Tracking reusable medical devices for patient tracing

Tracking reusable medical devices for patient tracing

If there is sterilisation process failure or medicolegal issue relating to sterilisation in the practice, it will be important to identify which patients may be affected.

The practice must therefore set up a system to track which loads of medical devices (eg instruments) were used in procedures with which patients, in order to trace all the patients affected by a non-conforming (and therefore potentially contaminated) load. In some circumstances, traceability of a specific reusable medical device (eg instrument) may be required.

This system must link steriliser cycle batch information to patient identification, including the following information:

• date of sterilisation and sterilising process cycle number
• identification of the steriliser
• identification of the reusable medical device (name of device or name of set of devices) and the number of those items within the load
• identification of the person responsible for loading the steriliser
• other records such as results of performance tests (leak rate test, Bowie-Dick type test), results of chemical and biological monitoring undertaken for individual cycles or periodically, electronic or hard-copy evidence of physical parameters reached during the cycle
• identification of the person responsible for release of the sterilisation load.

The practice’s system could be based on either of the following:

• recording patient identification numbers in the steriliser log against the pack/pouch date and load number
• entering data from the steriliser log (eg batch, pack/pouch number) into patient medical records.

Some reusable instruments have a unique identification number, which can be electronically or manually recorded.

If a sterilisation process failure or other reprocessing failure is identified after the release of items for use, the practice must identify, recall and quarantine items in the failed load that may still be in storage or have been used. The practice must follow the recall procedure according to the current standard, The practice’s recall procedures are designed for situations that warrant recall of a reusable medical device (eg a surgical instrument), such as when evidence of failure of cleaning, disinfecting, packaging or sterilizing processes has been identified, or there have been problems during transport and storage of a reprocessed device. The procedures are designed to allow prompt recall, and should identify who is responsible for coordinating the recall, who should be notified, which information is to be included in a recall notice, and include a system of accounting for devices (ie how the number of recalled items is reconciled with records for how items were distributed). which includes notifying state/territory public health authorities. Next actions will depend on assessed risk, and may involve contacting all affected patients for testing and counselling, in consultation with health authorities. See also Criterion GP2.2 – Follow-up systems of the RACGP Standards.

In the case of a medicolegal issue, the ability to access documented validated and process details of the cleaning and sterilisation process used in any individual case would support the case that reusable medical devices were sterile at the time of use.

Requirements depend on the device use (Table 10.2. Spaulding classification – application to reusable medical devices). Under current standards applicable to office-based health care facilities not involved in complex patient procedures and processes, instruments used in semi-critical procedures/sites are not required to be sterile at the point of use. Batch control identification (identification and traceability) is not required.