TEE reprocessing gone green

Evidence-based continuous improvement for high-level disinfection

The concept of healthcare quality has undergone many evolutionary changes over the decades. Established in 1952, The Joint Commission developed the first "minimum quality standards" for all North American hospitals. Medicare and Medicaid programs followed in 1965, redefining "quality of care" and leading The Joint Commission to require "optimum achievable standards." Healthcare stakeholders have since discussed many aspects of healthcare quality improvement, eventually agreeing on the need for greater collaboration and for providing effective, appropriate care more sustainably, standardizing performance measures, and promoting public reporting. The Affordable Care Act of 2010 later established national measures and reporting requirements for U.S. healthcare providers - the basis of today's healthcare performance standards.1

Medical Center of the Rockies (MCR), a 166-bed regional medical center in Loveland, CO, developed an evidencebased strategy - a continuous improvement case - that increased processing capacity and improved patient, staff and environmental safety.

Specializing in heart and trauma care, in the mid-2000s, MCR was performing two to three heart bypass procedures per day. These typically required using transesophageal echocardiogram (TEE) probes, which are commonly used during open-heart procedures and for evaluating and imaging the large vessels and valves of the heart.2 Considered semi-critical devices, they require cleaning and high-level disinfection before reuse.3-4

To help assure a controlled process, MCR's sterile processing department (SPD) was reprocessing the TEE probes using a manual soak process in PCI Medical's GUS Soak Stations, with an opthalaldehyde (OPA) high level disinfectant (HLD). Each cycle required 12 minutes of soak time to achieve high-level disinfection. To assure staff safety, venting reduced the fumes and employees were monitored for the permissible exposure limit to OPA. A spill kit was also available if needed. Once the 14-day useful life of the OPA expired, the solution was neutralized before it went down the sanitary drain.

New construction/ procedures - a benchmarking improvement opportunity

Around the same time, plans were in place to expand the cardiac program, which would add new procedures and at a higher volume. This provided every department the opportunity to audit current spaces, processes and performance and determine how they could be improved. Two challenges affected the processing of TEE equipment: Our SPD team was expected to expand productivity to meet the new surgical goal of five cardiovascular procedures a day; and we were asked to seek greener processes and products that would support environmental sustainability initiatives and thereby help the facility achieve LEED status.

We investigated STERIS Corporation's high-level disinfection chemistry, RevitalOx Resert High Level Disinfectant, which was compatible with our GUS systems and could address both these challenges and more. Compared to our existing HLD, which requires a 12-minute soak and has a 14-day reuse period, Resert HLD, an FDA-cleared oxidative chemistry,5 requires an eight-minute exposure time and provides a 21-day reuse period for each batch of solution. Switching chemistries would shorten each soak cycle and increase solution use for seven additional days, thus reducing our cycle time and increasing the number of daily cycles and procedures we could complete. It would also reduce staff effort for emptying, cleaning and mixing fresh solution for the GUS stations, and would cut inventory costs. Additionally, the hydrogen peroxide-based solution contains natural, biodegradable ingredients that break down to oxygen and water, and requires no special venting under normal use conditions. It has no irritating odor, passes aquatic toxicity standards and requires no detoxification before disposal. It also meets international standards of the European Community Regulation on chemicals and their safe use (EC 1907/2006), can save water since it requires only one rinse, and is packaged in 99 percent recyclable material.6

Overcoming obstacles

We had several challenges to address before we could present a business case for conducting an in-house trial using our own equipment, devices and process. Resert HLD was too new at the time to be listed in all TEE device manufacturers' instructions for use (IFU). MCR's clinical caregivers also needed reassurance about the product's safety for patients and the TEE equipment. Finally, we needed a systematic, evidence-based process for evaluating the new HLD and validating it for our specific process.

We turned to the ANSI/AAMI ST 79 2010 & Al, A2, A3, A4, Standard 12, New Product Evaluation, for guidance.7 We established a multidisciplinary committee comprised of clinical stakeholders and distributed relevant information to them about the test products. Next, we evaluated the product's intended application, contribution to patient and staff safety, cost-to-value, ease-of-use, compatibility with existing equipment, environmental impact, impact on standardization, and the education needed for implementation. A trial period was established, evaluation tools created, a process developed using our current GUS stations, and training implemented. We formed the Product Selection and Evaluation Committee (PSEC) to provide an objective and systematic evaluation and to assure that all stakeholders' questions and concerns would be addressed. Comprised of representatives from our Infection Prevention and Control, Surgical, SPD, Risk Management, and Staff Development/Education Departments, the PSEC is still active today.

Trial outcomes: change brings greater success

The trial was a success and provided a lot of useful information. Comparing the productivity of the two products, we validated that we could reduce the exposure time in each cycle by four minutes, increasing productivity by 150 percent. This enabled us to reprocess five TEE probes a day with existing staff and equipment, almost twice the current number. We could also use each batch of Resert HLD solution for a third week, increasing solution utilization by 150 percent and reducing the number of required solution exchanges and time spent emptying, cleaning, mixing and refilling by over 33 percent a year.

We also saved time and money by eliminating the monthly PEL monitoring, neutralizing chemistries and spill kits. The department's water costs also decreased, since only one rinse is needed per Resert disinfection cycle, compared to two or three rinses for the OPA process. Assuming the products are used per their IFU, and based on the average selling price of each chemistry, the cost per procedure (at five per day) is 36 cents, compared to 64 cents for the OPA product. Annual inventory costs for Resert HLD were also estimated at $637.50, compared to $1,170 for the OPA, yielding a savings of approximately 45 percent*

In addition, using Resert HLD in our GUS stations simplified our documented process and eliminated the time technicians previously spent on PEL monitoring, solution neutralization and exchanging solutions. And since minimal training was required for the new product, the added time savings freed staff for more valuable activities. Our TEE probes also looked cleaner, with no visible signs of damage.

Using Resert HLD enabled our department to contribute to the hospital's compliance and environmental initiatives and support LEED certification by helping the facility meet local, state and federal wastewater and pollution reduction requirements. It also eliminated Joint Commission audits for spill kits and disposal methods, and simplified process standardization. And since the cycle was shorter, there was more time to assure compliant care and handling of the devices per their IFU.

Based on these results, the PSEC approved a transition to Resert HLD. The team was able to document staff safety, cost reduction and environmental benefits as a result of the change, which enhanced the quality reporting for the facility. Today, the SPD staff is able to deliver more TEE probes each day, which allows the cardiac surgeons to reach their target of five daily procedures in the new facility's two to three cardiac rooms.

Your sterile processing department may be functioning smoothly, but that doesn't mean it can't be made safer, more productive or less costly. Follow the trends that impact your department so you can be proactive. Conduct process flow studies of your areas periodically to discover new ways to improve workflow and efficiency. Consider new technologies that enable you to meet or exceed your facility's objectives, and make sure to trial these products using your own protocols. Guidelines are available to help you build your evidence and achieve success. HPN

"Comparing the productivity of the two products, we validated that we could reduce the exposure time in each cycle by four minutes, increasing productivity by 150 percent. This enabled us to reprocess five TEE probes a day with existing staff and equipment, almost twice the current number. "

*Cost figures assume an average selling price: pricing may vary. They also assume that full manual reuse life is achieved per OEM labeling. Cost of test strips is not included.

References

1. Understanding the Evolution of Our National Healthcare Quality Improvement Process, http://www. sccm.org/Communications/Critical-Connections/Archives/Pages/Understanding-the-Evolution-of-OurNational-Healthcare-Quality-Improvement-Process.aspx Society of Critical Care Mediane, August 2011.

2. Transesophageal Echocardiogram. http://en.wikipedia.org/wiki/Transesophageal_echocardiogram), Wikipedia. 2015.

3. Guidelines for transesophageal echocardiographic probe cleaning and disinfection from the British Society of Echocardiography, http://ehjcimaging.oxfordjournals.Org/content/ejechocard/12/10/i 17. full.pdf

4. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008; http://www.cdc.gov/ hicpac/Disinfection_Sterilization/3_1 deLaparoArthro.html

5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingleUseDevices/ucm 133514.htm

6. https://practicegreenhealth.Org/product/16263/revital-ox-resert®-xl-hld-high-level-disinfectant

7. ANSI/AAMI ST-79, 2010 & Al. A2, A3, A4: Standard 12, New Product Evaluation. Association for the Advancement of Medical Instrumentation, 2013.

by Damien Berg, Performance Improvement Consultant, University of Colorado Health

Damien Berg, BA, BS, CRCST, is a process improvement consultant for University of Colorado Health and former manager of sterile processing. He has 22 years experience serving in multiple healthrelated capacities, including roles as an emergency medical technician, combat medic, surgical technician, sports therapist and sterile processing technician and manager. Berg has written several articles sterile processing leadership, is an active memberoflAHCSMM, serving on the Legislative Affairs Committee and representing several states in their efforts toivard state certification programs. He is an A AMI voting board member on ST79 (hospital steam sterilization) ST91 (flexible and semi-rigid endoscope processing) and Co-Chair on both ST77 (rigid containers) and ST86 (qualih/ systems). Berg also worked with AAMI and IAHCSMM to develop and implement the new benchmarking survey for sterile processing.