At first glance, gowns, gloves, drapes, masks, and eye shields might not look like things that could make the difference between life and death. But they are. They’re the modern day equivalent of helmets, shields, and armor when worn by healthcare workers to protect them and their patients in the 21st-century battle against infection, disease, and death.

So vital is barrier protection that an entire industry is continually working to develop and improve products used by healthcare workers, and researchers around the world are constantly performing clinical studies attesting to their value. But always, always, always we should remember that people, not products or studies, are the most important component in the barrier protection equation. People are the raison d’être for the barrier-protection industry and those who perform studies on the products.

An important step taken by the barrier-protection industry to help ensure the safety of healthcare workers and their patients is a new standard published by the Association for the Advancement of Medical Instrumentation (AAMI): Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70).1 Attesting to the weight this document is expected to carry, this new American National Standard "has been in the making since 1998," according to Jay Sommers, PhD, Director of Clinical and Scientific Documentation, Health Care, Kimberly-Clark, Roswell, GA, and a member of the AAMI Protective Barriers Committee.

The AAMI had tried since the early 1980s to develop a performance standard but was thwarted by the lack of consensus on test methods for assessing barrier performance. In the early 1990s, AAMI published a Technical Information Report2 describing important safety and performance attributes of surgical gowns and drapes but did not address performance limits. By the time the document was reviewed for updating in 1998, strike-through of barriers had become a major concern, as nosocomial infections and emerging and reemerging infectious diseases continued to rise.

The work is not quite over yet. The next step, said Sommers, is for the document to be presented to the Food and Drug Administration (FDA)’s Standards board so that it can be accepted for the 510(k) process required to introduce a new product to the market; then the decision must be published in the Federal Register. After the document has been accepted by the FDA, when a manufacturer develops a new gown or drape that is in compliance with the standard, they can file for an abbreviated 510(k), the groundwork having already been laid.

Microcool surgical gown from Kimberly-Clark

The new document answers a question raised in response to the Occupational Safety and Health Administration’s Standard on Occupational Exposure to Blood-borne Pathogens,3 which mandated that the "employer provide the healthcare worker with protective apparel that is commensurate with the ‘task and degree of exposure anticipated’."2,3 The medical community began to ask for a way to "intelligently assess a product’s protective capability and be reasonably assured that the garment they select is suitable for the ‘degree of exposure anticipated’."4 AAMI’s new standard supplies an answer to that question and more.

"For the United States, the biggest news in the barrier document," noted Sommers, "is a classification system" for protective clothing and drapes, based on their resistance to strike-through of blood and fluids. Barrier performance is divided into four levels, with level 1 offering the least protection and level 4 the highest. Unclassified clothing and drapes are considered as "nonprotective."

The classification system is designed to assist primarily manufacturers in testing and labeling the barrier performance of their products so that users have access to the information needed to determine the types of protective products most appropriate for the task and situation. In addition to labeling and performance requirements, the standard also outlines tests for determining compliance with the requirements and construction of protective apparel.

Cardinal Health’s Astound gown line provides a high level of barrier protection.

Curt Koehn, Director of Marketing, Convertors Products, Cardinal Health, McGaw Park, IL, had this to say about the new document: "The new AAMI standards will have a very positive effect on the healthcare industry by taking the guesswork out of the selection process. The rating each product receives will be identified on product packaging, making purchasing and procedure-picking decisions quick and efficient.

"Clinicians and buyers should be focused on patient care and managing their operations," explained Koehn, "not on interpreting confusing test data to make product selections. By standardizing the protection levels provided by these barrier products, AAMI will enable healthcare workers to focus on better patient care and staff safety. The standard will enable customers to use a subjective standard to select the proper drape and gown materials to satisfy the barrier requirements for each specific procedure. Prior to this standard, customers had to interpret industry standard test data for water impact and hydro static pressure to compare the non-impervious offerings from each drape and gown manufacturer. These two attributes work in concert to dictate the fluid barrier of a drape or gown. Until AAMI, there were no guidelines to help a customer understand how different materials and finished products measured up. Now, two standard tests have been combined and each assigned specific value ranges in each of the classification tiers. The highest classification established by AAMI incorporates industry-recognized tests for fluid and viral penetration (ASTM F1670 and ASTM F1671), mandating that a product passes these tests before achieving the highest classification. By standardizing the requirements to claim an AAMI ranking, this initiative will make comparisons and selection much easier for healthcare providers.

"We have a new high-barrier gown fabric called Astound," said Koehn, "which will be classified in one of the highest levels of barrier protection. For surgical drapes, our classification will be the highest level established by the new AAMI standards. We will continue focusing on designing products to meet the requirements for impervious protection in the critical areas of the drapes."                                      
 3M Impervious Drape 

Jim Pigott, president of the Proxima line, Medline Industries, Inc, Mundelein, IL, said, "Our feeling [about the new AAMI document] is that any further education that the manufacturers can supply in terms of utilizing the right gown for the right procedure is a good thing. Now the challenge will be for the manufacturers to do a good job of training clinicians who are interested in understanding [the standard] and trying to use it in their operating rooms.

"The Proxima drape and gown line already had products that fell within all the categories," said Pigott. "We were pleased about that. I think manufacturers will want to do a good job of offering options that meet all the levels, and it’s very important to offer clinicians choices in the different levels of protection. It’s a really important part of our strategy in the market.

"The challenge with surgical gowns in the marketplace today is that clinicians want both comfort and protection in a gown," said Pigott. Toward that end, Medline has developed a new gown, Aurora, to be added to the Proxima line. The gown is made of Suprel, a revolutionary new fabric manufactured by DuPont, Old Hickory, TN. The bi-component, nonwoven fabric is a result of a sophisticated technology that DuPont has been working on for several years. The two components are polyester and polyethylene; the polyester gives the gown strength, and the polyethylene gives it softness for comfort. "Up until now, most of what has been available hasn’t really been able to address both needs," explained Pigott. "Some gowns have very high barrier levels, but generally they tend to sacrifice something in comfort; other gowns are more comfortable, but they sacrifice something in barrier protection. So, we’re excited about this new Suprel fabric; we’re excited about anything that does a good job of addressing the clinicians’ need for comfort and protection."

Tronex SMS100 Isolation Gown

While the AAMI standard addresses only strike-through resistance to liquid and microbes, flammability resistance and linting also are important attributes of drapes and gowns. The Association of Operating Room Nurses published a recommendation document for selection of surgical gowns and drapes,5 stating that not only should barrier materials "be resistant to penetration by blood and other fluids" but that "barrier materials should resist combustion" and "should be as lint-free as possible."

Flammability has long been a concern in the operating room, but high-energy-using devices such as lasers, fiber optic lighting, and electro-surgical units used today create new opportunities for risk of fire, particularly when coupled with use of oxygen. One report states, "Lasers and other advanced electrical equipment are now used in 60% to 80% of all surgical procedures."6

  Suprel fabric by DuPont

Lint is certainly a housekeeping problem at healthcare facilities, but it also can create other problems. Lint can clog air filters and computers.7,8 Microbial particles can attach themselves to lint and settle in surgical sites and wounds, possibly increasing postoperative patient complications,8 but whether it creates an infection control problem is an issue yet to be settled.7 There even is the possibility that powder from latex gloves could cling to airborne lint and cause an allergic reaction for someone.7

Studies have been conducted in all three categories, barrier protection, flammability, and linting, on Kimberly-Clark’s spunbond/meltblown/spunbond nonwoven fabric (EVOLUTION), which is comprised of three thermally bonded layers. "It’s made of almost 100% polypropolene, so we have a synthetic material, where[as] a lot of the drapes and gowns previously were made of a wood pulp-polyester blend, and the performance between those products is very significant. [The wood pulp-polyester blend fabric] generated more lint, it wasn’t as good with ignition resistance performance, it wasn’t as good a barrier. We’re the only company, as far as I know, that has what we call the ‘clinical story’. We’ve done a number of clinical and scientific studies in all three areas, barrier,9,10 flammability,11,12 and linting,7,8,13 where we can show superiority to most of the other products."

The new AAMI standard opens with "The Objectives and Uses of AAMI Standards and Recommended Practices."1 It states that a standard is "intended to respond to clinical needs and, ultimately, to help ensure patient safety." Buyers have a huge responsibility in securing appropriate protection for healthcare workers and patients. Whether they choose products from the suppliers mentioned above or other products available on the market, buyers are in a position to make a difference in people’s lives. Choices buyers make might mean the difference in whether a surgeon lives to see her children graduate, in whether a hospitalized grandfather goes home to play with the grandchildren or is sent to a nursing facility to live out his few remaining days, in whether a child has a mother or father to nurture them to adulthood.

REFERENCES

1. Association for the Advancement of Medical Instrumentation. Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). 2003. Arlington, VA: AAMI; 2003.

2. Association for the Advancement of Medical Instrumentation. Technical information report (TIR11:1994). Selection of surgical gowns and drapes in health care facilities. Arlington, VA: AAMI; 1994.

3. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens–OSHA. Final rule. Fed Regist 1991;56(235)64004-64182.

4. Belkin NL. Selecting protective apparel for the degree of exposure anticipated. Infect Control Hosp Epidemiol 2000;21:436.

5. Association of Operating Room Nurses. Recommended practices for use and selection of barrier materials for surgical gowns and drapes. AORN J 1996;63:650, 653-564.

6. Sommers JR. Flammability standards for surgical drapes and gowns: past, present, and future. Surgical Services Management 1998;4:41-44.

7. Shimkus J. Abuzz about fuzz. Mater Manag Health Care 1998;7:50.

8. Glasgow D, Sommers J. Lint shedding cannot be overlooked. The Clinical Services Journal August 2003.

9. Granzow JW, Smith JW, Nichols RL, Waterman RS, Muzik AC. Evaluation of the protective value of hospital gowns against blood strikethrough and methicillin-resistant Staphylococcus aureus penetration. Am J Infect Control 1998;26:85-93.

10. Boyce JM, Chenevert C. Isolation gowns prevent health care workers (HCWs) from contaminating their clothing and possibly their hands with methicillin-resistant Staphylococcus aureus (MRSA) and resistant enterococci. Presented at the Eighth Annual Meeting of the Society for Healthcare Epidemiology of America; Orlando, FL; April 5-7, 1998. Infect Control Hosp Epidemiol 1998;19:707. Abstract S74.

11. Brodman M, Port M, Friedman F Jr, Sperling R, Dottino P, Thomas AG. Operating room personnel morbidity from carbon dioxide laser use during preceptored surgery. Obstet Gynecol 1993;81:607-609.

12. Mowrer FW, Ashman, MN. Flammability of Surgical Drapes. Final Report. No. FP93-01. College Park, MD: University of Maryland; 1993.

13. Edmiston CE Jr, Sinski S, Seabrook GR, Simons D, Goheen MP. Airborne particulates in the OR environment. AORN J 1999;69:1169-1172, 1175-1177, 1179.