CS Connection

In an ideal world, where a sterile processing and distribution department (SPD) has the necessary time and resources to perform every step of the cleaning, decontamination, disinfection and sterilization processes flawlessly and in accordance with manufacturer instructions for use (IFU) and industry standards, the risk of a contaminated instrument reaching a surgeon’s hands is slim.

But in the real world, where many SPDs are understaffed, underequipped and under pressure to quickly process a broad range of highly complex instruments, the risk of contamination is present and poses a significant risk to patient safety. During an unannounced inspection of multiple hospitals in 2009, 57 percent of facilities did not comply with standard operating procedures (SOPs) for reprocessing and had not properly trained staff on how to clean dirty endoscopes.¹

During the recent International Association of Healthcare Central Service Materiel Management (IAHCSMM) 2013 Annual Conference, one SPD professional described the pressures of preparing complex instruments for the operating room (OR) explaining how surgeons frequently "don’t have an in-depth background of how an instrument needs to be taken care of and as a result, the SPD is viewed as an obstacle to getting that product to the OR table."

Dana Products SteriScan All-in-One Reusable Test Pack

"As the healthcare system undergoes rapid changes, there is more and more cost pressure placed on institutions. As a result, hospitals are often left with the difficult task of finding ways to cut costs while at the same time maximizing patient safety," said Mark Bala, Vice President, Dana Products Inc. "Mostly unnoticed and unheralded by the average person, sterile processing professionals are on the front lines of patient safety in that best practices in sterility assurance are essential to infection prevention. A well functioning sterile processing department must find a way to maximize monitoring measures and manage an ever-increasing workflow while at the same time remaining mindful of cost pressures."

Healthcare Purchasing News explores some of the resources available to help SPD professionals overcome sterilization challenges, from education and training to new technologies that support efficient and cost-effective sterility assurance.

Organization-wide collaboration and communication

The path to effective sterilization doesn’t start when a product arrives at the SPD for processing but during the instrument evaluation process, according to Misty Whitecotton, Consumable Product Specialist at Getinge USA Inc. She believes multiple functions throughout a facility must have thorough knowledge of the sterilization process and the impact of instrument design and use on reprocessing, and the ability of the SPD to provide a sterile product to the OR.

"I truly believe the biggest challenge when looking at sterility and disinfection of equipment is understanding these processes and how they work," said Whitecotton. "We live in a world of ‘I need it now and right this minute’ and this could result in shortcuts being encouraged and taken. Administration, purchasing, infection control, epidemiology, surgeons and other clinical staff should understand sterilization, the science behind it and what it entails as they all play a critical role in the process. Through team work they can actually improve sterile goods management and not impede effective sterilization processes within the SPD."

Whitecotton notes that facility-wide knowledge of sterilization practices can aid in making educated product purchasing decisions. When evaluating a new surgical instrument, she urges surgeons and purchasing staff to evaluate the product’s instructions for use (IFU) to determine if the facility has the required equipment (i.e. sonics, washer/ disinfectors, sterilizers, sinks, trays, etc.) staff and training to effectively clean, disinfect and sterilize the instrument.

"A facility should balance a surgeon’s requirements and wants for instrumentation with the manufacturer’s instructions for use and the facility’s ability to effectively clean, disinfect, and sterilize those instruments. The impact to the SPD and thereby the OR, since the SPD is the first step in promoting positive patient outcomes, is of upmost importance when adding new procedures, new ORs, and new instrumentation," said Whitecotton.

Ongoing communication between the SPD and OR is critical to ensuring effective instrument care and sterilization. In his IAHCSMM 2013 Annual Conference presentation on sterilization best practices, Chuck Hughes, Vice President, Infection Prevention Consulting Services for SPSmedical Supply Corp., highlighted the need for SPD/OR collaboration when detailing the steps that OR staff should take to prepare used instruments before they head down to the SPD:

• Pre-clean instruments to remove gross soil immediately after use
• Arrange instruments in an orderly fashion with hinges open and keep sets or multi-part items together
• Moisten trays with a wet towel or an enzymatic solution to prevent blood from drying

"Improper reprocessing of instruments can be avoided by making sure proper resources are available Including environmental controls, physical space, training and education, supplies, equipment and time," said Hughes. "Sterile processing personnel must be informed of any new device to be reprocessed, and provided a copy of its validated IFU for review prior to use. They are the sterilization experts and utilizing their expertise in advance can prevent a surgical site infection due to non-sterile instruments, as well as show survey organizations that you are in compliance with national standards."

SPS Medical Rapicide OPA/28

"It’s really important that the OR staff have understanding and acknowledgement of the critical aspects that need to occur during instrument reprocessing," said Diane Koch, Global Marketing Manager for 3M. "I would encourage OR staff to work in the SPD for a few days to understand the level of complexity in the tasks and why certain standards and procedures must be followed. Likewise SPD staff should spend time in the OR to understand how their customer opens the packs as they prepare for surgery."

Trust but verify

Gary Jordan, President of Medisafe America, states that SPDs should trust that their reprocessing equipment is effectively cleaning, disinfecting and sterilizing surgical instruments but perform verification to ensure sterility.

Medisafe’s Wash-Check U indicator family

"Through Bowie-Dick tests, load indicators, individual indicators in packs and other testing methods, SPDs can have a variety of checks and balances to ensure their equipment is performing as required," said Jordan. "While these solutions add some cost up front, they significantly reduce costs on the back end by minimizing the risk of infection."

Medisafe’s latest product in this area is the Wash-Check U indicator for ultrasonics, which is designed for effective routine monitoring of ultrasonic soil removal efficacy when used in conjunction with the wash check holder. Medisafe recommends SPD staff use the Valisafe Wash-Check U at the start of every day in an empty load to provide machine release and then periodically throughout the day with instruments for load release.

Ruhof Clean Check

Ruhof recently launched its Clean Check Complete Monitor for the Automated Enzymatic Cleaning (AEC) Process, which monitors the cleaning efficacy of medical washer-disinfectors or ultrasonic cleaners using enzymatic detergents. The test incorporates a dyed protein that is bound in the indicator pad. During the wash cycle, the color of the indicator pad changes in response to detergent concentration, enzyme activity and exposure time as well as the wash cycle temperature and mechanical action.

Another new sterility assurance product in the marketplace is Dana Products’ SteriScan All-in-One Reusable Test Pack. Designed to generate cost and waste savings while providing an improved challenge, the SteriScan All-in-One Reusable Test Pack can be used as a process challenge device with biological indicators and SteriScan Class 5 and Class 6 chemical indicators, or as an air removal test with SteriScan Bowie-Dick indicators. The SteriScan Reusable Test Pack is the first product on the market to combine all of these tests into one device.

"Monitoring every load with a process challenge device (PCD) enables SPD professionals to deliver best in practice monitoring to the infection prevention arena. Yet, every load monitoring can often prove to be cost prohibitive for hospital SPDs that would otherwise implement this practice," said Bala. "In the long run, every load monitoring can contribute to cost reduction by enabling SPDs to prevent inadequately processed materials from reaching hospital circulation, thus eliminating the need to recall items or obtain patient consents. And of course it is impossible to put a dollar value on preventing even one infection."

What’s growing inside your scope?

Getinge Assure SafeStep Contamination Monitoring System

Endoscopes present a significant challenge to effective sterilization because bioburden such as blood, mucus, prep and feces, can remain inside the scope even after thorough cleaning. This can lead to the development of biofilm, an organized community of bacteria protected by an invisible layer of polysaccarides that protects bacterial spores and is highly resistant to disinfection.

Getinge USA recently launched its Getinge Assure SafeStep Contamination Monitoring System, which verifies the cleanliness of surfaces, endoscopes and cannulated instruments in 15 seconds by detecting adenosine triphosphate (ATP), the energy molecule found in all human, animal, plant, bacterial, yeast and mold cells, which is an indicator of residual contamination. ATP can be one tool that is used to aid in the reduction of healthcare acquired infections (HAIs) throughout any facility by providing a documented and verifiable benchmarking process by which weaknesses can be detected and process improvement plans can be enacted.

Doing it right

A SPD can have the latest and greatest technologies for sterilization but they provide little value unless staff is educated on how to use them and use them right. With hospitals continuously acquiring new instruments, industry associations issuing new guidelines and standards, and high staff turnover among SPD professionals, ongoing training is critical to ensuring staff have the information they need to perform effective sterilization.

Healthmark pocket microscope

"One of the great challenges to proper training is that sterile processing departments are a dynamic environment. Interruptions are the rule, not the exception," said Ralph Basile, Vice President for Healthmark Industries Inc. "I can’t tell you how many times I have been conducting an in-service and someone from the OR runs in needing help on something right away. That’s inevitable but it’s also an interruption to the training session and it may mean that one or more staff miss critical training entirely."

To perform effective training, Basile recommends SPDs schedule trainings at times and in locations where managers and staff are less likely to encounter unnecessary interruptions, such as early in the morning outside of the SPD. He also suggests SPDs record the names of each staff member that attended a training session so those staff members who were absent can be scheduled for a future education program.

Healthmark recently introduced its new MG10081-8 pocket microscope, which enables SPD staff members to view and study small instruments under high magnification. With a 20x to 40x zoom and super bright LED illumination, staff can use the microscope to easily identify if an instrument has been properly washed and is ready for use.

The 3M Attest Super Rapid Readout Biological Indicator System delivers pre-vacuum steam sterilization results in just one hour.

Many SPD equipment providers offer educational resources to support ongoing education on sterilization and related topics. Through its 3M Sterile U Network, 3M offers SPD professionals monthly webinars for free continuing education credit. Koch notes that many of the webinar topics have been taken from questions that 3M has received from customers through its technical help line.

"There are a lot of challenges around sterilization so keeping educated and communicating is critical," said Koch. "No one should ever make an assumption. SPD professionals must have the opportunity to ask questions. For example, if someone gets a positive BI result and doesn’t understand why, they can call our tech line and we can walk with them through their processes to help identify what could have contributed to that result."

Keeping up with instructions for use (IFUs)

The Association for the Advancement of Medical Instrumentation (AAMI) is currently working on an initiative to standardize IFUs, starting with non-hinged stainless steel instruments. Standardization will encompass special warnings, instructions, cleaning, inspection and testing, packaging, sterilization, storage and manufacturer contact information.

oneSOURCE Document Management Service provides immediate access to thousands of manufacturers’ IFUs.

While standardization of IFUs will likely go a long way in helping SPDs comply with manufacturers’ recommended sterilization processes, staff will likely continue to struggle with IFU storage and accessibility. That’s where Best Practice Professionals Inc. (BPP) comes in. BPP’s oneSOURCE Document Management Service, oneSOURCEdocs.com, is an online, electronic database that provides SPD staff and the entire facility with immediate access to thousands of manufacturers’ IFUs for cleaning, decontamination, assembly and sterilization of equipment and reusable surgical instruments and devices.

BPP President Jack Speer explains that oneSOURCE enables the entire healthcare facility to outsource the management of IFU documents, saving clients time, space and money. The oneSOURCE Customer Service Team will contact manufacturers on behalf of clients for specific IFU needs, update the database regularly, provide notification of revised documents, and add documents upon request, to eliminate compliance worries.

Sterility beyond the SPD

The need for cleanliness doesn’t end in the SPD but must extend to the patient bedside where the risk of infection comes from contaminated equipment and environmental surfaces. Clinicians can easily spread harmful microorganisms from contaminated surfaces to non-contaminated surfaces and to patients when they do not engage in effective hand hygiene practices. One study examining the effectiveness of disinfection with wipes against Methicillin-resistant Staphylococcus aureus (MRSA) found 42 percent of personnel who had no direct contact with MRSA-positive patients but had touched infusion pump buttons in the room showed MRSA-contamination on their gloves.²

AGILETRAC RFID tracking, information-sharing and alerts lead to healthier outcomes.

GE Healthcare is leveraging RFID tracking technology to provide more information to hospitals in the fight against HAIs such as MRSA. Using the company’s AgileTrac system in conjunction with RFID tagged equipment, such as infusion pumps, a healthcare organization can track when an item left a patient’s room, when it was cleaned, who cleaned it and where it is stored within their facility.

"Many hospitals put stickers on equipment to indicate that they’ve been cleaned after patient use but those stickers can fall off leaving staff to question what’s clean and what’s not," said Richard Neff, Vice President & General Manager for GE Healthcare. "With the AgileTrac system, staff can not only confirm that a piece of equipment has been cleaned but also know exactly where it is in the building, which helps with both efficiency and inventory management."

Neff notes that healthcare facilities can also use the AgileTrac system to help enforce hand-washing protocols. GE Healthcare adds an additional identifier (RFID) to hospital staff member’s badges and a sensor to the cleaning stations (such as a sink). When a nurse or other staff member approaches that station to wash his/her hands, the system matches the identifier on the badge to that station to confirm the staff member has approached the station and spent adequate time there to perform effective hand washing.

"The most successful solutions are those that don’t add additional steps to someone’s existing workflow," said Neff. "With our system, hospital staff members don’t have to do any extra work. They are still walking through patients’ rooms and washing their hands. We work with hospitals to make it as seamless as possible."

References

1. Keep the Bugs Out, Wava Truscott, PhD, Director Medical Sciences & Education, Kimberly-Clark Health Care, 2013 IAHCSMM National Conference

2. Cheng KL, Boost MV, Chung JWY. Study on the effectiveness of disinfection with wipes against methicillin-resistant Staphylococcus aureus and implications for hospital hygiene. AJIC, 2011:39(9):711-715.