The New Standard for Barrier Surgical Gowns and Drapes

March 1, 2006

The New Standard for Barrier Surgical Gowns and Drapes
What It Means to the Infection Control Practitioner


By Nathan L. Belkin, PhD


How it All Began

From the time that an operating room gown first became a part of the surgeons
armamentarium, its primary purpose was to protect the patient from the members
of the surgical team. In that capacity, the garment was made of a relatively
loosely woven, readily permeable, all carded cotton type 140 (thread count)
material generically known as muslin. The material fulfilled the essential
requirement of the application, in that it was considered effective in terms of
providing what was believed to be a satisfactory aseptic barrier, was readily
available, and was economical to use.

Then in 1952, the surgical community was alerted to the fact that although
the muslin material may have been considered an effective bacterialogical
barrier when it was dry, it lost its barrier capabilities once it became wet
even when multiple layers were used.1


The Need for a Liquid Barrier

This disclosure encouraged the textile industry to develop more satisfactory
materials for this unique application. In responding to the challenge, both
segments of the industry the nonwoven disposable and woven reusable
introduced a new generation of fabrics. Whereas both made claims about their
performance capabilities, there was no similarity to the tests upon which those
claims were predicated.

In the meantime, the American College of Surgeons (ACS) Committee on the
Operating Room Environment (CORE) charged the entire textile industry with the
responsibility to develop a test method that had the capability to simulate the
stresses that they astutely described as usual conditions of use.2

Not being able to either correlate the results of the tests being used by
industry or consider them as simulating usual conditions of use, a distinguished
surgical researcher not only developed a test method but introduced the term for
the phenomena of liquid penetration that has been commonly used ever since: strikethrough. The published results of his study indicated that some
of the nonwoven materials that had passed their Mason jar test proved to be
totally ineffective, and that some were moderately effective. However, included
with the number that performed quite well was one woven reusable.3 Be that as it
may, it was these findings that supported the researchers appeal to the
Surgical Device Classification Panel of the Food and Drug Administration (FDA)s
Bureau of Medical Devices for classification of aseptic barrier materials for
surgical gowns and drapes as Class II medical devices: high priority, that is,
those in need of performance standards.4

One response to the FDA classification process has been the development of
voluntary standards, user guidelines, and recommended practices by cooperative
working groups comprised of representatives from the clinical community, other
healthcare professionals, and industry. Thus it was that representatives from
the three groups formed an ad hoc committee to address the issue.

Subsequently, the group was formally organized under the auspices of the
Association for the Advancement of Medical Instrumentation (AAMI) and identified
as the Committee on Aseptic Barriers. Unfortunately, because of a lack of
consensus among its members, the Committee was disbanded and the task abandoned in May 1983.6


The Emergence of HIV

With the emergence of the era of the hazards associated with the transmission
of bloodborne pathogens, the primary purpose of the surgical gown suddenly
changed from third person to first person to protect the surgeon from the
patient. This also meant that whatever degree of strikethrough may have been
tolerated in the past was no longer acceptable.

It was during this period that two clinical researchers,7-8 working
independently of one another, reported on the barrier effectiveness of a variety
of products that were on the market. What exemplified the need for a standard
test method was the fact that some of the materials that had been found to be
satisfactory under the conditions of one of the tests would have failed when
subjected to the challenge of the other test that had been especially designed for this purpose. What is
particularly noteworthy is that the results of the less challenging test
reported detecting penetration of human immunodeficiency virus (HIV) through
plastic-reinforced materials in which strikethrough was not visible.

Nevertheless, the results of these studies exemplified the need for a
meaningful test method that could be adopted by both the clinical community and
industry for use in assessing a materials barrier capability. It was also
reasonable to assume that whatever test method would be developed would measure
a materials ability to resist liquid penetration at various levels.9 Rating
the materials in this manner would be in accord with the results of a
comprehensive in vivo study specifically designed for that purpose. 10 More importantly, it would facilitate the selection process mandated by the Occupational Safety and Health Administration (OSHA)s
final rule that the garments be appropriate for the task and degree of exposure anticipated.
11


The Development of New Tests

With the pressing need for a test method, an industry-driven committee of the
American Society for Testing Materials (ASTM) released a modification of one of
its existing mechanical devices that had originally been developed for
determining the effectiveness of protective clothing worn by chemical workers.
The group incorporated the methodology in two tests; one for liquid penetration
and one for viral penetration. Both methods were first adopted as emergency
standards and subsequently adopted as regular standards in 1995.

However, rather than the results of either of the tests being reported on a
comparative basis, they were identified as pass/fail, with a pass
predicated on the materials ability to resist penetration at a level of 2
pounds per square inch (psi). In responding to how that level of resistance was
selected, the tests developer and chairman of the ASIMs committee advised
that it had a high correlation to the manual elbow-lean test (simple and
manually executed) that had been used by one of its member manufacturers to demonstrate its materials effectiveness).14

It should be noted that prior to the ASTMs adoption of the test methods,
several reports had been published in the clinical literature that indicated
that the pressure exerted on surgical gowns and drapes in both in vivo and in
vitro circumstances had been found to be far in excess of 2 psi.15-17 As
observed by one of the researchers, Because conditions of use are known to
vary greatly by type of procedure and task, all materials do not need to have
the same level of resistance, yet the ASTM tests subject all to a single method.18

Notwithstanding the ASTMs noble mission to help reduce the risk of
occupational exposure to bloodborne pathogens, the fact of the matter is that
the healthcare delivery system is financially strained at an unprecedented level
and is being pressured to not only contain costs, but reduce them. Under these
circumstances, to indiscriminately provide all healthcare workers with what the
industry group believes to be the maximum level of protection would be neither
prudent nor fiscally responsible. All things considered, it appears that the
ASTMs tests may have been developed for the benefit of its industry committee
rather than for the benefit of the surgical community and can only be viewed as
being blatantly self-serving and morally irresponsible.


The New Standard

The American National Standards Institute (ANSI) has recently published a
document which is said to provide a solution to this half-century need.19 Titled
Liquid Barrier Performance and Classification of Protective Apparel and
Drapes Intended for Use in Healthcare Facilities,20 it has been adopted by
the FDA and is considered to satisfy the agencys need for performance
requirements for those Class II medical devices

The standard establishes the use
of four different test methods and two different liquids to classify the
differences in the levels of a materials barrier performance.

To accommodate the need for determining a materials barrier performance
for the duration and level of anticipated exposure, AAMIs Protective Barrier Committee selected two other tests, the American
Association of Textile Chemists and Colorists (AATCC) #42-2000 water impact
penetration test and their #127 hydrostatic test for that purpose. (It
should be noted that this same AAMI group had several years earlier maintained
that neither of the two tests were suitable for use for this purpose.21

Thus the new standard establishes four levels of barrier effectiveness. For Level 1, the lowest of the four, the AATCCs 42-2000 water impact
penetration test is used. (See Figure 1.) The materials capability to resist
penetration is determined by being challenged by a fixed amount of water sprayed
on it while being held at a 45-degree angle. An absorbent blotter affixed under
the fabric is then weighed to ascertain its weight gain. According to the
standard, the blotter should not have gained more than 45 grams to be considered
a Level 1 fabric.

For Level 2 fabrics, there are two tests that can be used. One is the same
test used for Level I except that the weight gain of the blotter can be no more
than 1 gram. An alternate test is the AATCCs 127-1996 hydrostatic head test.
(See Figure 2.) A sample of the fabric is clamped horizontally on the bottom of
a metered glass cylinder. The hydrostatic pressure is steadily increased as the
height of the water in the cylinder is raised. To be acceptable for a Level 2
barrier, it must resist penetration of water when it reaches a height of 20
centimeters.

For Level 3 fabrics, both of the AATCC tests may be used. However, for the impact penetration test, the weight gain of the blotter is
again 1 gram. For the hydrostatic head test, the water level in the cylinder
must be at least 50 centimeters. For level 4 fabrics, the ASTMs mechanical device is used for both. For
surgical gowns, the material must pass their F-1671 test for viral penetration;
surgical drapes need only pass the F-1670 for resistance to penetration to
synthetic blood. The test sample is mounted in a vertical position onto a cell
that separates the challenge and a viewing port. The time and pressure protocols
specify atmospheric pressure for five minutes, 2 pounds of pressure psi for one
minute, and atmospheric pressure for 54 minutes. The test is terminated if
visible penetration occurs before or after 60 minutes.

(It should be noted that the standard makes no mention of the level of
protection that a pass provides, i.e., 2 psi.)


Interpreting the Results

For Levels 1, 2, and 3, the results of the water impact penetration test must
stand on their own merit since there is no known method of correlating the
weight of the blotter to the level of pressure exerted on it.

For the hydrostatic pressure test used for Levels 2 and 3, the correlation
between the height (in centimeters) of water and the level of pressure is known.
For Level 2, the equivalent of pounds psi at 20 cm is 0.20; when the level of
water is raised to 50 cm, the psi is 0.73.

The question that logically arises is how the barrier effectiveness of a
material that is awarded a pass (at 2 psi) when tested with the ASTMs
device can reasonably be compared to the psi of the Levels 2 and 3?
Unfortunately, they cannot be. The culprit? Surface tension.


The Role of Surface Tension

As defined in the document, surface tension is the intermolecular forces
acting on the molecules at the free surface of a liquid. Surface tension affects the degree to which a liquid can wet a material
(i.e., the lower surface tension, the more easily the liquid wets a materials
surface). Surface tension is measured by a unit of dynes per centimeter.

Whereas water used in both of the AATCC tests measures around 72 dynes/cm,
blood is around 42 dynes/cm. (It is viscosity that makes blood thicker than
water.) This means that liquids, such as blood, which have a low surface
tension, can penetrate fabrics more readily than those with a higher surface
tension such as water. Thus, in terms of interpreting the results of the tests
for Levels 1, 2, and 3, they do not mean that under actual conditions of use,
they would not permit the penetration of blood.


Leakage in the Critical Zone

The ANSI/AAMI standard defines the critical zone as an area of protective
apparel or surgical drape where direct contact with blood, body fluids, and
otherwise potentially infectious material (OPIM) is most likely to occur.23

One of those areas of the surgical gown, in which leakage at the gown/glove
interface was first reported in 1975.24 Some 20 years later, in a multi-center study of blood contacts in 8,502 surgical
procedures, it was found that of the total of 1,043 contacts, 60 percent were
experienced by surgeons, and that 53 percent of those involved the fingers,
hands, and arms.25 (It is interesting to note that only 2 percent were on the
body.) A recent report on this danger zone included a proposed solution to this
problem area that has yet to be pursued commercially in a wide fashion.26-27 Nevertheless, it now appears in the list of exclusions as one of the items that the standard does not cover.

In response to an inquiry of the FDA about the exclusion, the agency advised
that AAMIs Barrier Committee excluded this subject because the standard is
for the barrier properties of the gowns and drapes, especially the critical
zone, and it is not possible to determine how an individual would select a gown
that assured there would no be a potential problem with this interface.29

In the interim, until such time as some changes in the design and
construction of this area, the protective capability of the surgeon gown,
regardless of the material of which it is made, will continue to be compromised.


Another Omission

It is to be noted that the standard classifies the patient drape as an item
of protective clothing. In so doing, it calls for the inclusion of a
barrier-quality material in the critical zone. As recently stated, the influence
of a barrier material on the incidence of surgical site infections has not been
assessed by scientific studies.30 This confirms the statement made on their use
more than 20 years ago. In a commentary on the factors that must be considered
that can influence post-operative wound infection, the author stated that there
is no convincing evidence for all of them; one of which was barrier materials.
Thus, he concluded that their use was predicated on anecdotal experience and
commercial interests rather than scientific studies.31

Not to be overlooked is the fact that the authors of the standard failed to
consider the widespread use of incise drapes and the advent of minimally
invasive surgical procedures that preclude the need of the protective capability
of a costly barrier material.


Nathan L. Belkin, PhD, retired in 1991 following a 40-year career in the
healthcare industry. He is the author of more than 100 articles and consulted
with a variety of healthcare organizations including APIC and AORN.



References:

1. Beck, W.C. and Collette, T.A. False faith in the surgeons gown and
surgical drape. Ann Surg. 85:125-126. 1952.

2. Bernard, H.R. and Beck, H.C. Operating room barriers: idealism, practicality, and the future. Bulletin of
the American College of Surgeons. 60(9):16.1975.

3. Laufman, H.A., Eudy, W.W., and Vandervoot, A.M. Strikethrough of moist
contamination by woven arid nonwoven surgical materials. Ann Surgery.
181:857- 862. 1978.

4. Laufman, H. Breach of truth in advertising regulations. Read before the
Surgical Device Classification Panel of the Device Agency, Food and Drug
Administration. 1978.

5. Belkin N.L. Textiles as aseptic barriers: the past, present and future. Medical Instrumentation. 14:233-8. 1980.

6. Beck, W.C. and Meeker, M.H. Demise of aseptic barrier committee: success
and failure. AORN Journal. 38:384-8. 1983.

7. Shadduck, P.D., Tyler, D.S., Lyerly, H.X., et al. Commercially available
surgical gowns do not prevent penetration of HIV-1. Surgical Forum.
41:77-80. 1990.

8. Smith, J.C. and Nichols, R.J. Barrier efficacy of surgical gowns. Arch
Sur
. 26:756-761. 1991.

9. Belkin, N.L. Gowns: selection on a procedure- driven basis. Infection
Control Hosp Epidemiology
. 15(11):713-716. 1994.

10. Quebbemen, E.J. and Telford G.L., et al. In-use evaluation of surgical
gowns.
Surgery Gynecology and Obstetrics
. 174:369-375. 1992.

11. Occupational Exposure to bloodborne pathogens: final rule. Federal
Register 56. Dec. 6, 1991. 64040-64182.

12. ASTM. Standard test method for resistance of materials used in protective
clothing to penetration of synthetic blood. F1670-95.

13. ASTM. Standard test method for resistance of materials used in protective
clothing to penetration by bloodborne pathogens using Phi-X174 bacteriophage
penetration as a test system. F1671-97b.

14. Stull, O.J. Response. OR Reports 2. July/August 1993.

15. Altman, K.W., et al. Transmural surgical gown pressure measurements in
the operating theatre. Am J Infection Control 19. June 1991. 147-155.

16. Smith, J.W., et al. Determination of surgeon-generated gown pressures
during various surgical procedures in the operating room. Am J Infection
Control
23. August 1993. 237-246.

17. Telford, G.L. and Quebbeman, E.J. Assessing the risk of blood exposure in the operating room. Am J Infection
Control 2. December 1993. 351-356.

18. Nichols, R.L. The operating Room. Hospital Infections, fourth edition. Chapter 27. Lippincott-Raven Publishers. Philadelphia. 1998.

19. Koch, F. Perspectives on barrier material standards for operating rooms. Am
J Infection Control.
April 2004. 115-117.

20. ANSI/AAMI PB 70:2003. Liquid barrier performance and classification of
protective apparel and drapes intended for use in healthcare facilities. 2003.

21. AAMI. Technical Information Report. Selection of surgical gowns and drapes in healthcare facilities. AAMI TIR 11.
1994.

22. Ibid. 20. Page 4 (3.2B).

23. Ibid. 20. Page 2 (3.9).

24. Ibid. 3.

25. White, M.C. and Lynch, P. Blood contact and exposure among operating room
personnel, a multi-center study. Am J Infection Control. 1993.
21:243-248.

26. Meyer, K.K. and Beck, W.C. Gown/glove interfaces: a possible solution to the danger zone. ICHE 16.
August 1995. 488-490.

27. Ibid. 20. Page 1.

28. Ibid. 3.

29. Personal communication with C.S. Lin, Office of Device Evaluation, FDA. Oct. 5, 2004.

30. Rutala, W.A. and Weber, D.J. A review of single-use and reusable gowns
and drapes in healthcare. ICHE 2001. 22:248-257.

31. Nichols, R.L. Postoperative wound infection. New England Journal of
Medicine.
1982. 307:21:1701-2.