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Product News
What's New for Flexible Endoscope Reprocessing
Marlene Brunswick
Publish Date: October 10, 2007   |  Tags:   Product News

Whether you're looking for faster solutions for colonoscope disinfection or less-harsh methods for sterilizing your laryngoscopes, here's what you need to know about the latest products for reprocessing flexible endoscopes of all stripes. They are listed in alphabetical order by product name.

Little information about this new sterilant and disinfectant is available, as it's not yet on the market, even though it received FDA clearance in May. According to FDA documents, Acecide is an 8.3% hydrogen peroxide and 7.0% peracetic acid solution. Contact time for sterilization is five hours at 25'C (77'F), with five days' maximum reuse. Contact conditions are based on the AOAC Sporicidal Activity Test only. For high-level disinfection, the FDA has approved a label claim of five minutes at 25'C, also with five days' maximum reuse. Contact conditions were established by simulated use testing with endoscopes.

"When evaluating new equipment and disinfectants, always check for material compatibility with the product manufacturer," advises George Koos, the senior manager of cleaning, disinfection and sterilization at Olympus. He notes that it may also be a good idea to check with your automatic endoscope reprocessor for validation.

Minnetech Corp., which will market the solution, says more information will be available in the coming months.

Aldahol III. This high-level disinfectant and sterilant received its 510(k) approval from the FDA in May. It's not on the market yet, but it's expected to hit shelves within the next six months, according to Norman Miner, PhD, the president of Microchem Laboratories, which holds the patent. Healthpoint Ltd. will distribute.

Aldahol III is a 3.4% glutaraldehyde, 26% isopropanol solution meant for reprocessing flexible endoscopes. According to FDA documents, the agency has approved label claims for both high-level disinfection and sterilization.

  • High-level disinfection. Contact time is 10 minutes at 20'C (68'F), with 14 days' maximum reuse. Contact conditions were established by simulated use testing with endoscopes.
  • Sterilization. Contact time is 10 hours at 20'C. Contact conditions are based on the AOAC Sporicidal Activity Test only.

The advantage of Aldahol III, says Dr. Miner, is that isopropanol has the ability to kill all mycobacteria - also known as tuberculosis; some mycobacteria are glutaraldehyde-resistant because of the waxy coating on the microbe. Alcohol penetrates that coat. Dr. Miner says that the solution kills at least 6 log of mycobacteria in 10 minutes at room temperature.

The short processing time and the fact that you don't need heating mechanisms can really help speed up turnover times, in my mind. However, reminds Lawrence F. Muscarella, PhD, the director of research for Custom Ultrasonics in Ivyland, Pa., isopropyl alcohol is flammable. In addition, be sure to check with both the solution's manufacturer and the maker of your automatic endoscope reprocessor to ensure compatibility.

No price has yet been set on Aldahol III.

Cidex OPA Concentrate.
The FDA cleared this liquid chemical concentrate in April. According to FDA documents, the 5.75% orthophthaldehyde high-level disinfectant is approved for a contact time of five minutes at 50'C (122'F) the in-use solution (0.05% OPA) passes the AOAC Sporicidal Activity Test in 32 hours at 50'C. The solution is approved only for use with the EvoTech Integrated Endoscope Disinfection System; both are manufactured by Advanced Sterilization Products.

The EvoTech, which received 510(k) clearance from the FDA in December, is a two-basin washer and disinfector for reprocessing flexible endoscopes, according to FDA documents. In addition, the system performs a leak test, block test, pre-rinse, wash, disinfect, rinse and alcohol flush on each endoscope. Endoscopes must still be manually cleaned before placement in the EvoTech.

EndoSheath System.
To reduce the potential for cross-contamination in flexible endoscopy, Vision Sciences offers the EndoSheath System, distributed by Medtronic Xomed.

Sterile, latex-free and disposable, EndoSheaths are available in a variety of styles for flexible endoscopes such as laryngoscopes, ENT scopes, cystoscopes and sigmoidoscopes. In the OR, you simply slide the EndoSheath onto the endoscope before use - it will then provide a barrier between the scope and the patient. After the procedure, you simply remove and red-bag the sheath. The idea, says Janis Saunier, RN, the director of marketing for Medtronic Xomed, is to make subsequent cleaning and disinfection easier, because the scope will have little or no gross contamination with bioburden.

"There is a large study out there on infections caused by improper bronchoscopy processing, and the sheath is meant to decrease exposure to body fluids," says Deb Richards RN, BSN, CGRN, the head of the endoscopy department at Skagit Valley Hospital in Mount Vernon, Wash. "But there's such a big push to properly clean scopes these days that I'd want to see research to back it up."

A FDA guidance document suggests that flexible endoscopes covered with the sheath be exposed to intermediate-level disinfection after each use, says Dr. Muscarella. "Only if failure of or damage to the sheath were detected after the procedure would high-level disinfection be necessary, to prevent disease transmission as a result of the potential for contamination of the endoscope during the procedure."

Therefore, it's a good idea to inspect the sheath for tears or damage both before and after the procedure.

Some EndoSheaths for gastroscopy, sigmoidoscopy, bronchoscopy and cystoscopy come with single-use working channels, which facilitate use of the air/water and work channels. This means you can do both diagnostic and therapeutic procedures with the EndoSheath in place, depending on scope-model compatibility.

Sheaths cost about $10 to $15 each, depending on the model and the quantity you buy, says Ms. Saunier. She also notes that you may be able to get reimbursed for the EndoSheaths by using HCPCS code A4270 with third-party payers.

Endozime Instrusponge.
From Ruhof, this long, flexible plastic wand has a sponge on the end; the sponge is impregnated with the company's Endozime AW Triple Plus. Instead of using a wire brush - which can scrape the channels of your flexible cystoscope - to loosen and clear debris, you dip the sponge in water to activate the enzymes, then push it through your scope's lumens to perform the all-important mechanical cleaning step of scope reprocessing. The product can also be used for rigid scopes and cannulated hand-held instruments with channel diameters of 2.5mm to 3mm.

They are designed for single-use to help decrease the risk of contamination, according to the company, and the sponge will not splatter bioburden when pulled from the scope.

"This looks interesting, but we would use it in addition to the enzyme wash our instruments already go through," says Ms. Richards. "So we would simply use them in place of our brushes. We have not been told by our repair service that brushing has ever caused internal damage, so if you're brushing properly, this product doesn't really provide an advantage in that respect."

Sterrad NX System.
This low-temperature hydrogen peroxide gas plasma sterilization system can be used for single-channel flexible endoscopes in addition to semi-rigid uteroscopes, hysteroscopes, choledoscopes, rigid scopes and other sensitive items that aren't autoclavable (such as batteries). You should contact Advanced Sterilization Products, the manufacturer, to ensure the instruments you want to sterilize with the Sterrad NX are compatible.

The system utilizes a new method of vaporization that removes most of the water from the hydrogen peroxide. The company says this improves diffusion of peroxide into lumens and results in a 38-minute cycle time for flexible endoscopes. The quick sterilization processing time helps your instrument turnover times if, say, you perform a lot of ENT-scope procedures.

However, the 38-minute cycle time does not include cleaning, which will typically add several minutes to the overall reprocessing time, says Dr. Muscarella. "Moreover," he says, "surgical instruments ' require complete drying after cleaning and rinsing."

The byproducts of hydrogen peroxide gas plasma sterilization are primarily water and oxygen. With no toxic residue or hazardous emissions, there is no need for aeration. In addition, the hydrogen peroxide gas plasma cassettes are self-contained for easy insertion and staff safety, the company says. Because it is a low-temperature method of sterilization, hydrogen peroxide gas plasma is said to be gentler than steam or peracetic acid, which can help delicate single-channel flexible endoscopes last longer.

Installation requirements are minimal, as the Sterrad NX needs no special electrical outlets, heating apparatuses or plumbing connections. This, along with the system's compact, portable size - the two-tired chamber is 1.1 cubic feet - lets you easily move it to or place it in OR substerile rooms and OR surgical cores, as well as central sterile processing. It can also be cart-mounted, the company says. The system also offers a color-coded touch screen for simple operation and instrument tracking, as well as networking software. The Sterrad NX lists for $45,000.

New stapler could increase GYN patient comfort
Time-consuming sutures and uncomfortable metal staples are no longer your only options for skin closure for GYN procedures. The Insorb 20 Subcuticular Skin Stapler from Incisive Surgical, Inc., is said to offer the speed of metal staples with the cosmetic results of sutures. The Insorb 20 uses bioabsorbable staples that are placed under the skin and that dissolve in the body within a matter of months. The staples, which are made of the same material as the leading bioabsorbable sutures, break down naturally, meaning there is no need for post-operative removal. The device lists for $39.50 per unit. For more information, visit www.incisivesurgical.com, call (952) 951-2543 or circle number 167 on your Reader Service Card.

Better positioning for ophthalmic procedures
During ophthalmic procedures, not every patient is able to maintain position on his own, and slight movements can compromise the procedure or bring it to a halt while the patient is repositioned. The Rousseau Ophthalmic Chin Lift from Rhein Medical solves this problem by eliminating the drifting that occurs during surgery and letting the surgeon ensure accuracy. The ophthalmic chin lift is fully adjustable to accommodate all patients and features a telescoping arm and an adjustable, padded, over-the-shoulder harness that is made to contour to any patient. The lightweight lift does not impede on the surgical field, says Rhein. The company did not give a price. For more information, visit www.rheinmedical.com, call (800) 637-4346, or circle number 168 on your Reader Service Card.