Policies and Regulations - Information Letter 90-97-4

90-97-4 Biological Monitoring Sterilizers

IL 90-97-4
December 31, 1996

Office of Acquisition and Materiel Management Information Letter

1. There has been a lot of discussions and questions on the biological monitoring of sterilizers in the Department of Veterans Affairs (VA), medical centers.   The purpose of this letter is to assure that the policy outlined in VA Directive 7176 is understood and that all items sterilized in VA medical centers are properly monitored.
2. All sterilizers used in VA medical centers for patient care items are to be biologically monitored at least once each day that they are used.   This include steam, ethylene oxide, plasma, chemical and gas sterilizers.   A biological monitor must be processed in each cycle containing an implant.
3. The biological monitors will be processed according to the manufacturer's recommendation, but will at least be recorded as follows:
   1. All biological monitors will be kept in the incubator and results recorded at 48 hours regardless if a reading was taken at 3 hours or 24 hours.   The records of these readings will be kept with other sterilization records for 3 years.
      
      NOTE:   The rapid readout biological may be used in the prevac steam sterilizers with wrapped supplies.   A reading may be taken at 3 hours and the results must be recorded.   However, another reading must be made at 48 hours and must be recorded.   Rapid readout biological monitors are not to be used in flash sterilizers.   Flash sterilizers are to be used in an emergency when other methods of sterilization are not available.   (If you can hold the item sterilized for 1 hour, it must be sterilized in a package.)
      
      
   2. All implants will be held for the 48 hour recording.   If it is necessary to obtain an early release from the Chief of Staff for an implant to be used in an emergency, the result of the 3 hour reading may be recorded on the request form if the rapid readout biological is used.
   3. A biological control will be processed each day and the results must be recorded each time the test results are recorded.   The control must have the same lot number as the test biological.
   4. All biological monitors will be stored and handled according to the manufacturer's recommendation.   Some biological monitors may require storage in a refrigerator.
4. This information will be incorporated into the next revision of VA Handbook 7176.
5. If you have any questions, please contact Bobby Osburn at (202) 273-6117.

/s/Charles E. Roberson
Associate Deputy Assistant Secretary
for Program Management and Operations (Logistics)

Distribution:   RPC 7060