Some experts now question certain long-held infection control practices, like mask-wearing and draping, because clinical study results are inconclusive and sometimes contradictory. Yet, simultaneously, their concerns about bloodborne pathogens have strengthened the rationale for maximizing barrier protection during surgery. While these two trends may seem contradictory, they are in fact working in unison to create a more efficient and effective approach to personal protection in the OR. Here's a look at this evolution.

Patient drapes
In theory, drapes protect patients from surgical site infections (SSIs) by preventing or inhibiting microbes from invading the wound. Researchers have shown that incise drapes in particular can help prevent the patient's skin microbes from migrating into the surgical wound as long as the drapes stay uniformly adhered. Nevertheless, current evidence does not clearly show that draping reduces SSI. One review of seven studies by Nathan L. Belkin, PhD, a 40-year research and development veteran of the surgical textile industry, indicates some studies show an SSI reduction when gowns and drapes are made of modern barrier materials, while others show no difference when older, more permeable draping materials are used. The Centers for Disease Control and Prevention (CDC) says the reason it is so hard to determine the clinical impact of draping is that studies are limited and vary widely in design and products. In addition, many factors that are difficult if not impossible to isolate and analyze in clinical studies may influence SSI risk - such as the amount of fluid, degree of pressure, procedure duration, patient condition, antibiotic prophylaxis, supplemental oxygen, environmental conditions, instrument maintenance/sterilization and discipline of the surgical team.

Where does this leave outpatient practitioners when it comes to draping practices? The opinion of Fran Koch, RN, administrative director of surgical services at Presbyterian Hospital in Dallas and co-chair of the Association for the Advancement of Medical Instrumentation (AAMI) Protective Barriers Committee, mirrors that of most experts. "While there is little question about the need for draping," she says, "it's time we rid ourselves of excessive draping practices." Here are three ways experts recommend doing so:

• Eliminate excessive layering. Ms. Koch says many surgeons continue to layer drapes, a throwback to days when multiple layers of linen drapes promoted absorption and prevented strikethrough of liquid-borne microorganisms. Modern, tough materials that maintain barrier properties in the face of fluid, pressure and time, however, render layering unnecessary. For example, Curt Koehn, the director of marketing for the Cardinal Health Convertors products, says his firm's new "impervious" and "neutrally-priced" Tiburon draping material is intended to help "re-baseline" excessive draping practices by obviating the need for fan-fold down drapes and plastic split sheets during extremity and orthopedic procedures. Adds Microtek Medical, Inc., market manager Laurie C. Lander, RN: "Fluid control is infection control, and one factor very important in today's drape material is its ability to absorb fluid. This property means less fluid escapes to contaminate equipment, the floor and shoes." Single-piece construction and strategically placed fluid-collection pouches, she says, also can obviate excessive, adjunct drapes.
• Consider isolated or custom drapes. Some facilities are moving toward half-body drapes that isolate the surgical field during, for example, ENT and skin procedures that focus on specific anatomic areas - including head-only draping for routine cataract extractions. In addition, says Microtek vice president of marketing communications Kathy Zachary, procedure-specific drapes eliminate makeshift draping that can result in costly excess. For example, says Ms. Lander, Microtek's Lingeman line of patient drapes offers features like leggings, under-buttocks, abdominal sheets, arm board covers, fluid collection pouches, speculum pockets, cord holders, abdominal and perineal fenestrations, instrument pockets and other features in one piece. "These drapes typically displace three to four packs and, in so doing, reduce the cost of both the actual drapes as well as time and personnel required to stock, pull, open and place the drapes, not to mention the trash generated by the separate packaging of all these items," she says.
• Use incise drapes wisely. Experts also recommend using incise drapes only where needed. A 3M Healthcare publication, for example, recommends reserving incise drapes for longer clean procedures and those involving high-risk patients, as well as procedures involving implants, such as certain orthopedic surgeries, which may be more prone to infection.

Surgical gowns: comfort and protection
Though gowns were originally intended to protect patients from healthcare worker-transmitted pathogens, they now provide crucial protection for the OR team against patient-transmitted bloodborne pathogens such as hepatitis B (HPB) and C and HIV, according to the Occupational Safety and Health Administration (OSHA), CDC's Hospital Infection Control Practices Advisory Committee (HICPAC) and AORN. Both roles are important and scientifically supported, they say. While rare, even small amounts of contaminated blood can strike through a scrub suit and can be infectious, according to researchers.

The challenge of surgical gown selection, then, is not whether to wear one but how to find one that incorporates comfort and protection. Until recently, there has not been a method to objectively assess a gown's level of protection against strikethrough. Yet this can vary significantly with the barrier material, type and placement of reinforcements/coatings of high-contact areas and, if reusable, the number and method of launderings. So to help users quantify the barrier properties of gowns and drapes, says Ms. Koch, experts have created a classification system that stratifies strikethrough properties of the most critical zone of gowns and drapes - including seams and attachments - into four levels. Late last year, the AAMI Standards Board, along with the Food and Drug Administration (FDA) and the American Society for Testing and Materials (ASTM), approved voluntary standards for manufacturers. Ms. Koch explains the levels like this:

• Level one - Procedures involving little fluid or pressure (some dermatology, ophthalmology, simple ENT surgeries).
• Level two - Hernias, orthopedic procedures with tourniquets and tonsillectomy/adenoidectomies.
• Level three - Procedures such as mastectomies, arthroscopies, general surgeries.
• Level four - Highest protection, equivalent to FDA-labeled impervious gowns, for large abdominal cases, orthopedic cases without tourniquets, trauma, C-sections, cardiovascular procedures.

"When evaluating gowns and drapes, you'll be able to look at the amount of fluid on the field and how vulnerable the field is to splashes or sprays, as well as how much pressure is anticipated," adds Ms. Koch.

Most manufacturers are on board with the new standards and, ultimately, most agree, the classification is likely to reduce costs to surgical facilities. "The standard will help clinicians objectively evaluate materials in a way that is less complicated for them," says Lori Gettelfinger with DuPont Medical Fabrics. "And it certainly has the potential to reduce costs as well."

Before you dismiss surgical masks...
Since their inception, surgical masks have served one primary role: To protect the surgical site from healthcare-worker transmitted pathogens. As with drapes, however, there is no research to clearly show that masks, in and of themselves, reduce SSIs. A recent literature review located just two controlled evaluations, with contradictory results. "Some research has shown that, during clean surgery, masks were not effective," says Dr. Belkin.

Yet, as with other personal protection items, there remains a strong theoretical rationale for mask-wearing during most surgical procedures. Both AORN and CDC's HICPAC view masks as key to maintaining sterility in the OR; both recommend them whenever the procedure requires opening of sterile instruments or other supplies. (HICPAC also recommends masks whenever a procedure is about to begin or is underway.) In addition, according to an OR Manager survey, the practice of mask-wearing is optional at some institutions only for surgeries that do not require the creation of an open surgical wound - such as myringotomies and tonsillectomies/adenoidectomies, D&Cs, endoscopy procedures and closed reductions.

"It's important not to discount the role of masks as patient-protection items," says Jay R. Sommers, PhD, director of clinical and scientific documentation for Kimberly-Clark Health Care, noting that a significant portion of healthcare workers carry methicillin-resistant Staphylococcus aureus in their nares. Research shows that S. aureus can be cultured from the anterior nares of 30 percent to 40 percent of the general population alone, causes about 10 percent of all nosocomial infections, and is the leading cause of SSIs.

Given the growing awareness of patient-transmitted bloodborne pathogens, masks are also becoming increasingly important as splash protectors for the surgical team. The FDA has told manufacturers it wants every surgical mask to offer some fluid resistance, and the industry is working to propose universal testing guidelines. The final standards will likely derive from voluntary ASTM tests that measure three levels of fluid resistance depending on the speed at which fluid will penetrate the mask: 80, 120 or 160 mmHg - with only the latter threshold considered truly fluid-resistant.

"Importantly," notes Jon Stamm, Cardinal Health's marketing director for masks. "Fluid resistance often goes hand-in-hand with the filtration of microorganisms. It's a matter of finding the right balance between cost and performance, and that includes comfort." (The FDA currently requires standard surgical masks to filter particles of 0.3 microns and larger, but even the least-porous masks cannot filter viruses or volatile organics from laser plume cautery smoke.)

Surgical gloves don a new role
No one questions the essential role of surgical gloves as a two-way infection control barrier. More recently, however, their role in ensuring safety and comfort has become more important - namely, the newest gloves are designed to preserve practitioners' skin integrity and prevent barrier breaks that increase the risk of patient-transmitted infection.

• Skin integrity. With about 15 percent to 20 percent of OR personnel having some latex sensitivity, and with some patients having latex sensitivity themselves, glove makers are racing to find the ideal synthetic replacement. Some say that the recent introduction of polyisoprene has brought the finish line closer; polyisoprene mimics the fit, feel, comfort and barrier properties of latex more closely than any other synthetic, claim industry representatives, because its molecular structure is nearly identical to rubber latex's. "With the advent of polyisoprene, whole hospitals are going latex-free," says Jeannie Thomas, Cardinal Health's vice president of marketing for medical gloves.

Still, just 10 percent to 15 percent of the overall surgical glove market is currently synthetic because, says Janie R. Thomas, RN, BSN, MA, clinical consultant for Ansell Healthcare Products, latex remains the gold standard for barrier, fit, feel, comfort and economy - and because modern latex gloves are more skin-compatible than ever before. According to Ansell's Ms. Thomas, the issues that prompted the latex allergy epidemic a decade ago have been largely addressed in low-protein, powder-free latex formulations.

"When OSHA's Universal Precautions and Bloodborne Pathogens Act came out in the early 1990s, there was a huge disparity between supply and demand," she explains. "Some manufacturers tried to shorten their glove manufacturing cycles, and some rubber producers gave chemicals to rubber trees to make them produce faster. The resulting gloves were high in protein, causing a significant host response."

She says these poor-quality gloves contained as much as 2,000 'g/g of protein in their outer film, whereas current low-protein gloves must meet FDA standards of '50 'g/gof protein. Eliminating powder has also been key because sensitization can occur when sweat mixes with the powder to create a protein-rich paste inside the glove.

Still, glove allergies and sensitivities are likely to remain a focus, according to Regent Med-ical representatives, because rubber latex proteins aren't the only offending agents in surgical gloves. "Persons who experience type 4 reaction may also have reactions to the chemical accelerators in synthetic gloves," says Virginia James, Regent's product manager for medical gloves. (Type 4 is a delayed hypersensitivy reaction, or allergic contact dermatitis, that often occurs within 72 hours of exposure.) In fact, she says, some who believe they are allergic to latex may actually have a chemical allergy. "We are working to identify the actual number of healthcare workers experiencing type 4 responses to offending chemicals versus type 1 reactions to latex proteins so they understand the differences and ultimately are able to assess their precise needs," she says.

• Barrier breaks. With about two million occupational exposures to HPB, nearly one million to HPC and 170,000 to HIV occurring worldwide annually, says Carolyn LeSac Twomey, RN, clinical nurse consultant with Regent Medical, the ability of gloves to resist tears, punctures and other breaks is more important than ever.

"Seventy-five percent of patients with hepatitis B and C present with nonspecific viral symptoms or no symptoms at all, and I don't think healthcare workers, in general, appreciate the risks," says Ms. Twomey. "We know from published studies that glove failure rates vary from 11 percent to 51 percent, depending on specialty and the degree of sharps, instrumentation and bone involved in the case. We also know the risk of barrier breach rises just over 1 percent with every 10 minutes of surgery." So many experts now recommend you consider double-gloving; a review of the literature shows the practice reduces the risk of barrier breach by about two-thirds. AORN, in particular, recommends it for "some procedures" to reduce exposure to the patient's blood and body fluids.

The challenge of double-gloving: finding a glove combination that is dermatologically compatible, is easy to don, best preserves tactile sensitivity and doesn't increase hand fatigue. And you should take surgeon preference into account. Says Ms. Twomey: "Manufacturers should make available individuals knowledgeable in gloves and the needs of the OR so they can recommend options that work together within their glove line."

Ms. Twomey and others also recommend educating surgeons on their risks, enlisting "champions" to help promote the switch to double-gloving, and providing a glove-fitting station so users can find combinations that work best for them. Finally, give users time and support, because the difference in feel requires some getting used to. "Studies show people can function well if they give themselves enough time to make the transition," says Ansell's Ms. Thomas.

Ongoing evolution
Overall, thanks to technological advances, more knowledge and new standards for evaluating protective items, personal protection is becoming more efficacious. According to industry representatives, this evolution is likely to continue as glove, gown, drape and glove makers continue to engineering materials that offer better barrier properties, improved functionality and more comfort.