Infection control in surgery centers over the past decade has focused on ensuring all medical devices and equipment are safe to use. When accreditation surveyors visit sites, they often identify issues related to basic infection prevention practices, dilution of disinfectants, sterilization, and following manufacturing instructions.

“Following manufacturing instructions for use is huge,” says Sylvia Garcia-Houchins, RN, MBA, CIC, director of infection prevention and control, division of healthcare improvement, at The Joint Commission. “Equipment is incredibly complex these days, and there are a lot of integral parts that need to be monitored and maintained.”

Ambulatory surgery centers (ASCs) can improve infection prevention practices and avoid deficiency findings by focusing on some of the most problematic areas, she says. There are several important practices:

Check equipment. Surgery equipment and devices, as well as other equipment, need continual maintenance and assessment. For example, valves meant to protect patients can fail, if not maintained, and backflow contaminants to patients. Endoscopes can contain pinpoint holes that can miss detection and become contaminated with bacteria if staff fails to perform leak testing, Garcia-Houchins says.

“It is important to review all of the manufacturer instructions and designate someone who is detail-oriented to make sure that each step is being followed as specified by the manufacturer,” she says.

This especially can be a problem for smaller ASCs, which might not employ designated staff to keep current on manufacturer’s instructions and updates, Garcia-Houchins notes.

Carefully note which cleaning materials are appropriate. Facilities might own more than 1,000 different instruments, and each comes with its own manufacturer’s instructions. Even tools that look the same, but are produced by different manufacturers, can require different cleaning instructions.

“I performed a survey of 11 different manufacturer instructions for use and identified six different instructions for the same common instrument,” Garcia-Houchins says. “Products used to clean the instrument might damage an instrument’s finish and lead to corrosion, depending on the manufacturer.”

Each manufacturer performs its own compatibility testing. While all manufacturers might say, “Don’t let blood dry on the instrument,” instructions can be divided on whether to use detergent A vs. detergent B.

“Keeping up with manufacturing instructions is an incredible challenge, but it is an essential step for patient safety, as well as the bottom line of an organization,” Garcia-Houchins adds.

For instance, Garcia-Houchins has visited ASCs that purchased instruments of inferior quality to save money, or they reused instruments that were sold to them as single-use disposable items. Over time, certain instruments discolor or their surface becomes damaged because they weren’t compatible with the detergent or cleaning process that the ASC used to clean other instruments. There’s a huge level of detail to cover when reading manufacturer’s instructions, she says.

Make priorities. When revamping a reprocessing and instrumentation cleaning program, ASCs should start with the instrumentation and processes that carry the highest risk for infection, Garcia-Houchins suggests.

“Most organizations know their top scheduled procedures. For example, if your primary focus is orthopedics, identify the procedure your ASC performs most often or that has previously caused an infection problem,” she says. “If a patient had a breast augmentation, and your ASC received a report that the patient developed a surgical site infection, staff should review the manufacturer’s instructions for reprocessing those instruments.” Questions to ask include:

- Did staff follow all steps?

- Did staff use compatible products and equipment?

- Is all equipment used for the procedure maintained in accordance with manufacturer instructions?

- Is there anything from an instrument processing or equipment maintenance standpoint that could contribute to the risk of surgical site infection?

Answers to these questions can point the ASC in the best direction to focus on infection prevention resources. “Start somewhere that makes a difference, and, over time, go through the process with all of the instruments and equipment,” Garcia-Houchins adds.

Learn to interpret manufacturer’s instructions. “The best time to read the manufacturer’s instructions for use is before buying the equipment,” Garcia-Houchins says. “Find out how long it will take to maintain and clean that piece of instrumentation or equipment. Staff may find that the facility cannot follow the cleaning process specified by the manufacturer or that it will take three times as long to clean; thus, any money savings is gone because the ASC cannot use the equipment without additional resources.”

Sometimes, it seems easier to rely on the sales rep to explain and demonstrate the equipment’s cleaning process. However, this person may not present or follow all the manufacturer’s instructions, Garcia-Houchins notes.

“It might turn out he or she has not taught the facility every step of the manufacturer’s instructions for use,” she explains. “ASCs could have problems at a survey because surveyors are very good at reading manufacturer’s instructions.”

It’s important to remember that routine maintenance of the equipment is a key element of the manufacturer’s instructions, Garcia-Houchins adds.

Put someone knowledgeable in charge, and ensure staff are competent. The person responsible for reprocessing must be qualified and experienced in instrument reprocessing and equipment maintenance. Instructions are complex, and, often, background knowledge is needed to ensure correct application. Just because a manufacturer says a product is compatible does not mean that it is the appropriate product to use for final disinfection.

Garcia-Houchins gave an example in which the manufacturer provided instructions for disinfection with two products that were appropriate for the intended use of the item. In addition, it provided compatibility information with products that would not be appropriate disinfectants based on the intended use of the item, but could be used for cleaning after use.

The correct product to use for disinfection wasn’t clear, unless the person was an expert on instrument reprocessing. It was easier for the facility to use one of the products listed as compatible by the manufacturer, and facility staff didn’t understand the difference between a cleaning product and a disinfecting product.

“These types of instructions add to confusion,” Garcia-Houchins says. “But people reading those instructions need to understand the differences in terminology, cleaning vs. disinfection, and read the product labels to make sure they are appropriate for the items’ intended use.”

The person responsible for reading manufacturer’s instructions and training staff on cleaning processes could improve their skills by obtaining training through professional organizations like the International Association of Healthcare Central Service Materiel Management. They also could take supply processing technician courses online or in person, attend seminars, or review online courses provided by manufacturers of products they use. Training isn’t a one-and-done deal. Employees might require continual training and assessment for weeks to learn the proper cleaning, disinfection, and sterilization methods, Garcia-Houchins notes.

“Surgery centers need someone at the facility who is an expert on reprocessing equipment,” she says. “People assume that because you are a nurse, you know how to reprocess instruments, but nurses do not learn instrument reprocessing in nursing school.”

Do not assume that employees can correctly learn this on their own. Providing training opportunities and making certain employees are competent in cleaning and reprocessing is important. Ample staff should be trained to cover vacations and illnesses.

“Don’t have just one person who is trained, because that one person will go on vacation or call in sick, and whoever is processing instruments has to be competent,” Garcia-Houchins says.

The one time an ASC comes up shorthanded in reprocessing skills could be the time a surveyor visits and finds that the surgery center’s staff is not competent to process instruments, she adds.

“Have a back-up employee rotate through the area and keep staff’s skills current, so the ASC is not dependent on one person,” she adds.

Assess compliance. Some surgery centers use a detailed checklist to assess staff’s competency. It might take a couple of hours to go through such a checklist, but it accurately identifies problem areas, Garcia-Houchins says.

“Some facilities might perform an audit and review once a month, but others check every day, for weeks, to make sure employees had the process down,” she says. “They start with checking every day, move to once a week, then go to every week and, finally, once a month, followed by a spot check.” There is constant vigilance and constant striving for improvements in keeping patients safe, Garcia-Houchins adds. An essential element of an ASC’s infection prevention program is staff that follow cleaning, disinfection, and sterilization protocols and processes. “There are many steps in reprocessing, and staff often do not realize how detailed you must be,” Garcia-Houchins says. “They sometimes think reprocessing is simple, but it is actually very complex.”