Infection prevention and control guidelines

10. Reprocessing reusable medical devices

Record keeping

      1. Record keeping

Record keeping

After each cycle, the designated staff member reviews the printout or download (see Documenting reprocessing including steriliser cycles). The result (success or failure of the cycle) must be recorded in the steriliser log at the end of each cycle. The printout or datalogger result may be kept (eg for a month) for evidence and to assess trending temperatures and pressure. Printouts liable to fading need to be transferred to digital medium. Electronic downloads can be stored digitally.

The steriliser log (logbook/steriliser cycle book record) must be retained with the same requirements as a medical record Retain records for at least seven years from last entry. This period is in line with specific legislation relating to medical records and health information in New South Wales, Victoria and the Australian Capital Territory. . If the printer is faulty/out of paper, or if the data logger is inoperative or the data cannot be viewed, the load cannot released until the data are retrieved.

The log for each cycle contains all of the following data (Table 10.11. Sample steriliser log):

  1. Data recorded before the cycle by the loading operator:
  • date
  • cycle number
  • load type/description of each pack
  • cycle program selected
  • identification of loading operator
  1. Data recorded at the end of the cycle by the unloading operator:
  • whether the physical parameters have been met
  • whether internal/external chemical indicators received a pass result
  • whether packages meet criteria for conforming: correctly labelled, package and seal intact, and the Class 1 indicator is present with colour change
  • identification of the unloading operator.

Sterilisers without a printer or data logger are obsolete and should not be used.

Table 10.11. Sample steriliser log

Date1

Load no.2

Person preparing load (name or ID)3

Load contents description4

Time and temperature printout or Class 4, 5 or 6 chemical indicator5

Class 1 chemical indicator change6

Packs dry and intact7

Person releasing load (name or ID)8

Steriliser maintenance and repairs9

Comments (including name or ID)10

2/11/22

             

Cleaned, water changed

M Gale, Registered Nurse

2/11/22

1

H Hodder

3 x suture sets

4 x scissors

1 x excision set

Printout passed

3.5 min @ 134°C

Pass

Yes

J Ramirez

   

3/11/22

1

K Krane

6 x forceps

2 x scissors

Failed – load rejected

       

Printer broken (K Krane)

Load repacked and repeated with Class 6

chemical indicator (H Hodder, practice nurse)

1. The date of the steriliser batch or maintenance.

2. The load consecutively for each day (eg 2/11/22 load 1, 2, 3; 3/11/22 load 1, 2).

3. Identification of the person preparing the load.

4. Description of each pack in the load.

5. Time and temperature measurement obtained from either a printout of the cycle or a data log. The time and temperature must match the chosen parameters (eg 134°C for 3.5 minutes). If a printout or data log is unavailable or manual recording is not performed, a Class 4, 5 or 6 indicator must be used in each load and the colour change noted (eg ‘pass’ or ‘fail’). If different time and temperature parameters are used, these should be recorded. The printout or data can be kept.

6. A Class 1 indicator indicates exposure to heat, and must be included in each pack or, in the case of unpacked items, on the tray. The results of the colour change are noted (eg ‘pass’ or ‘fail’).

7. This is an essential prerequisite to releasing a pack or load for use. If a pack is moist or damaged, or the seal is not intact when it comes out of the steriliser, it is failed, repacked and resterilised. The results of the pack check are recorded (eg ‘pass’ or ‘fail’).

8. Identification of the person releasing the load.

9. Maintenance needs to be performed according to the manufacturer’s instructions. Refer to the steriliser operating instructions for details.

10. This column is also to record any pertinent information about the steriliser or load, including reason for rejecting the load, and any follow-up action. Both scheduled (eg daily cleaning, weekly water changes, annual calibration and servicing prior to validation) and unscheduled (eg printer repaired, heater element replaced) maintenance is outlined in this column.

Source: The RACGP Steriliser Record System (2019)


 

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