Medical Device Sterilization

Medical Device Sterilization


Sterilization can not only kill disease causing microorganisms but also eliminates transmissible agents such as spores and bacteria. It achieves this through the use of Sterilants such as radiation, chemicals, heat, etc.

Different methods of sterilization

Sterilization methods remove or destroy all forms of microbial life including bacterial spores by either physical or chemical processes. Sterilization is accomplished principally by steam under pressure, by dry heat, and by chemical sterilants. The choice of the method for sterilization depends on a number of factors including the type of material that the object to be sterilized is made of, the number and type of microorganisms involved, the classification of the item, and availability of sterilization methods.

NOTE:

  • Boiling and flaming are not effective sterilization techniques because they do not effectively kill all microorganisms.
  • Large health care facilities should have more than one type of sterilization system in case of power outage, equipment failure, or shortage of supplies

Listed below are a few industry recommended practices for Sterilization

  1. Effective sterilization cannot occur without effective cleaning. The process of sterilization is negatively affected by the amount of bioburden and the number, type, and inherent resistance of microorganisms on the items to be sterilized. "Cleaning" the device prior to the sterilization process, will remove any soils, oils, and other materials that may shield microorganisms on the device from contact with the Sterilant.

  2. Utilizing appropriate packaging (as per industry standards) ensures that sterility can be achieved and maintained to the point of use.

  3. Sterilized materials should be packaged, labeled, and stored in a manner to minimize exposure to moisture, dust, temperature, humidity, handling, etc and thus ensure sterility. Each item should be marked with the sterilization date.

  4. Transportation of sterile devices needs to be controlled, since it is dependent on the amount of handling, external conditions, packaging quality and other factors.

  5. Sterilization records have to be maintained as per specifications of health care organization's policies and in compliance with local, state, and federal regulations. Documentation should include: the assigned lot number, contents of each load, and results of physical, chemical, and biological monitors.

  6. Policies and procedures for sterilization processes should be developed, reviewed periodically, and readily available in the practice setting.

  7. Quality control programs that enhance personnel performance and monitor sterilization efficacy should be established to promote patient and employee safety.

This information was provided by Sterilization Validation Services, a Division of Life Science Outsourcing, Inc. For more information visit www.lso-inc.com/svs