3M 290 manual Positive Control, Interpretation of Results, Disposal, Instructions For Use

INSTRUCTIONS FOR USE

Positive Control

Crush, tap and incubate at least one non-processed Attest 1291 or 1292 RRBI to use as the positive control each day that a processed RRBI is incubated and read by the unit. Write a “C” (for “control”) and the date on the label. The positive control can be placed in any incubator well of the unit. The positive control should be the same part number, from the same manufacturing date and lot number as the processed RRBI in the unit.

It is good practice to use a positive control each day a sterilized RRBI is processed. This helps ensure:

-correct incubation temperatures are met.

-viability of spores has not been altered due to improper storage temperature, humidity, or proximity to chemicals

-capability of media to promote rapid growth, and

-proper functioning of Attest 290 Auto-reader components.

Interpretation of Results

Each incubation/reader well has three corresponding indicator lights: a red (+), yellow (•) and green (-) light. After placing a RRBI into a corresponding color-coded well, a yellow light will illuminate to indicate that incubation/reading is in progress.

A red light (+), will illuminate and an alarm will sound (if the sound feature is turned on), as soon as a positive RRBI result is detected.

At the end of the specified incubation time, if a negative RRBI result is detected, the green light (-) will illuminate indicating an acceptable sterilization process.

After either the green or red light comes on, the RRBI can be removed from the well. The RRBI should not be removed or touched when the yellow light is on.

The positive (unprocessed) control RRBI must provide a positive fluorescent result (red light +). Processed RRBI results are not valid until the positive control reads fluorescent positive (red light +). With the processed RRBI, a positive (red light +) result means a sterilization process failure may have occurred.

The final negative processed RRBI reading for a fluorescence change (green light -) after 1 hour (1291) or 3 hours (1292) indicates an acceptable sterilization process. The positive control should read positive (red light +).

If the processed RRBI is further incubated for a visual pH color change, when special studies are desired, the media color change from purple to yellow will also indicate a sterilization failure. The positive control should show a yellow color change at 24 hours (1291) or 48 hours (1292). A final negative color change result (no color change), media remains purple , is made at 24 hours (1291) or 48 hours (1292).

Act on any positive result immediately. The positive result indicates a sterilization process failure may have occurred. Determine the cause of the positive RRBI following current facility policies and procedures. Always retest the sterilizer and do not use the sterilizer for processing loads until 3 consecutive RRBI results are negative.

Disposal

Dispose of the used Attest RRBI according to your healthcare facility policy.

You may wish to sterilize any positive RRBI prior to disposal.

3M © 2003 78-8078-8977-5 Page 6 of 9 Attest 290 Auto-reader