AORN Journal: Recommended practices for selection and use of surgical gowns and drapes

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Recommended practices for selection and use of surgical gowns and drapes

The following recommended practices were developed by the AORN Recommended Practices Committee and have been approved by the AORN Board of Directors. They were presented as proposed recommended practices for comments by members and others. They are effective Jan 1, 2003.

These recommended practices are intended as achievable recommendations representing what is believed to be an optimal level of practice. Policies and procedures will reflect variations in practice settings and/or clinical situations that determine the degree to which the recommended practices can be implemented.

AORN recognizes the numerous types of settings in which perioperative nurses practice. These recommended practices are intended as guidelines adaptable to various practice settings. These practice settings include traditional ORs, ambulatory surgery units, physician's offices, cardiac catheterization suites, endoscopy suites, radiology departments, and all other areas where operative and other invasive procedures may be performed.

Purpose: These recommended practices provide guidelines for evaluation, selection, and use of surgical gowns and drapes. These products should provide a safe, effective means of protecting patients and health care personnel during use. Patients are at risk of contamination from both endogenous and exogenous microorganisms. Health care workers are at risk of contamination from a variety of blood-borne pathogens that can be contracted via exposure to patients' blood and body fluids. The barrier quality required of surgical gowns and drapes varies according to the planned use of the product and its anticipated exposure to blood and body fluids.

RECOMMENDED PRACTICE I

Surgical gowns and drapes should be evaluated according to the AORN "Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings."(1)

1. Materials selected for construction of surgical gowns and drapes should be safe, meet identified needs, and promote patient and personnel safety.

2. Selection of gown and drape products for use in the practice setting should be based on criteria specific to the products' function and use. Surgical gowns and drapes are constructed of either single-use or reusable materials. Each of these has advantages and disadvantages. Further, in each of the two categories, design and performance characteristics vary. This variation stems from trade-offs in cost, comfort, and the amount of barrier protection provided. Both single-use and reusable gowns and drapes often are reinforced to improve their barrier quality. Reinforcements may consist of additional layers of the same material or layers of different material(s). (2)

RECOMMENDED PRACTICE *

Materials used for surgical gowns and drapes should be resistant to penetration by blood and other body fluids as necessitated by their intended use.

1. Perioperative managers and purchasing agents should obtain from manufacturers data verifying that materials used in gowns and drapes are protective barriers against the transfer of microorganisms, particulates, and fluids to minimize strikethrough and the potential for personnel contamination. Microorganisms can be transferred through barrier materials by wicking of fluids and/or pressure or leaning on a flooded area of the product. Mechanical action such as pressure can result in both liquid and dry penetration of microbes if the pressure exceeds the maximum level of resistance that the material provides?

2. 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 Occupational Safety and Health Administration guidelines for use of personal protective equipment. (4) Short procedures 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.

RECOMMENDED PRACTICE III

Surgical gowns and drapes should maintain their integrity and be durable.

1. Surgical gowns and drapes should have an acceptable quality level (ie, be free of holes/defects).

2. Surgical gowns and drapes should be resistant to tears, punctures, and abrasions. The inability to withstand tears, punctures, and abrasions may allow for passage of microorganisms, particulates, and fluids between sterile and nonsterile areas and expose patients to exogenous organisms. Health care workers may be exposed to bloodborne pathogens. Reusable materials should be inspected visually to determine their integrity before use. (5) Reusable textiles should be patched with heat-sealed patches of the same quality material as the item to which they are applied. If the item is of a single-ply material, a patch need only be applied to one side of the item. Patches must allow for penetration and removal of sterilant while maintaining the integrity of the barrier quality of the item. The percentage of exposed surface that can be patched is dependent on the sterilization method and the number of layers of patched textile. (6) Areas covered by heat-sealed patches on woven textiles should be examined carefully before the fabric is used. The patched area should maintain the original barrier properties each time the product is used. Patches of any kind should never be stitched to woven barrier materials as a method of repairing holes. Stitching creates permanent holes that reduce the barrier quality of the item. (7)

3. Surgical gowns and drapes should be low-linting. Barrier materials used for surgical gowns and drapes should be as lint-free as possible. Lint particles are disseminated into the environment where bacteria attach to them. This bacteria-carrying lint may settle in surgical sites and wounds with a resultant increase in postoperative patient complications. (8)

4. Seams of barrier materials should be evaluated to determine their capability to minimize either penetration or passage of potential contaminants. Many surgical gown seams have little or no barrier property. If wicking or pressure on a seam causes liquid transfer between sterile and unsterile surfaces, one or both sides may become contaminated. (9)

RECOMMENDED PRACTICE IV

Materials used for surgical gowns and drapes should be appropriate to the method(s) of sterilization.

1. To achieve a sterile product, the sterilizing agent must contact all surfaces of the item to be sterilized. Common sterilization methodologies include

* radiation,

* steam, and

* ethylene oxide.

The primary methodologies used in health care facilities are steam and ethylene oxide. Most facilities have neither the capability of nor access to radiation as a means of sterilization.

2. Tightly woven reusable textiles will lose their protective barrier quality after repeated processing. Manufacturers' written instructions for handling, the suggested number of processings, and the useful life of barrier materials should be provided and followed. A system should be established to track the number of processings for each item. This tracking should include, but not be limited to, the number of wash cycles and sterilization processings to which the textile product is subjected. Repeated processing ultimately will diminish the protective barrier ability of reusable textiles; however, items constructed of reusable textiles should continue to meet the original barrier quality level throughout the manufacturer-recommended life cycle (ie, number of processings) for the textile. The user facility should monitor the barrier quality of reusable textiles at intervals while the product is in service. Purchasers of reusable textile gowns and/or drapes should obtain from the manufacturer instructions for testing the material to document the ongoing barrier quality of the item(s) for the entire useful life of the item(s). (10) Products that no longer meet the manufacturer-stated barrier level should be downgraded to a nonprotective category and used accordingly.

3. Unused, single-use surgical gowns and drapes should not be resterilized unless manufacturers provide specific written instructions for reprocessing or the US Food and Drug Administration (FDA) regulations are followed. Surgical gowns and drapes intended for single use may not sterilize adequately, may be damaged during the sterilization process, or may retain toxic residues. (11) If a health care facility chooses to reprocess single-use items, including gowns and drapes, the FDA considers the facility to be the manufacturer of the item(s) and, as such, the facility is subject to the same stringent regulations as the original manufacturer of the item. (12)

RECOMMENDED PRACTICE V

Surgical gowns and drapes should resist combustion.

1. Gowns and drapes selected for use should be consistent with accepted flammability standards that will provide the safest environment for patients and health care workers. (13) Specific standards for surgical materials have not been developed. All materials used in the surgical environment will bum given the right conditions.

2. Barrier materials are made of natural and/or synthetic fibers and may be flammable, needing only a combination of heat, fuel, and oxygen to ignite. (14) Care should be taken when gowns and drapes are exposed to light and heat sources, electrosurgical devices, lasers, and other power equipment. Materials ignite and bum at various rates. Even materials said to be flame-resistant might bum or melt when subjected to intense heat or an oxygen-rich environment. (15) Some materials not only ignite more easily than others but also may bum more rapidly.

RECOMMENDED PRACTICE VI

Surgical gowns and drapes should be comfortable and contribute to maintaining the wearer's desired body temperature.

1. Surgical gowns and drapes should be free of toxic ingredients and allergens. Patients and/or health care workers may experience untoward reactions to toxic ingredients and/or allergens, ranging from mild discomfort to anaphylactic collapse.

2. Surgical drapes should have limited memory and be flexible enough to conform loosely to the patient's contour, allow for placement and unhampered manipulation of surgical instruments, and appropriately drape related equipment. (16) Surgical gowns should have limited memory and be flexible enough to conform loosely to the wearer's body while at the same time protect the wearer from contamination from blood and body fluids.

3. Surgical gowns and drapes should have the ability to maintain an isothermic environment for patients and health care workers. People vary in their ability to tolerate heat and cold. Thermal comfort exists when a balance occurs between the heat the human body loses and the heat the body generates. Care must be taken to avoid hypothermia or hyperthermia in surgical patients. Normothermic or near-normothermic patients may have a more favorable postoperative course. (17)

RECOMMENDED PRACTICE VII

Surgical gowns and drapes selected for use should have a favorable cost:benefit ratio.

1. Surgical gowns and drapes should not be selected on the basis of cost only. Nor should cost be the primary consideration when making a selection. In today's economic environment, however, it is imperative that after providing for patient and provider safety, fiscal factors be considered. Careful selection of the appropriate gowns and drapes for the practice setting will contribute to the fiscal soundness of the provider facility. (18) A lesser-priced product that fails consistently is not cost effective because additional volume will be required to replace the defective or poorly-performing item(s).

2. Surgical gowns and drapes are considered medical devices, and failure of these devices is subject to medical device reporting requirements according to the Safe Medical Device Act of 1990 (19) (SMDA) and/or the FDA voluntary Problem Reporting Program. This voluntary program provides users with a mechanism for reporting events that do not meet the strict reporting criteria of the SMDA. Reports should be filed by telephone at (800) 638-6725. Consistent failure of a surgical gown or drape product should be reported to the manufacturer and the FDA. Any strike-through constitutes a threat of exposure to potentially harmful bloodborne pathogens.

RECOMMENDED PRACTICE VIII

Policies and procedures for selecting and using surgical gowns and drapes should be developed, reviewed regularly, revised as necessary, and readily available in the practice setting.

1. These recommended practices should be used as guidelines when developing policies and procedures. Written policies and procedures establish authority, responsibility, and accountability. They serve as operational guidelines in the practice setting. Other AORN recommended practices addressing packaging systems, sterilization, creating and maintaining a sterile field, and surgical attire also should be consulted when developing policies and procedures for the selection and use of surgical gowns and drapes.

2. Orientation and ongoing education activities for personnel should include an introduction to and/or review of policies and procedures to be applied in the practice setting. Compliance with policies and procedures helps develop and reinforce knowledge, skills, and attitudes that affect patient outcomes. Policies and procedures also may be an integral part of continuous quality assessment and improvement activities.

GLOSSARY

Barrier material: Material that minimizes or retards the penetration of microorganisms, particulates, and fluids.

Heat-sealed patch: A patch of the same textile with an adhesive back applied to reusable textiles containing a hole or tear with high-intensity heat.

Isothermic environment: The surroundings, conditions, or influences that affect maintaining an equal temperature.

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 yams. Nonwovens are bonded to each other by friction and/or cohesion and/or adhesion. They are designed as single-use materials.

Strike-through: Penetration of microorganisms, particulates, or fluids through a barrier material.

Useful life: The anticipated life of a product, such as a woven material. Useful life is affected by the number of sterilization processing and washing cycles a product can endure and yet maintain an acceptable barrier capability.

Wicking: Absorption of a liquid by capillary action along a thread or through the material.

Woven material: Fabric constructed from yams made of natural or synthetic fibers or filaments that are woven together to form a web in a repeated interlocking pattern.

NOTES

(1.) "Recommended practices for the evaluation and selection of products and medical devices used in perioperative practice settings," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2002) 305-307.

(2.) K K Leonas, R S Jinkins, "The relationship of selected fabric characteristics and the barrier effectiveness of surgical gown fabrics," American Journal of Infection Control 25 (February 1997) 16-23; Selection of Surgical Gowns and Drapes in Health Care Facilities (Arlington, Va: Association for the Advancement of Medical Instrumentation, 2000) 4-12.

(3.) Ibid.

(4.) "Occupational exposure to bloodborne pathogens; Final rule," Federal Register 56 (Dec 6, 1991) 640004-64182; N L Belkin, "A historical review of barrier materials," AORN Journal 76 (October 2002) 648-653.

(5.) Processing of Reusable Surgical Textiles for Use in Health Care Facilities (Arlington, Va: Association for the Advancement of Medical Instrumentation, 2000) 23-28.

(6.) Ibid 27-28; American Society for Healthcare Central Service Professionals of the American Hospital Association, Training Manual for Central Service Technicians, third ed (Chicago: American Hospital Association, 1997) 136.

(7.) Ibid.

(8.) Processing of Reusable Surgical Textiles for Use in Health Care Facilities, 24; Selection of Surgical Gowns and Drapes in Health Care Facilities, 16-17; C Edmiston et al, "Airborne particulates in the OR environment," AORN Journal 69 (June 1999) 1169-1183.

(9.) J Pournoor, "New scientific tools to expand the understanding of aseptic practices," Surgical Services Management 6 (April 2000) 28-32; J W Smith et al, "Determination of surgeon-generated gown pressures during various surgical procedures in the operating room," American Journal of Infection Control 23 (August 1995) 238; E A McCullough, "Methods for determining the barrier efficacy of surgical gowns," American Journal of Infection Control 21 (December 1993) 368; I D Learmonth, "Prevention of infection in the 1990s," Orthopedic Clinics of North America 24 (October 1993) 736; K W Altman et al, "Transmural surgical gown pressure measurements in the operating theater," American Journal of Infection Control 19 (June 1991) 147.

(10.) Selection of Surgical Gowns and Drapes in Health Care Facilities, 17, 18, 23; Processing of Reusable Surgical Textiles for Use in Health Care Facilities, 14, 24, 25; D Fogg, "Infection control," in Alexander's Care of the Patient in Surgery, 11th ed, M H Meeker, J C Rothrock, eds (St Louis: Mosby, 1999) 145.

(11.) Good Hospital Practice: Steam Sterilization and Sterility Assurance (Arlington, Va: Association for the Advancement of Medical Instrumentation, 1994) 9.

(12.) Ibid; "Reuse of single-use devices," (Clinical Issues) AORN Journal 73 (May 2001) 957-966; "AORN guidance statement: Reuse of single-use devices," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2002) 113-119.

(13.) Selection of Surgical Gowns and Drapes in Health Care Facilities, 15, 16, 18; "Standard for the flammability of clothing textiles," in Code of Federal Regulations (CFR) 16: Commercial Practices, Part 1610 (Washington, DC: US Government Printing Office, 2001) 608-616; "Standard for the flammability of vinyl plastic film," in Code of Federal Regulations (CFR) 16: Commercial Practices, Part 1611 (Washington, DC: US Government Printing Office, 2001) 622-630.

(14.) Ibid; J R Sommers, "Flammability standards for surgical drapes and gowns: Past, present, and future," Surgical Services Management 4 (February 1998) 41-44; Fire Safety in the Perioperative Setting (Woodbury, Conn: Cine-med, 2000) Videotape; "Surgical fires in the OR," ORRM 2 (1992).

(15.) Ibid; "Recommended practices for laser safety in practice settings," in Standards, Recommended Practices, and Guidelines (Denver: AORN, Inc, 2002) 277-281.

(16.) Selection of Surgical Gowns and Drapes in Health Care Facilities, 13, 14.

(17.) Ibid; A C Meling et al, "Effects of preoperative warming on the incidence of wound infection after clean surgery: A randomised controlled trial," The Lancet 358 (Sept 15, 2001) 876-880; Agency for Healthcare Research and Quality, University of California, San Francisco-Stanford Evidence-Based Practice Center, Making Healthcare Safer: A Critical Analysis of Patient Safety Practices (Rockville, Md: Agency for Healthcare Research and Quality, US Department of Health and Human Services, 2001) 231-234; A Kurz, D I Sessler, R Lenhardt, "Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization," The New England Journal of Medicine 334 (May 9, 1996) 1209-1215.

(18.) Selection of Surgical Gowns and Drapes in Health Care Facilities, 19.

(19.) Safe Medical Devices Act of 1990, sec 519 (21 USC 360); "Medical device reporting," in Code of Federal Regulations (CFR) 21: Food and Drugs, Part 803 (Washington, DC: US Government Printing Office, 2002) 38-55; "Medical devices: Reports of corrections and removals," in Code of Federal Regulations (CFR) 21: Food and Drugs, Part 806 (Washington, DC: US Government Priming Office, 2002) 55-58.