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Operating Room by Jeannie Akridg There used to be a time when surgical gown wearers were put in the compromising position of having to choose between ultimate comfort and maximum protection. Thanks to new fabric technologies and a variety of intuitive product enhancements, clinicians are finally getting what they want. "There’s a certain portion of your population that wants maximum protection no matter what, and there’s another portion that really wants comfort at the expense of protection, and so [in the past] it’s become sometimes a tradeoff," said Lori Gettelfinger, business development leader, DuPont Medical Fabrics (Old Hickory, TN). "In the last 25 or 30 years the disposables on the market were really either products that were comfortable with limited repellency or high-barrier products that weren’t really comfortable," said Frank Czajka, president, Proxima division, Medline Industries (Mundelein, IL). The good news for materials managers is that today’s new generation of surgical apparel won’t break hospital budgets, and may even save a few bucks in the long run.
"Users want gowns that provide ultimate protection, yet remain cool and comfortable. Material managers want gowns that combine not only these features, but which render a cost savings," said Amy Cash, product marketing & communications specialist, Precept Medical (Arden, NC). Medical fabrics conform Much of the focus for vendors over the last few years has been on enhancing product performance through innovative fabric technology that keeps users cool and comfortable while meeting and exceeding barrier protection standards. For example, DuPont’s Suprel medical fabric that hit the market in 2003 in the form of Medline’s Aurora surgical gown, uses a unique bi-component technology that combines the softness of polyethylene with the strength of polyester. It tests exceptionally high for tear-strength, yet is very soft and drapeable, so it moves with the user. It also offers enhanced breathability in terms of allowing moisture vapor to escape through the gown. Cardinal Health (Dublin, OH) achieves ultimate protection without compromising comfort through the breathable fabric of its SmartGown. The fabric reacts to increasing temperature by increasing its water vapor transfer rate. "As the temperature rises, the amount of water vapor that escapes from the material also increases, by as much as 64 percent, allowing the wearer to stay cool and comfortable through even the most demanding procedures," explained Lisa Krebs, market manager, Cardinal Health. Kimberly-Clark Health Care (Roswell, GA) is in its 8th generation of non-woven fabrics. The company’s SMS (spunbond/meltblown/spunbond) and breathable impervious fabrics found in the Kimberly-Clark ULTRA and MICROCOOL Breathable Impervious Surgical Gowns balance the essential properties needed in a surgical gown: comfort, protection, abrasion resistance and flammability resistance. "The Association of periOperative Registered Nurses (AORN) recommends in its Standards and Practices that buyers consider four key areas when selecting surgical gowns and drapes: barrier integrity, linting, flammability and comfort," said Brian Wagner, general manager, global surgical solutions for Kimberly-Clark Health Care. The newest feature to be added to select Kimberly-Clark surgical gowns is SECURE-FIT, a proprietary technology shown to reduce the amount of surgical glove slipdown when used with market leading surgical gloves. "In listening to customers, we found that the bloodborne pathogen risks associated with glove slipdown during surgery was a major concern for caregivers; Kimberly-Clark’s solution was to develop SECURE-FIT," said Wagner. Precept Medical offers two basic lines of surgical gowns: a line of SMS gowns and gowns made from DuPont’s Softesse material. The SMS gowns are made of multiple layers of spunbond and meltblown polypropylene. These multiple layers of fabric provide excellent fluid repellency and a barrier against bodily fluids and pathogens. Softesse gowns provide comprehensive barrier properties with material that remains cool and breathable.
Precept’s Excel gowns are generously sized in the chest and underarm area, to allow for ease of movement during procedures. The seams have been moved to the top of the set-in sleeves to help prevent the possibility of strikethrough by keeping the seam away from the work area. All of Precept’s gowns are available in regular and nontraditional sizing, including a line of extra long gowns. Dow Fiber Solutions has developed an olefin-based stretch fiber, DOW XLA HTT, designed for workwear applications such as reusable surgical apparel. DOW XLA can withstand repeated washings and tunnel drying up to 95° degrees Celsius without losing shape or fit for a more durable fabric. Because surgical garments made with DOW XLA provide optimum stretch properties, wearers can perform their work without feeling restricted or compromising their movement. Manufacturers can also produce fewer sizes because the stretch of the graments allow them to fit more body shapes comfortably. Standardization trends Formally introduced three years ago, the Association for the Advancement of Medical Instrumentation’s (AAMI’s) Standard PB70:2003 for Liquid Barrier Performance of Protective Apparel provides specific guidance on barrier protection. The AAMI standards denote barrier protection capabilities for gowns, drapes and other protective apparel based on four levels, with a Level 1 gown providing the lowest amount of protection and a Level 4 gown providing the highest according to standardized industry tests for strength and strike-through. According to the AAMI Standard PB70, AAMI Level 4 surgical gowns must pass ASTM F1671. "The significance of a gown that passes ASTM 1671 is that it can claim ‘imperviousness’," said Kimberly-Clark’s Wagner. "This is the most stringent of barrier tests in the industry. All surgical gowns that can claim ‘impervious’ possess the necessary fabric barrier to drive towards an AAMI Level 4 claim. To make the claim AAMI 4, an ‘impervious’ surgical gown must also pass ASTM 1671 in all elements of the critical zone." The new AAMI standards are serving to not only level the playing field for surgical apparel manufacturers but are also helping to educate buyers and users on the differences in surgical gown protection capabilities. "Although AAMI Standard PB70 is relatively new to the industry, we have already seen changes in user behavior," said Cardinal Health’s Krebs. "Many customers are seeking more protective gowns and have begun requesting gowns by AAMI level such as, ‘I only want a Level 3 or Level 4 gown.’" Cardinal Health’s recent educational efforts regarding the AAMI standard include a continuing education study guide that’s been provided to over 300 healthcare facilities so far. "We truly believe education is the key to assisting healthcare workers in choosing gowns that offer adequate protection," said Krebs. Gettelfinger notes that DuPont is also working on educating those in the field, with specialists who are out in the hospitals educating end users and buyers about their gown and drape choices. "I think you have greater awareness of the differences in barrier protection that are available. And oftentimes hospitals want to standardize with two offerings that will meet their needs across the board. And in that case they’re looking for a product for general surgery that’s either an AAMI Level 2 or an AAMI Level 3. And then they want a product that’s totally impervious either with a film-reinforced product or a total film impervious product that would be AAMI Level 4 for their high fluid cases, and specifically orthopedics and cardiovascular," said Gettelfinger.
"This standard and especially the new technical information report, TIR, that’s been issued along with that, gives guidance around which level is most applicable based on the different surgical procedures. You might have a hospital that had defaulted to all Level 4 gowns – through this approach they might realize that they were over-protecting, and in turn over-paying for a good percentage of their procedures, and they can then reevaluate to see if there’s a better option." "The AAMI standard can act as an objective equalizer, that lets the hospitals have a way to evaluate fluid protection across the range of competitive alternatives," added Gettelfinger. "Everybody tests the same, following the same methodology, so it’s very appropriate to compare numbers from one company to the next, so it gives them a way to objectively evaluate fluid barrier." "AAMI has proven helpful to buyers and users by providing them with a clear benchmark to compare the barrier protection qualities of different gowns," said Kimberly-Clark’s Wagner. "Through its campaign in promoting the standard, AAMI has brought barrier protection to the forefront of buyers’ and caregivers’ minds." "Anything that’s going to provide more information for the buyer and the user is going to make it easier to standardize. The trend is to pick two gowns," said Medline’s Czajka. "You need something that’s going to protect the clinicians in a wet case…that’s impervious to blood and body fluid and bacterial transmission. So choose a level 4, and then you can either choose a mix of a 2 and a 3; or you can choose all 3s and 4s. And you can target it by case. We do consultative work; we can benchmark your usage and make recommendations." The important thing to remember, he said, is that "the incidence of mis-pick goes up tremendously if you have five gowns versus two." Medline’s Aurora gown featuring Suprel is classified as AAMI Level 3, and can accommodate up to 90% of a facility’s case load, said Czajka. "The fact that Aurora gowns can encompass 80 to 90% of surgical cases in a one-ply gown greatly reduces costs becuase you don’t have to reinforce the gown," he said. Choosing the wrong gown has implications, whether the problem is over- or under-protection. "First, selecting the right gown for the right procedure is key," said Wagner. "From there, facilities should look to standardize their gowns, and all PPE for that matter, as much as possible. Our sales force works with customers to improve utilization and reduce waste." "Customers are thinking more broadly about cost related to outcomes," he continued. "Cost for proper gown/drape usage is more involved than the individual price of the product. We conducted surveys and found that people have used or know someone who has used the wrong gown, even though the right gown is available, approximately 47% of the time. This can have a negative impact on a caregiver if they are under-protected." "Cost is a significant factor in selecting surgical gowns, but it is important for the facility to consider overall costs, not just unit costs," emphasized Krebs. "For example, if a facility is purchasing gowns with less protection than necessary, a healthcare worker may use more than one gown throughout a procedure. Alternatively, if the gowns provided for a case are highly protective but too hot, someone might pull a second, more comfortable gown from the shelf to wear instead. In both cases, the unit cost of the original gown might be lower than a breathable impervious gown, such as SmartGown, but the overall costs will be higher." "There are companies out there that want you to buy up to 40 to 50% of the totally impervious gown. Those are the most expensive gowns out there," said Czajka. "If you benchmark it, today’s surgery is low blood loss in a lot of ways. Advances in surgery have helped skew that mix and it’s incumbent on us as a manufacturer to shift the paradigm a little bit... the utilization savings will be tremendous." Grab-and-go gowning with New color-coding systems from vendors are also making it easier for end users to pick the right gown for the right case without expensive waste or worrying whether they’re adequately protected. "It can be difficult for caregivers to identify gown types, in sterile packaging, on the back-table or in-use. Even though an incorrect selection doesn’t happen often, any occurrence of it can have negative consequences for both patients and staff such as lack of protection including strike-through, compromising the sterile field, inefficiency in the O.R., increased cost to the facility, and anxiety and fear of not being adequately protected. We introduced the Kimberly-Clark Color-Key to provide caregivers a simple, common sense approach to gown selection," said Wagner.
"The most important thing about the AAMI standards in my opinion is to make sure the clinicians are getting what they need and not just what’s on the shelf," said Medline’s Czajka. "So what Medline has done – and this came with heavy advice from end users – is we’ve color coded our gowns to AAMI. Nurses are extremely visual and our packaging will be one of three different colors: Our Level 2 package is green. Our Level 3 package is purple and our Level 4 package is navy blue. We reinforce that color on the neck binding of the gown to the corresponding color of the level, and also the pass card of the gown. "Those three visual triggers…make it easy for end users to pick the right gown every time they put on a gown. And that helps reduce the mis-pick and then the incidence of break-through," said Czajka. Cardinal Health also recently introduced a color-coding system for its surgical gowns based on the AAMI PB70 classification system. "By color-coding different elements of the gown to include packaging, transfer tabs, and informational stickers on the gown, our system helps healthcare professionals easily identify the gown needed for a particular case based on anticipated exposure to fluid," said Krebs. "Based on customer input, we use the AAMI standard as the platform for our program." Kimberly-Clark takes a slightly different approach to color-coding basing its system on the type of gown, rather than on the AAMI standards. Non-reinforced gowns are designated as yellow, fabric reinforced gowns are coded green, and fully impervious gowns including Kimberly-Clark’s MICROCOOL, are designated red. Color-coded neckbands, tie cards with color-key and color-coded packaging all help to confirm the type of gown. Wagner explains. "Under the current AAMI PB70:2003 standard, most manufacturers will have their non-reinforced and fabric reinforced surgical gowns classified as AAMI 3. These gowns are actually very different in terms of comfort and product performance. Our Kimberly-Clark Color-Key system clearly defines the differences in those two products with different colored neck-bindings to ease the product selection process at the shelf." "From a business perspective, O.R. managers and material managers can visually look into an O.R. and understand whether their staff is adequately and appropriately protected for the procedure," Wagner added. "We also offer an online Gown Selector Tool which is a guided decision-making tool for choosing the right gown for a procedure," he continued. "It helps to differentiate the K-C Surgical Gown line in terms of fluid levels and procedures, then guides the user to an appropriate choice based on the criteria they choose. Again, the goal here is to help facilities standardize and save money, while adequately protecting caregivers." Drapes keep patients under cover Today’s drapes are tailored to specific surgeries for the highest level of protection and ease-of-use features. Drapes must be safe for the patient, create a sterile field and must pass tests for both flammability and linting. "A skin surface covered with a sterile incise drape essentially eliminates the transfer of bacteria to items that would come in contact with the wound such as gloves, instruments and sponges," said Deborah Gardner, LPN, OPAC, CIC, technical service specialist, 3M Health Care (St.Paul, MN). 3M recently introduced two new surgical drapes. One is the 3M Steri-Drape Craniotomy Drape with Ioban 2 Incise Film, which the company describes as a "time-saving drape" that combines superior fluid control with persistent antimicrobial properties.
3M’s Steri-Drape Absorbent Prevention Fabric Drapes are low-linting, nonwoven, absorbent fabrics laminated to plastic film that are designed to soak up spills and splatters without fluid strike-through. The fabric is absorbent and impervious throughout the entire drape, keeps fluids from running off the drape surface and eliminates the need to define the drape’s critical zone. Fluid control pouches and absorbent pads are incorporated into many of 3M’s drapes. These features channel and collect body and irrigation fluids, reducing patient exposure and minimizing fluid run off which can be a hazard to O.R. staff. 3M drapes may also feature adhesive apertures which prevent drape migration into the operative site reducing the risk of contamination. The drapes are resistant to tears, punctures and abrasions. 3M’s new Ioban 2 Antimicrobial Incise Drape - 6661EZ has a unique framed delivery system enabling simple, one-person application. The drapes are made from a polymeric film coated with a pressure-sensitive adhesive. An iodophor complex is incorporated into the adhesive and releases microbicide to the skin, providing continuous antimicrobial activity during surgery. They help prevent surgical site infections by reducing bacterial migration from the patient’s skin to the surgical wound. Secure adhesion, even after several hours, ensures the barrier and antimicrobial properties are utilized all the way to the wound edge.
Cardinal Health’s Tiburon drape is impervious and also absorbent for enhanced fluid control. The benefit of added absorbency is improved control and containment of fluids that typically either pooled on the drape or rolled off onto the floor. Tiburon is made of synthetic materials that are flame-resistant and will melt away versus ignite when in contact with a heat source. To make them easy-to-use, Tiburon Surgical Drapes are clearly marked with directions on how to orient the drapes and unfold them when they are placed on the patient. Drapes available within each procedure segment may include cord control features, fluid control pouches, instrument pouches, and reinforcements specific to the key clinical requirements for associated surgical procedures. "According to the CDC’s 1999 Guidelines for the Prevention of Surgical Site Infection, surgical drapes should be impervious to both blood and viral penetration. Drapes historically feature an impervious reinforcement immediately surrounding the incision site. However, Cardinal Health’s Tiburon Surgical Drapes are made with a composite material that extends that same level of impervious protection throughout the entire drape," said Michael Duski, senior market manager, surgical drapes. "Most surgical drapes meet AAMI Level 4 requirements because they are impervious within the critical zone," said Duski. "Being fully impervious, Tiburon meets AAMI Level 4 requirements throughout the entire drape not just within the critical zone."
Medline has expanded the use of DuPont’s Suprel fabric to its drape line, including the new OrthoMax drape. OrthoMax features a heavier basis weight of DuPont Suprel fabric that offers even higher hydrohead and more strength and fluid protection to be able to withstand the rigors of orthopedic surgery. The new Aurora drape line features a lighter basis weight of the Suprel but still offers superior fluid protection and also excellent strength for the majority of the cases, that don’t have as much rigor as orthopedics. The Suprel fabric also allows the drapes to conform to the patient enhancing the sterile field. Czajka notes that Medline’s drapes are designed to be longer and wider than many drapes to better cover the operating field. "We actually put a very large patient on an AMSCO 2080 table and made our drapes to fit our large demo patient and table," he said. Kimberly-Clark’s drapes are easy to open and to apply with clear body stamps and arrows to show caregivers exactly how to place the drape. Adhesive materials (tape or incise) secure easily and quickly. In addition, specialty drapes are designed with attention to unique needs of the procedure, including a choice of fabric reinforcements designed to either reduce instrument slippage or control fluid run-off; product offerings with fluid collection pouches with suction drainage port for fluid disposal; and convenient tube and line management systems, including tube holders and hook and loops. Kimberly-Clark drapes meet the maximum rating for flame resistance for use around lasers and other electrical instruments; are resistant to tears, strikethrough and abrasion; feature low lint to reduce the risk of airborne bacterial transmission; and include absorbent material that helps to control fluids. "Using the correct drape that offers the adequate level of protection for every application means ultimately a lower cost per procedure. The customer will use what is clinically needed without paying for costly over-protection," said Wagner. Precept’s drapes utilize Precept’s UltraGard SMS fabric, which is low linting, yet has excellent barrier and fluid repellency properties. The drapes are available in sterile and non-sterile put-ups. Customers can buy procedure packs directly from Precept, or they can create their own packs using Precept products and a custom tray company. 3M’s Gardner notes that a drape that performs correctly can save costs in terms of avoiding surgical site infection. "A surgical site infection adds 7.3 additional post-operative hospital days and costs $3,152 in extra hospital charges. That adds up to more than $5.4 million per day, or $2 billion per year in the U.S. alone.1Additional costs that come from having to treat a surgical site infection include extra office visits, post surgery antibiotics, increased insurance rates, re-hospitalizing the patient if the severity of infection warrants, personal and social costs associated with a delay in the patient’s return to normal daily activities." "And, even though some of these costs may be reimbursed under managed case, ultimately surgeons and hospitals end up absorbing major costs," Gardner added. "If an incise drape helps prevent even a minor surgical site infection, it might be worth the investment." The right surgical drape can also deter surgeons from wastefully layering drapes for better protection. "Recognizing the importance of enlarging the critical zone, many surgeons layer drapes to reduce the chance of strike-through. In fact, 76% of surgeons said that the main reason they layer when draping is to create a barrier. 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," said Gardner. Masks help surgeons breathe easy An equally important piece of surgical apparel used to protect staff is the surgical mask. BARRIER wearing apparel from Mölnlycke Health Care consists of an extensive range of single-use items for personal protection including disposable scrubs, masks, headwear, glasses and goggles. The BARRIER mask line features extra long ties and extra width for a secure fit and optimal facial coverage which helps to minimize breathing resistance and maximize comfort. The BARRIER line also includes a range of hypoallergenic masks.
3M Health Care offers a full-line of surgical, specialty, and face shield masks as well as N95 NIOSH approved respirators. 3M’s masks provide high fluid resistance, are easy to breathe through and designed for comfort. 3M also offers a unique flat-fold tri-panel design N95 respirator that can be conformed to fit a variety of face shapes and sizes. Look for masks that help keep the wearer cool and comfortable with enhanced breathability. "3M understands that mask breathability is the most significant product feature to clinicians," said Maret Millard, NREMT-B, technical service specialist, 3M Health Care. 3M’s masks also feature malleable nosebar materials that undergo rigorous testing to ensure conformity and comfort for the user. The Tie-on Surgical Mask and Filtron High-Performance Tie-On Surgical Mask from 3M are available with an anti-reflective, anti-fog face shield that reduces glare greater than 80%, said Millard.
Kimberly-Clark’s FLUID-SHIELD Surgical Mask with Anti-Glare Visor includes a patented breathable film layer that offers protection against blood and body fluids, passing ASTM F 1862 at the maximum value of 160 mm Hg. (To claim fluid-resistance, a mask must pass ASTM F 1862 at a minimum pressure of 120 mm Hg.) Cardinal Health distinguishes its Secure-Gard Fluid-Resistant face mask with a multi-color outer facing. These masks feature super-soft ties and bindings, smooth interfacing, fog-free strips, eyeshields and Secure-Bill front. The Secure-Gard masks pass ASTM 1862 for synthetic blood penetration at 160 mm Hg.
The Prohibit series of face masks from Medline are designed for comfort and breathability, and exceed AORN standard of 95% Bacterial Filtration Efficiency (BFE) and undergo testing by Nelson Laboratories. As a result of recent increased demand, Medline now offers six lines of N95 particulate respirators, as well as a qualitative fit test to ensure ultimate comfort and protection for staff. Also new from Medline, is a face mask that’s subtly scented with spearmint to help cover odors during bone cases, for example.
Precept Medical recently introduced FluidGard masks with SnapShields, a new line of fluid resistant masks with removable face shields. Precept has also added a line of full and ¾ length face shields intended to be worn with surgical masks. Precept recently modified its FluidGard line of face masks, to make them cooler and more breathable. In addition to providing added comfort, this change also enhanced the protective qualities of the masks. These masks now pass the ASTM blood splash test at the highest level of 160 mm Hg, and provide bacterial filtration efficiencies exceeding 99%, noted Cash.
Precept offers "Comfort Days" for its mask line that allows hospitals to evaluate both product performance and comfort prior to committing to a product. Outlook on surgical apparel In the coming months, surgical apparel vendors are focused on enhancing existing product lines with even more choices. Medline is looking at ways to expand its Aurora line of drapes and gowns. "We’re rapidly expanding the product category and hopefully by the end of the year we’ll have a whole product line of Aurora packs, drapes and gowns." said Czajka. Kimberly-Clark will soon offer small sizes in its MICROCOOL SECURE-FIT Surgical Gown line, and is also looking at new options in specialty drapes for release next year. Precept Medical is responding to customer needs and suggestions and will soon be introducing several new procedure packs, said Cash. "Many of our products are designed through our customers working in tandem with our product development team." The primary focus for Mölnlycke Health Care in the area
of surgical apparel has been on developing a unique line of disposable
scrubs that provide an alternative to traditional cotton. "Facilities
are looking for an alternative to the multiuse traditional scrub for
cleanliness, cost containment and theft reduction," said Lydia
Dodson-Lehrer, surgical product "Moving forward Mölnlycke will continue to be responsive to customer needs further expanding our line of surgical apparel to address this ever changing environment particularly focusing on our proprietary disposable scrub line and masks," said Dodson-Lehrer. HPN Reference:
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