The thought of a non-sterile instrument being used during a medical procedure is enough to send chills down any patient’s spine. A simple Google search shows that dirty surgical and diagnostic equipment such as endoscopes remains omnipresent in healthcare and can propose threats to patient safety by potentially increasing risk of surgical site infections (SSIs).
While it’s critical to mitigate any risk of deviation from sterilization processes within a healthcare facility, it’s also important to pay attention to how sterilized instruments are stored and transported afterwards. Sterile packaging systems play an ever-important role in ensuring the sterility of instruments until they reach the next surgical case—yet, they are often overlooked.
Today, there are several options for sterile packaging systems that can be used in the central sterilization (CS) department, including rigid containers, peel pouches of plastic and/or paper, and sterilization wraps (constructed of either woven or nonwoven materials). Each option has its own potential risks to patient safety. Luckily, there’s data available to help healthcare organizations identify these hidden areas of risk within their own CS department and put strategies in place to reduce those risks.
Reviewing the Literature
There are four scientific peer-reviewed studies conducted in the past 13 years focusing on identifying and mitigating sterile packaging system-related risks (See Table 1). While each focuses on different aspects of sterility maintenance, all point to the following key considerations:
- When rigid containers are in use, there is potential for instruments to become contaminated during storage and transportation.
- Rigid containers become less effective at maintaining sterility of instruments over time.
- Visual inspection is not enough to identify sterile packaging system sterility risks. The water test is an effective and simple standardized functionality test that can be used in conjunction with visual inspection.
Considering Compliance
Potential performance issues inherent with certain types of sterile packaging systems are not the only factor to consider with regard to compliance. Using a mix of sterile packaging systems—which is common—or pressure to meet throughput demand can also impact compliance with a sterile packaging system manufacturer’s instructions for use (IFUs). Anything less than 100 percent compliance with IFUs can lead to improper processing and may impact sterilization packaging performance. By delivering surgical instruments to the OR that haven’t been monitored or processed properly, CS departments can create a false sense of confidence to those who will be utilizing them and potentially put patients at risk.
From Knowledge to Action
It’s impossible to eliminate all risk from sterile processing and the sterile packaging system used along the way, but there are a number of ways healthcare organizations can reduce potential threats to patient safety:
- Ongoing Education: Your sterile packaging system mix may change year-to-year—and with it the corresponding IFUs. Develop a program that both assesses and strengthens user competencies for all sterile packaging systems used within your CS department.
- Thorough Assessment: Perform a facility risk assessment of sterile packaging systems on at least an annual basis and at any equipment or processes change. A thorough risk assessment should take into account average age of container inventory; adherence to IFUs; sterile packaging system integrity and repair; and tear rates.
- Successful Collaboration: Once you have the data and considerations specific to your own organization, share that information far and wide to ensure collaboration on risk mitigation with key partners to the CS department, including surgery and infection prevention.
Protecting patient safety is a shared responsibility across healthcare organizations. While SSIs are on the decline, it remains critical that healthcare professionals continue to identify new potential sources of infection, including sterile packaging systems, and work collaboratively to mitigate those risks.
* Research was funded by Halyard and conducted by Applied Research Associates, an international research laboratory. Halyard did not have any direct involvement in execution of the study. The study took place in an independent laboratory in Panama City, FL, and the study was conducted by independent researchers.
Read More
Sterilization Pouches: What You Need to Know About the Essential Medical Sterilization Product
Sterilization pouches play a key role in sterilizing reusable devices – contributing to an environment of safe and quality patient…
Air-Tight and Under Wraps: Sustainable Sterile Instrument Storage and Containers
Healthcare Purchasing News’ article “Eight tales of transformation: Sterile Processing Innovation” featured the Banner-University Medical Center (UMC) Tucson Sterile Processing…
Eight tales of transformation: Sterile Processing Innovation
Healthcare Purchasing News’ article “Eight tales of transformation: Sterile Processing Innovation” featured the Banner-University Medical Center (UMC) Tucson Sterile Processing…
The case for conformity, collaboration in managing case carts
Cory Ezell, North America Sales Director for Belintra, partnering with O&M HALYARD shares insights on selecting surgical case carts for…
Increasing Efficiencies and Improving Outcomes with the HALYARD* and BELINTRA STERISYSTEM®
When we learned about BELINTRA, we saw a potential solution to make the most of our current layout in an…
The Evidence is Mounting: The Case For Sterilization Wrap vs. Rigid Containers
ALL STUDIES POINT TO THE FOLLOWING When rigid containers are in use, there is potential for instruments to become contaminated during storage and transportation. Rigid containers become less effective at maintaining sterility of instruments over time. While visual inspection of all SPS helps to identify sterility risks, additional mechanisms beyond
Three Questions to Ask When Considering Surgical Case Carts for Your SPD
To a surgeon and an Operating Room team, just up the hall may as well be on the other side…
3 Design Considerations for Sterile Processing Departments
If someone is planning to build their dream kitchen, design is sure to play a central role. Perhaps that’s locating…
Packaging Dental Instruments for Sterilization
OSHA (Occupational Safety and Health Administration) OSHA’s mission is to save lives, prevent injuries, and protect the health of America’s workers. As part of the Department of Labor, OSHA (and the states that operate OSHA-approved state plans) establishes guidelines and standards to promote worker safety and health that apply to
From Blue to Green: Implementing a Sterilization Wrap Recycling Program
As the greater population places a more watchful eye on environmental practices, organizations are responding by developing sustainability programs. They are looking for ways to lower their environmental impact by reducing waste and contributing, when possible, to a more circular economy. A changing recycling industry – with China no longer