When thinking about equipment failures that impact surgical procedures, the first thing that comes to mind for most of us is the quality and integrity of the surgical instruments used on the patient. But quality assurance starts not in the operating room (OR) with the devices themselves, but back in the central sterile/sterile processing department (CS/SPD) with the equipment that is used to prepare those instruments for the case.
Automated washers, disinfectors and sterilizers must be properly maintained to ensure that fully cleaned devices emerge from the high-level disinfection (HLD) or sterilization process ready to return to the surgical suite. Water quality is another area that can impact instrument processing so routine testing is critical.
But even with preventative maintenance and routine testing, breakdowns in equipment function and water quality do occur. There are times when instruments fail cleaning standards because the devices and supplies used on them weren’t up to standards.
In this article, we offer insights from CS/SPD professionals and equipment suppliers on quality assurance/sterility assurance best practices, as well as advice on how to prepare for and manage unexpected breakdowns.
Getting the resources you need — it starts at the top
In an ideal world every CS/SPD would have everything it needs to process instruments in an effective, safe and efficient manner. But in reality many CS/SPD professionals are working in departments with outdated equipment and lacking the tools they need.
“In the private sector it often comes down to funding, and staff are put in difficult situations where they don’t have what they need to get things done,” said Brian Reynolds, CRCST, CIS, CHL, Assistant Chief of SPS for Birmingham VA Medical Center. “Those people above making decisions need to come down into the department to understand why we need what we need in order to make sure our patients are safe. They need to understand that either they pay on the front end for the necessary equipment, or will pay on the back end if a patient is harmed — and that back-end payment will be far more expensive than an initial investment in their department.”
Reynolds has found that in medical facilities that are part of the Veterans Health Administration (VHA), such as his own, executive leadership is often more willing to fund CS/SPDs because of strict rules regarding adherence to IFUs.
“In the VA world we have to follow the IFU to the letter and if we need a certain piece of equipment then we are going to get it,” said Reynolds. “I see changes for the better in the private sector with facilities making investments in their CS/SPDs in reaction to scope-related infections. But I hate that the industry has to be so reactive. We are dealing with life and death and need to ensure our patients are our top priority and walk away better than how they came in.”
Maintain your equipment
Amanda H. Coss, CSPDS, CSPM, CRCST, CIS, CHL, National Education Coordinator for Mobile Instrument Service & Repair, recommends that CS/SPD professionals conduct visual inspections of automated washers at least daily to ensure everything is in working order, such as checking to make sure the spray arms are attached and drains are not clogged. She also stresses the importance of complete routine maintenance and preventative maintenance.
With regards to HLD and sterilization equipment, Coss says staff should check and clean drains daily, routinely clean sterilizers per manufacturers’ instructions for use (IFUs) and have the sterilizers professionally cleaned annually. She adds that staff must ensure steam indicators have changed to appropriate color after the process has occurred, and routinely inspect for package integrity concerns.
Coss says that for all of these equipment categories, CS/SPD professionals should apply routine quality assurance programs that include random inspection and adenosine triphosphate (ATP) testing, and record the results of these tests.
Verify your processes
While instruments might appear clean following an automated washer cycle, high-level disinfection or sterilization, countless studies have shown that dangerous microbes are invisible to the naked eye. Therefore, monitoring, logging and verifying the ongoing adequacy of the cleaning cycle are of the utmost importance.
For automated washers, Coss recommends CS/SPD staff perform cleaning verification testing that complies with the new Association for the Advancement of Medical Instrumentation (AAMI), Association of periOperative Registered Nurses (AORN) and ASTM International guide at least weekly, but preferably daily (see January 2018 HPN article Immaculate perception).
For HLD and sterilization equipment, Coss says CS/SPD staff should ensure the minimum weekly biological monitor result is on file and logged. She adds that staff should also articulate the reasons for instrument recall/re-sterilization occurrences and make the appropriate notations in the log.
“Cleaning indicators provide a more sensitive audit tool compared to visual inspection of instruments and help maintain performance of automated cleaning units,” said Greg Sautter, Product Sales Manager for Serim Research Corporation. “By choosing the correct cleaning indicator, CS staff can quickly determine suboptimal temperature, time, enzymatic detergent concentration and fluid action in a washer-disinfector that can occur during normal use of automated cleaning units and ultimately result in inadequately cleaned instruments.”1
“Detergent age and dilution also affect instrument cleaning, especially when coupled with other suboptimal conditions,” Sautter added. “Daily use of a cleaning verification test responding to these multiple factors often provides the first identification of conditions affecting instrument cleaning and the need for preventative or corrective maintenance.”
The PINNACLE Monitor for Automated Enzymatic Cleaning (AEC) from Serim Research Corporation was designed to respond to all critical factors influencing cleaning, including enzyme concentration and activity, wash cycle time, temperature and mechanical action of the cleaning unit. All of these factors impact instrument cleaning and are affected by performance issues with automated cleaning units. The PINNACLE AEC test provides a cost-effective verification of the cleaning process and can be used for daily testing of both washer-disinfectors and ultrasonic cleaning units.
What’s in your water?
Water quality is fundamental to the safe and effective processing of surgical instruments. AAMI TIR34:2014, Water for the reprocessing of medical devices, states: “The water used to reprocess a medical device needs to be of sufficient quality to ensure that the device is not damaged and that the patient will not be injured by contact with the device.”2
In this technical information report, AAMI specifies the water quality that should be used at each step in sterile processing, since various stages require different levels of quality. AAMI defines two categories of water for medical device processing:
- Utility: Water from the tap that is usually used for flushing, washing and rinsing.
- Critical: Water that has been extensively treated so it can be used during the final rinsing stage or steam sterilization.
The report provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.3
“Poor water quality can cause instrument malfunction during a procedure,” said Coss. “This can be due to corrosion of a surgical instrument, which can impede the mechanical movement of the device. Improper water quality can obstruct the removal of residual debris due to inactivation of the detergent. Water quality can also result in surgical site infections from the use of contaminated devices such as salt or organic deposits from the water. These contaminates could inactivate the disinfectant or sterilant or could protect microorganisms from the disinfection or sterilization processes.”
As the weather changes, the water quality changes as well so CS/SPD staff should conduct routine water testing seasonally, according to Coss. She also recommends that departments have their detergent manufacturers check their water chemistry often, noting that water quality changes may require chemistry adjustment.
Preparing for potential breakdowns
Every CS/SPD at one time or another experiences equipment breakdowns as a result of a mechanical failure, utility issue or other factors. Reynolds recounts a time when an air pressure failure brought down two of his department’s washers, leaving staff with just one washer to process all of their cases.
“We had 18 cases that were scheduled to be processed, as well as additional instrumentation coming in from emergent cases. Furthermore, because it was during the holiday season staffing levels were lower than usual,” said Reynolds.
In preparation for unexpected breakdowns such as this, Birmingham VA Medical Center has contracted warranties with its vendors and biomedical department staff on call to service CS/SPD equipment. In this specific instance, Reynolds and his team were able to catch up with processing volume later that same day thanks to the resources they had in place.
Michele DeMeo, CSPDT, CRCST, Independent CS/SPD Consultant at MDD Virtual Consulting, says quality assurance/sterility assurance policies and procedures are only as good as when they are put to the test or “flagged as required,” stating:
“Quality often fails when out of the ordinary events occur such as triggering Creutzfeldt—Jakob disease (CJD) precautions or more often when a department must be temporarily suspended or closed due to reasons such as a sewer back up, a staff walk out, a flood, fire or contaminated water source,” said DeMeo. “In other cases quality is compromised when new and/or ill-prepared technicians are training new staff or temps — or just want to help — or unprepared OR staff members are willing to ‘pitch in’.” In any of these cases it is not a simple matter when sterile processing ‘goes down.’”
DeMeo shared some of her own personal experiences of breakdowns that occurred while she was working in various CS/SPDs throughout her career. When she was 18 years old and on the job for just six months in a CS/SPD, an extreme ethylene oxide (EtO) spill injured a technician. Another facility experienced an entire CS/SPD staff walk out, leaving instruments, in DeMeo’s words, “not just unwashed, but torn apart, mixed up and literally piled all over on every tiny surface and on the floors, carts, etc.” This same facility also experienced a massive sewer back up that required top to bottom decontamination, reprocessing of everything within the unit, processor testing and environmental swabbing, according to DeMeo.
“There will come a time when every sterile processing department will experience utility failures. Loss of electricity or water can disable a washer disinfector and backup patient cases. Your SPD needs to have a plan for these types of events,” said Mark Duro, Director of Education, SPS Medical/Crosstex International.
Duro believes having a back-up water supply is essential, as a utility failure will impact sterilizers as well. He explains how a dedicated reverse osmosis/deionized system can help in the short term as most systems can store 750 to 1000 gallons of backup water. In addition, he recommends that a portion of a department’s reprocessing equipment be on an emergency generator.
Birmingham VA Medical Center is currently renovating its CS/SPD and one significant upgrade will be the installation of a reverse osmosis (RO) system that will supply water to all areas of the department, including sinks, washers and sterilizers.
“When there is a breakdown in the city of Birmingham’s water system we cannot process items until the city has given us clearance to do so,” said Reynolds. “For example, there was a recent waterline break that led to dirt entering the water supply. All we could do was wait until the issue was resolved. The new RO system will be a tremendous improvement as it will take the guesswork out of water quality for our facility.”
In cases where all of a CS/SPD’s washers go offline, staff might have to revert to manual cleaning. Duro explains how it is important to look at the manufacturers’ IFUs for the devices being reprocessed to ensure they can be manually cleaned in the event of an emergency.
“For devices that require automated cleaning, utilizing a nearby network hospital is a common option,” said Duro. “Remember, if the items being transported are contaminated, transportation must meet local and state department of transportation (DOT) requirements.”
“When sterilizers go offline, depending on the issue, you may need to get a mobile sterilization unit to your facility,” said Coss. “Another possibility is to use a satellite or sister site of your healthcare organization. Check your IFUs for alternative recommended methods of sterilization/disinfection offered for instrumentation.”
“In worst case scenarios surgical procedures may have to be postponed or cancelled,” said Duro. “In events like this we must always remember patient safety comes first. Each SPD should have a fully outlined plan and train all employees on what to do in the event of these emergencies.” hpn
References:
- Alfa, MJ, Olson, N. Comparison of Washer-Disinfector Cleaning Indicators: Impact of Temperature and Cleaning Cycle Parameters. Am J Infect Control, 2014 42: e-23-e26.
- http://www.aami.org/productspublications/articledetail.aspx?ItemNumber=4265
- http://my.aami.org/store/detail.aspx?id=TIR34-PDF
Kara Nadeau | Senior Contributing Editor
Kara Nadeau is Sterile Processing Editor for Healthcare Purchasing News.
