Sterile Services Legislation, Standards, and Risk Assessment - Essay Example

If sterile services standards are not met, the final product may carry great risk to the patient when it is administered, due to the possibility of microbial contamination.
The design of the sterile services department facility must be perfect in every detail to prevent microbial contamination of the area and the products. The entryway must be set up to prevent unauthorized persons from gaining access and to stop workers from entering while wearing improper or insufficient protective clothing since this traffic would bring outside contaminants into the sterile area. There must be space to separate sterilized equipment from contaminated equipment so that no microbial cross-contamination occurs. Washrooms and changing rooms must be available to the staff and set up so that workers' outside clothing never comes into contact with their sterile gear (Sterile Services 2004).

Due to the strenuous nature of these and dozens of other requirements, many hospitals, and medical offices now choose to obtain their sterile equipment through a commercial retailer rather than have their own sterile services department on-site (Lawrence & May 2003). This is preferable for patient safety than a medical center that attempts to make use of sub-par facilities, as all of the above standards are in place to ensure that contamination by bacteria, viruses, other microbial life, and debris is kept to an absolute minimum.

The work in a sterile services department is usually performed inside of a clean room, which is kept as isolated as possible from the outside air. Cleanroom standards cover nine classes with varying permitted levels of particulate matter in the air (ISO 1999). The level of particulate matter in the air is used to calculate the possible amount of microbial life present in the cleanroom facility, as well as dust and other contaminants such as ski and hair. (Rousseau 2004). It is monitored by a discrete-particle counter, which can detect particle diameters anywhere between 0,1 and 5 μm to aid in determining the ISO cleanroom class of the facility (Schicht 2003).

A sterile services department is required to contain the necessary equipment to disinfect medical products in an approved manner, following a validated sterilization process; the preferred method is steam sterilization (Russel, Hugo, & Ayliffe 1999). Steam sterilization is used because it is non-toxic and provides the most effective method for destroying many types of microbial life. Unfortunately, many contemporary surgical tools and medical devices are made of plastic, and would not survive a steam sterilization cycle. These items are decontaminated with a low-temperature method, such as acid immersion (HIPAC 2008). Because many medical devices are considered a critical risk, designed to come in contact with a patient sub-dermally, it is vitally important for a sterile services department to keep their sterilization equipment in perfect working order. The sterilizer itself must be tested daily to ensure it functions properly and completes an entire sterilization cycle, weekly for safety and function, and annually by a testing technician to check the sterilizer against manufacturer specifications (Lawrence & May 2003).

These tests help the sterile services department ensure that their sterilizer is actually removing the microbial load.
Since the margin for error with sterilization is so narrow, a sterile services department must also ensure all incoming utilities, especially steam, meet the appropriate standards for contamination. Steam sterilization must be done with clean steam, defined by US Validation “meeting specifications established by...the US, British and European[s]” if the steam passes a test at “less than or equal to 10 [colony forming units]/100 ml” (US Validation), or with pure steam, which is of an even higher level of sterility. The use of microbial monitoring confirms that the steam being used is actually of clean or pure quality so that no unexpected contamination occurs by exposure of the items being cleaned to the steam. Read More