When giving medication, we consider the five rights: right patient, right medication, right dose, right route, right time. When prepping a patient for surgery, we consider these three rights: right patient, right procedure, right side - left or right. When purchasing sterilization equipment, we need to consider another set of rights: right method, right turn-around time, right size and right price.
Sterilizers range in size from countertop to walk-in. Methods include liquid chemicals, steam, ethylene oxide gas (EtO), hydrogen peroxide, gas plasma and the newest addition to the U.S. market, ozone. Each method has its plusses and minuses, and not one is best for all circumstances.
Method is usually the least-negotiable of the considerations. There are two proven general-purpose methods in use today, high-temperature steam and low-temperature EtO. While you can sterilize stainless-steel surgical instruments with virtually any method, many delicate electronic and microsurgical instruments must be sterilized via a low-temperature method.
EtO, partly because it's suitable for all instrumentation, has been the low-temperature method of choice for delicate devices and is still in wide use. The larger EtO sterilizers that used a mixture of ethylene oxide gas and a fluorocarbon are being phased out because of depletion of the earth's ozone layer by fluorocarbons. Modern EtO is done with 100 percent ethylene oxide. "No other sterilization technology has been able to replace the versatility of ethylene oxide," says Ted May of Andersen Products, manufacturers of the EOGas and Anprolene lines of sterilizers. Mr. May says that the new generation of gas sterilizers uses less gas and offers faster cycle times.
The EPA is expected to release in 2006 abatement protocols for ethylene oxide exhausted into the atmosphere.
Plasma sterilization, another low-temperature method, is done with a vaporized hydrogen peroxide solution. Currently the only plasma sterilizer on the market is the Sterrad offered by Advanced Sterilization Products. Sterrad devices come in three sizes, all suitable for use in the ambulatory surgical environment. Visit the company's Web site (www.sterrad.com) to view the 1,400 items approved for sterilization with this method, including lumen lengths and diameters.
Skytron introduced ozone sterilization to the United States this year with the TSO3 125L Ozone Sterilizer. This low-temperature device, which only needs a 120-volt outlet, medical oxygen and water for installation and generates its own ozone sterilant, is being touted as a green alternative to ethylene oxide because its only waste products at the end of a cycle are oxygen and water. The ozone sterilizer is said to be good for most goods needing low-temperature sterilization, including rigid scopes, cords, cables, cameras and surgical instruments. It's not approved for flexible scopes and reactive metals such as copper or brass. The 125L is compatible with most anodized aluminum sterilization containers and all plastic containers. A proprietary plastic peel pouch is offered.
Liquid chemical sterilization is most often seen in the form of the venerable Steris System 1. This countertop device is ubiquitous to both rigid and flexible endoscope processing and also is used to process cameras, cords and endoscopic instruments. The device uses peracetic acid as the sterilant. Instrumentation processed in the Steris System 1 comes out wet and the device is intended for point-of-use sterilization. Most manufacturers of rigid and flexible endoscopic equipment approve their instruments for compatibility with reprocessing in the Steris System 1. While Olympus hasn't confirmed compatibility with Steris System 1 for the majority of its product line, certain products, such as the Olympus Visera line of surgical cameras, are compatible with Steris System 1, according to the company.
Steam sterilization, the gold standard for terminal sterile processing, is suitable for most instrumentation, textiles and liquids. Steam has the widest variety of available products in the broadest range of price and processing capacity.
Right turnaround time
Say a facility buys a $45,000 hospital-type flash sterilizer to take advantage of the quick processing time and to cut down on instrument inventory. The facility operator can be "sterilizer poor," with over-capacity and corresponding high service and utility costs making it difficult to cover a few busy moments during the day. A close analysis of the bottlenecks might reveal that more instruments may be the answer, not more sterilizers. Of course, this depends on the instrumentation costs.
One answer to the need for speed and more flash for less cash is the Statim 5000 countertop cassette steam-injection sterilizer. This point-of-care device uses a cassette to hold the instrument and can provide a nine-minute unwrapped flash cycle. If a facility has a need for flash back-up for single instruments, then you should consider this machine. The standard cassette has interior dimensions of 15 inches by 7 inches by 3 inches; extended-length and endoscope cassettes are offered. This sterilizer is also great for eye, endo and ENT instruments and other small sets and can process small containerized or wrapped packs.
As a general rule, countertop autoclaves cannot do a quick flash. They have to boil water first, before the cycle time even begins. If small sets need processing and fast turnaround is not required, a countertop could be adequate for a facility's needs or as a supplemental sterilizer. Most countertop sterilizers require that the door be manually cracked to dry a wrapped load. The most notable countertop sterilizer I've seen is the Scican Quantim 16, which will run a complete cycle, including drying, unattended with the door closed. Countertop sterilizers are generally 120 volts and plug into a standard outlet. Virtually all countertop sterilizers require that you pour water into them, which means stand-alone operation without hard plumbing.
Floor mounted autoclaves can flash and run terminal, standard cycle, wrapped loads. They require hard plumbing and floor drains and either piped-in steam or high-voltage electrical service to power their integral steam generators.
Ethylene oxide sterilizers range in size from 2 cubic feet to 33 cubic feet. While the electrical requirements are minimal, the venting and exhaust requirements are stringent.
Bigger doesn't mean better when it comes to sterilizers. Analyze what's being sterilized, when it's being sterilized and how it's being sterilized to determine requirements.
If method is the least negotiable consideration, price is a close second. You must consider the capital investment as well as installation and operational costs. To mitigate variability, first determine what the need is before proceeding to shopping for the device to meet the need. Don't let the vendors define your needs; let them address needs you've defined.
Consider remanufactured sterilizers from reputable refurbishers. Check out companies other than the couple biggest. Put a request for pricing out on the street and let several vendors respond with their proposals - including how they'll deliver, install and maintain their sterilizers.
A happy soul
John Steinbeck wrote that "A sad soul can kill you quicker, far quicker, than a germ."
There is nothing in the surgical facility manager's mind that causes a sad soul quicker than an unreliable device that's too expensive or that doesn't fit the facility's needs. The aim is to reliably kill the germs. First define your needs, then shop smart.