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With an eye towards matching surgical apparel to the task at hand, Kimberly-Clark Health Care launched an expanded surgical products portfolio at the 55th annual congress of the Association of periOperative Registered Nurses (AORN) in Anaheim, CA, this Spring. Designed to provide facilities with a choice of solutions to meet both their clinical and financial needs, the portfolio includes three performance classes of gowns, drapes and packs – KC100, KC200 and KC300.

The new KC100 line provides users with access to reliable, cost-effective sterile and non-sterile protection for everyday use in lower-fluid, shorter procedures such as outpatient surgery, ophthalmic surgery, ENT, hernia, etc. Meeting industry performance standards, the KC100 gowns feature SMS (spunbond/meltblown/spunbond) fabric for barrier protection, set-in sleeves and hook-and-loop closures.

The KC200 line delivers a balance of comfort and protection appropriate for a wide range of surgical procedures from laparoscopy, minimally invasive surgeries to arthroscopic procedures such as gallbladder surgery and hysterectomy. KC200 surgical gowns meet AORN standards for fluid-, flame- and lint-resistance and are made with comfortable SMS fabric that protects from blood strikethrough.

For best-in-class protection during longer, more invasive and fluid-intensive procedures such as orthopedic surgery, C-sections, etc., the KC300 surgical tier features top-performing ULTRA and MicroCool gowns. Optional Secure-Fit technology prevents gloves from slipping down over the cuffs of the gown during the procedure.

"Not only is [glove slip-down] a distraction for the surgeon, but it also exposes both patient and surgeon to fluid contamination," said Judson Boothe, marketing director of medical supplies for Kimberly-Clark Health Care, Roswell, GA.

BD Visidrape Ophthalmology drape

Outfitting surgeons and nurses with exceptional softness, Cardinal Health debuted its RoyalSilk surgical gown in a clever haute couture style fashion show at the 2008 AORN Congress. RoyalSilk features a proprietary SMS fabric designed for comfortable, lightweight, breathable softness with protection classified as Level 3 according to the Association for the Advancement of Medical Instrumentation’s (AAMI) PB70:2003 Liquid Barrier Performance of Protective Apparel standard. (AAMI classifies gowns into four categories according to the degree of liquid barrier penetration, with AAMI Level 1 providing the least protection, and AAMI Level 4 providing impervious protection.)

According to Carl Hall, director of marketing for clinician apparel and patient protection, Cardinal Health, McGaw Park, IL, user trials show that the silky, lightweight material of the RoyalSilk gown also helps to reduce glove roll-down.

RoyalSilk was developed via a customer-centric approach that included customer observations and one-on-one interviews to understand unmet surgical gown needs, remarked Hall. "Obviously surgeons and nurses want something that’s not distracting. They want to be able to focus on their procedure and not think about the gown that’s on their back. They also want to make sure that they have the appropriate protection." At the same time, "materials management wants to make sure that their surgeons and nurses are happy," he added.

Medline Industries offers users a choice of fabrics on the marketplace with its surgical gown and drape lines. "We’re not tied to a fabric technology," said Frank Czajka, president, Proxima drapes and gown division, Medline, Mundelein, IL. "Some fabrics are higher barrier, some have better drapeability or strength, so across that spectrum Medline gives clinicians the choice." Medline’s Aurora gown is made from DuPont’s Suprel fabric to combine high barrier protection with softness and strength. "High barrier gowns have typically been more brittle, hotter to wear and less comfortable," commented Czajka.

With so many gowns on the market to choose from, manufacturers are making it easier for buyers and end-users to pick the right gown at the right time, as well as incorporating brand-name recognition into apparel designs.

To help identify levels of protection, gowns in the KC200 and KC300 lines feature the Kimberly-Clark Color Key which includes color-coding on neck bands, individual gown packages, and tie cards that explain the type of protection the three different colored neckbands represent. Each surgical gown also features the Kimberly-Clark brand logo on the chest. In addition, the Kimberly-Clark Gown Selector Tool and the Kimberly-Clark Surgical Draping Guide are available online at www.kchealthcare.com/tools.

"It is key to understanding and knowing what types of procedures that your facility is performing to help determine the correct type of surgical gown and drape that is needed to stock," said Boothe. "A purchaser’s goal should be focused on providing the correct level of protection that will best fit the needs of the staff that are performing the procedures. Purchasers need to know the average length of time staff members spend in surgery, amount of fluid exposure, etc.

"By organizing the surgical portfolio into three distinct categories based on barrier protection levels, it provides ease of selection to buyers when purchasing gowns and drapes," Boothe continued. "Depending on the types of procedures that their facility or department performs, the purchasing manager can easily determine if they need more or less protection overall. It is important to balance these multiple needs in order to provide the correct amount of protection, while staying within the budget. K-C created the three tiers to assist purchasers in choosing the right protection for the right procedure at the right price."

Each of Medline’s surgical gown offerings, Eclipse, Aurora and Sirus, are available in multiple AAMI levels from 2 to 4, achieved by adding reinforcements to the gown. Medline color-codes its gowns on the outside packaging as well as on the passcard and neck binding of the product according to AAMI levels, with Level 2 gowns color-coded green, Level 3 gowns as purple and Level 4 gowns as navy blue.

Cardinal Health color-codes the transfer tabs and chest stickers on its surgical gowns for easy selection as gowns are laid out prior to a procedure. (Cardinal’s Level 4 SmartGown and all surgical drapes are color-coded purple, and Level 3 RoyalSilk and Astound gowns are blue). Cardinal also now includes the brand and company name on the chest of their SmartGown and RoyalSilk gowns.

A safeguard for both patients and healthcare personnel, surgical drapes "should act as a protective barrier to minimize strike-through and the potential for contamination," said Caroline Krubsack, marketing, 3M Health Care, Saint Paul, MN.

3M Ioban 2 antimicrobial incise drape

Krubsack identified six principles of draping addressed by 3M’s disposable drape line: Isolation – isolating dirty, contaminated areas from clean areas; Barrier – preventing fluid penetration; Sterile Field – creating a sterile operative environment by aseptic application of sterile materials; Sterile Surface – creating a sterile surface on the skin which acts as a barrier to prevent skin flora from migrating to the incision site; Fluid Control – channeling and collecting body and irrigation fluids; and Equipment Draping – allowing non-sterile equipment to be brought into the sterile field.

"There are several key features that should be carefully considered when comparing surgical drapes to one another," offered Boothe. "It is important to look for products that meet industry specific requirements such as AORN standards for barrier protection, flame resistance, and lint- and abrasion-resistance. In addition, a range of features from tube-and-line controls to highly-absorbent reinforcements are considered in designing drapes for specific procedure requirements."

He added, "To help reduce the risk of wound contamination and related post-operative complications, drapes must withstand a great deal of rubbing and abrasion throughout a procedure without generating particulate contaminants. Also, does it provide ease of use, flexibility, proper coverage and fenestration design, and other features to aid the surgical team during the procedure?"

Krubsack suggested buyers look for drape fabric that is lightweight, breathable, drapeable and conforms to the contours of the body.

Carrie Block, senior market manager for Cardinal Health’s surgical drapes and packs noted that for a drape to be categorized as AAMI Level 4, it must be impervious in the critical zone, which AAMI’s PB70:2003 standard defines as the "area surrounding the fenestration of the opening" – a definition she feels may mislead end-users to believe that because a drape is categorized as AAMI Level 4 that it is fully impervious throughout the entire drape; when in fact many manufacturers’ drapes are impervious only in the reinforcement area. Cardinal’s Tiburon drapes provide AAMI Level 4 protection outside of the reinforcement of the critical zone for a fully impervious drape top to bottom, she said.

3M Steri-Drape Absorbent Prevention Fabric Drapes are low-linting, non-woven, absorbent fabric laminated to plastic film. They absorb spills and splatters and eliminate fluid strike-through. Absorbency and Level 4 barrier performance throughout the entire drape eliminates the need to define a "critical zone", indicated Krubsack.

As surgeries become more complex, manufacturers have responded by "designing fabrics that are stronger, pouches that are more useful, more fluid management, more isolation with better tapes and incise films, constantly allowing for skin flora breatheability and great infection control," said Medline’s Czajka.

Medline has added a unique element to the standard drape with a built-in safety measure to help prevent a common operating room error. "Wrong site surgery is the number one reported sentinel event to The Joint Commission," said Czajka. "There have been 691 reported cases of wrong site surgery since they started keeping records in 1995. As of December 2007, it became the number one reported sentinel event."

To help assist in the prevention of wrong site, wrong procedure, wrong patient surgeries, Medline has developed the new S.T.O.P. (Surgical Time Out Procedure) drape. Available in a variety of configurations, such as a strip across the fenestration or a tag through a line holder, the S.T.O.P. drape features a "Time Out" sticker in the shape of a stop sign that must be removed before surgery can begin. The sticker provides a location to write and confirm the patient’s name, procedure, site and side, date, time and surgeon’s initials, and once completed is placed in the patient’s chart.

Czajka noted that the S.T.O.P. drape was developed in answer to specific customer requests, "As we have basically the last line of defense in the surgical drapes that are used in the operating room, what can we do to make it easier for the team to remember to do that each and every time?"

Medline’s S.T.O.P. drape

With surgical site infections a continuing target of the Centers for Medicare and Medicaid Services (CMS) Quality Program, "It is important for all facilities to understand and recognize the total impact that SSIs have on their patients’ and on their hospital’s financial well-being," said Boothe. "On average, a patient with an SSI can stay up to seven days longer in the hospital, is 60 percent more likely to spend time in the ICU, and five times more likely to be readmitted within 30 days of discharge. All of this equals higher cost in treatment for the hospital and the patient."

He continued, "It is key for staff to know and understand what barrier protection is needed for the procedure at hand. For example, in lengthy, high-fluid procedures such as heart surgery, where developing an infection is a high risk, it is important to use drapes that have very low lint generation to reduce the risk of airborne bacterial transmission."

Low lint producing drapes are also particularly important for procedures such as ophthalmology. Non-woven material Visitec and Visidrape ophthalmologic drapes from BD Medical – Ophthalmic Systems, Franklin Lakes, NJ, offer the comfort of a woven drape with extremely low linting properties. "Since ophthalmic surgery is performing micro incisions in the eye, it is of great importance that the drape is made of a low-linting material since any particles that might be transferred from drape to eye, could cause significant complications, or a potential infection," explained a BD company spokesperson.

Incise drapes and films also play an important role in preventing contamination of the surgical site, and some manufacturers have opted to include antimicrobial properties within the incise drapes themselves, such as 3M’s Ioban 2 Antimicrobial incise drapes and Medline’s ActiGard incise drapes.

"There are four features of incise draping associated with helping to reduce the risk of wound contamination," said Krubsack, 3M. "They include: immobilizing bacteria on the skin, creating a sterile surface, adding continuous antimicrobial activity under the drape where it cannot be washed away, and continuous antimicrobial activity while ensuring the most reliable drape adhesion."

She added, "Contrary to popular belief, skin cannot be disinfected. Skin surface covered with a sterile incise drape essentially eliminates the transfer of bacteria to items that come in contact with the wound such as gloves, instruments and sponges. 3M Ioban 2 Antimicrobial Incise film provides continuous, broad-spectrum, antimicrobial activity impregnated in the drape adhesive where it cannot be washed away."

"The drape’s barrier and antimicrobial properties are only effective when the drape is securely adhered to the patient’s skin," Krubsack emphasized. "3M’s Ioban 2 Antimicrobial Incise Drapes feature long-lasting, secure adhesion that ensures the barrier and antimicrobial properties are utilized all the way to the wound edge. In addition, 3M Absorbent Prevention Fabric provides Level 4 protection throughout the entire drape to provide an effective barrier against transmission of microorganisms to help protect the patient against surgical site infections."

Sources agreed that secure adhesion is key to preventing contamination of the surgical site. "Certainly what you’re trying to do is create just a phenomenal skin to drape interface," said Czajka. "We want to give the clinical staff the product that’s going to allow them to have the best adhesion to the outside." To help meet this goal, Medline uses ample surgical tape in its drapes, provides larger fluid management zones with more surface area to soak up fluids, as well as larger drapes in general to help create a better sterile field. Tape applied flush to the fenestration rather than off the edge of the drape helps to prevent pooling underneath the product, and allows fluid and irrigation media to go up onto the surface of the drape, he explained.

Kimberly-Clark KC200 surgical drape

Block commented that rather than incorporating antimicrobial properties directly into the drape to help prevent surgical site contamination, "Cardinal Health takes the approach that the Chloraprep patient perioperative skin prep product is the main contributing factor for the reduction of microorganisms on the patient’s skin. Many studies show that applying the antiseptic directly onto the skin is the preferred method to reduce the microorganisms to the lowest number possible and to provide more of a clean surface for that procedure," she said.

Kimberly-Clark’s comprehensive approach to address risk factors that are known contributors to SSIs includes solutions that are designed to: maintain patient core temperature with the Kimberly-Clark Patient Warming System; reduce skin flora contamination of the surgical site throughout the surgical procedure by using InteguSeal Microbial Sealant; provide barriers to prevent transfer of contaminants from person to person and to protect a surgical wound from contamination through the use of Kimberly-Clark surgical gowns, drapes and masks.

As with surgical gowns, drapes should be selected based on the type of procedure being performed and anticipated fluid levels.

Block, Cardinal Health, observed that while there are some basic needs common to all surgical drapes, "there are some carve-out segments that have additional needs specific to their procedure type."

"The market has been segmented into two different categories," she explained. "The first category includes concentrated fluid intensity procedures. These are procedures in which there may be a lot of fluid, or there may be a little bit of fluid; but the way in which the drape is designed, and the way in which the patient is positioned allows for the fluid to be concentrated to a specific area of the drape within the critical zone. At the same time, there’s another segment of categories of procedures that are more variable in fluid intensity. Again, these could be high fluid intensity or low fluid intensity, but with the patient positioning and the drape design combination there’s really no rhyme or reason as to where that fluid could go on the drape, thus making it necessary to use a fully impervious drape.

"With a variable fluid intensity procedure such as orthopedics or cardiovascular, the fluid could go anywhere in that procedure, so it’s extremely important that materials managers understand the true need for a fully impervious drape such as Tiburon," Block emphasized.

Layering may be trendy, but it’s just not good practice in the O.R. Drapes customized to specific procedures can help break surgeons of the habit of layering drapes. "If a drape that is specifically designed for a procedure is not used, the surgeon may be required to use multiple drapes which increase the possibility of compromising the sterile field," said Krubsack. "Seventy-six percent of surgeons said the main reason they layer when draping is to create a barrier."

Krubsack noted that while higher levels of barrier protection are suggested in those surgeries that are at a higher risk of surgical site infection (including orthopedic, cardiovascular and cesarean procedures) an absorbent, impervious material can help do the job with just one product. "Recognizing the importance of enlarging the critical zone, many surgeons layer drapes to reduce the chance of strike-through. A drape that is absorbent and strike-through resistant is designed to help prevent risks of penetration and roll-off, and eliminates the need for layering while protecting the healthcare worker. 3M Absorbent Prevention Fabric is absorbent and strike-through resistant throughout the entire drape."

3M Steri-Drape Cesarean Section Drape

3M recently introduced the 6682 3M Steri-Drape Cardio/Chest Drape with Ioban 2 Incise Film, specifically designed for chest, back and cardiovascular procedures. The drape provides the broad spectrum antimicrobial activity of 3M’s Ioban 2 Incise Film, combined with the benefits of 3M Absorbent Prevention Fabric to prevent contamination of the operative site. The one-piece drape design offers full body coverage, extended width for arm coverage, reinforced anesthesia screen with cord organizer, divided bilateral side pockets for instruments, and bilateral under pocket cord organizers.

"Customized drapes are extremely important to cost savings as well as in ease of use for healthcare workers," added Boothe. "For example, instead of using four individual drapes to cover an abdominal or chest area, a customized drape allows the staff to easily place just one drape, saving the facility from stocking multiple single drapes and extra cost in usage."

"Another advantage of going with a customized drape such as Kimberly-Clark’s ORTHOArts and CVArts drapes, is that they provide attachments to secure the various lines and tubes that staff would have to deal with during procedures such as heart surgery," he continued. "Customized drapes also feature incise areas that secure quickly and easily to the patient."

BD’s company spokesperson noted that for ophthalmology procedures, "the adhesive used for the incise within drapes needs to be sufficiently strong to hold the drape in place, whilst being removed easily at the end of the procedure – something particularly important for those patients with frail skin."