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KSR Publishing, Inc.
Copyright © 2008

People, Places, Processes & Products that Influence the Supply Chain

INSIDE THE CURRENT ISSUE

October 2007

Operating Room

Out Patient Connection

New CPR promises better results by compressing abdomen, not chest

A biomedical engineer at Purdue University has developed a new method to perform cardiopulmonary resuscitation that promises to be more effective than standard CPR because it increases nourishing blood flow through the heart by 25 percent over the current method. A new technique is desperately needed because conventional CPR has a success rate of 5 percent to 10 percent, depending on how fast rescuers are able to respond and how well the procedure is performed. For every one minute of delay, the resuscitation rate decreases by 10 percent. Leslie Geddes, Showalter Distinguished Professor Emeritus in Purdue’s Weldon School of Biomedical Engineering, has developed the first new CPR alternative, called "only rhythmic abdominal compression," or OAC-CPR, which works by pushing on the abdomen instead of the chest.

In standard chest-compression CPR, which has been in practice since the 1960s, the rescuer pushes on the chest and blows into the subject’s mouth twice for every 30 chest compressions. However, the risk of infection is so grave that many doctors and nurses often refuse to administer mouth-to-mouth resuscitation. In one 1993 study of 433 doctors and 152 nurses, 45 percent of doctors and 80 percent of nurses said they would refuse to administer mouth-to-mouth resuscitation on a stranger. OAC-CPR eliminates the need to perform mouth-to-mouth resuscitation. The American Heart Association requires that rescuers administering CPR push with enough force to depress the chest 1 and a half to 2 inches at a rate of 100 times per minute. "To depress the chest 1.5 to 2 inches takes 100 to 125 pounds of force," Geddes said. "So you have to push pretty hard and pretty fast, and two people are needed to perform it properly. One blows up the lungs and the other compresses the chest. And when the one who’s compressing the chest gets tired, they change positions." Instead of two breaths for every 30 chest compressions, the new procedure provides a breath for every abdominal compression because pushing on the abdomen depresses the diaphragm toward the head, expelling air from the lungs. The release of force causes inhalation. The procedure provides a new way to effectively perform "coronary perfusion," or pumping blood through the heart muscle, which is critical for successful resuscitation because the heart muscle is nourished by oxygenated blood, Geddes said. "Unfortunately, in standard chest-compression CPR, blood sometimes flows in the wrong direction, which means the coronary blood flow goes backward, bringing de-oxygenated blood back into the heart muscle," Geddes said. Findings showed that OAC-CPR eliminates this backward flow and that using the new method and pushing with the same force recommended for standard CPR provided 25 percent more blood flow through the heart muscle without retrograde flow in the coronary arteries.

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Medical Concepts Development Actigard application

The big cover-up

by Julie E. Williamson

If skin can best be analogized as nature’s suit of armor, then what is placed over it can best be described as a veritable shield – an insurance policy of added protection whose importance cannot be overestimated, particularly in the fluid-intensive, microbial-rich surgical environment.

In the operating room, it’s gowns and drapes that really rise to the occasion in that role, serving as an effective barrier against bloodborne pathogens and microbial invasion. Not surprisingly, purchasing professionals and end users are looking for gowns and drapes that possess a wide range of qualities, with adequate protection for both staff and patients ranking highest on their list of priorities.

But that’s not all customers want. Driven by technological and procedural advancements, and the demand for enhanced comfort, durability, ease of use, cost-effectiveness, customization, and a host of other factors, gown and drape manufacturers have developed products that go far beyond their traditional scope of duty.

"Users want more from their products and it’s up to manufacturers to listen to what their customers want and need, and then develop and refine products that will help them perform their job more effectively and efficiently," said Mark Benjamin, marketing communications specialist, Medical Concepts Development, Woodbury, MN, adding that it’s not enough to maintain the status quo, especially in the surgical environment where technology and procedures are ever-evolving. "Manufacturers that don’t meet customers’ changing needs will be [left behind]."

Gowns go high-tech

Today’s surgical gowns have quite a long list of noteworthy attributes, beginning with improved imperviousness that provides exceptional fluid resistance and viral protection.

What makes modern-day gowns even more user-friendly, however, is their ability to blend a high level of protection with enhanced comfort – a combination that was difficult to achieve in the not-so-distant past.

"Historically, comfort and protection were mutually exclusive of one another. The more you moved up on one, the more you had to suffer with the other," noted Rob Lockwood, senior product manager for drapes and gowns for Medline’s Proxima Division.

Even the highest level of protective gown, classified as a Level 4 under the Association for the Advancement of Medical Instrumentation’s liquid barrier protection classification, can offer surgical staff a high degree of comfort — a significant benefit that can be credited to advanced fabric technology and other value-added design features.

Cardinal Health’s Smart Gown, among the newest in the Convertors line, is a Level 4 barrier that is impervious to fluids, but also soft and highly breathable. Its breathability comes from a responsive membrane that reacts to the end user’s body temperature during the procedure and allows the moisture escaping the body to transfer through the gown. The company’s Astound gown is designed with microfiber technology with a comfort- and protection-upgraded fabric that makes it 35 percent lighter, while allowing 25 percent more air permeability than earlier models.

Medline Industries’ Aurora Gown, classified as an AAMI Level 3 barrier, features DuPont Suprel, a bi-component material comprised of polyethylene and polyester that ensures a blend of exceptional comfort, drapeability and protection. The gown is also roomier through the chest and sleeves and features longer lengths and reinforced zones for added comfort and protection.

Medline Aurora

Comfort perks are also coming in the way of roomier designs and innovative seaming techniques, which allow for greater movement without the risk of sleeve tearing and separation. Slip-resistant elements have also made their way onto the scene. In 2006, Kimberly-Clark Health Care, Roswell, GA, introduced SECURE-FIT, a proprietary slip-resistant coating that is thermally embedded into the surgical gown fabric on select Ultra Non-Reinforced and MICROCOOL surgical gowns. SECURE-FIT was designed to protect caregivers from fluid contamination stemming from glove roll-down during surgery. Market research conducted by K-C revealed that the distraction caused by glove slippage is a major concern for surgical staff – so much so, in fact, that some survey respondents indicated that they routinely improvised solutions to maintain the interface between the surgical gown and gloves. Aside from placing healthcare workers at risk of infection, exposed skin caused by glove roll-down can also make it possible for skin flora to flake and contaminate the surgical site.

Product and packaging enhancements are also simplifying gown selection and facilitating ease of use. Every K-C surgical gown is visually branded with a combination of the Kimberly-Clark Color-Key and logo imprint. The Color-Key consists of three color-coded components, including neck bands, individual gown packages and tie cards; each color denotes a different type of surgical gown, with yellow being non-reinforced, green being fabric reinforced and red being impervious. A redesigned tie card also features the Color-Key, providing an added measure to confirm the type of gown the colored neckband represents. Visual features help staff more quickly and easily select the appropriate gown, improving overall efficiencies and minimizing risks of inadequate protection (as well as the costly practice of using the highest level gown for low-risk, low-fluid procedures). [K-C also offers an online Gown Selection Tool to help customers determine the best gown for various procedures.]

Linting and fire resistance are other safety factors that healthcare professionals should consider when evaluating surgical gowns. As David Parks, K-C’s general manager of global business management, pointed out, low-linting is important for avoiding wound contamination that may come from the products themselves. "Fire resistance is another high level concern, especially for surgeons using [electrocautery] tools in the OR," he explained.

Disposables versus reusables

Although efficiency and "green" concepts have gained momentum in a growing number of industries, including healthcare, disposable gowns appear to be holding their ground – at least in US hospitals.

As Lockwood noted, in the late 70s to early 80s the market shifted to more than 80 percent of the nation’s hospitals using disposable products, a trend that has remained steady over the years.

"One of the big challenges with reusable products is making sure you have the logistical chain in place to provide a sterile, consistent product. In the past there also may have been a slight cost advantage with reusables due to the number of processings that facilities could get out of the reusable products – if you could keep it in the system for that length of time," explained Lockwood, adding that technological advancements have now made disposables quite cost-effective."

Carl Hill, Cardinal Health’s director of marketing, noted that disposable gowns can drive efficiencies in several ways. Not only do they consume less storage space (a significant benefit in space-constrained hospitals), they also provide assurance that the gown’s integrity has not been compromised.

"From a total cost of ownership perspective, disposables bring in more efficiencies. With reusables, there are factors that need to be considered, such as the laundering process and having many different hands touching [the product along the way]."

Consistent performance is perhaps the biggest driving factor behind facilities’ gravitation toward disposable gowns, however. As Parks explained, the process of laundering can lead to barrier property degradation, thereby stripping away any inherent value.

That’s not to say there aren’t some good reusable gowns on the market – or some good reasons to use the products, however. According to Richard Stewart, vice president of product management for Cincinnati, OH-based Standard Textile Company Inc., "growing concerns with environmental stewardship and protection, as well as an increasing resolve to contain health delivery costs have aided the sales of reusable surgical textile and apparel products."

He acknowledged that products used in surgical applications do introduce the need for a level of precision in the design and manufacturing processes. "In the realm of surgical textiles this involves attributes such as the level of barrier protection, the ability of the fabrics and/or products to withstand commercial processing, and fabrication that is well-suited to the procedure for which it will be used." To that end, he said a "whole team" collaborative approach should be utilized when selecting surgical textile products.

"The requirements of the clinician are obviously the highest priority, but consideration also needs to be given to the concerns of those involved in laundry, pack making, sterilization, and other related functions."

Standard Textile recently introduced the ProMax surgical gown, which incorporates a proprietary tri-laminate barrier material that offers a high level of protection, as well as both a patented and patent-pending sleeve fabrication method that enhances comfort and performance.

"As far as we are aware, the ProMax surgical gown is the only reusable FDA-registered AAMI Level 4 gown," said Stewart.

Drapes get sophisticated

Like surgical gowns, drapes have become far more advanced in recent years, with products offering a number of innovative protective features and benefits.

Today’s drapes offer enhanced softness, drapeability and breathability, along with improved adhesives, minimal-linting top layers and advanced fluid control. Medline, for example, offers two drape fabrics – Eclipse (spunlace) and Aurora (SMS polypropylene) – both of which provide great patient conformity and low memory. Cardinal Health offers a fully impervious drape, as opposed to just an impervious critical zone, to improve fluid control beyond the surgical site. 3M Health Care’s Steri-Drape Absorbent Prevent Fabric Drapes are low-linting, non-woven, absorbent fabrics laminated to plastic film.

Kimberly-Clark Cath-Lab Drape

"They soak up spills and splatters and eliminate fluid strike-through," noted Shawn Matalas, technical service representative, 3M Health Care, St. Paul, MN, adding that absorbency and Level 4 barrier performance throughout the entire drape eliminates the need to define a "critical zone." Having a drape that is absorbent and fluid-resistant helps prevent the risk of both strike-through and roll-off, and eliminates the need for drape layering (a common occurrence by surgeons who want to create a more resistant barrier, according to 3M).

Matalas went on to explain that there are six principles of draping: isolation, barrier, sterile field, sterile surface, fluid control and equipment draping – with 3M offering many single-use disposable surgical drapes to meet these principles. Many 3M drapes also incorporate fluid control pouches and absorbent pads. Drapes may also feature adhesive apertures which prevent drape migration into the operative site, thereby reducing the risk of contamination.

Hospitals are also able to say goodbye to one-size-fits-all draping thanks to specialized, size-optimized drapes.

"We’re seeing trends in the direction of specialization of draping products that can be customized to meet the very specialized needs of specific procedures," Parks said. "As we see changes or evolutions in technology, procedures and clinical practices, it’s our job to stay on top of that and redesign our draping products to meet those changing needs." K-C’s latest specialized drape is its femoral angiography product. The Impervious Extra Long Femoral Angiography Drape was designed to deliver the fluid control required for diagnostic and interventional procedures performed in the cath and interventional radiology labs. Available in both sterile and nonsterile versions, the drapes feature a film layer that provides impervious protection against blood and body fluid strikethrough, as well as dyes, Heparin and saline solutions.

3M offers a one-piece, fully-body coverage drape sheet for many specialty procedures, including a recently introduced one-piece 6687 craniotomy drape with Ioban 2 Antimicrobial Incise film (the drape also has a large rectangular fluid collection pouch with dual exit ports). Also introduced is the 3M 6682 Cardio/Chest drape with Ioban 2 Incise film for use in thoracic, breast and cardiovascular procedures.

Lockwood explained how surgical equipment, such as new tables, is impacting drapes’ effectiveness. A good example, he said, is to look at how prevalent Jackson tables are now in the OR, and their increased use in orthopedic cases. To accommodate such changes, Medline has added extra length (12-plus inches in some cases) to its Ortho drapes to give clinicians full coverage without having to pull extra sheets.

"If you are just looking at a low-cost drape, but it does not give [adequate] patient coverage, you might end up pulling two to three three-quarter sheets for this one patient," continued Lockwood. "This makes your true cost for that particular surgery higher than if you paid a little more for a large drape [that offers] fuller coverage."

Layering on the benefits

Vendors are also incorporating design features, such as Velcro line holders, to keep patient lines and cords in place, and there are even some that aim to push the limits of the prevention of microbial contamination.

3M Health Care and MCD both offer antimicrobial drapes. "The 3M Ioban 2 Antimicrobial Incise Film drapes have continuous broad-spectrum antimicrobial activity in the drape adhesive where it can’t be washed away," said Matalas. The drapes are also clinically proven to help reduce the risk of surgical wound contamination and bacterial migration, while provding reliable adhesion to the wound edge.

MCD’s ACTI-Gard Antimicrobial Incise Drape’s adhesive contains a patented antimicrobial iodine-releasing agent that has low water solubility, and is heat, ethylene oxide and gamma stable. The antimicrobial agent in ACTI-Gard will not leach out in wet environments and is easily sterilized using standard methods, and is also heat-stable during shipping and storage. MCD notes that the most important clinical feature of ACTI-Gard Antimicrobial Incise Drapes is the ability to place them in custom procedure trays without individual packaging and special handling.

3M’s Ioban 2 antimicrobial incise film

"We can package our drapes sterile or non-sterile and they don’t have to be sealed to prevent the iodine-containing agent from breaking down," said Benjamin. Antimicrobial drapes may come at a slight price premium, but being able to buy them non-sterile and in bulk can help keep costs to a minimum, he explained.

Although other leading drape manufacturers, including K-C, Cardinal Health and Medline, have yet to board the antimicrobial bandwagon, sources from each company said they are keeping their eye on the science behind it and will consider incorporating antimicrobial protection if clear clinical results demonstrate its effectiveness.

"The feedback on [antimicrobially-impregnated products] is mixed right now. It might really offer a benefit and [it might not]. We want to fully explore and understand the true science behind it rather than just jumping into that market," Hill noted.

Rather than offering an antimicrobial-impregnated drape, K-C has developed a microbial sealant product that is applied to the exposed skin after the area has been prepped (clinical studies show that some skin flora remains after being prepped and can multiply over the course of the procedure, thereby increasing the risk for surgical site infection). The InteguSeal product essentially locks any remaining microbial organisms in place, preventing them from migrating into the surgical site.

"We see the InteguSeal as a natural extension to skin prepping and draping. Since it doesn’t rely on an antimicrobial, there’s no risk of building up resistance," Parks explained.

Regardless of the plethora of innovative gowns and drape features available today, customers can expect even more from their products in the near future, including greater comfort, durability and strike-through protection, and more user- and environmentally-friendly materials and packaging – all while meeting healthcare facilities’ ever-pressing pricing demands.

"There’s some rich, fertile ground in terms of continuous performance with barrier and comfort, and then going beyond that with more value-added benefits targeted toward improving order, flow, efficiency and quality in the OR," said Parks. "With ever-changing practices, procedures and technology it’s inevitable that these products will continue to evolve. There’s always room for improvement."