IC in Care Series: Sterile Processing

By Kelly M. Pyrek

The sterile processing department (SPD) can be one of the more challenging environments in which to uphold infection prevention and control principles. As an example, the decontamination area of the SPD can pose a significant threat to its technicians "because of the numerous and unknown microorganisms that pass through," confirms Nancy Chobin, RN, AAS, ACSP, CSPM, a sterile processing educator and consultant. "In addition, there is the potential for a sharps injury due to sharps that are handled in this area as well such a towel clips, etc.," she says.

"The decontamination area environmentally is the area that will have a higher number of microorganisms, that is why PPE is necessary," says Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, president/CEO of  Seavey Healthcare Consulting, LLC. "However, if proper PPE is worn and changed ASAP if there is a hole in the gloves or strike-through on the gown. PPE removed properly the risk is low. In addition we must follow processing guidelines, such as only brush under water, keeping the ultrasonic lid closed, etc."

As consultants, both Chobin and Seavey have witnessed their share of breaches of practice that jeopardize worker safety in the SPD. "The most alarming issue is non-compliance with facial protection and barrier gowns," says Chobin. "Most often the gown issue is due to excessive heat in the area.  Many facilities are not aware that there are intermediate steps that can be taken to control the heat and humidity in the decontamination area.  Use of a large air conditioner that is connected to the ventilation system can provide comfort to decontamination personnel who are wearing plastic gowns, gloves, etc. all day long. When the area is too hot, they will switch to a cloth or other gown that does not provide sufficient protection.   Many SPD personnel do not like to wear a face shield and mask.  So, they don’t, they will just use a mask. I have seen GI scope processors without any facial protection at all.  I don’t think it is a lack of education, it is just “I am too busy” or “it is too uncomfortable.” My question is, 'Where is management?' Who is responsible to enforce compliance with OSHA standards?" 

Seavey confirms that not wearing proper PPE (e.g., using procedure gloves, not wearing a mask in addition to a face shield) is a big problem. Why are these issues allowed to persist? Not understanding the issues and concerns for self-protection.  It may also be because the temperature and humidity is higher than recommended and therefore comfort becomes an issue."

Compliance with infection prevention and control principles in the SPD remains an ongoing challenge, particularly when it comes to technicians following manufacturer's instructions for use (IFUs) for decontaminating, cleaning, high-level disinfecting and sterilizing complex endoscopes and surgical instruments.

"I see less than 10 percent compliance with IFUs," says Chobin. "Many facilities have the IFUs but they are old or outdated. Many have the IFUs but are not accessible to the staff for review and compliance. There is far less compliance in the Decontamination Area than the sterilization area.  Most facilities are sterilizing items according to the IFUs however I still see facilities that “batch” items.  Meaning if one trays requires 12 minutes, rather than run the tray alone as required, they will place other sets/devices in the load even though their IFU did not specify 12 minutes of sterilization.  The thought process is 'if a little is good, more must be better.' We need to change this perception.  Another area is environmental sanitation.  Unfortunately, many SPD departments do not get cleaned every night.  In addition, SPD is responsible to maintain their workstations and all storage locations clean.  When event related dating went into effect, the monthly cleaning of the storage areas, to remove outdated or near outdated items, stopped.  I see far too many sterile storage areas with dusty shelves and bins."

While some practices still need improvement -- such as standard precautions, wearing proper PPE, lack of knowledge of infection transmission, not following IFUs -- Seavey says technicians are showing improvement in getting educated, emphasis on having the IFU readily available, working with their IP to understand the risks and how to address them.

So what does it take to drive real change when it comes to infection control improvement in the SPD?

"There has to be leadership and education," Chobin says. "The SPD staff needs to understand the ramifications of non-compliance with all standards.  These are employee and patient safety issues.  I see far too little time being given to education in SPD.  Often the education relates to a new tray or new piece of equipment-important, yes.  But what about the core competencies of cleaning, packaging, sterilization, new standards, etc.?  It is management’s responsibility to provide training and education for their staff members.  Education money is the first to be cut, if there is even any budgeted for SPD.  However, there are many webinars that are available and most are free.  I always hear “we don’t have the time for training and education”.  How can we afford not to do this?"

Seavey concurs and emphasizes the importance of checking the competencies of SPD technicians. "Lack of competencies regarding reprocessing is one of the main reasons facilities are being cited from accreditation surveyors. If you don't know what you don't know, how can you be sure to do the right thing?" she says. "I believe every facility should have a subject matter expert that is the educator for processing. That person must have the resources to stay current, be certified and ensure the staff are competent (return demonstration, test taking or simulation) in every part of their assigned responsibilities." Seavey adds that infection control improvement in the SPD is driven by a partnership between SPD, OR, IP, risk management, quality, safety and facilities. "We need to write policies according to evidence based guidelines and ensure they are being followed to a "T" for the safety of the patients as well as the employees."

Audits are a critical component of ensuring good outcomes, Seavey says, adding, "What gets checked and monitored gets improved. We often fall back into old habits or take short cuts due to time constraints and pressure from customers such as the operating room or physicians." Seavey adds, "Critical aspects of infection prevention include proper reprocessing procedures and sterility maintenance.  Facilities should perform routine audits for all reprocessing and sterilization areas.  These audits should be conducted by the SPD manager and infection prevention and control professionals."

Seavey says the delivery of sterile healthcare products for use in patient care depends not only on the efficacy of the sterilization process itself but also on the following factors: efficient facility design; proper training of personnel; good infection prevention and control practices designed to prevent health-care-associated infections; effective quality controls and process improvement systems that encompass all aspects of device reprocessing from point of use through sterilization to reuse; and appropriate documentation and reporting practices that enable traceability of each facility-sterilized medical device to the patient on whom it was used. An audit can uncover issues related to these factors that need to be remediated quickly.

An audit checklist that Seavey designed and based on recommendations from AAMI, AORN and the CDC addresses such key components as design considerations for the SPD; personnel issues; receiving , handling, collection and transport of contaminated items; cleaning and other decontamination processes; packaging, preparation and sterilization; quality control and quality process improvement; new product evaluation; and policies and procedures.

One of the key concepts of infection prevention in the SPD is addressed in a new guidance document, Standards of Infection Prevention in the Gastroenterology Setting (2015), from the Society of Gastroenterology Nurses and Associates, Inc. (SGNA). It emphasizes the role that endoscopes play in the potential transmission of pathogenic organisms in the reprocessing area and that these devices can facilitate cross-contamination: "The environment plays a key role here since disinfectants and cleaning materials themselves can be contaminated. Inadequate cleaning, disinfection, and drying procedures; contaminated AERs and endoscope design flaws; or equipment damage all play a role in microbial transmission. Reprocessing steps must be followed stringently, and the environment well-maintained."

A number of guidelines outline the optimal physical characteristics of a reprocessing area that maximizes infection prevention and control. As the SGNA (2015) notes, "The reprocessing area should be physically separated from the patient procedure rooms. The area must be specifically designed and dedicated to address reprocessing activities of decontamination and disinfection. The area should be restricted to authorized personnel. The physical space should be an appropriate size in relation to the volume of equipment processed and the reprocessing equipment specifications. Space should be adequate to allow for the manual cleaning and rinsing of devices during decontamination. The work area identified should be sufficient so that 'dirty' areas are physically separated from 'clean' areas. The reprocessing work flow should be from dirty to clean to avoid cross-contamination. There should be clean and soiled utility areas located outside of the reprocessing room. There should be negative air pressure in the reprocessing room and a minimum of 10 exchanges per hour, with at least two being fresh, outside air. Exhaust should be vented directly outside. It is also important that staff understand the concepts of negative airflow, when to use negative airflow, and how to properly use the negative airflow. Chemical vapors should not exceed allowable limits. Air handling in procedure rooms should conform to current CDC guidelines. Temperature and humidity should be regulated according to local and facility requirements. Reprocessing areas should have dedicated plumbing and drains. The room must have more than one sink and separate handwashing facilities. Sinks should be deep enough to allow complete immersion of the endoscope to minimize aerosolization and wide enough to avoid tight coiling of the endoscope. There should be ergonomic considerations to prevent undue physical strain on personnel. Storage areas and other critical areas should be clearly labeled . There should be suitable storage areas for clean endoscopes so that they can hang freely and vertically. Scopes must be stored in a manner that prevents them from becoming re-contaminated. Storage cabinets should have doors, and the interior of the cabinets must be clean, free of debris, and dry. The route from the reprocessor machine to the storage cabinet should not cross through the soiled processing area."

Additionally, the SGNA's revised guidance document, Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes, advises: "The reprocessing environment includes procedure rooms and reprocessing rooms. Procedure rooms contain clean areas and contaminated areas. To prevent cross-contamination, most areas of the room should be designated as clean areas. Contaminated areas where accessories and specimens are handled should be separated from clean counter areas. All contaminated areas must be cleaned and decontaminated between patients with an Environmental Protection Agency (EPA) registered, hospital-grade disinfectant appropriate for the specific microorganism."

This standard adds, "The reprocessing room is a designated area that is dedicated to reprocessing. It must be a room that is separate from where endoscopic procedures are performed. Current local regulations, state codes, and federal guidelines should be incorporated into the design of any reprocessing area. Considerations include adequate space for reprocessing activities, proper airflow and ventilation requirements, work flow patterns, work surfaces, lighting, adequate utilities such as electrical support and water, hand washing and eye washing facilities, air drying capability, and storage. Tap water and/or water that has been filtered by passage through a 0.2 micron filter or water of equivalent quality (i.e., suitable for drinking) should be available in the reprocessing area. Bottled sterile water may be used … A Food and Drug Administration (FDA) cleared high-level disinfectant or sterilant and 70 percent isopropyl alcohol are needed in the reprocessing room for high-level disinfection. An EPA-registered hospital-grade disinfectant should be used for surface cleaning appropriate for the specific microorganism."

While the principal activity in the sterile processing department (SPD) is the cleaning, disinfection and sterilization of medical devices and surgical instruments, the department itself requires thorough, rigorous and proper decontamination for the level of grime that it collects daily. Terminal cleaning, defined by the Association of periOperative Registered Nurses (AORN) as “thorough environmental cleaning that is performed at the end of each day when the area is being used,” is particularly critical in the SPD during times when SPD technicians are not actively engaged in their duties.

Cleaning in the SPD must be performed daily; however, this can be challenging because some institutions operate the SPD 24 hours a day, seven days a week. The most optimal time for terminal cleaning of both the decontamination and sterile pack areas should be determined; ideally this is when the volume of work is at its lowest level of the day and workflow utilization patterns can be managed. 

Lisa Huber, ACE, CRCST, FCS, sterile processing manager at Anderson Hospital in St. Louis and a fellow and past president of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) says that the areas in the SPD that are the most contaminated are the floors, horizontal surfaces and especially the decontamination area -- the first stop for all contaminated devices and instrumentation used in the operating room (OR). Due to the nature of the work performed in the decontamination area, it can be one of the most hazardous sections of the SPD in terms of exposure to pathogenic organisms.

Carts filled with contaminated instruments from the OR are transported to the decontamination area in the SPD. This is where they are decontaminated and cleaned. Devices and instruments are then taken to the clean set-up area where technicians assemble and wrap cleaned instruments to prepare them for the sterilization process. After sterilization, devices and surgical instruments are taken to the in sterile storage area where they await use by the OR.

It is important to remember that the SPD has unrestricted and semi-restricted zones that are defined by the task being performed in each area, with distinct traffic patterns of SPD personnel based on movement of devices and instrumentation from dirty to clean areas. The SPD should have signage that designates these areas and any personal protective equipment (PPE) that must be worn. Unrestricted areas include break rooms and locker rooms. Semi-restricted areas that require PPE use include work areas for processing surgical instruments and storage areas for clean and sterile supplies. Restricted areas are marked with red lines to remind personnel that the areas have exposure risks for not only SPD staff but the environmental services (EVS) personnel as well. It is essential to reiterate that EVS personnel who are cleaning contaminated surfaces in the SPD must wear the proper PPE. 

Staying safe while cleaning the SPD is an imperative. Huber says that key concepts to boost occupational safety and health include:
• Follow label instructions on all disinfectants
• Use PPE appropriately
• Ensure that wet floors are adequately marked
• Make sure staff is well trained

Regarding cleaning best practices, Young (2014) notes, "AORN and the Association for the Advancement of Medical Instrumentation (AAMI) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from 'dirty to clean' areas."

Areas that should be cleaned first include the point of clean distribution; preparation and packaging; sterilization processing; and sterile storage. Then personnel should clean the dirty areas of decontamination, including sinks and other mechanical washing areas. Experts say that systematic cleaning can be facilitated by using a clockwise or counter-clockwise cleaning method when performed with a prescribed clean-to-dirty and/or a top-to-bottom cleaning method.

"It is important to go from clean areas to dirty areas when cleaning the SPD," confirms Huber. "Separate and dedicated cleaning equipment, such as mops and buckets, should be used in the decontamination area."

Using the right supplies and chemicals is a key aspect of cleaning the SPD. Personnel who are responsible for this task should assemble the various detergents and disinfectants, low-linting cloths and single-use disposable wipes, as well as mops and other tools.

When cleaning surfaces in the SPD, personnel should use a detergent prior to using a disinfectant to ensure that all gross soil and other dirt and debris are removed, especially when visibly dirty. This is essential because this bioburden can act as a barrier, thus preventing or hampering pathogen kill by the disinfectant. Chemistries designed for this task are numerous and cleaning/disinfecting products can be one-step, meaning that they are a combined detergent and disinfectant; or they can consist of a two-step process wherein two separate products -- detergent and disinfectant -- are used together to achieve cleanliness.

"Disinfectant types are all very different and it is important to use the right disinfectant for the task," Huber says. "One wouldn’t use the same disinfectants for instruments and for the department. The decision regarding the appropriate one for environmental cleaning should be made jointly with input from environmental services and infection prevention." Huber says that staff should be trained to follow product manufacturers' instructions for use (IFU) for:
• Label claims regarding organisms the disinfectant is effective against
• Wet time required
• Characteristics such as residual activity, material compatibility, etc.
• Dilution, temperature requirements, disposal

Manufacturers' safety data sheets (MSDS), which are documents that provide greater detail on the properties of each product, should also be consulted for instruction relating to use, storage and disposal of the products.

Huber emphasizes that cleaning and disinfecting environmental surfaces is fundamental in reducing the potential contribution of those surfaces to the incidence of healthcare-acquired Infections (HAIs). "In addition to hand hygiene, cleaning and disinfecting can help to minimize the transfer of microorganisms that can occur via hand contact between contaminated surfaces and patients," she says.

Huber outlines some key best practices for cleaning the SPD, according to the IAHCSMM Central Service Technical Manual (seventh edition):
• Horizontal work surfaces should be cleaned at least daily
• Light fixtures or their covers should be cleaned at least every six months
• Floors should be cleaned (wet mopped) at least daily (floors should never be swept or dust-mopped)
• Walls, shelves, cabinets, etc. should be cleaned on a regularly scheduled basis

The very best cleaning and disinfecting protocols can falter if there is no official institutional policy delineating who will actually performing the cleaning and disinfection tasks.
"In the two hospitals where I have worked, environmental services has been responsible for cleaning the SPD, but what that means can vary; therefore, policies and procedures are very important," Huber says. "For example, environmental services only cleans the floors and takes out the trash, so SPD staff is responsible for cleaning all other surfaces in the department. The adage, 'If somebody is supposed to do the cleaning then nobody probably will' is very true. Policies and procedures can help ensure that all areas are cleaned routinely and cleaned appropriately. Checklists can also be helpful so that nothing is forgotten and staff is accountable."

As Young (2014) notes, "Designated cleaning responsibilities are important to reduce the number of items that personnel forget to clean. Environmental cleaning service and sterile processing personnel need to decide who is responsible for cleaning what. In the surgical processing area at Overlake Hospital Medical Center in Bellevue, Wash., Don Williams, CRCST CIS, CHL, manager, has environmental cleaning service staff do the wet mopping, empty the trash, and clean walls, vents and lights. Sterile processing staff clean all work surfaces on a daily basis: sterilizer carts, sterilizer chambers, and storage shelves and cabinets." This list should be expanded to cover all the areas of the SPD.
Studies have demonstrated that monitoring cleaning and disinfection practices and then relaying feedback to personnel is a successful way to boost compliance. Huber says that the current four methods to monitor the cleaning/disinfection process -- visual inspection, microbial methods, fluorescent markers and ATP bioluminescence -- can be used. The Centers for Disease Control and Prevention (CDC) document, Options for Evaluating Environmental Cleaning, is a good resource that explains these four methods.

With feedback to personnel comes opportunities for educating staff about cleaning imperatives in the SPD. "There seem to be more journal articles written on the subject that can be shared with staff," Huber says. "There are certainly standards (AAMI ST79 Section 3.4, CDC Guidelines for Environmental Infection Control, 2008), too, and the information in the IAHCSMM CS Tech Manual can be helpful. It is my opinion that this kind of education should be part of annual staff competencies for SPD staff and any EVS staff who cleans the SPD."

References and Resources:

Association for the Healthcare Environment of the American Hospital Association. Practice Guidance for Healthcare Environmental Cleaning. 2nd ed. Chicago, IL: American Hospital Association; 2012.

Association of periOperative Registered Nurses (AORN). Recommended practices for environmental cleaning. In: Perioperative Standards and Recommended Practices.

Association of periOperative Registered Nurses (AORN). Environmental Cleaning Tool Kit. Available at: http://www.aorn.org/toolkits/environmentalcleaning/

Centers for Disease Control and Prevention (CDC). Guidelines for environmental infection control in health-care facilities. Centers for Disease Control and Prevention. Available at: http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_hcf_03.pdf.

Guh A and Carling PC. Options for Evaluating Environmental Cleaning. December 2010. Available from the Centers for Disease Control and Prevention (CDC) at: http://www.cdc.gov/hai/toolkits/Evaluating-Environmental-Cleaning.html

Pyrek KM. Environmental Cleaning and Disinfection in the Sterile Processing Department. Infection Control Today. 2015.

Seavey Healthcare Consulting. Sterile Processing Best Practices Audit Checklist. http://www.seaveyhealthcareconsulting.com/id75.html

Seavey R. Sterile Processing In Healthcare Facilities: Preparing for Accreditation Surveys. Available from AAMI.org

Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes. 2015.

Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standard of Infection Prevention in the Gastroenterology Setting. 2015.

Young M. Environmental cleaning in sterile processing areas. OR Manager. Vol. 30 No. 9. September 2014.