What Works

New EtO controls shorten sterilization time and save money for Forum Health Systems

by Susan Klacik and Jonathan Wilder

The Forum Health System Sterile Processing Department reduced its ethylene oxide [EtO] sterilizing costs, simplified its operations, and increased its ability to respond to surgical center needs. It achieved this by "right-sizing" its sterilizer through the installation of a Stericert Control System on one of its AMSCO Eagle sterilizers.

Forum Health System, located in Northeastern Ohio, is composed of several hospitals and free standing surgical centers. All of the employees working in the Sterile Processing departments are Certified Registered Central Service Technicians. Since the late 1960’s, Forum Health has used EtO blends to sterilize heat- and moisture-sensitive medical devices. Originally, 12-88 was used and, when that was phased out, Forum Health converted to Honeywell Oxyfume EtO blend gas.

As with most technologies over the years, EtO sterilization has undergone some changes. The most notable of these have included changes in the blend, revised OSHA Safety Regulations and the introduction of a single chamber for sterilization and aeration.

The EtO sterilization process
at Forum

Forum Health has two Amsco Eagle EtO Sterilizers which were purchased in 1981. The large sterilizer is 24 cubic feet and the smaller sterilizer is 8.8 cubic feet. A bit later, both sterilizers were converted to sterilizers/aerators after those units became the industry standard in 1984. Then in 1990, all EtO sterilization was consolidated onto one Forum campus in 1990.

The EtO sterilizers are located in a dedicated room with a separate exhaust that provides 15 room air exchanges per hour. EtO environmental probes are located directly in front and behind the EtO sterilizer, in an enclosed tank room, and in the employee work prep & packaging area directly outside of the sterilizer room. The EtO monitor is located outside the sterilizer and tank rooms. This location was chosen so that if there were an EtO leak, employees could monitor it remotely.

The Forum problem:
Underutilized EtO sterilizers

Plasma sterilization was introduced at Forum in 1997 and reduced EtO sterilization by about 85%. But since there are certain medical devices that can only be sterilized using EtO,1,2,3 Forum was running approximately three loads per week in the small EtO sterilizer.

This system worked well until 2003, when the small EtO sterilizer fell into disrepair and Forum was forced to use the larger EtO sterilizer, which has three times the capacity and costs three times as much to run. At that time, Forum began looking into purchasing a new EtO sterilizer. The health system preferred to utilize the blend gas, since studies have shown that the blend is a more effective sterilant2, 3, but they found that only 100% EtO sterilizers were available. Based on the success with the blend EtO sterilizers and the research Forum did on EtO sterilization, system administrators and clinicians investigated other options.

The Forum solution:
A new EtO control system

In 2004, H & W Technology introduced a retrofit control system that was used to convert the Forum EtO sterilizers to run both the traditional 16-hour cycle as well as a new ten-hour Economy Cycle. This Stericert control system interested Forum since they could still use the EtO blend sterilizer, and the cost of the conversion was less than the purchase of a new 100% EtO sterilizer.

The Stericert Control System for an AMSCO Eagle sterilizer at Forum Health System has
cut EtO sterilizing cycles from 16 to 10 hours.

The converted EtO sterilizer would provide two EtO sterilization cycles. The Normal Cycle is identical to the EtO sterili-
zation cycle before the conversion while the second cycle, the Economy Cycle, uses 25% less EtO than the current cycle. Best of all, the entire cycle time is reduced from 16 hours to ten hours. The ten-hour cycle allows Forum Health to begin the loads late in the day, or even do two loads a day. Both cycles were validated following AAMI Standard ST24.

The previous 16 hour cycle had to begin at 2 p.m. to assure that the products would be returned to the proper campus by 7 a.m. the following day. Considering the preparation steps required to make the devices ready for sterilization, the items needed to be in Sterile Processing by 1:30 PM. This was a hardship on Surgery, since the surgeon may still be using the medical device at that time and the Surgery Center may be across town. Also, should a malfunction such as a power outage occur, the load would be delayed which, in turn, could possibly delay surgery cases. To get around these problems, some additional instruments were purchased. However, not all instruments could be duplicated due to high cost or low usage.

Benefiting from ten-hour
EtO cycles

The ten-hour cycle has eliminated these problems. Forum Health can receive the medical devices as late as 8:30 p.m. for preparation to begin the load at 9 p.m., and the cycle ends at 7 a.m. the next morning.

The retrofitted sterilizer has the control panel located outside of the EtO sterilizer room. Having the control panel outside of the EtO room gives the operators the ability to glance at the monitor throughout their shift as they walk by. In addition, should there be a leak, the operators do not need to enter the sterilizer room. The control panel allows Forum to provide load and sterilizer operator identification as the sterilizer load is initiated.

Each of the Sterile Processing technicians has an identification number that they use to begin the cycle. Once in process, the control panel counts down the time left on the cycle, giving technicians a realistic projected time of completion. The monitor shows the cycle in action and provides a printout for permanent documentation. Future plans include having the EtO sterilizer hooked up to the hospital computer network, so that the Supervisor and Clinical Engineering can monitor the loads remotely, and cycle records can be stored on a hospital server.

Since this is the only EtO sterilizer for this multi-hospital organization, flexible start times are necessary to ensure that the medical devices are back to Surgery between 6 and 7 a.m. Some medical devices are sent for processing as early as 10 a.m. and as late as 6 p.m. The ten-hour cycle time now allows for two cycles to be processed daily, if needed.

The cost analysis

To obtain a true cost of the conversion, Forum first calculated how many cubic feet of loads per year they ran in the under-used 24 cf chamber, and how much they spent on the gas. They assumed that Forum would run the same annual volume of loads in the converted, smaller chamber and calculated how much less would be spent on that amount of gas, to determine how long it would take to pay back the Stericert conversion cost. Besides the gas savings from using a smaller chamber, Forum also saved gas by using the Economy Cycle on the Stericert controls, which uses 25% less EtO than the normal cycle.

As it turned out, there was an annual cost savings of $11,700, which meant that a $25,000 conversion cost would be paid back in 2.1 years. An added benefit of this conversion is that the Forum Health Clinical Engineering Department is now trained to perform service on this equipment, while non-proprietary repair parts can be acquired at local hardware stores, computer stores, or from component distributors. This means repairs will be quicker, although Forum hasn’t experienced many breakdowns so far. In addition, the technicians are comfortable operating the equipment.

As with any new process, there were a few wrinkles that needed to be ironed out. But Forum Health Systems has been using the Stericert controls for nearly a year now and the EtO sterilization benefits are substantial, including the "peace of mind" of a ten-hour turnaround for their surgical centers, increased reliability, and lower costs. HPN

About the Authors:
Susan Klacik is corporate director of sterile processing, Forum Health Systems. Jonathan Wilder is president, H&W Technology.

References

1. Kanemitsu, Keiji, Imasaka, Takayuki; Shiho et.al. A comparative study of ethylene oxide gas, hydrogen peroxide gas plasma, and low-temperature steam formaldehyde sterilization, Infection Control and Hospital Epidemiology, May 2005,Vol. 26:5, 486-489..

2. Alfa, MJ, DeGagne, P, Olson, N., Bacterial killing ability of 10% ethylene oxide plus 90% hydrochlorofluorocarbon sterilizing gas– Infection Control and Hospital Epidemiology –September,1997, Vol 18:9, 641-645.

3. Alfa, MJ, DeGagne, P, Olson, N. Puchalski,T. Comparison of ion plasma, vaporized hydrogen peroxide, and 100% ethylene oxide sterilizers to the 12/88 ethylene oxide gas sterilizer – Infection Control and Hospital Epidemiology, February 1996,. Vol. 17:2, 92-100

June
2006