Here’s what one purchasing analyst had to say about her hospital’s recent RFP for packs and kits, and an eventual vendor change.

"One of the primary drivers for our re-evaluation of sterile drapes and gowns was concern about penetration," said Leslie DeBaun, purchasing at Delnor-Community Hospital in Geneva, IL. "We also had some concerns about customer service from the vendor that we had been using. We invited manufacturers of the custom sterile single-use fabric products (gowns and drapes) to participate in a bidding and evaluation process."

"We  then formed a core group of people from Purchasing and Surgery to manage the process. The coordination of the testing of all products was done between surgery, the vendors and purchasing. Each department ran its own tests in the clinical setting. Physicians were strongly encouraged to try the gowns and test the drapes to approve or disapprove them."

One hospital’s quest
Barrier protection
"As indicated above, strike-through was of major concern," said DeBaun. "AAMI liquid barrier protection classifications were part of the information referenced during the evaluation. During the test process, one of the gowns failed to perform when the surgeon was not adequately protected from fluid during major abdominal surgery."

Flammability
"Of great concern, and a major issue with AORN, is the flammability property of fabric. The statements given by some sales representatives seemed to have conflicting information, noted DeBaun. "The vendors have written material on combustibility and flammability. They may reference the National Fire Protection Association test method 702-1980 either as an acceptable or unacceptable test. They may reference the Federal Flammable Fabric Act, Title 16, CFR 1610. They may reference testing performed by a private party. Each type of fabric has different flammability properties; manufacturers can have several different fabrics. It is important to compare "apples to apples" on the types of fabric being evaluated between various vendors. In all this, we were aware that the OR has an oxygen enriched environment that is a contributing factor to fire.

Breathability
"One physician is only comfortable in cooler fabrics," said DeBaun . "For that physician we tested and then later, decided to stock a gown that has more breathability yet maintains the other properties we desired."

Drapability, linting
"We checked for drapability. Also, it was important to keep linting to a minimum."

Evaluation outcomes
"During the evaluation process that lasted several months, Purchasing negotiated pricing and value-added offers from the vendors involved.

As of today, we have changed almost all our apparel and drapes to a new vendor. We still have a few special drape requirements that may only be met when a new model is made or we may need to order a custom drape. Overall, we have provided to our staff and physicians an improved product, decreased safety risks and saved money," concluded DeBaun.

Will AAMI standards clear
the waters?
HPN talked with many of the major surgical drape and gown suppliers to find out how their products stack up to the new AAMI liquid penetration standards, what new developments have come down the pipeline in terms of new fabrics, and other factors to consider in drape and gown selection.

With the new AAMI standards that were discussed in our March 2004 issue ("Barrier Protection", also available online), and that have been ten years in the making, those involved in the purchasing and use of surgical gowns and drapes now have an industry-accepted standard for measuring barrier protection.

As explained by Lisette Swenson, brand manager, US, Barrier, Mölnlycke Health Care Inc., "AAMI has tried to clear the waters and say, ‘manufacturers, you have to have clearly stated claims, and you have to back that up with your test methodology and where your fabric met it according to our guidance. And although it’s not legally required, I think everyone pretty well accepts that it’s going to be the professional technical guidance."

She adds, "I think the wonderful outcome of the AAMI guidance is that clinical end users today can now say to manufacturers, ‘I understand your claim. Now, show me the data to back that up.’"

To that end, Mölnlycke provides product data sheets that state the AAMI level of protection, fabric, weight, and other technical specifications, as well as additional testing results.

"AAMI only really looks at hydrostatic head, strength, and depending on what level, they’ll look at the impervious barrier. We like to go a step further and look at breathability, abrasion resistance and linting," clarified Swenson. She adds that all testing is external, including tests derived from independent medical test laboratory, Nelson Labs.

Jeff Schneider, Global Surgical Products, Kimberly-Clark Health Care said, "I think one of the reasons the AAMI standards have received a lot of work and attention, is to get to some level playing field in the market, and to clarify the true level of protection that drapes or gowns provide." He adds that Kimberly-Clark is waiting for FDA’s adoption of the AAMI guidelines for the requirements that will be specified as to package and product labeling, and other communication.

Prior to AAMI, materials mangers were at the mercy of the data provided by the vendor regarding barrier and other apparel qualities. For example, one vendor might use a hydrohead test and another might use a water impact test for barrier protection.

"The AAMI standards really combine the industry standard tests together, so that all you need to know is one is the lowest and four is the highest," said Jessica Lenhardt, market manager, surgical gowns, Convertors Products, Cardinal Health.

Swenson adds that in additon to AAMI, end users should consider professional guidance such as provided by AORN, and other technical guidance such as ASTM, and the upcoming AAMI technical information reference document on drape and gown selection.

It’s all in the details
Prior to AAMI standards, a manufacturer could claim that a gown was impervious simply by virtue of the barrier protection of the fabric itself.

"A very important part of AAMI guidelines is to look at the protection capability of the total gown not just at the fabric itself. This includes the construction of the gown, the sleeve seams, and areas where ties attach to the product," said Kimberly-Clark’s Schneider. "All protective areas of the gown that can potentially come into contact with blood and fluids have to meet AAMI requirements to qualify for a certain level of protection."

Lenhardt explains how Cardinal Health took it upon itself to test the entire structure of its gowns even prior to the AAMI standards. "For example, our sleeves are fully impervious. We’ve tested that, but that wasn’t necessarily the case with the rest of the market. So it’s very important to not only look at the fabric that’s used but also the quality of the manufacturing."

Curt Koehn, director of marketing, Convertors Products, Cardinal Health adds, "We’ve always used the rule of thumb at Convertors and Cardinal Health that in order to allow ourselves to use the term impervious, not only the material, but any structure made with that material, would have to pass ASTM 1670 and 1671. What AAMI has done is actually require a manufacturer, if they want to claim level 4 for a product, not only does the fabric have to pass both 1670 and 1671, but the structure in the critical areas also has to pass those tests."

Comfort meets protection
While AAMI standards provide a superb indicator as to barrier protection, perhaps an even greater challenge lies in comparing comfort levels of various surgical apparel.

For one, comfort is an ambiguous term that is often in the eyes of the beholder, or in this case the wearer. As is the case with the example given by DeBaun, many surgeons have specific requests when it comes to their ideal comfortable fabric.

And secondly, talk to any manufacturer out there and nearly every one will tell you they have a product that provides a high level of protection in the most comfortable fabric.

So how do you sort through
these claims?
To answer that question, you might start with the technology behind the fabrics being offered today.

Until OSHA’s bloodborne pathogen rules came into the picture around 1995, the U.S. gown market was historically 80% wood pulp polyester spunlace fabric, relates Molnlycke’s Swenson. Being a natural fiber fabric, it was very soft. In addition, said Swenson, the old spunlace fabrics, not having film laminates, and not being embossed or heat-sealed, were also very breathable.

As Cardinal’s Koehn describes spunlace, "It feels like felt." He adds that "there is a population of clinicians who have used nothing but spunlace for their entire careers and are very comfortable with the protection and the way the material feels to them."

Currently, much of the advances in surgical medical fabrics are being made in synthetic fabrics. Lenhardt attributes this to the fact that synthetic fabrics can more easily be manipulated to achieve desirable qualities. "With a natural fiber you have to add a couple of layers to get more protection, which makes it thicker and a lot heavier to wear."

Adds Koehn, "With synthetics, we’re able to dial back on the basis weight of the material and make it thinner than spunlace, but with about two and half to three times the barrier of the spunlace."

New fabric technologies
One of the newer technologies on the synthetic medical fabric market involves the blending of polymers.

For example, DuPont has been enjoying great success with its Suprel fabric. The fabric is currently being sold in a Medline gown, under the Aurora brand name.

According to Lori Gettelfinger, marketing and sales manager, DuPont Medical Fabrics, Suprel is a combination of polymers: polyester for strength and polyethylene for comfort and softness.

She confirms that while their previous fabric, Softesse, which was made of spunlace technology, was very comfortable, the fluid barrier protection was not as high as some of the competitive polypropylene SMS fabrics. "Users have had to make a tradeoff between comfort and protection until now."

The Suprel fabric has been tested to meet AAMI Level 3 protection standards. Gettelfinger notes that while AAMI standards consider a Level 3 gown, anything over 50 cm. of hydrohead protection, Suprel rates at 85 cm. hydrohead.

Results of informal testing at the product’s introduction at AORN, showed that of 3000 nurses who tried on gowns made with Suprel, 95% said they preferred it to what they were currently wearing in terms of comfort, said Gettelfinger.

3M Steri-Drape 9000

Another new fabric, that is not currently used in any gowns or drapes on the U.S. market, but which its manufacturer, the Polymer Group Inc. (PGI) said is currently being considered by several vendors, is MediSoft. According to Rick Pearce, senior director, business marketing, the company takes traditional spunmelt technology and adds a proprietary processing touch to give MediSoft its high barrier protection qualities coupled with softness. The fabric, which was well-received this year at the IDEA show in Miami, FL, measures at AAMI level 3, and Pearce notes that the product could be custom manufactured to meet specific qualities that a customer may want in their product. For example, if a customer feels they need a higher hydrohead rating in a gown.

PGI has rated the comfort of its fabric using INDA’s Handle-o-meter test (IST 90.3-01) as well as the Coefficient of Friction (ST 140.1-01). PGI has also tested the breathability of MediSoft with Air Permeability tests. Pearce noted that by the end of September, PGI should have results back from a Comfort Test which is being performed by North Carolina State University’s department of textiles. He notes that some competitive manufacturers have completed this test. "We’re going to do it just to make sure we’re where we say we are in terms of comfort," qualified Pearce.

Still, what may prove to be the best way to determine the comfort level of a product is to actually put the gown on and try it yourself.

Frank Czajka, Proxima product manager, Medline Industries is so confident about the combination of comfort and protection of the Aurora gown made with DuPont’s Suprel, that it is offering any facility that wants to test the gown for a day, a free day’s supply of Aurora gowns. "There’s so much marketing in the surgical arena that Medline’s come up with a program to test the product where it really counts. The ‘free gowns for a day’ program with Aurora, gives the clinician an opportunity to wear the gown where it counts, and see and feel the performance."

In terms of a fully impervious, breathable gown Kimberly-Clark’s MicroCool gown has been a staple on the market since the late 1990s. The gown offers Level 4 AAMI protection that has been tested in a comfort lab setting simulating the clinician work environment. Schneider said the fabric is a film construction Kimberly-Clark has developed that allows moisture vapor to pass through the fabric for comfort, yet prevents the passage of fluids or microorganisms from an external perspective.

In addition, Kimberly-Clark surgical fabrics have long exceeded industry standards by adhering to the most stringent flammability requirements (Class 1) of the NFPA-702 Flammability Test. All Kimberly-Clark SMS fabrics are classified as Class 1.

Cardinal Health has several gowns made from a microfiber material, one being the Astound. The line includes an unreinforced AAMI Level 3 product, up to the Astound impervious gown, which meets AAMI Level 4 barrier protection standards.

Cardinal also has its SmartGown, which is its newest breathable impervious gown, utilizing a microfiber composite and a monolithic film, that is rated AAMI Level 4.

"One of the things I’ve heard anecdotally as I’ve been out in the field talking to people who wear nothing but SmartGown, they’ll say, ‘for the first half-hour, I feel warm,"said Koehn."Because an impervious gown doesn’t put out the same degree of comfort as an unreinforced gown. But then they say, ‘a half-hour into the procedure, I begin to feel very comfortable and cool.’ And that’s because with SmartGown, there’s a point to where the Moisture Vapor Transfer Rate (MVTR) really kicks in to an exponential degree. That’s why we call it smart technology, because as the moisture level raises underneath the gown, the rate of transfer out of the gown increases exponentially."

Mölnlycke recently launched its new Barrier gown line, with several gowns to meet all AAMI levels.

"The reason for this is the end users have different protection requirements, but they also have different fabric preferences," said Swenson.

The Barrier Surgical Gown II is a highly repellant,

AAMI Level 3 gown that uses a new meltspun technology for barrier protection and breathabiltiy.

The Barrier Fluid Protection Plus gown is a micro-porous film laminate that passes the ASTM 1670 test for fluid impervious claims. The gown meets AAMI Level 3 standards. But notes Swenson, while AAMI Level 3 gowns only have to be highly repellant, this gown also provides a high level of fluid impervious protection. She adds thatMölnlycke is introducing a new viral protection Level 4 gown at the end of the year.

Koehn notes that while natural fiber fabrics still carry the advantage of softness, "Synthetics are getting closer to natural fabrics in terms of comfort levels. One day very soon you may be able to surpass what spunlace is able to provide because of the advances in synthetic medical fabric technology."

DuPont is in fact working on some additional new fabrics, according to Gettelfinger. "We do anticipate that we’ll be coming out with a drape fabric based on the Suprel technology in the near future," she said. "This new technology platform really gives us an ability to make custom solutions and so we’re looking at unmet needs in the marketplace and how we can use this technology to come up with even more innovative fabrics. I think this will be the first of many great new things that DuPont will be bringing to the medical market."

Standardization and cost issues
While standardization is always a concern with materials managers, most vendors agree that the majority of facilities will need to carry anywhere in the range of two to four gown lines in order to optimize utilization. It was also generally agreed upon that the majority of surgeries could conceivably be performed in a Level 3 gown.

Interesting to note, while an AAMI Level 4 gown does tend to carry a cost premium over other levels of gowns, costs for gowns in levels one through three do not vary significantly.

Cardinal’s Lenhardt explains, "A lot of it has to do with construction, not necessarily the cost of what goes into it."

Swenson adds that Mölnlycke is looking at new high technology films to help shrink the gap between the cost of a Level 4 gown and lower level gowns.

Drape technology
Several companies also have new releases in the patient drape arena ranging from specialty drapes to new fabric technologies. Karin Slootjes, global marketing development manager, fabric drapes and gowns for 3M Health Care, offers the following list of attributes to consider when selecting drapes:
•No fluid strike-through material
•Absorption capacity
• Non-breathable
•Good wide adhesive (at least two inches in width) for good isolation of the surgical site
•Low linting
•Flammability
•Soft, drapeable, not slippery
•Strong
•Standardization possibilities
•Total cost per procedure, not per drape
•Complete line (plastic drape; equipment drape; accessories: tube organizers, Op tape, etc.; fluid collection pouches; incise drapes and antimicrobial Incise drapes)

SmartGown by Cardinal

While 3M does not offer surgical gowns, it does have an extensive line of drapes that were launched in 2002 in the US market, called Steri-Drape Absorbent Preven fluid strike through, the non-woven will prevent fluid run-off, because it is absorbent. The plastic material is soft and non-slippery to make it comfortable for the patient and to prevent the drape from slipping off the patient. All 3M drapes feature an absorbent, no fluid strike-through material throughout the drape. This qualifies 3M Drapes as level 4 throughout the entire drape, not just in the critical zone.

"Our drapes are completely reinforced; we do not have critical zones incorporated, because we consider the whole area (drape) a critical zone. Blood and other body fluids do not stay within the typical critical zone area near the incision," said Slootjes. "To prevent fluid strike-through many healthcare workers will add layers of fabric, adding cost to the procedure. If you use a drape with a level 4 throughout the fabric, this will not be necessary anymore."

Specialty drapes
Mölnlycke has developed new drapes for pediatric surgery in conjunction with one of the leading children’s hospitals that are primarily designed for abdominal and thorasic procedures and are contoured to fit pediatric and adolescent anatomy while eliminating unnecessary draping. All Mölnlycke patient drapes meet AAMI Level 4 standards.

Swenson said the company has also improved many of its drapes by adding fluid containment pouches, absorbent areas, and Velcro-like tabs for cord control.

The cord control feature is one that many companies have incorporated in response to the growing number of minimally invasive surgeries being performed.

Schneider said Kimberly-Clark has been watching the technology trends in procedures moving to more of a minimally invasive surgery. "Given the increase in technology around the operative site, a lot more is needed from a line control or tube control standpoint, using hook and loop materials, pouches or flaps…anything that we can use to control those lines during the procedure and make sure they don’t enter the operative site."

Kimberly-Clark has also developed a laparoscopic abdominal drape that addresses the reduced fluid control needs of a minimally invasive surgery, while providing line control around the procedure.

Schneider adds, "The new laparoscopic abdominal drape is one that really addresses the opportunity to standardize on one drape for a multitude of procedures, given the flexibility in its ability to cover a significant number of procedures."

The Tiburon drape from Cardinal Health was introduced just over a year ago. Said, Koehn, "Like SmartGown, it’s a microfiber composite material. It passes the industry standard tests for fluid as well as viral penetration. The Tiburon fabric is also absorbent. Up to this point, many surgical fabrics had been treated to be repellant in order to prevent strike-through. With Tiburon, because the middle layer is impervious, we can actually aid in controlling the fluid by treating the drape to be absorbent, so the fluid doesn’t’ run down into valuable control panels, or the shoe covers of the clinicians."

Cardinal also has just come out with a drape called Rapid-Ex, short for Rapid Extremity drape, that is designed specifically for hand and arm orthopedic cases. Rapid-Ex has a stockinette built into the body of the drape.

Koehn explains that the drape was originally designed for the surgery center market where room turnover is key. "They time themselves with a stopwatch so they remain optimized, efficient and profitable."

Rather than the typical 3 SKUs ordered for an orthopedic case (an impervious plastic U-drape, a hand drape and a stockinette), the Rapid-Ex has all three components built into one.

Czajka said Medline makes drapes that are larger than the industry norm, with impervious zones tested to meet AAMI Level 4. "We give much larger impervious absorbent zones on our drapes in order to create a complete sterile field with one drape." Medline’s Proxima line of drapes are made of DuPont Softesse fabric for drapablility.

He adds, "We use only premium tapes and incise films in all of our products so that you get great drape to skin adhesion." The Medline drapes also incorporate Velcro style line holders across the board.

On a final note, Slootjes addressed the ways that the OR, CS and Infection Control departments can collaborate in making a drape selection. "For CS, the less drapes the better. A reduction in the amount of linen towels used in surgery will allow CS to better utilize the steam sterilizers and shorten the cycle for sterilization of instruments." Linen towels are often used because of the inability of many disposable drapes to absorb high amounts of fluids, she notes.

"Those in the OR department will look for ease of application and aseptic application. They will look for good isolation of the incise area in an adhesive. Plus, they’ll look at absorbency. OR will also want to prevent contamination of the surgical site and surgical site infection by choosing drapes with no fluid strike through and incise drapes.

"Infection Control will be most interested in how to maintain aseptic circumstances, and how to prevent Surgical Site Infection. Infection Control will be less interested in ease of application.

"Preferably they all work together for a system that is cost effective, gives the least risk for surgical site infections, and is easy to apply and store," she concludes. HPN