Sterilization Wrap & Rigid Containers: Comparing Sterilized Packaging Systems
You may have thought you were protecting your patients by using rigid sterilization containers to sterilize your instruments. But a recent independent study showed - after terminal sterilization - 87% of rigid sterilization containers do not maintain sterility through transport and handling.2 Shockingly, even new rigid sterilization containers showed contamination.3
Concerned about the potential risk for your facility and patients?
Complete the form below to view this important study - the 2nd in this decade to show similar findings.
If you are researching the topic, you’ll find that this webpage includes several important studies --- two in the past decade alone --- that show rigid sterilization containers do not maintain the level of sterility previously thought. Further, you will find that these studies show a disconcertingly high level of contamination to be associated with rigid sterilization containers vs. sterilization wraps. You will also discover a variety of educational journal articles and analyses which concur. In addition, you’ll find a selection of effective tools for performing testing/analysis of the rigid sterilization containers at your own facility.
Sterility Maintenance Study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress (2nd in a decade)
Background: Sterilized packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use. This study evaluated the effectiveness of rigid containers versus wrapped instrument trays, sterilized using North American sterilization protocols, to maintain a sterile internal environment post-sterilization when challenged with aerosolized bacteria under dynamic environmental conditions.
Methods: Using a custom aerosol chamber, 111 rigid containers of various durations of use (unused, used <5 years, used 5-9 years) and 161 wrapped trays using 3 grades of sterilization wrap were challenged with ̴ 102 colony-forming units per liter of air containing aerosolized Micrococcus luteus with a count median particle size of 1 µm, while simultaneously experiencing air volume exchanges due to vacuum cycles-two 1-psi cycles, three 0.7-psi cycles, and three 0.4-psi cycles-to simulate air exchange events occurring during the sterilization, transportation, and storage of sterilized instrument trays in health care facilities.
Results: Of 111 rigid containers tested, 97 (87%) demonstrated bacterial ingress into the container. Of 161 wrapped trays, 0 (0%) demonstrated bacterial ingress into the tray. Contamination rates of rigid containers increased significantly with increasing duration of use.
Conclusions: In this study using a dynamic bacterial aerosol challenge, sterilized wrapped trays demonstrated significantly greater protection than sterilized rigid containers against the ingress of airborne bacteria.
- Press Release with Video Reviewing Study Protocol & Results
- Easy to Understand Infographic Covering the Big Picture, Study Methodology, Testing Protocol & the Results
- Educational Poster Covering the Study Presented at this year’s 2016 IAHCSMM Annual Conference & Expo
- Frequently Asked Questions About this Important Study
- Randell Sprouse LSSBB, Manager Sterile Processing, busts the urban legends about containers being faster, more efficient, more cost-effective and safer than sterilization wrap.
- View the results of a head-to-head analysis of containers vs. wrappers that measured time-efficiencies, cost-effectiveness and labor requirements conducted by Randell Sprouse LSSBB, Manager Sterile Processing.
- Are containers more cost-effective than a single-use sterile wrap for surgical instrument sets? Download your complimentary copy of this article from the study author Randell Sprouse LSSBB, Manager Sterile Processing who reviews the Lean Six Sigma methodology and study results.
- Learn the surprising results of a study; the second study done in 10 years to have similar findings, that found wrap was more effective than rigid containers at maintaining sterility4 measuring the microbial barrier effectiveness of containers in the prevention of nosocomial infections.
- There should be a complete seal between the lid and the bottom of each of your rigid containers. Learn how to test for barrier breaches.
- To maintain sterility, rigid containers should provide a complete and proper seal. To check your container seals, all you need is a crisp dollar bill!
- A complete operating room/central supply checklist for inspecting the performance of your rigid containers to ensure they are not at risk for failure.
- Are your containers as safe as they were on day you purchased them? Over time, rigid containers often develop hard-to-detect breaches in barrier that can allow contamination of instruments. Consider the right mix of rigid containers and wrapped trays to achieve the best protection from infection for your patients.
If you are concerned that you may be putting your patients at risk, Halyard Health is standing by to help you with valuable information, tools, and resources to evaluate your rigid sterilization containers to determine their effectiveness in sterilizing your surgical instruments. That's the Halyard Advantage!
Click Here and your own Halyard Health representative will schedule an on-site analysis of your rigid sterilization containers.
For additional information, please email us at SterilizationInformationRequest@hyh.com
Research was funded by Halyard Health, Inc. (formerly Kimberly-Clark Heath Care) and conducted by Applied Research Associates, an international research laboratory. Halyard Health did not have any direct involvement in execution of the study. The study took place in an independent laboratory in Panama City, Florida, and the study was conducted by independent researchers.
1 Harry L. Shaffer MS†, Delbert A. Harnish MS†, Michael McDonald MS, Reid A. Vernon BS, Brian K. Heimbuch MS†. Sterility maintenance study: Dynamic evaluation of sterilized rigid containers and wrapped instrument trays to prevent bacterial ingress. Am J Infect Control. 2015 Dec;43(12)1336–1341.
2 Out of 111 rigid containers tested, 14 (12.6%) had no bacterial ingress, 25 (22.5%) had ingress of 1-9 CFU, 52 (46.8%) had ingress of 10-99 CFU, and 20 (18.0%) had ingress >100 CFU. † Harry L. Shaer MS, Delbert A. Harnish MS, and Brian K. Heimbuch MS contributed to/authored the above article at the time they had a financial consulting relationship with Halyard Health, Inc.; however, they were not compensated by Halyard Health, Inc. for their respective contributions/authorship of the article.
3 72% of unused containers showed some level of bacterial ingress.
4 The 2006 study, “Measurement of the microbial barrier effectiveness of sterilization containers in terms of the log reduction value for prevention of nosocomial infections,” was published in the American Journal of Infection Control and conducted by Hartmut Dunkelburg, MD, and Friederike Fleitmann-Glende, MS, from the Medical Institute of General Hygiene and Environmental Health, University of Goettingen in Germany. The study was conducted with a microbial challenge of 216 sterilization containers of four central sterile supply departments of different hospitals in Germany. It found that nine out of 11 containers with paper filters and 70 out of 79 containers with textile filters failed to maintain barrier performance.
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