Keeping the "Clean Room" Clean

Processes inside the sterile processing and central sterile (CS) supply areas are imperative. Sterile processing department (SPD) technicians work hard to maintain sterility, but unfortunately, others compromise this work through improper storage and handling practices.

There are methods to this madness called sterile inventory. Many of these methods are common sense approaches such as not storing sterile items on the floor or too close to the floor and covering shelves to protect items from dust. Other methods can get more involved. In the end, appropriate departmental flow, storage and handling all must be considered to develop an effective system — and one that requires the least amount of contact with the sterile inventory as possible.

For departmental flow, Don Gordon, MPS, CRCST, FCS, director of central sterile processing at New York-based Hospital for Special Surgery, advises staff be assigned to specific areas of the SPD with defined responsibilities. For example, he offers, “We use floor loader sterilizers. The person assigned to sterilization performs the entire process including removing the sterilization cart from the sterilizer and that same cart is used for cooling.

“After cooling, the trays are removed from the cart and placed in the case cart/storage area by staff assigned to this area. The trays are either stored on the tray storage shelf or placed in a closed case cart for distribution to the OR (operating room). Once in the OR, the only person handling the trays are the staff within the operating room. In this scenario, only two — and a maximum of three — staff handle the tray before its arrival at its destination in the OR.”

Best practices for handling and storage of sterile inventory will always involve full inspection of the items touched. “When handling the sterile inventory, inspection of wrapped trays is a priority,” Gordon asserts. “Trays must be examined for tears, worn edges or punctures. The staff must observe for signs of moisture and check to make sure the process indicator ensures that the item was subjected to the sterilization process. Container systems should be checked for locks and sterilization process indicators,” he adds.

Appropriately carrying the trays also is an important aspect. Gordon says it is important to instruct staff to handle the trays as if they are carrying a precious, breakable item — carefully and with both hands under the tray. “We don’t want them to cradle the trays,” he clarifies. “We don’t want them to carry them under their arms, hold the containers by one handle or drop the tray on the floor and place it back in the case cart or on the storage shelf.”

When removing wrapped trays from the shelf, Gordon points out that the hands should be placed underneath the tray and lifted to avoid dragging the tray and tearing or snagging the wrapper. Moreover, “properly labeling shelves and trays facilitates the location of trays and creates easier access,” he says. “If you have a tray tracking system, scanning is essential for locating any given tray. We have a saying in our department when it comes to locating a tray: ‘You are only as good as your last scan.’”

Cycling stock is just as important in this setting as it is in the food service setting. This is because just like in the food industry, product needs to be kept fresh, clean and up-to-date. Gordon uses the “left to right system” to keep his stock cycling.

“In the storage area, if there are multiple trays, the ‘left to right system’ is used, with the newest items placed on the left and older items on the right,” he explains. “The trays on the right are removed first. However in a busy central sterile processing department, this procedure is usually a moot point with some trays going from the cooling carts directly to the case carts.”

A few of the common problems that can occur in CS/SPDs can be easily remedied. For instance, to help in reduction of package tearing, converting to a container system may help. Gordon says container systems reduce the possibility of tears in wrapped trays and solve the issue of stacking wrapped trays on top of each other as well. “Savings can be realized over the years in the cost savings of wrap and tray corner guards making the conversion a fiscally sound investment,” he notes, adding too that in order to tackle the common problem of adequate storage space for trays, “investing in a storage shelf system on tracks can create as much as 50 percent additional storage space.”

Access to the sterile storage area should be limited. “We use an electronic identification card-locking system in our department to ensure that other hospital staff do not wander into our area,” Gordon offers. He adds that education of staff must be ongoing, “with constant supervision and reinforcement of best practice technique in all areas.”

Ensuring the areas for sterile storage are always kept clean and dust-free is a very important part of CS/SPD success. This includes the broader aspect of these areas — the looming machines and wire racks around which all of these items are stored.

Appropriate cleaning and infection control practices regarding areas of the CS/SPD should be in place. Linda Clement, BSM, CRCST, consulting services manager for STERIS Corporation, points out that cleanliness and infection prevention practices are deeply rooted in this area.

“Items processed in decontamination areas are potentially pathogenic and pose a potential exposure risk to employees working in these areas,” she shares. “Therefore, good infection prevention processes must be in place to prevent cross contamination.

“Because of this,” she continues, “the cleaning and disinfection of work surfaces is extremely important and should be maintained following the Association for the Advancement of Medical Instrumentation (AAMI) recommended practices. Housekeeping procedures for decontamination areas should be the same as those used in operating and delivery rooms, and floors and horizontal work surfaces should be cleaned at least daily,” she adds.

Clement says that in the SPD, medical equipment poses a risk of operator exposure to blood and bodily soils, and other safety hazards before and during processing. She says that is why it's important to wear personal protective equipment (PPE) and to follow good work practices, including following manufacturers’ instructions. “Whether it is a sterilizer, a washer/disinfector, an endoscope or a surgical instrument, it is classified as a medical device by the Food and Drug Administration (FDA),” she says. “It is best to follow the device manufacturers’ instructions found in operator manuals and other product documentation for handling, operation, cleaning and disinfecting medical equipment.”

Inevitably, equipment will break and maintenance will be needed. John Brown, director of service engineering for STERIS, points out that while most repairs do not pose a significant infection risk, they do still require the standard PPE. He also notes that when performing maintenance activities, additional PPE may be recommended, including:

eye protection and steel-toed shoes at all times leather gloves are used for handling potentially sharp objects such as stainless steel panels and plumbing piping gloves and heat-resistant arm sleeves are worn for working around steam piping a face shield should be used when working with cleaning chemicals or working on chemical injection systems appropriate ladders and fall protection are required when working off the ground

“When providing equipment maintenance, infection control-related precautions are required, especially if the equipment did not completely finish a processing cycle (such as a decontamination cycle),” Brown says. “Products being processed should be handled using Occupational Health and Safety Administration (OSHA) precautions and treated as if they are contaminated and they should be removed by the equipment operator or maintenance technician if necessary using appropriate PPE for the specific task, as required in the OSHA bloodborne pathogen standard (29 CFR 1910.1030) and in AAMI ST79:2006.

“All personnel working in the decontamination area should wear clean, facility-provided uniforms that are donned at the facility,” he adds. "In addition, general purpose utility gloves, a liquid-resistant covering with sleeves (for example, a backless gown, jumpsuit or surgical gown), a surgical face mask and eye protection should be worn at all times in the decontamination area. Appropriate PPE would also be required when working on the drain line of equipment that did not complete a cycle.”

Original equipment manufacturers’ (OEMs) service documents and training programs should contain warnings and cautions about the use of PPE for specific products and tasks being performed, Brown notes. The OEM operator and maintenance documents would also cover specific procedures and requirements for the wide range of medical products available on the market. “However, these types of questions should be directed to the facility’s risk manager, to ensure that maintenance and operator personnel follow the local facility guidelines, which are designed to cover the specific types of cases a facility performs and to coincide with the total safety program at that facility,” he suggests.

In addition, Brown points out that it is important to ensure that service personnel working on medical equipment have received all appropriate immunizations and inoculations.ICT

Sterile Storage At A Glance:

Sterile supplies should be stored separate from clean supplies

Sterile supplies can be stored in either open or closed shelving

Sterile supplies should be stored at least eight to 10 inches from the floor

Sterile supplies should be stored at least 18 inches from the ceiling

Sterile supplies should be stored at least two inches from outside walls

Sterile supplies should be stored above clean supplies

A barrier should be created between the floor and the bottom shelf when open shelving is used

Sterile supplies should be housed with a room temperature of between 65˚ to 72˚ F (18˚ to 22˚ C) with humidity maintained between 35 percent and 50 percent

Sterile supplies should be stored in a positive pressure room with a minimum of 10 air exchanges per hour

Source: AORN Journal

Polishing Policies

The Joint Commission requires that a hospital’s policies and procedures be reviewed and updated every three years. “Since each hospital provides different services based upon its customer base and its mechanical and physical layout, it is important to develop policies and procedures that are specific to your process,” offers the Certification Board for Sterile Processing and Distribution (CBSPD) Web site.

Policies and procedures specific to central sterile and sterile processing departments (CS/SPD) such as, but not limited to, receiving; decontamination; preparation; sterilization; storage and distribution all should be closely reviewed and revised when necessary.

It is important to follow government regulations as well as national guidelines when developing hospital policy. These resources contain information that can enhance the professionalism and credibility of the manager and department, and help them defend policies.

Government regulations are minimum standards that must be met and may differ from national standards or guidelines. In cases where they differ, the more stringent of the two should be selected.

Once policies have been reviewed and/or revised, they must be submitted through your organizational chain of command for final adoption. In most cases, revisions will be submitted to the infection control committee and or safety committees for review and approval.

Source: CBSPD. International Standards Organization (ISO) quality system model to central services. The full text version is available online at