When it comes to surgical drapes, the quests are isolating the surgical field, and doing it effectively and with minimal cost. Sometimes more is not better, it is only more. "I have heard stories of 20-plus drapes used for some orthopedic procedures," says Bob Lusk, RN, BSN, MBA, CNOR, director of surgical services at Union Hospital in Elkton, Md.

But how do you know how many drapes and what types of drapes to use for each procedure? The answer depends on the condition and duration of the procedure, among other factors. Fortunately, you can consult manufacturing standards that classify the levels of protection that different drapes offer ' and still reach your goal of preventing microbes from entering the wound and causing surgical site infections in a safe, economical and efficient manner.

Levels of protection
The Association for the Advancement of Medical Instrumentation (AAMI) in 2003 led a consortium of government, occupational and industrial organizations in developing manufacturing standards that identify the level of protection that drapes and gowns offer.

"It's a standard that guides manufacturers in labeling their products, and allows users to look at what kind of protection the product provides," says Fran Koch, MSN, CNOR, the administrator of surgical services at Presbyterian Hospital in Dallas and co-chair of the AAMI's protective barriers committee. "In the past, manufacturers basically did the same tests, but the results were not standardized."

The standards classify barrier materials into four levels of protection, ranging from Level 1 (procedures involving minor amounts of fluid and pressure, such as ophthalmology, simple ENT procedures and some dermatology) to Level 4 (the so-called impervious materials for cardiovascular surgery, large abdominal cases, trauma and other complex procedures). The standardized levels, which were recognized by the FDA in 2004 for the labeling and marketing of manufacturers' new products, revolve around the protection that gowns and drapes demonstrate during lab testing. Here's a look at the "AAMI Liquid Barrier Performance and Classification of Protective Apparel and Drapes Intended for Use in Health Care Facilities."

• Level 1. Resists liquid impact penetration, or strikethrough. Used for ophthalmology, ENT and other low-fluid, low-pressure surgery.
• Level 2. Resists liquid strikethrough and liquid pressure. Used for tonsillectomies, adenoidectomies and some orthopedic surgeries.
• Level 3. Resists liquid strikethrough and higher liquid pressure. Used for general surgery and arthroscopy.
• Level 4. Impervious. For drapes: resists all liquid penetration. For gowns: resists all liquid and viral penetration (tested using inactive strains of a bacteriophage called Phi-X 174). Used for cardiovascular and large abdominal and orthopedic surgeries.

"The types of things that are done at surgical centers are varied, which is the value of the different protection levels," says Amy Hughes, BSN, CNOR, the infection control manager for Lankenau Hospital in Wynnewood, Pa. "You don't need the heaviest gown on the market for every operation ' if you're doing a cataract case, you don't need the same protection level as for an open heart case ' but for some operations, you'd want a heavier gown that protects you when you get splashed."

The standards were 23 years in the making, a delay Ms. Koch attributes to the difficulty of documenting products' levels of protection when the products were rapidly changing.

"In the early 80s, it was a totally different scenario," she explains. "People had always been using reusable drapes ' 140-thread-count muslin was a plain, old sheet that would absorb as much water as you poured on it ' and single-use products were just coming into the market. Products have changed radically since then."

Labeling confusion
The FDA took part in the development of the AAMI's standards, and has recognized them as a method of labeling products, at least in part.

"The FDA doesn't approve products, but it gives you the right to market them," says Jay R. Sommers, PhD, director of clinical and scientific documentation for the Kimberly-Clark Corp., a manufacturer of barrier materials. "It's very clear that if you have a new product, you can use these standards."

The agency, however, hasn't yet decided how to handle the labeling of products it granted manufacturers the right to market before the standards were developed. The FDA is poised to issue an additional ruling on pre-existing products, perhaps by year's end. Currently, the standards only apply to new barrier-protection products as they're introduced.

"If you already have a Level 4-quality product on the market, you can't label it as Level 4," says Dr. Sommers. To do so, manufacturers would have to resubmit their products to the FDA for a second nod to market it. For manufacturers, this could prove time- and money-consuming.

"It's very controversial," adds Dr. Sommers. Since the FDA might decide later this year the course of action to take on the matter, many manufacturers are playing wait-and-see, he says. "Why should we do it if the FDA's just going to change its ruling?" he asks.

Some comfort
The debate over whether drapes have any effect on SSIs may rage on (see "Are Drapes Really Necessary?"), but for many, the standardized levels of protection are where the choice comes in.

"With drapes, it's pretty basic," says Ms. Hughes. "You want it to stay where you put it, you don't want it flapping around. And cost is an issue. Don't use more than you need, but don't skimp. Drape what's appropriate to the case."

"That's the beauty of the levels," says Ms. Koch. "It allows you to make the decision in order to provide the safest care in the most cost-efficient manner."

Cost can also be an issue in the still-available choice of single-use versus reusable materials. While Ms. Koch explains that both options can provide "total protection that will serve you well," Ms. Hughes adds that calculating the expense isn't as easy as it might seem.

"I always liked the reusable products," says Ms Hughes. "We had cloth here for years. But you've got to monitor the frequency of washing, repair holes in them, be sure to throw them away after a certain number of launderings when the thread count breaks down. With disposable, you open it up, it's sterile, you drape it and you throw it away. The cost of the one versus the labor involved in the other is probably why so many have chosen the single-use."

More to come
Having standardized protection levels for the manufacturers of drapes and gowns, the AAMI's protective barriers committee is presently planning the publication of a technical information report that explores the materials' other qualities for the benefit of their users.

The report, currently in draft stage, focuses on the selection and use of protective apparel and surgical drapes, examining their composition, safety, performance characteristics and care.

"It's more user-oriented," says Ms. Koch. "It reviews all the characteristics of the materials and offers a lot of different tests for judging them."

Ms. Koch anticipates the committee will publish the report later this year. "In my opinion, it's every manager's obligation to be familiar with this document, to provide the best care for their patients," she says.