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

August 1, 2003

Automated Washers Boost Patient Safety, ReduceHealthcare Personnel Injuries

Automated Washers Boost Patient Safety, ReduceHealthcare Personnel Injuries

By Kelli M. Donley

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

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

Washers and disinfectors, according to JohnWegschaidler, 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 placedin the system, the healthcare worker (HCW) is gloved; when they come out the HCWactually 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 foruse on a patient.

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

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

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

The end result is instruments that have beenwashed, disinfected and sterilized to provide the highest level of instrumentquality for patients. However, Wegschaidler says there is another benefit of awasher/disinfector automated system. He says hospitals can reduce the number ofsharps injuries occurring in CS departments by eliminating the laborioushandwashing system.

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

The user selects a cycle to suit theapplication 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 waterprewash, a wash with detergent injection, rinse one, thermal disinfection rinsetwo, and/or a purified water rinse. We also offer the option of injecting lubebefore the instrumentation is put into the dry cycle and also an enzymaticinjection during the prewash.

Wegschaidler describes similar cycle options withSkytrons systems.

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

Then once all the washes are completed, theywould do an instrument lube so that way all of the hinged instruments havesmooth operations.

Regulation of Systems

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

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

The FDA goes on to list different regulations forwashers and disinfectors intended for different uses, including processinggeneral-purpose hospital articles (i.e., laboratory glassware). Infectioncontrol practitioners and hospital administrators should be aware of specificpublic health implications the FDA has noted with washers and disinfectorsintended for reusable medical devices. The literature reads, FDA hasconsidered two important public health implications in the regulation forwashers and washer-disinfectors intended for use in processing reusable medicaldevices: 1. When the washer-disinfector is used as the terminal process and 2.The impact on the effectiveness of a terminal sterilization process when thewasher is used during an intermediate cleaning step. FDA recognized theinterdependency of cleaning and the effectiveness of a terminal process andbegan to ask reusable device manufacturers to validate the recommendedprocessing steps for their devices. Since the cleaning and disinfection ofreusable medical devices in a washer-disinfector may be a terminal process (thefinal treatment prior to the reusable medical devices use on a patient), itis critical that these washers-disinfectors be effective. If they areineffective, then devices that are processed in them may have an increasedpotential for the transmission of diseases and multidrug resistantmicroorganisms. Furthermore, published reports indicated that sterilizationprocesses require the proper cleaning of reusable medical devices. Cleaningfailures negatively impact the effectiveness of these processes.1

The best idea for infection control practitionersis to evaluate the system in place in their CS department to determine if a newor different washer/disinfector system could reduce sharps injuries andnosocomial infections or reduce costs in the department. If a system ispurchased, policy for CS workers should be written, considering the vagueness ofthe FDAs guidelines, to ensure instruments are being processed efficientlyand safely.