"Busy healthcare facilities are continuously searching for ways to improve instrument turnaround time. Since many of the sterility assurance products out on the market require time to read results, this time can equate to downtime for surgical staff and increased inventory levels," explained Nooney of STERIS. "Manufacturers are capable of producing products that provide faster results, but, ultimately, it is the facility that must determine how to adopt the new technology to assure maximum efficiency without introducing additional patient risk."

Sometimes, the IFUs themselves are to blame for user error and sterilization failure. Getinge’s Rockow explained that as different products, instruments and equipment all vary, it is sometimes difficult to have them all work in unison. An instrument manufacturer may say to process for 13 minutes at a particular temperature, for example, and another instrument may require something entirely different. "The instructions may require different sterilizer temperatures, and the process challenge device instructions are outside the parameters," she said. "FDA, AAMI and manufacturers will need to work in unison."

While each of these challenges, and more, can negatively impact sterility assurance, the good news is most problems can be corrected through comprehensive, ongoing staff education. "Overall, misuse of QA tools occurs due to a lack of training and understanding of end users. It is essential that all personnel using QA devices receive proper training and education on the use and interpretation of the products they use," said Taurasi. He noted that users must demonstrate their competency in using such tools, and they should also have a complete understanding of the sterilizers and various cycles they are using.

Nooney suggested that healthcare facilities designate a team leader to assure that new hires are properly trained and that departmental procedures are correctly followed. "These best practice activities will make the department run smoother and, more importantly, help reduce sterile processing errors."

Sterilizer qualification testing is another factor that SPD staff cannot overlook. According to Sandra Velte, BA, CSPDT, who serves on 3M Sterilization’s Technical Service Team, this testing is sometimes performed incorrectly following a steam sterilization process failure. "Qualification testing is conducted after events occur, which could affect the ability of the sterilizer to perform. This testing is performed after sterilizer installation, relocation, malfunction, major repairs, and sterilization process failures," she stressed.

Checklists can prove invaluable for ensuring that staff members follow proper protocol and performs routine checks to ensure that equipment and monitoring devices are being used correctly and are in good working order. According to Stephen Kovach, Healthmark’s director of education, these checklists should include every step leading up to and including sterilization — beginning with cleaning. This checklist can then be used as staff training tools, he said.

Documentation of the entire reprocessing workflow is also critical for identifying missing steps and mistakes, according to Nooney. "The chart can even point out functions that need to be improved and assist in identifying areas where additional monitoring would be beneficial."

Digital documentation solutions are going a long way toward driving process quality in the SPD and beyond. Tracking systems available today allow departments to, among other things, electronically store records, interface with BI incubators, alert users if they are using the wrong cycle, or flag if there’s a positive BI, Seavey noted.

The ANSI/AAMI ST79 "Decision Tree" and "Checklist" are also valuable tools to assist in taking actions and investigating when physical monitors, CIs, BIs and PCDs indicate a sterilization failure, added Larson of 3M.

Of course, ST79, in its entirety, is one document that every SPD should have on hand — and use often, stressed Healthmark’s vice president, Ralph Basile. "Make sure all staff in the OR and SPD are familiar with [this standard]." Joint Commission surveyors are being trained on ST79 and are looking to see that policies are current and aligned with the standards.

Knowledge on demand

More than ever, vendors, too, are playing a more active role in ensuring that end users are competent and well-versed on the products and equipment being used in their departments.

STERIS’ Clinical Education team, for example, supports and delivers best practice-based educational activities. This includes educating learners on the importance of following IFUs and the importance of documentation of sterility assurance policies. Individual customers may also join STERIS University, an online adult learning environment that allows registered customers to complete clinical self-study guides, e-learning courses, webinars, and other offerings that cover relevant science and clinical topics, while also earning continuing education credits.

Stressing the importance of providing SPD professionals with easy access to current IFUs, Larson said that many facilities store IFUs in three-ring binders or scan them into a local digital archive, which can be difficult to maintain. "Another solution to this information management challenge that is becoming more common is a subscription-based online service," she said. 3M recently launched a promotion with oneSOURCE Document Site, a subscription service that provides healthcare facilities with unlimited access to manufacturers’ IFUs through an online database, to offer limited-time, complimentary access to the current IFUs for 3M’s sterilization assurance products.

At the very least, Seavey recommends the periodic review of IFUs to stay abreast of updates. She’s also a proponent of tapping vendor-provided educational offerings to train staff. At least annually, she recommends having all staff perform competency checks that include return demonstrations on sterility assurance monitoring. These competency checks should be documented in employee files.

"There are way too many facilities or staff reprocessing medical devices that are not getting the education — or managers that are not enforcing best practices," Seavey stressed. "This is another point to be made for the need for certification in the profession."