QUALITY SOLUTIONS, INC.

MEDICAL DEVICE STERILIZATION CONSULTING

The Need For Sterilization Consulting

All manufacturers of sterile medical devices are responsible for validation and constant monitoring of the sterilization process. Whether they sterilize in-house, or with an external contract sterilizer, the responsibility for assuring that process output consistently meets its predetermined specifications remains with the manufacturer; it cannot be delegated. Compliance with international sterilization standards, therefore, is critical for the continued success of the manufacturer.

The vast assortment of medical devices currently manufactured presents an infinite number of unique product/packaging characteristics all of which must be identified and evaluated for their potential to affect the sterilization process. Starting with the concept of a new device and continuing throughout its development and production, the manufacturer must make continuous critical evaluations such as: 

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  • design specifications and use of cleanrooms;
  • routine monitoring and control of manufacturing equipment and the environment;
  • biocompatibility of select materials;
  • compatibility of device design, construction, and packaging with available sterilization methods - ethylene oxide, gamma, electron beam, steam;

No standard could ever be written so as to specifically address each and every medical device. As a result, process validation and control requirements are written in a generic fashion. Manufacturers are then responsible for taking these 'general-purpose' requirements, correctly interpreting their intention, and applying them on a case by case basis to each and every device they intend to manufacture. To successfully do this requires an intricate understanding of the regulations and this can only be achieved through experience.

Quality Solutions, Inc., and its network of affiliated consultants, offers technical services covering all facets of medical device sterilization and the related laboratory services. Our knowledge and training come from direct industry experience as well as extensive involvement in AAMI standards committees. Whether a manufacturer wishes to construct an in-house sterilization operation, retrofit an existing sterilizer, arrange the selection and validation of an external contract sterilizer, or routinely monitor sterilization services, our experience in these fields assures that the quality of process output receives top priority. Being hired directly by the manufacturer, there is no chance that we will suggest anything but what is best for the manufacturer.

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