Nearly one-third of sterile processing departments (SPDs) reported not having a tracking system in place to manage the sterilization process, according to preliminary results of a research project called “What Counts in Sterile Processing Departments: Measuring Defects and Responses.”
The project, which was supported by the AAMI Foundation’s 2022 Mary K. Logan Research Award Program, used surveys to analyze how SPDs across the country approach the measurement of processes, defects and outcomes, and which factors they feel most impact their effectiveness. The research team was led by Jessica Williams, associate professor of health policy and administration at Pennsylvania State University (PSU).
The team hypothesized that even high-performing SPDs may have different strategies to prevent patient infection. Despite efforts from standards developers like AAMI to bring end-user experts together for information sharing, the factors that influence a department’s best practices remain difficult to account for. This is, in-part, why standards themselves tend to focus on the “what” of safe and efficient SPDs, but not necessarily on the specifics of “how.” Seeking more information, the PSU team aimed to identify consistent methods for linking the efficacy of medical device sterile processing practices to patient safety.
“Despite processing millions of instruments each year and being an essential component of accreditation, these departments are often taken for granted by hospital administration, health care providers, and even health services researchers unless something goes wrong, like delayed surgeries or infection outbreaks traced to unclean instruments,” Williams said in a past interview with AAMI.
The study took place from 2022 to August 2023. Williams later collated and reported the preliminary results of the project to AAMI. “We were excited to get responses from people working in different types of hospitals and ambulatory surgical centers (ASCs), with good variation in whether the locations were urban, rural or suburban,” she said.
The researchers noted that there was a large range in the staff size of the SPDs that participated in the surveys. Thirty percent reported having between 1-4 full-time equivalents (FTEs), and about 21% reported having 5-9 FTEs. About 13% of SPDs had more than 40 FTEs.
Employment practices also varied among SPDs. Nearly one-third of SPDs reported that certification was not required for employment. However, the majority of SPDs reported that they required certification at hiring or within 1-2 years of employment. That can be troubling for teams with heavy workloads and little time for professional development. Over half (57%) of SPDs reported having 12-23 hours of lead time for cases, and slightly under half (49%) of SPDs reported receiving add-on cases very frequently.
“Interestingly, we found that 27% of SPDs did not have a tracking system in place,” Williams said.
Among the SPDs that took part in the surveys, the most reported defects were compromised sterile wrap and missing instruments. Overall, 90% of SPDs reported that at least one of the measured defects occurred at least once in the week prior to completing a survey. Williams noted that some of the items measured as “defects” – such as whether there were extra or missing items in sets and trays – were not issues with sterilization.
Additionally, SPDs that reported “never” or “very rarely” getting extra cases were less likely to report any defects in the reporting period, and this effect was statistically significant at the 1% level.
“Longer lead times for cases were also associated with a lower likelihood of reporting any defects,” Williams said.
The research team at PSU is currently analyzing data from the project. The team is also in the process of submitting peer-reviewed manuscripts for publication and looking for ways to fund additional research in the human and organizational side of SPDs.
“We are hoping [the results] can be used to advocate for resources for sterile processing and quality improvement and provide a better understanding of the factors that affect sterile processing,” Williams said.
KILMER Conference 2025 – Call for Abstracts
The Association for the Advancement of Medical Instrumentation (AAMI) and the Parenteral Drug Association (PDA) are pleased to announce a call for abstracts for sessions and posters for the 2025 KILMER Conference, which will be held from February 3-6, 2025, in Orlando, Florida. The theme for the 2025 KILMER Conference is Next Generation Microbiological Quality and Sterility Assurance. The groups are seeking submissions broadly reflecting this theme and addressing topics related to industry innovations in sterilization, sterility assurance, and microbiological quality for medical devices and pharmaceuticals, including but not limited to the following areas:
- Emerging technologies or approaches for cleaning, disinfection and sterilization
- Microbiological quality control, aseptic and sterilization process validation and monitoring
- Microbiological or alternative testing method
- Sterilization processes and modalities
- Pathways to facilitate or innovate regulatory approvals
- Quality control and assurance
- Materials compatibility
- Device and drug product packaging innovation
- Application of process control or parametric approaches
- Successes in industry-academia research partnerships
- Industry approaches and innovations for infection prevention and contamination control in clinical settings
- Sustainability
- Leveraging lessons from pandemics or outbreaks (e.g., supply chain.)
- Career development
Abstracts should be submitted at https://www.surveymonkey.com/r/3LZK8YM. If a proposal is accepted, indviduals will be notified by October 1, 2024. Note that most sessions at the 2025 KILMER Conference will be between 15 and 20 minutes, and single presenters are preferred. Proposals not accepted for a session may still be considered for a poster presentation.
Interested parties are encouraged to submit their abstracts for consideration. Questions may be directed to Amanda Benedict, AAMI vice president of sterilization at abenedict@aami.org.
