Primary Care Catalogue

FOCUS ON COMPLIANCE: REPROCESSING OF REUSABLE MEDICAL DEVICES

STERILIZATION 1: CLEANING The first and most crucial step in instrument reprocessing is cleaning. Improper cleaning can impede the sterilization process. Manual cleaning the instrument in enzymatic solution INTRODUCTION Following established protocols and requirements established by standards such as PIDAC and CSA (i.e. best practices for instrument reprocessing) is an important aspect of modern health care as it helps to minimize the patient’s risk of infection. Key elements of a reprocessing program are outlined with the intention of providing recommended steps and focus products available in this catalogue to help facilities meet these requirements.

bath for at least 3-5 minutes will soften and loosen the soil that may have dried on the instrument between the time it was used and the time cleaning has started. A good quality enzyme detergent (Valsure Enzymatic 1C5208) is preferred as they help to break up organic soil more readily as well as protect your devices from the harmful effects of poor water quality.

2: CLEANING VERIFICATION It is well known that you can sterilize what is not cleaned. Cleaning verification within

standards (CSA Z314.8) are becoming more prevalent as part of good practice recommendations. These tests should be performed on a routine basis with documented results. For automated washers and ultrasonic cleaners, All Clean and Verify Ultrasonic Indicators can be used to verify the system performance. Verify All Clean monitors the effects of time, temperature, impingement and chemistry within an automated wash cycle and Verify Ultrasonic Indicators monitor the cavitation.

3: HIGH LEVEL DISINFECTION Medical devices classified as Semi–Critical according to the Spaulding classification must minimally be disinfected chemically by high-level disinfection. Semi-Critical devices contact, but do not penetrate mucous membranes and sterile areas of the body. Examples of these devices may be flexible endoscopes or ultrasonic probes used in diagnostic imaging. Revital-Ox Resert can be used to achieve high level disinfection following precleaning and following the manufacturer’s instruction for use. Resert is an aldehyde free product which is more desirable for patient and user safety.

4: STERILIZATION MONITORING Sterility assurance of processed instruments should be routinely verified using three (3) types of indicators; physical, chemical, and biological.

Chemical Indicators Chemical indicators should be used in every pack. Type 5 and Type 6 Chemical indicators (CIs) are the indicators of choice for a quality sterility assurance program. These indicators provide change color or show movement during the sterilizer cycle to verify that all sterilization parameters have been met for that specific cycle.

Biological Indicators Biological Indicator (BI) monitoring is a requirement for sterility assurance as BI’s contain bacterial spores that test the lethality of sterilizers. This is performed every day that the sterilizer is operational and for each load containing an implant. Incubation times range from 24 hours down to as little as 40 minutes for routine monitoring.

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