Shelf life of sterilized packaged items stored in acute care hospital settings: factors for consideration
Prabha Lakhan A C , Joan Faoagali B , Rosemary Steinhardt A and Dolly Olesen AA Centre for Healthcare Related Infection Surveillance and Prevention, Communicable Diseases Unit, Chief Health Officer Branch, Health Service and Clinical Innovation Division, Queensland Health.
B Princess Alexandra Hospital, Ipswich Road, Woolloongabba, Qld 4102, Australia.
C Corresponding author. Email: Prabha_Lakhan@health.qld.gov.au
Healthcare Infection 18(3) 121-129 https://doi.org/10.1071/HI13002
Submitted: 3 January 2013 Accepted: 24 March 2013 Published: 7 May 2013
Abstract
Introduction: Reusable medical devices are sterilized and stored before their use in hospital settings. The length of time the sterilized item can be stored (shelf life) to maintain sterility has been discussed in the literature over the last four decades, with a shift to an event rather than time-related determination of shelf life. This paper reviews the evidence and provides a summary of some key issues for consideration when adopting event-related or time-based shelf life recommendations for packaged sterile items in Australian hospitals.
Discussion: Australian and international standards provide guidelines for procedures to be used for sterilization of reusable medical devices and storage conditions following sterilization. Reusable medical devices are sterilized by commercial manufacturers or sterilizing departments located in hospitals. Commercial manufacturers allocate expiry dates on sterilized items which should be respected, unless sterility is compromised by an event. The shelf life of items sterilized in hospital is debated, with growing support for event- rather than time-related sterility. Many factors determine whether event- or time-related shelf life should be followed. Well designed experimental studies into shelf life of sterilized items are lacking, with some small studies indicating that items can remain sterile for 12 to 24 months. Factors for consideration by hospitals are outlined and an algorithm to assist in implementation of event-related or time-based shelf life for reprocessed reusable medical devices is provided.
Conclusion: The method of determining shelf life in hospitals is dependent on adequacy of processes for sterilization, monitoring of sterility over time and storage conditions.
References
[1] Australian Commission on Safety and Quality in Health Care (ACSQHC). National Safety and Quality Health Service Standards. Sydney: ACSQHC. Available from: http:/www.safetyandquality.gov.au/wp-content/uploads/2011/09/NSQHS-Standards-Sept-2012.pdf. [verified April 2013][2] International Organisation for Standardization. ISO 11607-1:2006 Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. Geneva, Switzerland.
[3] International Organisation for Standardization. ISO 11607-2:2006 Packaging for terminally sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes. Geneva, Switzerland.
[4] Standards Australia. Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment and maintenance of associated environments in health care facilities. AS/NZ 4187 : 2003. Sydney: SAI Global; 2003.
[5] Belkin NL. Should shelf-life policy be determined by events or time? Todays Surg Nurse 1996; 18 15–8.
| 1:STN:280:DyaK28zotVKjtQ%3D%3D&md5=22e7fd50ee758fd1b557d703f9c48b4eCAS | 8788620PubMed |
[6] Rutala W, Morelli L, Weber D, Thomann C. Effects of long-term storage on sterility of medical supplies. Am J Infect Control 2006; 34 248
| 16679187PubMed |
[7] Schroeter K. Implementation of an event-related sterility plan. AORN J 1994; 60 595
| 1:STN:280:DyaK2M%2FptFCrtw%3D%3D&md5=e337a468eb8f82e86cc3dbc787bfa1e3CAS | 7998801PubMed |
[8] Standard P, Mackel D, Mallison G. Microbial penetration of muslin and paper-wrapped sterile packs stored in open shelves and in closed cabinets. Appl Microbiol 1971; 22 432–7.
| 1:STN:280:DyaE38%2FktFeiug%3D%3D&md5=e9a847be0488e228aca1d89520be2a8dCAS | 5119207PubMed |
[9] Gardner J, Peel M. Sterilization, Disinfection and Infection Control . 3rd edn. Sydney: Churchill Livingstone; 1998.
[10] Polzella M, Holbeche B. A study to evaluate the effectiveness of sterile wraps over an extended period of time at the Northern Hospital Melbourne. Sterilization in Australia 2002; 21 18–21.
[11] Rutala W, Weber D. Healthcare Infection Control Practices Advisory Committee H. Guideline for disinfection and sterilization in healthcare facilities, 2008. Available from: www.cdc.gov/hicpac/pubs.htm [verified March 2013].
[12] Barrett R, Stevens J, Taranter J. A shelf-life trial: examining the efficacy of event related sterility principles and its implications for practice. Aust J Adv Nurs 2003/2004; 21 8–10.
[13] Bhumisirikul W, Bhumisirikul P, Pongchairerks P. Long-term storage of small surgical instruments in autoclaved packages. Asian J Surg 2003; 26 202–4.
| 14530104PubMed |
[14] Hebert CG. Two studies of event-related sterility. Patient safety. Mater Manag Health Care 1995; 4 44–6.
| 1:STN:280:DyaK2M7nvFSguw%3D%3D&md5=93dc02e437c57d275f5c5d323819ce1cCAS | 10140313PubMed |
[15] Schwartz R, Butt W, Bradley D, Mayhew R. Safe storage times for sterile instrument packs. Mil Med 1992; 157 406–9.
| 1:STN:280:DyaK38vgvFSksw%3D%3D&md5=d96f435cf114e34df17da213eb6024f2CAS | 1528486PubMed |
[16] Schwartz R, Davis R. Safe storage times for sterile dental packs. Oral Surg Oral Med Oral Pathol 1990; 70 297–300.
| 1:STN:280:DyaK3M%2Fhs1aqug%3D%3D&md5=e3ddcb798df2fbedb2beff1f8b07c38aCAS | 2216356PubMed |
[17] Webster J, Lloyd W, Ho P, Burridge C, George N. Rethinking sterilization practices: evidence for event-related outdating. Infect Control Hosp Epidemiol 2003; 24 622–4.
| 12940587PubMed |
[18] Commonwealth of Australia. Australian Regulatory Guidelines for Medical Devices (ARGMD) Part 2 – Pre-market version 1.1, May 2011 . Available from: http:www.tga.gov.au/pdf/devices-argmd-p2.pdf [verified April 2013].
[19] McAuley T. Specifications for temperature and humidity in sterile storage environments – where’s the evidence? Healthc Infect 2009; 14 131–7.
[20] Drake B. Infection control in hospitals. ASHRAE 2006; 48 H12–17.
[21] Gniadek A, Macura AB. Air-conditioning vs. presence of pathogenic fungi in hospital operating theatre environment. Wiad Parazytol 2011; 57 103–6.
| 21682095PubMed |
[22] Queensland Health. Airconditioning: AC14 HVAC System Hygiene Inspection Task Specification. Available from: http://qheps.health.qld.gov.au/asset-properties/task_specs_revised/air_con/ac14-ov.pdf [verified December 2012].