Barrier Protection

ICT takes the roundtable approach to discuss today’s surgical barrier products.

Our panel of experts includes:

(DS) Debra Schotz, vice president of marketing with Cardinal Health’s convertors division
(BW) Brian Wagner, general manager of global surgical solutions with Kimberly-Clark Health Care
(LG) Lori Gettelfinger, business development leader with DuPont Medical Fabrics
(DG/CW) Deborah Gardner, LPN, OPAC, CIC, technical service specialist for 3M Health Care and Carol Watson, market development manager for 3M Health Care’s surgical drapes division

Q: What is the No. 1 misconception concerning the use of barrier protection?

(DS) “The No. 1 misconception pertaining to the use of barrier protection is that a repellant material is always impervious. Impervious means that a fabric is impenetrable by fluids and microorganisms. When fluid contacts a repellant material it beads up, giving the appearance that no strikethrough will occur; however, given enough time, fluid and pressure strikethrough may occur.”

(BW) “All barrier protection of surgical gowns and drapes is not created equal, even though they may look similar. Caregivers need to be aware of using the appropriate level of protection for the procedure at hand.”

(LG) “Some clinicians believe that they have to choose between comfort and protection. They assume that products that offer high levels of fluid protection must be hot to be protective. Historically, there was some truth to this as gowns that were comfortable offered less protection. However, with advances in material technology users can get high fluid protection and comfort from one material.”

(DG/CW) “The biggest misconception regarding barrier protection and draping is if you apply drapes in layers they will create a barrier. However, when the drapes become permeated or moist, they must be considered contaminated. Corrective action must be initiated to cover the area in question, or unless the drape has a ‘barrier’ or impervious film layer to prevent strike-through, the drapes must be changed. It is important to remember that when you have fluid and pressure, it always results in strike-through unless you have an impervious layer.”

Q: Can you explain the different fibers used for such products? What are the more effective materials for protection?

(DS) “Disposable surgical drapes and gowns are made from natural or synthetic fibers. Spunlace is a material made of both wood pulp (natural) and polyester (synthetic fibers). Surgical drapes and gowns constructed of spunlace offer a lower level of protection compared to products made entirely of synthetic materials. Additionally, the wood pulp fibers used to create spunlace material may burn at a higher rate than fully synthetic materials. Synthetic fibers such as polypropylene and polyethylene are also commonly used in the construction of surgical drapes and gowns. When variations of synthetic fibers are combined, a higher level of protection can be created. Synthetic fibers also tend to melt away when in contact with a heat source, reducing the potential for a fire hazard.”

(BW) “While there are many unique polymer combinations used to drive different barrier levels in surgical products, the one commonality is that the more uniform the coverage of the barrier layer of material, the better the level of protection will be against strikethrough.”

(LG) “Spunlace fabrics are made with polyester and wood pulp and offer excellent splash resistance and comfort, but lower fluid protection under pressure. Gowns made with spunlace fabrics can be reinforced with fabric or film to provide additional fluid protection. Polypropylene SMS provides higher fluid barrier than spunlace but is less breathable, and can be stiff making it a less comfortable choice. The newest innovation in medical fabrics is made with bi-component technology combining polyester for strength and polyethylene for softness. It offers higher fluid barrier than even PP SMS and is very soft and comfortable. The highest level of protection — AAMI (Association for the Advancement of Medical Instrumentation) level 4 — products must be reinforced with a film to make them totally impervious.”

(DG/CW) “Common drape materials include linen/cotton (reusable drapes), nonwovens, or plastics with adhesive areas. A nonwoven is a fabric produced by bonding or interlocking fibers. The most common nonwovens include one layer treated with fluorchemicals for fluid repellency; two or more layers of nonwoven; and two or more layers of which one is made of a plastic “Nonwoven draping products treated with a fluorchemical are repellent. If fluid is applied to a repellent drape, it will run off unless pressure is applied at the fluid site. Two or more layers of a non woven will only ‘slow’ down the penetration of fluids. The best barrier is a drape with a plastic or film layer which creates an impervious barrier.

“Although there are no standards, when draping, the AORN guideline recommendations state, ‘They should provide barriers to microorganisms, particulate matter, and fluids.’ Drape materials should be resistant to penetration by blood and other fluids under normal conditions. But that’s not the only important characteristic of a barrier drape. An impervious drape that is fluid repellent, for example, may be ideal for some applications, but because of its repellency, fluids may bead up and roll off the drape onto the floor or onto the healthcare worker. A drape that is absorbent and impervious is designed to help prevent the risks of both strike-through and roll-off, and eliminates the need for layering while protecting the healthcare worker.”

Q: What aspects should healthcare clinicians be aware of when choosing the correct level of protection?

(DS) “To determine the correct level of protection, a clinician should answer the following four questions:

• What type of procedure is being performed?
• How long will the procedure last?
• How much fluid will be present during the case?
• What is the clinician’s role in the procedure?

“Once these questions are answered the clinician can select the appropriate drape and gown for the procedure. All drapes and gowns are classified with an AAMI level. This AAMI level indicates the level of protection offered by the product on a scale of 1 to 4 based on testing conducted on the critical zones. Level 1 offers minimal protection, while 4 offers the most protection. Typically, AAMI level 4 products are used for long, fluid-intense procedures as they offer impervious protection.”

(BW) “According to AORN Standards, Recommended Practices and Guidelines, there are four critical criteria that should be considered when selecting surgical gowns and drapes:

Barrier Integrity

Surgical gowns and drapes should be resistant to penetration by blood and other bodily fluids, which can serve as vehicles for blood viral transmission.

Linting

Gowns and drapes should be resistant to tears, cuts, and abrasions and low-linting. Lint can contribute to the transmission of bacteria, or cause foreign-body reactions if particles enter an open wound. Abraded materials can generate lint and distort the original physical properties of the surgical products.

Flammability

Gowns and drapes should resist combustion. The OR environment contains the necessary fuel, heat source, and oxygen to cause a potential fire. Choosing materials that resist rapid flame spread will help improve reaction time in the event an OR fire occurs.

Comfort

Gowns and drapes should be comfortable and contribute to maintaining the wearer’s desired body temperature. This allows personnel to more readily focus on what is truly important, the procedure at hand.”

(LG) “Clinicians need to evaluate the level of fluid challenge that they are likely to be exposed to in a procedure, and they can then choose the right level of protection. Many cases have very low risk of fluid exposure and an un-reinforced gown provides appropriate comfort and protection. AAMI has developed a Technical Information Report (TIR 11:2005) to provide guidance to clinicians regarding which level of protection is suitable for the major procedure classifications.”

(DG/CW) “The purpose of a drape in infection control is to create a sterile field to eliminate or minimize the passage of microorganisms from non-sterile to sterile areas. Thus it is important to be aware of the amount of absorbency as well as the barrier properties of a drape material. It is also crucial to know the procedure the drape will be used for, and be aware of the amount of fluid generated during that surgical procedure. Accessories should also be chosen based on the procedure (e.g. fluid pouches, equipment drapes, etc.).”

Q: Do you see any common areas of misuse when it comes to barrier products?

(DS) “Barrier products are often misused due to both a lack of product knowledge and cost saving measures by the facility. Some users perceive fully impervious products to be warm and uncomfortable, thus opting to sacrifice protection in pursuit of comfort.”

(BW) “The most common misuse is under- or over-protection. This can be problematic because caregivers need adequate barrier protection and by not optimizing the level of protection, facilities spend needlessly. By standardizing on fewer and smarter products, facilities can make product selection simpler and save money. “Another area is caregivers employing makeshift solutions to prevent problems they encounter when using barrier protection. For example, caregivers will use self-adhesive sterile tape or adherent incise drapes to prevent slip-down of their gloves during procedures.”

(LG) “We have seen some hospitals that are using all level 4 gowns to provide the ultimate level of protection for their staff, and this is overkill. Hospitals can best meet their staff and patients’ needs by using a mix of protection levels based on their procedure mix. This will be the most cost effective for the hospital and provide the staff with the best combination of comfort and protection. Many hospitals have found that they can standardize with two gowns based on the new options in materials and meet all of their needs for protection.”

(DG/CW) “Not understanding that fluid strikethrough can occur anywhere within the sterile field, not just in the critical zone.”

Q: What message would you most like to convey concerning the “critical zone”?

(DS) “The introduction of AAMI PB70:2003 has helped to more clearly define the critical zones of surgical drapes and gowns. AAMI’s definition of critical zones encompasses not only the base fabric but also the construction method of specific areas such as surgical gown sleeve seams.”

(BW) “Know how the products used perform in the critical zones. Clinicians should select a gown whose critical zones have protection levels that are appropriate for the anticipated amount of fluid exposure and the duration of a procedure. In surgical gowns, the critical zone is the front area of the gown from chest to knees and the sleeves from cuff to above the elbow. For the surgical drape critical zone, one should understand how well the reinforcement manages fluids, lints at low levels, and resists rapid flame spread in the event of an OR fire. Most manufacturers define the critical zone of a drape to be the reinforcement area or the immediate area surrounding the fenestration.”

(LG) “One important point is that the level of protection for drapes is defined by the critical zone established by the drape manufacturer. This is commonly the absorbent reinforcement surrounding the fenestration area. This is the area of the drape where fluid barrier is important.”

(DG/CW) “Although the critical zone has been defined as an area approximately 12 inches entirely around the incision area, fluid is very seldom contained to that area. The risk of infection increases when strike-through occurs anywhere within the sterile field — not just in the traditional critical zone. “Sterile surgical drapes protect the patient from infection by preventing microorganisms from making their way into the skin opening created during surgery. Surgical drapes are effective because microorganisms cannot move by themselves and rely on dust, fluids, or contact to move them. If a drape material allows fluid to penetrate, it creates a pathway and mode of transportation for organisms to invade the sterile field. The penetration of a drape, gown, or mask by fluids is known as strike-through. To prevent fluid strike-through anywhere on the drape, many healthcare workers will add layers of fabric. If you use a drape with a barrier material throughout the fabric, it will eliminate the need for layering while giving added protection to your patient.”

Q: Can you share some tips on the proper procedure to don a gown? How can you ensure the highest level of protection throughout use of the gown?

(DS) “When donning a surgical gown it is important to ensure that all gown ties are adequately adjusted and that the neck closure provides a secure fit. Clinicians should take the time to ensure that the gown is donned properly so that complications with the gown do not occur during the procedure.”

(BW) “One important tip when donning single-use gowns is to be sure to grab a handful of gown material and pull at the seam when adjusting your surgical gloves. This will ensure the gown does not tear. If your skin feels wet, remove the gown and don a new one.”

(LG) “The highest level of protection can be insured by choosing gowns that are made with fabrics offering good fluid barrier. Users also should evaluate the gown construction and look for gowns that are constructed well with neck closures that stay closed, like Velcro, and with heat-sealed seams. Also seam placement can be important. Seams on the top of the sleeve vs. the bottom offer less risk of a breakdown in barrier in the sleeve.”

Q: Can you share some tips on the proper procedure to place drapes? How can you ensure the highest level of protection throughout use of the drapes?

(DS) “All disposable surgical drapes provide detailed orientation and donning instructions. In order to ensure the highest level of protection it is recommended that a fully impervious drape be utilized.”

(BW) “Drapes should be applied in a smooth, controlled fashion and handled as little as possible during the draping procedure. Follow the manufacturer’s instructions; use the body stamp and arrows to properly place the drape. Don’t move a drape once it is in place. Make sure the prep solution is dry before draping. Use proper disposal methods. “Though drapes will resist punctures, avoid placing shape objects and electrical instruments on the drapes. Make sure lines and cables don’t pull on the drape. If the drape has pouches, make sure they are open before starting the procedure. Use a drape that has low linting and doesn’t abrade.”

(LG) “The highest level of protection throughout the use of the drape can also be insured through selecting materials that provide excellent fluid barrier and strength as well as fabrics that drape well and stay in place.”

(DG/CW) “Standardized symbols are placed on drapes for direction. Always make sure you begin with the drape in the correct direction. The center of the final fold is commonly lined up with the center of the incision area. Once a drape is placed it should not be moved around. Drape adhesion is very important to prevent drape migration. If a material does not contain a laminated plastic layer, it is important to create a barrier level, (ideally with a plastic drape) prior to placing your final drapes.”

Q: Can you explain the testing these products endure to be cleared as safe for its purposes?

(DS) “As all surgical drapes and gowns are class I medical devices, Cardinal Health must submit and obtain 510(k) approval from the FDA (Food and Drug Administration) prior to making the product available for commercial use. Biocompatibility is one of the main tests required within the 510(k) submission and is conducted on all surgical drapes and gowns. This test ensures that the products do not cause adverse reactions when in contact with living tissue.”

(BW) “Our goal at Kimberly-Clark is to closely align our product specifications with that of AORN Standards, Recommended Practices, and Guidelines. Depending of the type of surgical gown for barrier protection, we use:

• Spray Impact AATCC 42, which stimulates the resistance to liquid penetration by water spray impact
• HydroHead Test AATCC 127, which measures the resistance to the penetration of water under static pressure
• Kimberly-Clark Blood-Strikethrough Test Method
• ASTM 1670 (for drapes only), which measures resistance of materials used in protective clothing to penetration by synthetic blood and ambient pressure
• ASTM 1671 (for gowns only), which measures resistance of materials used in protective clothing to bloodborne pathogens using viral penetration and ambient pressure For linting, we use:
• Gelbo Lint Test which determines the relative number of lint particles released from a fabric • Martindale Abrasion Test ASTM D4966, which compares the abrasion resistance of fabric

For flammability, we use:

• NFPA 702-1980, the most stringent measure ignition rate and flame spread

For comfort, we use:

• A ‘cup crush’ test which measures the drapeability of a fabric
• Air permeability measures air flow through a fabric
• Moisture vapor transmission rates which identifies the ability of a fabric to transmit moisture vapor

Gown design is a consideration; gowns with raglan sleeve design offer a wider range of motion as opposed to those with set-in-sleeves.”

(LG) “DuPont Medical Fabrics go through extensive testing measuring their fluid barrier to determine their performance vs. the AAMI standards that have been established. In addition to fluid barrier, DuPont Medical Fabrics are evaluated for strength characteristics, alcohol repellency, MVTR (moisture vapor transmission rate), surface stability, and flammability using the CPSC (16 CFR part 1610). Medline evaluates all of the gowns and drapes made with DuPont Medical Fabrics to meet rigorous quality standards to meet their customers’ needs.”

(DG/CW) “Standards only apply to these materials when they are converted into drapes, gowns, or masks intended for sale. The FDA regulates these products as Class 1 sterile medical devices, per Rule 1 for non-invasive devices, meeting all standards for basic safety and efficacy. Every surgical drape on the market has met these basic standards to gain approval for sale. Drape manufacturers also receive guidance from industrial associations such as the Association of the Non Woven Fabric Industry (INDA) and AAMI. The purpose of these industrial associations is to create standardized terms and test methods, which will protect the interests of the industry at large, and member companies specifically. Standards and test methods developed under these organizations are voluntary and enforced by the member manufacturers. These guidance tests include absorbency, level of barrier, linting, etc.”