Infection Control Today - 08/2003: Automated Washers Boost Patient Safety

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Automated Washers Boost Patient Safety, Reduce Healthcare Personnel Injuries

By Kelli M. Donley

Trays of miscellaneous surgical instruments trickle into the central sterile (CS) department steadily; they are brimming with tools that just minutes ago may have been life-saving. But now, covered in potentially infectious matter, they could be life-threatening for CS workers who do not have an appropriate washer/disinfector system at their disposal.

Hospital administrators must weigh the importance of employee health as high as patient health when considering their method of washing and disinfecting reusable surgical equipment. The wrong choice can leave workers exposed to sharps that are just one accident away from causing disaster.

Washers and disinfectors, according to John Wegschaidler, assistant product manager for Skytron, based in Grand Rapids, Mich., are the first step to preventing fomite-induced nosocomial infections.

The system washes and disinfects, he says. Once the instruments come out, they are safe to handle. When they are placed in the system, the healthcare worker (HCW) is gloved; when they come out the HCW actually can pick them up with his/her bare hands and they are safe to handle. But with an autoclave, once they go in and come out, they are safe enough for use on a patient.

Wegschaidler explains the basic differences between a washer, disinfector (also known as a decontaminator) and an autoclave.

You have to wash the instruments prior to being autoclaved, he describes. Typically the instruments have to be cleaned when they come down from the OR by hand, or they would go into an automated system such as a washer/disinfector.

When they are done with that system, they go to a wrapping station, are wrapped up according to their procedures and then they are put into a sterilizer for sterilization.

The end result is instruments that have been washed, disinfected and sterilized to provide the highest level of instrument quality for patients. However, Wegschaidler says there is another benefit of a washer/disinfector automated system. He says hospitals can reduce the number of sharps injuries occurring in CS departments by eliminating the laborious handwashing system.

Ken Barnett, western regional manager for washer/disinfector manufacturer Scientek, located in Richmond, British Columbia, says in addition to reducing risks for workers, such systems provide more options. Scienteks systems come 10 programmable cycles.

The user selects a cycle to suit the application for the instrumentation load that they have loaded into the machine, he says. All of our cycles are variable so typically we have a cold water prewash, a wash with detergent injection, rinse one, thermal disinfection rinse two, and/or a purified water rinse. We also offer the option of injecting lube before the instrumentation is put into the dry cycle and also an enzymatic injection during the prewash.

Wegschaidler describes similar cycle options with Skytrons systems.

There are gentle cycles if you are running cannulated instruments through the machine to limit the high pressure going through the system, he says. Depending on how the facility is set up, they may use an enzymatic cleaner and then alkaline detergent and then they may run a neutralizer through to get that alkaline down and back to its normal pH balance.

Then once all the washes are completed, they would do an instrument lube so that way all of the hinged instruments have smooth operations.

Regulation of Systems

According to the most recent information published by the U.S. Food and Drug Administration (FDA), there is some ambiguity on regulations of these systems.

Washers and washer-disinfectors intended for the cleaning and disinfection of other reusable medical devices, such as stainless steel devices, surgical instruments, including devices with lumens, respiratory therapy equipment, and other medical devices, were legally marketed medical devices prior to the enactment of the Medical Device Amendments of 1976. FDA has not initiated classification procedures to formally classify this category of devices and is thus unclassified. While the Agency has reviewed and cleared pre-market notifications for these devices for use in the processing of reusable medical devices, we recognize that there is confusion within the regulated industry on whether 510(k) submissions are needed for these devices.

The FDA goes on to list different regulations for washers and disinfectors intended for different uses, including processing general-purpose hospital articles (i.e., laboratory glassware). Infection control practitioners and hospital administrators should be aware of specific public health implications the FDA has noted with washers and disinfectors intended for reusable medical devices. The literature reads, FDA has considered two important public health implications in the regulation for washers and washer-disinfectors intended for use in processing reusable medical devices: 1. When the washer-disinfector is used as the terminal process and 2. The impact on the effectiveness of a terminal sterilization process when the washer is used during an intermediate cleaning step. FDA recognized the interdependency of cleaning and the effectiveness of a terminal process and began to ask reusable device manufacturers to validate the recommended processing steps for their devices. Since the cleaning and disinfection of reusable medical devices in a washer-disinfector may be a terminal process (the final treatment prior to the reusable medical devices use on a patient), it is critical that these washers-disinfectors be effective. If they are ineffective, then devices that are processed in them may have an increased potential for the transmission of diseases and multidrug resistant microorganisms. Furthermore, published reports indicated that sterilization processes require the proper cleaning of reusable medical devices. Cleaning failures negatively impact the effectiveness of these processes.1

The best idea for infection control practitioners is to evaluate the system in place in their CS department to determine if a new or different washer/disinfector system could reduce sharps injuries and nosocomial infections or reduce costs in the department. If a system is purchased, policy for CS workers should be written, considering the vagueness of the FDAs guidelines, to ensure instruments are being processed efficiently and safely.

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