New gown, drape features have O.R. staff covered
by Julie E. Williamson

Precept Medical Excel Surgical gown

With an ongoing push for patient and healthcare worker safety, and heightened awareness on the infection control front, it stands to reason that facilities are seeking surgical products that go beyond their typical call of duty to drive better outcomes and overall value.

Surgical gowns and drapes are no exception. While protection for the patient and healthcare worker still remains the products’ core function, that isn’t the sole factor driving purchasing decisions within the operating room. Along with seeking products that offer unsurpassed protection from a range of hazards in the O.R. – including blood and body fluid strike-through, particulates that can lead to surgical site infections, and surgical fires — today’s savvy surgical staff have their eyes on cutting-edge designs that provide greater absorbency and versatility. Foolproof features that make selecting the right product for the right procedure a snap are also on their radar.

"In addition, they’re looking for comfort in order to stay focused on the procedure at hand," noted Jeff Schneider, general manager of surgical products for Kimberly-Clark Healthcare, Roswell, GA.

If gown and drape selection boils down to protection, comfort, value and ease of use, O.R. personnel will be pleased to know that vendors have them covered from all angles. In fact, some of the latest products to hit the market not only meet these critical criteria, but exceed them.

Cardinal Health Tiburon drape

Gowns go high-tech
One of the biggest complaints of the past when it came to surgical gowns was that staff had to choose between protection and comfort. Today, however, one needn’t forsake one for the other.

Vendors have been focusing much of their research and development efforts on technologies and designs that can keep the user cool and comfortable, while allowing unparalleled ease of movement and protection. Mundelein, IL-based Medline Industries’ Aurora gown, for example, which is the latest product in the Proxima line of disposable protective surgical apparel, features repellent Suprel DuPont medical fabric that blends polyester (for strength) with polyethylene (for comfort). The gown’s smooth texture also helps prevent catching and grabbing, Medline notes, and works to quickly transfer heat away from the body.

According to Frank Czajka, product manager for Medline’s Proxima division, the Aurora gown "has become the fastest growing product" in the division – a fact he directly attributes to its ability to offer a high level of barrier protection in a breathable, comfortable design.

Even the most impervious of gowns, whose high-level barrier protection historically rendered the wearer hot and uncomfortable, are being constructed of softer, more breathable materials. Kimberly-Clark’s Ultra Impervious Gown features a soft, breathable, three-layer fabric that is designed to resist blood strike-though and reduce risk for cross contamination.

Gowns are also becoming more technologically intuitive, with built-in features that promise to wick moisture away from the body to keep wearers cooler and drier, while at the same time, filtering out bacteria to a particle size smaller than Hepatitis C. Kimberly-Clark’s MicroCool Surgical Gown is impervious and disposable, and features "microporous technology" to allow perspiration to pass through easily, while providing protection from blood and body fluids.

The Smart Gown from Cardinal Health couples an impervious barrier with an interactive, "responsive" membrane that increases the water vapor transfer rate to keep caregivers cool.

Kimberly-Clark color- coded surgical gowns

"Basically, the hotter it gets the harder the gown works to keep you cool," explained Lisa Krebs, marketing manager, surgical gowns and protective apparel, Cardinal Health, McGaw Park, IL. The single-use gown, classified as Level IV under the AAMI Guidelines for Barrier Performance, also features impervious, continuous sleeve seams for added strength and protection against strike-through.

Mölnlycke Health Care (Newtown, PA) offers several fabrics and all levels of AAMI protection with its BARRIER line of surgical gowns. One recent addition, the BARRIER Fluid Protection Plus gown is an embossed PE film laminated to a spun-bond nonwoven that provides comfort and breathability in an AAMI Level III protection gown. This gown also provides the added advantage of being impervious to fluids.

"What’s unique about the Fluid Protection PLUS, is although it’s a level III gown, it additionally passes ASTM 1670, which is the guidance for claiming fluid or liquid permeability," explained Lisette Swenson, U.S. brand manager, BARRIER products, Mölnlycke Health Care. So they get a high-performing gown at a low cost." She explained that while the gown doesn’t meet AAMI Level IV viral protection, it does perform to the fluid impermeability standards that a level IV gown provides. "And it’s not zoned; it’s all-over protection," she added.

The BARRIER Surgical Gown II from Mölnlycke offers AAMI Level III protection with a meltspun technology that combines polyester and polyethylene for a soft, breathable, strong and high-performing fabric. The company’s BARRIER Extra Protection PLUS and Ultra Protection PLUS surgical gowns provide AAMI Level IV zoned viral protection in the sleeves and front panel in a breathable fabric.

Enhanced gown comfort and protection is also coming in the way of roomier designs, longer lengths and stronger reinforcements in gown sections most prone to strike-through, such as wrist, forearm and abdominal areas. All of Medline’s Proxima gowns, for example, are cut wider in the chest and sleeves for a better fit and ease of movement. The gowns also feature an adjustable Velcro-style neck closure that ensures proper fit and helps prevent gapping in the front.

In some cases, even the simplest change can make a big difference in terms of comfort and protection. For Precept Medical Concepts, that meant changing the sleeve seam to create a gown that combined the comfort of the raglan sleeve with the protective features of a set-in sleeve.

Mölnlycke BARRIER Fluid Protection PLUS and Surgical Gown II

"We took the seam from the underside of the sleeve, where there’s a greater potential for strike-through, and moved it to the top of the arm where there’s less contact risk," said Amy Cash, Precept Medical’s product coordinator.

Eye on visual cueing
As surgical procedures advance and evolve, it becomes paramount that O.R. personnel reach for the right gown for the right procedure. Not only does donning the right product make sense from a patient and healthcare worker safety perspective, it also has a positive impact on the bottom line.

"Customers are thinking more broadly about cost related to outcomes. Cost for proper gown and drape usage is more involved than the individual price of the product," Schneider explained.

A survey conducted by Kimberly-Clark revealed that approximately 47 percent of the time, O.R. staff have either used the wrong gown themselves or knew of someone who did, even though the right gown was available.

"This can have a negative impact on a caregiver if they are under-protected," added Schneider. At the same time, over-protecting can increase costs for a facility.

To simplify the product selection process, some vendors are incorporating "visual cueing" features into their products – either in the way of color-coding or unique labeling. Both Medline and Kimberly-Clark have opted for color-coding, although the manner in which they do so varies. Medline color-codes in conjunction with AAMI’s Guideline for Barrier Performance, which refers to the four levels of protection as defined by the Association (with Level I offering the lowest level of barrier protection and Level IV offering the highest).

In May, K-C began combining the Kimberly-Clark Color-Key and logo imprint to help aid the product selection process. The Kimberly-Clark Color-Key is comprised of three color-coded components: neck bands, individual gown packages and tie cards. Rather than corresponding colors to the AAMI levels of barrier protection, the Color-Key denoted different types of surgical gowns, from non-reinforced and fabric reinforced to impervious.

"We’ve received really positive responses [from our customers]," said Schneider, adding that a K-C survey found that 90 percent of respondents consider color coding an optimal visual cue. "To be able to visually cue [the product] and make selection virtually foolproof, our customers have one less thing to worry about as they prep the O.R. for a patient and a procedure."

Color-coding also makes it easy for O.R. managers and even material managers to quickly identify whether surgical staff is adequately and appropriately protected, according to Schneider.

While few can argue the value of color-coding, some vendors are concerned that a lack of consistency in what the color denotes (AAMI levels of barrier protection versus type of gown) may add to user confusion. Until the FDA issues guidance related to labeling for the AAMI standards, Cardinal Health will continue to visually cue with sticker labeling. A sticker denoting the AAMI level of protection can be found on the packaging, as well as the chest of the gown.

"We believe that color-coding can be beneficial, but at this time, we believe it can create confusion because [users] may assume they are getting more information [from the color-coding] than they actually are," said Debra Schotz, marketing director for Cardinal Health’s Convertors drape and gown business.

New packaging from Mölnlycke is designed for clear identification of its surgical gowns. The outer packaging prominently displays the gown’s AAMI level of protection alongside a picture of the gown. As a final measure of precaution – there is a sticker below the neckline of the gown, stating the size and level of AAMI protection, that the surgeon sees when he puts his arms into the sleeves, explained Swenson.

Schneider said K-C research revealed that customers want to know the type of gown they’re donning and whether it is appropriate for fluid-levels during the procedure. Still, he stressed that the company will adhere to the labeling standards as the AAMI standards become clearer. He anticipates FDA guidance on the issue in the fourth quarter of this year.

Drapes draw on versatility
Like surgical gowns, drapes have also gotten noteworthy makeovers, with vendors working hard to develop flexible designs that offer better protection, absorption, strength and efficiency.

More than ever, manufacturers are offering procedure-specific drapes that can meet the demands of even the most high-risk, rigorous procedures. Medline’s OrthoMax drape, for example, is designed with stronger pouches and more malleable corners to prevent tearing.

"In orthopedic procedures, the pouches are placed under great stress and can be susceptible to tearing," Czajka explained. "Having stretchable corners on the pouch improves strength and reduces the risk for tearing."

Kimberly-Clark also offers a full line of surgical drapes, including a specialty line (which includes products such as the Orthopedic and Beach Chair Shoulder Drape), which are uniquely tailored to specific procedures and can help eliminate layers of draping. The Kimberly-Clark Orthopedic drape is constructed of heavy-duty fabric and is reinforced for optimal fluid management.

Mölnlycke worked with Dr. Mark Jewell, president of the American Society of Aesthetic Plastic Surgeons (ASAPS) to design a new line of four BARRIER drapes specifically for aesthetic/plastic surgery, one of the fastest growing surgical markets in the U.S. All are made with a fabric that is designed to absorb fluid yet be impervious, meeting or exceeding AAMI Level IV protection at the incision site.

Softer, more drapeable and breathable fabrics are also key features of today’s surgical drapes, as are easily adjustable line holders and larger impervious reinforcement zones that absorb fluids. Medline’s Proxima drapes feature Softesse medical fabric from DuPont, which gives the drapes a cloth-like feel and conforms easily to the body. They also feature Velcro-style line holders with offset tabs that make for easier lifting, even when wearing gloves. Premium tape and incise film is manually placed flush to the fenestration to help prevent fluid pooling underneath the drape, while large impervious reinforcement areas absorb fluid.

Cardinal Health’s Tiburon drape is fully impervious and reinforced around the operative site, and also features an absorbent, low-linting top layer. According to Brodie Bauders, marketing manager for Cardinal’s Convertors gown line, absorbency is critical not only from an infection control perspective; it also can make surgical suite clean-up and turn-around easier and more efficiency by minimizing fluid spills.

"Wicking away fluid at the [operative site] helps prevent fluid from rolling onto shoes and onto the floor," he said.

Drape manufacturers are also working to offer more customizable products that are driven by customers’ unique demands. According to Cash, Precept Medical can modify product features, addressing anything from seam issues to different size requirements.

"Procedures and technology are always changing, so it’s important to work with the customer to develop products that can effectively suit their needs," Cash said.

Antimicrobial protection is the heart of 3M Healthcare’s latest drape innovation. In June, the company introduced a built-in antimicrobial incise for its drapes designed for high-risk procedures. The 3M SteriDrape Craniotomy Drape with Ioban is designed to reduce the risk of surgical site infections, according to Deborah Gardner, technical service manager for 3M Healthcare’s surgical drape line.

"With the Ioban incise, there’s less worry about migration of the patient’s own flora into the operative site."

Vendors said customers can expect even greater product versatility and design enhancements in the future as technology in the operating room continues to evolve.

"As we move forward, we’re going to have to continue to keep up with advancements in surgery and be very flexible to the market needs," Czajka noted.

Schneider predicts that increased customer awareness in regard to improving patient safety and mitigating risks of preventable errors will also drive change.