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What do you mean you can't sterilize it? The reusable medical device matrix
Anne Stephens1, AnnMarie Assang
1University Health Network, Toronto General Hospital, USA. Anne.Stephens@uhn.on.ca
Abstract:
Health Canada recommends that hospitals should have procedures in place to ensure Reusable Medical Devices (RMD) are cleaned, disinfected and sterilized according to the manufacturer's instructions. For the purpose of this paper, reusable medical devices will be referred to as RMDs and include all instrumentation and devices that the Central Processing Department (CPD) resterilizes for use in the hospital. Patient safety in surgery begins in CPD. Manufacturer recommendations for the decontamination and sterilization of surgical instrumentation are of utmost importance to Operating Room (OR) and CPD staff. With recommendations that are unclear, nonspecific or unattainable there was a need to define what it means institutionally to meet standards and provide safe patient care while continuing to support the advancement of surgical technology. The purpose of this paper is to describe the challenges faced by one multisite organization (The University Health Network) in managing the sterilization of surgical instrumentation. The development of The Guidance Matrix by the network's inter-professional Reusable Medical Device (RMD) Committee, will be discussed along with information about the elements of this tool and an illustration of how it is used. The key benefits of The Guidance Matrix, including how its use has facilitated transparent decision-making, communication and collaboration regarding sterilization issues across the sites, will be described. Sterilization processes in Central Processing Departments (CPD) include chemical indicators, dated load indicators, and tamperproof locks and filters. The lack of an indicator of sterilization can be a frustrating experience for an OR Nurse. But do we really understand the critical importance of all these indicators? The foundation of sterilizing reusable medical devices (RMDs) begins with proper processes, standards and subsequent scientific validation from the vendors. According to AORN, patient safety is vital and it begins with proper cleaning and processing of the surgical instruments. Surgical site infections can increase the length of stay and the cost of the patients' hospitalization, as well as increased risk, morbidity and even mortality. 1 Today's patients are far more informed than they were in the past. They can gather information from the internet as well as from television, radio, and print media. This knowledge empowers the patient to expect that their healthcare providers are practicing due diligence. It is the ethical duty and responsibility of nurses to provide safe, competent care while protecting the rights of the patient and being accountable to the professional governing bodies. In other words, we are advocates for both our patients and the healthcare system.2 Using both new and innovative instruments in the OR was, in the past, as simple as a surgeon requesting an instrument, the perioperative nurse ordering the instrument and CPD processing it for use in the OR. That is no longer the case. With a wide range of more complex instrumentation and an increasing focus on sterilization strategies, healthcare facilities have had to adopt a more rigorous approach. There are many challenges in the world of sterile processing. A common one, faced on a regular basis, is the provision of vague, inaccurate reprocessing recommendations from the medical device manufacturer. Canadian centres are not able to meet European standards for reprocessing. European cycles, often referred to as "Fractionated Steam Cycles", are different than the pre-vacuum steam cycles run in Canada.
Insights
Central Processing Departments face challenges in sterilizing reusable medical devices due to unclear manufacturer instructions. The Guidance Matrix was developed to improve decision-making and collaboration for safe patient care.
Area of Science:
- Healthcare Management
- Surgical Technology
- Infection Control
Background:
- Health Canada mandates proper cleaning, disinfection, and sterilization of Reusable Medical Devices (RMDs) per manufacturer instructions.
- Patient safety in surgical settings is critically dependent on effective sterilization processes managed by Central Processing Departments (CPDs).
- Vague or unattainable manufacturer recommendations pose significant challenges to ensuring RMD safety and compliance.
Purpose of the Study:
- To describe the sterilization management challenges faced by a multisite healthcare organization.
- To introduce The Guidance Matrix as a tool to standardize and improve sterilization practices.
- To highlight the benefits of The Guidance Matrix in facilitating transparent decision-making and inter-site collaboration.
Main Methods:
- Development of an inter-professional Reusable Medical Device (RMD) Committee.
- Creation and implementation of The Guidance Matrix tool.
- Discussion of the elements and application of The Guidance Matrix.
Main Results:
- The Guidance Matrix provides a framework for institutional standards in RMD sterilization.
- Implementation has led to enhanced transparency, communication, and collaboration across multiple healthcare sites.
- The tool aids in navigating complex sterilization issues and supports advancements in surgical technology.
Conclusions:
- Standardized processes and tools like The Guidance Matrix are essential for safe patient care in surgical settings.
- Effective RMD reprocessing requires collaboration between manufacturers, CPDs, and Operating Room staff.
- Addressing challenges in sterilization management is crucial for preventing surgical site infections and improving patient outcomes.
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