Question

discuss the importance of sterilization documentation and logging. mention recalls:

Answer 1

Sterilisation record for each cycle should be documented in paper or electronically . The following should be documented

Lot number

Content of load

Exposure time and temperature

Operator identification

Results of biological or chemical indicator testing (also the lot number,incubation time,expiry of the biological indicator)

Any inconclusive or non responsive indicator test results

Documentation of sterilisation is important because of the following reasons:-

1)In cases where patient files a case against the hospital for a postoperative infection, the sterilisation documents help to prove that the infection control practices of the hospital is well maintained.

2)In cases of prosthetic implant surgeries where the instruments has been contaminated with seropositive specimens or prions etc ,definite documentation of the sterilisation procedures done after the surgery has to be documented.This will be useful, if there is a case of post operative infection or sharp injury with such equipments later on.

3)In case of sterilisation with harmful gas such as ethylene oxide,definite documentation about the aeration time has to be documented, because patient can file a case telling that the toxic effect of the gas is responsible for his/her condition.

4) During auditing ,the sterilisation register is usually asked by the auditor to check whether the sterile supplies department is functioning as per norms.

5) Documentation is necessary to determine the reason for sterilisation failure.

When to do a recall

As soon as the biological indicator, turns positive,all load processed since the last negative biological indicator should be recalled.The purpose of recall is to retrieve the processed items that are suspected to be non sterile and to inform the clinician ,and for patient surveillance.Give information to the respective personnel and departments from where the instruments has to be retrieved before they reach the patient.To avoid recalls,ideally enough number of devices have to be available ,so that the devices can be quarantined till the result of biological is obtained.