Sterilization expiry date of health care products: an experimental study

• Grant number: 10/18239-1
• Support Opportunities: Regular Research Grants
• Start date: January 01, 2011
• End date: December 31, 2012
• Field of knowledge: Health Sciences - Nursing - Medical-Surgical Nursing
• Principal Investigator: Kazuko Uchikawa Graziano
• Grantee: Kazuko Uchikawa Graziano
• Host Institution: Escola de Enfermagem (EE). Universidade de São Paulo (USP). São Paulo , SP, Brazil
• Associated researchers: Giovana Abrahão de Araújo Moriya

Abstract

Concerns about the effectiveness of processing and maintenance of the sterility of critical health care products by ensuring the quality of care provided in hospitals is always discussed when the matter is primarily sterile is the "shelf life" of these products. In Brazil, traditionally, the expiry dates for sterile products are set sometimes for a week, sometimes for 15 days or even for few months. Today, a better understanding of this issue can be achieved through the scientific knowledge. A newly sterile material can become contaminated after a few hours of sterilization, well before the established expiry date. The truth is that microorganisms do not use calendars or clocks. A new way of thinking about this issue is to link the validity of sterilization with the quality of packing biobarrier, safe sealing, appropriate storage conditions and control of related events that may threaten the integrity of the packaging. Several countries have already regulated the validity of sterilization using these assumptions. The Association of periOperative Registered Nurses (AORN), in 2000 recommendations, has already stated that the shelf life of sterile products is associated with related events and not with the time clock. Daily practices firmly rooted are very hard to change, especially if they are part of documents prepared by government agencies responsible to regulate and monitor like Collegiate Board Resolutions (RDC) of the Brazilian National Sanitary Surveillance Agency (ANVISA) and state and municipal resolutions. This project proposes to conduct an experimental research, trying to prove the hypothesis that the sterilization expiry date may be considered "indefinite" under certain conditions, that may help changes in the current official recommendations and therefore enable a more rational practice with waste reduction. (AU)