Batch Control Identification (BCI) with GKE
Batch Control Identification (BCI), also referred to as instrument tracking, is the process of assigning the steam steriliser’s cycle details to a ‘batch’ or group of packaged reusable medical devices (RMDs). This creates a definitive link between 1. the patient, and 2. the sterilised RMDs used on said patient in the procedure and offers sound evidence that the RMDs used came from a successful steam sterilising process.
BCI is a ‘Shall’ in AS5369:2023, which means all healthcare facilities including dental are mandated to implement a BCI system. The ADA Gudelines for IP&C (5th Ed.) state the same mandatory requirement. At a minimum, the steam steriliser identification number, the cycle number and the date of processing is recorded to the label, which is then adhered to the sterile barrier system (SBS), i.e. pouch or wrapped cassette prior*1 to the steam sterilisation cycle. BCI is mandated for critical RMDs*2 (used in surgical procedures) but not for semi-critical procedures – although you may consider labelling all your wrapped critical / semi-critical RMDs to identify all patients where a recall is required. Labelling all wrapped RMDs also reduces the risk of a missed critical RMD through error.
GKE’s documentation system is a low cost, simple to administer BCI system using rolls of ‘stickers’ (labels) with Type 1 process indicators, inserted to a label gun, allowing easy change of process details and quick attachment to the SBS – noting to place the label on the ‘plastic’ side of the pouch to avoid impeding air removal and steam penetration through the paper-side! The ‘piggy-back’ design of the adhesive labels allows details to be transferred to patient notes, with the Type 1 indicator a convenient chairside visual reference of process exposure.
The GKE logbook allows for the recording of the cycle details by adhering a label from the label gun alongside a description of the RMDs within the load. The logbook also incorporates space to adhere the Process Challenge Device (PCD) indicator for both the daily performance test3 (mandatory) as well as for batch monitoring of steam penetration (recommended). Should an adverse event occur with a patient, we can use the recorded details in the patient’s notes (steriliser identification number, the cycle number and the date of processing) to find the appropriate daily logbook entry as well as the steam sterilising cycle record or print-out. This links the RMDs used on the patient that day (description of RMDs in logbook) to a successful sterilising process. Environmentally friendly, all chemical indicators are protected from bleeding by a polymer binder and surface coating and can be disposed with normal garbage. They are also guaranteed to not change colour or revert during storage.
Talk to your Henry Schein Team Member about either implementing new or enhancing your existing BCI system to offer increased assurance and reduced workflow to your dental practice.
*1, *2 – AS5369:2023, 6.4.2 (vi)
*3 – PCD conforming to ISO 11140-6
Chris Jobson
Territory Manager and Dental
Market Specialist GKE Australia
chris@gkeaustralia.com