric’s structure can
be determined using the ASTM D3776, Standard Test Methods for Mass Per Unit
Area (Weight) of Fabric. A numerical rating is appropriate.35
• Absorbent. The Measuring Absorbency Time, Absorbency Capacity, and Wicking
Rate test (IST 10.1) determines the volume of fluid absorbed by a fabric.36 It
indicates how much fluid a fabric can hold. The wicking rate test measures
the rate at which water is absorbed into a fabric. It indicates how fast a fabric
will absorb fluid. A high rating, on either of these tests, indicates superior
performance.
• Non-glare, to minimize eyestrain and distortion from reflected light.
• Soft.
• Quiet.
• Nonirritating.
• Nonabrasive.
Flammability
All surgical gowns, whether they are made of natural or synthetic fibers, are flammable
under the right circumstances, especially in the oxygen-enriched environment of the
operating room. The most basic concept in fire prevention and control is the “fire triangle,”
21
which is the three key elements that must be present for a fire to occur: a combustible
material, an ignition source, and oxygen or an oxidizer to support combustion. Most
barrier materials used in surgical gowns are made of natural and/or synthetic materials
that ignite and burn at various rates. Carefully choosing and handling flammable
materials can help reduce the risks of ignition and fire. Fire prevention also requires safe
handling of ignition sources, minimization of oxygen accumulation, and training of staff on
proper actions in the event of a fire emergency.
Lint Generation
Some materials have a tendency to generate more lint (minute nonviable particles) than
do other materials. As noted, surgical gowns should be low-linting. Lint has been reported
to be a pathway for the introduction of viable organisms into the surgical site.37
The Gelbo Flex Test (IST 160.1) is the standard test method for measuring resistance to
linting of nonwoven fabrics.38 It determines the relative propensity of fabrics to generate
particles when continuously flexed and twisted by a particle generator. A low number on
the Gelbo Flex Test indicates superior performance.
The Helmke Drum Test (BS 6909) determines the cleanliness of garments by measuring
the particles emitted per minute when test samples are rotated in a stainless steel
drum.39 The test determines particle counts on wipes, instrument wraps, facemasks, and
similar woven and nonwoven fabrics; the smaller the count, the cleaner the garment.
Toxicity
Materials used in the construction of surgical gowns should be free of toxic chemicals,
non-fast dyes, noxious odors, skin irritants, or allergens. Permanently bonded chemicals
or other additives are sometimes used to enhance barrier properties or stain resistance.
Some of these substances may leach out; others may be non-leaching.
Efficiency
A number of criteria for the selection of barrier materials fall under the heading of
efficiency. Packaging and folding methods, for example, have implications for ease and
convenience of use. Today, many gown manufacturers are color-coding gown packaging
to reflect the gown’s classification level according to AAMI/ANSI PB70 standard.
Personnel can quickly and efficiently reach for the gown packaged in the color that
corresponds to the level of protection required for the procedure.
Ready availability of product is another consideration. Large inventories and storage
space cost money. Among other things, products should be selected based on how
responsive the vendor is in supplying needed items quickly without overloading
storerooms. A “just-in-time” inventory may be ideal.
Contracting with a full-line supplier provides a number of advantages, as a full-line
supplier may be able to:
22
• Help reduce costs by taking advantage of volume discounts;
• Incorporate waste management into the total service package; and
• Design custom packs for specific procedures and physician preferences.
In addition, vendors that offer value-added programs or efficiency studies can provide
valuable information to assist in the decision-making process.
Cost-Effectiveness
Factors to take into account when comparing the costs of different surgical gowns include
initial purchase costs, storage costs, inventory costs, reprocessing costs for reusable
gowns, replacement costs, and disposal costs. Choosing the right products for the right
procedures makes the best use of available economic resources. For example, gowns
with minimal reinforcement can be used very effectively for less-invasive procedures,
while impervious reinforcement may be necessary during more fluid-intensive
procedures.
Barrier products often are misused due to both a lack of product knowledge and
cost-saving measures by the facility, with the most common misuse being under- or
over-protection.40 This can be problematic because caregivers need adequate barrier
protection and by not optimizing the level of protection, facilities spend needlessly or
sacrifice protection. For example, some users perceive fully impervious products to be
warm and uncomfortable and thus opt for comfort over protection; on the other hand,
some facilities are using all Level 4 gowns to provide the ultimate level of protection for
their staff, which can be seen as “overkill.” Health-care facilities can best meet the needs
of both staff and patients by using a mix of protection levels, based on their procedure
mix. This is usually the most cost-effective option, and still provides the staff with the
best combination of comfort and protection. Many facilities have found that they can
standardize gowns based on the new options in materials and meet all of their needs for
protection. By standardizing on fewer and smarter products, facilities can make product
selection simpler and more cost-effective.
Environmental Concerns
Gowns used in the OR are constructed of either single-use or reusable materials, which
each have advantages and disadvantages. Environmental considerations that do not
compromise the quality of patient care, such as the potential for reprocessing/recycling,
opportunity to decrease waste, conserve resources, and reduce costs, often play a part
when deciding what type of gown to use41. The decision to choose disposable or reusable
gowns depends on all of the criteria discussed above, as well as issues related to the
availability and condition of laundry, sterilization and/or incineration facilities, storage
capacity, and cost considerations. Each facility’s needs must be analyzed in detail in
order to develop a cost-effective system of disposables, reusables or both.
It is also important to keep in mind that the transport and disposal of waste materials
must follow local, state, and federal regulations. When choosing barrier materials for use
23
in a surgical setting, consider the incineration, processing, and/or storage capabilities
of the practice setting, as well as community requirements for collecting, transporting,
and disposing of waste materials. Ensure that materials used in surgical gowns are
compatible with landfill and incineration requirements.
Clinical Evaluation
In addition to reviewing test data provided by manufacturers, users may need to conduct
clinical product evaluations, particularly if comparative tests are not conclusive as to the
most appropriate product for a particular use. For example, few, if any, standard tests
are available for certain performance qualities and aesthetic and comfort considerations.
It is recommended that health-care personnel first screen products based on material
test data and then evaluate the safety and performance of selected surgical gown
products under actual conditions of use. Clinical product evaluations should include
as many conditions of use as possible in order to evaluate product acceptability. The
gowns chosen should reflect the protective materials used in construction, the intended
application, and the manner in which the product will be integrated with other protective
products (eg, boots, face shields) into a complete personal protective system.
Staff should be involved in clinical product evaluations. Rarely can department managers
make product choices for successful large-scale conversions without staff involvement
and input, including in-use trials. This is true because of the variety of clinical input
needed and because of the psychological impact of active participation.
Some have argued that, rather than choosing surgical gowns from the perspective of
their performance on standard tests of barrier effectiveness, the materials manager
should evaluate them from the perspective of their influence on the outcome of the
surgical procedure (ie, the rate of SSIs).42 Of course, such an approach is necessarily
retrospective and thus is of limited value in the initial product evaluation.
MAKING A FINAL DECISION
The classification system defined in ANSI/AAMI PB70 is designed primarily to assist
manufacturers in testing and labeling the barrier performance of their products. While it
provides common definitions for four different levels of barrier protection, it does not take
into account potential variations in procedures and techniques used in different healthcare
facilities.
Choosing products with the appropriate level of barrier protection will require a thorough
understanding of the hierarchy of risks associated with the anticipated volume of
blood, bodily fluids, and OPIMs in the type and duration of procedure or activity being
performed. Ultimately, the end-user is the best judge of the barrier level required,
based on experience and on known exposure risks. The end-user should choose the
appropriate gown according to the:
• Barrier performance class of the product; and
• Anticipated degree of exposure of health-care personnel to blood, bodily fluids,
and OPIM during a given procedure or activity.
24
Within each facility, users will have to assess their own situations and make a
determination of how much fluid is expected for specific procedures and surgeons and
then decide the appropriate level of protection:
• Level 1 is the lowest level of protection. It describes surgical gowns and other
protective apparel that demonstrate the ability to resist liquid penetration in one
laboratory test (AATCC 42, Water Resistance: Impact Penetration Test).
• Level 2 provides a slightly higher barrier protection than does Level 1. It describes
surgical gowns and other protective apparel that demonstrate the ability to resist
liquid penetration in two laboratory tests: AATCC 42 and AATCC 127 (Water
Resistance: Hydrostatic Pressure Test).
• Level 3 provides good fluid barrier protection, but is not considered impervious. It
describes surgical gowns and other protective apparel that demonstrate the ability
to resist liquid penetration in two laboratory tests: AATCC 42 and AATCC 127. For
Level 3, the test criterion for AATCC 127 performance is set at a higher value than
for Level 2.
• Level 4 provides the highest level of barrier protection: an impervious barrier, in
the entire critical zone, including any seams or other attachments, such as the
front belt on a gown, that are in the critical zone. It describes surgical gowns and
protective apparel that demonstrate the ability to resist liquid and viral penetration
when tested according to ASTM F1671.
The challenge with surgical barrier materials is that clinicians want both comfort and
protection. Impervious fabrics can sometimes be very uncomfortable to wear for long
periods of time. However, the microfiber technology used in some Level 4 gowns allows
the gown to react to increasing temperature by increasing its moisture vapor transfer
rate. Some Level 4 gowns are made of multi-layered, high-performance fabrics.
SUMMARY
Surgical gowns are an important link in the prevention of disease transmission for both
patients and staff members because they serve a critically important dual purpose in
the operating room: they are worn to reduce the incidence of healthcare-associated
wound infections in patients and to prevent the exposure of personnel to pathogens in
blood and other bodily fluids from the patient. In an attempt to provide barrier materials
that are safe, comfortable, and cost-effective, manufacturers have developed surgical
gowns designed to meet the needs of the end-user. Selection of surgical gowns based
on standard selection criteria can help end-users to make appropriate choices, based on
the gown’s planned used as well as the anticipated exposure to blood and bodily fluids.
The revised ANSI/AAMI PB70 standard simplifies the selection of barrier products by
providing examples of expected use conditions and procedural applications for surgical
gowns based on the required level of barrier protection, thereby making purchasing
and case-picking decisions quicker and more efficient. It enables consumers to use an
objective standard to select the best gown materials to satisfy the barrier requirements
for specific procedures.43
25
CASE STUDY
The following case study is presented to allow the learner to synthesize and apply
the concepts discussed in the study guide to workplace scenarios. Read the scenario
carefully, integrating the data and information to discuss the points to consider.
Susan, RN, has 3 years of medical-surgical nursing experience and is on an orthopedic
surgery rotation in her perioperative nursing internship. The next case for which she is
scheduled to scrub is a left knee arthroscopy; as Susan is going over the supplies pulled
for the case before setting up, she notices that the surgical gowns pulled are labeled
and color-coded as Level 4, which were the same gowns pulled for the first case, a right
total hip arthroplasty. She remembers the recent in-service when the new gowns with the
color-coded labels (according to the new AAMI standard) were introduced and believes
that a Level 4 gown is not needed for this procedure. However, when she goes to the
supply cabinet in the room, only Level 4 gowns are there. When she asks the circulating
nurse why only Level 4 gowns are in the room, she replies that “because that is all the
orthopods will wear in here, no matter what they are doing.”
Points to Consider
• What are the key factors that Susan must take into consideration in selecting a
gown for the knee arthroscopy?
• What should Susan do next?
Discussion of Points to Consider
• What are the key factors that Susan must take into consideration in selecting a
gown for the knee arthroscopy?
o Barrier products are often misused due to both a lack of product knowledge
and cost-saving measures by the facility, with one of the most common
misuses being over-protection, as in this case.
o Surgical gowns should be selected for use according to the barrier quality
of the item and the wearers’ anticipated exposure to blood and body fluids
in accordance with the OSHA guidelines for use of personal protective
equipment. Short procedures during which there is little or no anticipated
exposure to blood or body fluids (eg, a knee arthroscopy with small incisions
and the use of a pneumatic tourniquet) can be completed successfully using
a surgical gown with minimal barrier protection; it may not be necessary for
staff to wear an impervious AAMI Level 4 gown. For a complex and lengthy
procedure such as the hip arthroplasty, where there is an increased potential
for exposure to blood-borne pathogens, the use of a Level 4 surgical gown
was prudent.
• What should Susan do next?
o She can select a gown with a lower barrier protection for the knee arthroscopy.
o She should consider discussing the appropriate use of gowns for orthopedic
26
procedures with her preceptor, manager, orthopedic team leader, or
appropriate person in the department. The use of Level 4 gowns for all
orthopedic procedures may not be the most cost-effective practice for the
facility. Instead, using a mix of protection levels based on the orthopedic
procedure mix can best meet the needs of both the patients and staff while
being cost-effective for the facility. In addition, standardizing on fewer and
smarter surgical gown products can make product selection simpler for the
staff.
27
Glossary
Acceptable Quality Level (AQL) For a continuous series of lots, the quality level that,
for the purpose of sampling inspection, is the limit of
a satisfactory process average.
Aseptic Technique Methods by which contamination with
microorganisms is prevented.
Bacteriophage A type of virus that infects only bacteria. It causes
lysis of host bacteria by multiplying within the
bacterial cell, using the bacterial cell metabolism for
growth and development.
Barrier Material A material that minimizes or retards the penetration
of microorganisms, particulates, and fluids.
Blood-borne Pathogen An infectious bacterium, virus, or other diseaseinducing
microbe carried in blood or other body
fluid; includes HIV, HBV, and HCV.
Critical Zone An area of protective apparel or surgical gown
where direct contact with blood, body fluids, and
OPIM is most likely to occur.
Impervious Incapable of being passed through by liquids or
microorganisms and has passed ASTM F1670 and
1671.
Lint Fuzz or fine ravelings of fiber created as a result of
abrasion, wear, or the nature of the material.
Manufacturer According to the FDA, “any person who designs,
manufactures, fabricates, assembles, or
processes a finished product; includes, but is
not limited to, those who perform the functions
of contract sterilization, installation, relabeling,
remanufacturing, repacking, or specification
development, and initial distributors of foreign
entities performing these functions.”
Microbial Barrier Prevents the penetration of microorganisms.
Nonwoven Material A manufactured sheet, web, or batt of directionally
or randomly oriented fibers or filaments, natural or
man-made, excluding paper and paper products,
that are woven, knotted, tufted, or stitch bonded and
have not been converted into yarns. Nonwovens
are bonded to each other by friction and/or
cohesion and/or adhesion. They are designed as
single-use materials.
28
Occupational Exposure Reasonably anticipated skin, eye, mucous
membrane, or parenteral contact with blood or other
potentially infectious materials that may result from
the performance of an employee’s duties.
Other Potentially Infectious The following human bodily fluids: semen, vaginal
Materials (OPIM) secretions, cerebrospinal fluid, synovial fluid,
pleural fluid, pericardial fluid, peritoneal fluid,
amniotic fluid, saliva in dental procedures, any
bodily fluid that is visibly contaminated with blood,
and all body fluids in situations where it is difficult
or impossible to differentiate between bodily fluids;
any unfixed tissue or organ (other than intact
skin) from a human (living or dead); and HIVcontaining
cell or tissue cultures, organ cultures,
and HIV- or HBV-containing culture medium or
other solutions; and blood, organs, or other
tissues from experimental animals infected with
HIV or HBV.
Personal Protective Specialized clothing or equipment worn by
Equipment (PPE) an employee for protection against a hazard.
General work clothes (eg, uniforms, pants, shirts
or blouses) not intended to function as protection
against a hazard is not considered to be personal
protective equipment
Rejectable Quality Level (RQL) The level of quality that the sampling plan will accept
10% of the time, ie, lots at or worse than the RQL
are accepted 10 % of the time at most.
Seam An area at which two or more pieces of material are
joined together.
Strikethrough Penetration of microorganisms, particulates, or fluids
through a barrier material, including its seams and/or
points of attachment.
Surgical Gown A device intended to be worn by operating room
personnel during surgical procedures to protect both
the surgical patient and operating room personnel
from the transfer of microorganisms, body fluids, and
particulate matter.
Synthetic Blood A mixture of red dye/surfactant, thickening agent,
and distilled water having a surface tension and
viscosity representative of blood and some other
bodily fluids, and the color of blood.
29
Woven Material Fabric constructed from yarns made of natural
or synthetic fibers or filaments that are woven
together to form a web in a repeated interlocking
pattern.
30
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31
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