CS Questions & CS Answers

Question: Often the sterile packages we receive from the sterile processing department are very warm. On occasion we have observed small amounts of moisture on the inside of some of our wrapped instrument sets. Our nurse manager claims it is ok to use these sets as long as the outside of the packaging is dry and shows no sign of contamination. I was always of the opinion that if moisture was present that the wrapped items are not sterile. If a wrapped set is only damp or moist on the inside but the outside is completely dry do you agree that the instruments are safe for use?

Answer: If moisture or any signs of wetness are found on the inside or on the outside of any wrapped sterilized goods they must be considered contaminated and should not be used. Moisture, whether on the inside or the outside, allows wicking, which may provide an avenue for microbial penetration and strike through which in turns contaminates the contents of the wrapped package. There is no sure way of knowing the source of moisture found inside, the pack may have been wet on the outside and dried before it was opened. Any wetness or dampness present in or on the outside creates doubt and the package and contents should be considered unsterile. Many years ago as a young student I still remember one of my mentors in the OR while teaching aseptic technique emphatically preaching "when in doubt – throw it out". Those words serve me to this day!!
After the sterilization cycle is complete there is still steam vapor in the packages. During cooling, the sterilizer cart should be left in the sterilizer with the door open or placed in a low-traffic area away from any HVAC vents until it is completely cool. Wrapped items that are still very warm should not be handled. Hot packs act as wicks when touched, and can absorb moisture and bacteria from hands. Transferring hot items to a cold cart can also cause the formation of condensation on the inside or exterior of the pack, which would result in a wet, contaminated pack. Warm items should not be handled, touched, or moved to another cart until they have completely cooled. For more information and documentation you may consult AAMI ST46, AORN recommended practices, and/ or the technical manuals published by ASHCSP and IAHCSMM.

Question: Are there any specific worker safety or infection control practices relative to the use, handling or disposal of biological indicators?

Answer: It is essential that you do have very specific and detailed policies and procedures relative to the storage, use, handling and disposal of biological indicators (BIs). You should obtain documentation and instructions for use from the manufacturer of the BIs you are using. Manufacturers usually include this information in each package when shipped. This information will guide you in the development of your hospital procedures. Most manufacturers recommend that BIs be cooled before crushing or handling. Excessive handling of hot BIs may cause the glass ampule to burst, which could result in personal injury and or exposure to contaminants. The use of safety glasses when crushing or handling BIs can minimize the potential of such risks. After completion of the sterilization cycle, the sterilizer door should be opened, leaving the sterilized goods and test pack inside for a minimum of 5 minutes to achieve adequate cooling. BIs contained in a test pack, or other absorbent materials, should be removed from the sterilizer in order to allow the heat to dissipate; the packaging should be opened allowing the BI to cool for another 5 minutes. The BI then may be removed and allowed to cool for another 10 minutes outside of the pack prior to further handling and crushing. When a BI is not contained in a test pack or absorbent material it should be allowed to cool for an additional 10 minutes after removal from the sterilizer prior to crushing. Most manufacturer’s recommendations for storage state that BIs should be stored in a dry, clean environment away from sterilants and other chemicals. Temperatures in the storage area should be controlled between 59 –86 degrees Fahrenheit with relative humidity (RH) between 35 – 60%. Disposal of used BIs should be in accordance with your specific hospital policy. You may choose to sterilize positive BIs prior to disposal. It is imperative that you use the appropriate BI for the method of sterilization you are using as well as the type of cycle. Often a different type of BI is required for pre vac and gravity cycles. This is especially the case with the rapid response BIs. Labeling should be observed for any expiration or shelf life dates, stocking, storage rotation procedures and inventory levels should be in accordance. Staff should be trained and demonstrate competence in all policies and procedures relative to the use of biological indicators.

Question: Are there any legal requirements for sterile processing technicians to be registered or licensed? If so what are the requirements for attaining such?

Answer: Presently there is only one state (New Jersey) that mandates certification for all sterile processing practitioners, technicians and managers. The state accepts and recognizes the certification credentials granted by the International Association of Healthcare Central Service Materiels Management (IAHCSMM) and The Certification Board for Sterile Processing and Distribution (CBSPD). Currently many other state CS associations are actively working with and lobbying their elected officials to develop state mandated certification or similar credentialing for sterile processing practitioners. Those of us in the field recognize the importance and need to require that individuals working in CPD must be educated, competent professionals. The NJ central services organizations have established rigid standards and worked diligently with the state’s health department and legislators to institute the certification requirements. You may get assistance and more information by contacting IAHCSMM and CBSPD. HPN

Ray Taurasi is Director of Professional Services for Case Medical Inc. Ridgefield, NJ.

August
2005