Decontamination is the combination of processes (including cleaning, disinfection, and sterilization) used to make a re-usable item safe for medical use. It is important to have an understanding of the meaning of each of these terms as well as their application. Cleaning: a process to remove infectious agents and organic matter. The effectiveness of reducing microbial contamination will vary dependent upon the efficacy of the cleaning process and the initial bio- burden. It is important to note that this process does not necessarily destroy infectious agents and is a pre-requisite to disinfection and/ or sterilization. Disinfection: a process to reduce the number of viable infectious agents and which is commonly achieved either chemically or thermally. For some infectious agents (such as certain viruses and bacterial spores) it is not an effective method for inactivation and will not achieve the same level of reduction as is achieved through terminal sterilization. Sterilization: a process which renders an object free from viable infectious agents, including viruses and bacterial spores. Sterilization is achieved most commonly using a prescribed ratio of time, temperature, and steam or chemicals such as hydrogen peroxide, gas plasma, or ethylene oxide. The effective decontamination of re- usable medical devices is essential in reducing the risk of transmission of infectious agents with the chosen method of decontamination being detailed in the manufacturer’s decontamination guidance or instructions for use (IFU), supplied when a medical device is purchased. The guidance will reflect the validation that was carried out prior to the release of the product by accredited laboratories to ensure that the cleaning guidance is both effective and will not adversely affect the device. The aim of the decontamination process is to: 1. Reduce or completely remove microbial contamination to such a level that it is both safe to handle for staff and safe for further use on patients. 2. Ensure that there is no toxic chemical residue on the surface of the device that could cause adverse reactions when used on a patient. 3. Ensure that the decontamination process is compatible with the device and that it does not damage the device through the use of chemicals that can have an adverse effect on the device or by exposing it to either heat or water, which may cause damage.
The Turkish Medicines and Medical Devices Agency: Comparison of Its Registration Process with Australia, Canada, Saudi Arabia, and Singapore
