How Well Do Packaging Systems Preserve Sterility of Hospital Instruments? Interview with:
Peggy Luebbert, MS, MT, CIC, CHSP, CBSPD; Infection Preventionist at Nebraska Orthopaedic Hospital; Owner and Consultant at Healthcare Interventions, Inc.; and
Brian Heimbuch, MS, Associate Division Manager/Sr. Bioaerosol Scientist, Applied Research Associates

MedicalResearch: What is the background for this study?

Mr. Heimbuch: The purpose of the study was to examine the ability of sterilization packaging systems to maintain sterility of surgical instruments and devices from the time of sterilization until use.

Ms. Luebbert: Maintaining a sterile environment in the operating room is essential for preventing the estimated 300,000 surgical site infections (SSIs) that occur annually in U.S. hospitals and result in approximately 9,000 deaths.[i]-iii

Sterilization packaging systems are designed to maintain the sterility of surgical instruments and devices from the time of sterilization until use in the operating room. The two primary types of sterilization packaging systems include trays covered in sterilization wrap and rigid containers. Sterilization wrap is composed of polypropylene or cloth and is disposed of after use. Rigid containers are reusable and come in a variety of materials (including metals, aluminum and polymers) and sizes.

Mr. Heimbuch: Our study, which was funded by Halyard Health (formerly Kimberly-Clark Health Care), was published in the American Journal of Infection Control and designed to evaluate the capability of rigid containers and sterilization wrap to maintain a sterile internal environment, after terminal sterilization, under test conditions designed to simulate a typical hospital setting.iv This is the second study of its type to report similar findings.

MedicalResearch: What are the main findings?

Mr. Heimbuch: 87 percent (97 out of 111) of the rigid containers failed to maintain barrier performance after terminal sterilization, allowing bacterial contamination to occur during transport and handling and compromising the sterility of the contents.v 100 percent (161 of 161) of the wrapped trays maintained their sterility, preventing bacterial

We also found that rigid containers become less effective the longer they are in use. Surprisingly, even some unused containers failed to maintain barrier performance under the test conditions used.

MedicalResearch: What should clinicians take away from your report?

Ms. Luebbert: The type of sterilization packaging system a hospital uses is a multidisciplinary effort between hospital leadership, infection preventionists, perioperative specialists and materials management, among others. It is critical that we consider this recent scientific data to make the best, most informed decisions possible when it comes to sterilizing surgical instruments.

This study and its predecessor call into question the assumption that rigid containers maintain the sterility of their contents post-sterilization. What is especially surprising is that even unused rigid containers allowed for bacterial ingress. Practitioners in the field are well aware that failures in sterilization packaging systems may lead to contamination of the contents and ultimately, increase the risk for SSIs. This is a reality that needs to be shared with a wider audience.

MedicalResearch: What recommendations do you have for future research as a result of this study?

Ms. Luebbert: Given the heightened awareness and critical importance of maintaining sterility in the hospital setting, this study’s impact cannot be ignored. When you consider the fact that this is the second study in a decade to arrive at similar conclusions, it underscores the need for further examination of the reasons for rigid containers’ failure to maintain sterility even when manufacturer guidelines are being followed.


[i]   Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, et al. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol 2008 Oct;29 Suppl 1:S51-61.

ii Engemann JJ, Carmeli Y, Cosgrove SE, Fowler VG, Bronstein MZ, Trivette SL, et al. Adverse clinical and economic outcomes attributable to methicillin resistance among patients with Staphylococcus aureus surgical site infection. Clin Infect Dis 2003 Mar 1;36(5):592-98.

iii Kirkland KB, Briggs JP, Trivette SL, Wilkinson WE, Sexton DJ. The impact of surgical-site infections in the 1990s: attributable mortality, excess length of hospitalization, and extra costs. Infect Control Hosp Epidemiol 1999 Nov;20(11):725-30.

iv Shaffer H, Harnish D, McDonald M, Vernon R, Heimbuch B. 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):1336-41.

V Ibid.

vi Ibid.

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Peggy Luebbert and Brian Heimbuch (2016). How Well Do Packaging Systems Preserve Sterility of Hospital Instruments?