CS CONNECTION
hung up on sterilization yet European countries, including Germany, France and The Netherlands, have performed hundreds of thousands of studies on HLD and its killing effec- tiveness and they have not
“One thing I would like to point out is Damien Berg
found a smoking gun showing that items undergoing HLD versus sterilization are the ones causing negative outcomes in patients, if the device can be properly cleaned.” But as Berg points out, the endoscope that the CS/SPD has processed as a semi- critical device, one that does not penetrate sterile tissue, using H as specified by the Spaulding Classification, could potentially be used more invasively. There is typically a knowledge gap between CS/SPD and the clinician performing the procedure as to how the scope will be used and whether it has been processed as a semi-critical or critical device.
“There are cases when the doctor who is performing an evaluation of the stomach sees something that warrants him or her to get a little more invasive with the scope,” said Berg. “Under the Spaulding Classi- fication, that could require a sterile scope because of crossing the mucosal barrier. But typically, the doctor does not know whether the scope in his or her hand was processed with HLD or underwent sterilization. That is where the push and confusion is. The push is to get everything sterile because we don’t know how it will be used. And that is a very valid point for all involved.”
Manufacturer IFUs
It is important to note that the decision to use HLD or sterilization when processing a scope or other device ultimately comes down to what the device’s manufacturer has specified in its instructions for use (IU).
Casey Stanislaus Czarnowski, BA, CRCST, CIS, CER, Sterile Processing Educator, Stanford Health Care, helped to facilitate a complete turnover of a previous hospital’s endoscopes from HLD to sterilization, with the exception of gastroscopes and colonoscopes, to improve standard of care. “We wanted to sterilize everything we could
– anything the manufacturer told us we could render sterile. Even if is was not necessarily for a sterile procedure, we wanted to sterilize it,” said Czarnowski. Czarnowski said the greatest lesson learned
during the process was that provider engage- ment was critical to its success. The team en- gaged with providers at the onset of the project, and together convinced the hospital’s leadership that the required investment to switch from
that with the recent media coverage on endoscopes I have seen a lot of hospitals switch to EtO or another form of steril- ization to reduce the risk further for the patient. However what we must remember is that the endoscope manufacturer does not specify that you can do both - HLD followed by sterilization,” said Garry Bassi, BSc, CMDRT, Director, Medical Device Reprocessing Department, Mount Sinai Hospital, Toronto. “This deviates from the manufac- turer’s instructions for use and will increase material degradation on your scope. Either you wash the scope and perform HLD and then store the scope to dry, or
Garry Bassi
you wash the scope and perform sterilization and store the scope.”
“We have not made any recent changes,” said Mary K. Lane, MHA, CSPDM, CSPDS, CSPDT, MK Lane SPD Consulting. “We adhere 100 percent to the manufacturer’s instructions for use; however, most of our instrumentation is sterilized using steam ster- ilization. Steam sterilization is the preferred modality in comparison to high-level
Mary K. Lane
disinfection due to the risks associated with the use of chemicals. Further, steam steriliza- tion provides a higher level of patient safety and continuity of care when compared to high-level disinfection.”
Impact on workflow Another consideration in the HLD versus sterilization debate is how the chosen mo- dality will impact the CSSP’s workow. Most CS/SPDs have limited time and staff resources to manage an ever-increasing
One hospital’s sterilization story
HLD to sterilization of scopes was important to patient care and safety. Another major consideration was transport
and storage. Because the scopes are used throughout the hospital and stored in various places outside of the CS/SPD, the transition team had to ensure they were protected from potential contamination. They switched to rigid containers and coordinated with service line leaders to make sure they understood the proper way of storing sterile instruments. This meant having the right shelving and atmospheric condi- tions. Because scopes are also used on traveling carts, the team had to also stress the importance of getting these carts back to the CS/SPD in a timely manner so that the scopes could be steril- ized and ready for subsequent cases.
The final consideration, which Czarnowski
stresses as most important, was training on point of use scope cleaning. As he explains, regardless of how a scope is processed, the IFUs of the scopes required that they be pre-cleaned at point of use. Czarnowski and his team took this as an opportunity to perform a facility-wide training. “Anyone who touches a scope got new train- ing or retraining on point of use care, including how to pre-clean a scope before sending it back to sterile processing,” said Czarnowski. “That was a big advantage for us because we had the opportunity to speak with folks who use these scopes, including some we had never engaged with before, to demonstrate the proper way to care for them.”
hpnonline.com • HEALTHCARE PURCHASING NEWS • December 2019 29
volume of cases performed with increasingly complex instrumentation that is challenging and time-consuming to process. If there is the question of switching from H to steril- ization for any given device, the department must consider the potential ramifications. “Our patients are not decreasing and the procedures are continuing to grow and be- come more complex. Evaluating a modality that takes a fixed amount of time to produce it safely, you must determine whether that time commitment is feasible for your depart- ment,” said Berg. “And even if suppliers introduce a faster sterilizer, faster biologic or some other type of product, that doesn’t necessarily mean we can do it faster in our department. There is a push to do it fast but the focus should be do we have enough time and training to do it right!” “Many times steriliation methods require long exposure times, harsh chemicals, seal- ing spaces off or separate chambers,” said Lorcheim. “There are various other factors as well, but many of these methods are not conducive to the fast-paced environment of the healthcare setting. High-level disinfec- tion can be applied in a variety of methods, quickly, easily and effectively to maintain a safe healthcare environment while still maintaining a realistic working and living environment for those within it.” “Sterilization is the end goal and I believe where we can sterilize a device we shall sterilize; however, there is going to have to be a balance in the future with cost of devices and reprocessing requirements,” said Bassi. “Procedures using endoscopes are short in duration, which means a larger inventory is required to support the daily volumes or the reprocessing department manages a smaller inventory by turning the scopes around frequently. With the cost of such devices many healthcare facilities cannot afford to
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