Do the terms “tracking”, “tracing”, “traceability” and “batch control identification” confuse you? You are not alone. Even the experts have trouble agreeing on what these terms mean. Because we use these terms in relation to reprocessing (sterilisation) of Reusable Medical Devices (RMD) in dentistry and medicine, it is very important that we have a clear idea about their purpose.
Where do the terms come from?
The terms tracking and tracing have logistical origins.
Tracking is a process where you know where any item is at any time.
Tracing is being able to tell the history of where an item has been.
Why does it matter?
1. In the event of a failure in your reprocessing system you need to know how to do a recall of instruments (tracking) or recall of patients who were exposed to those instrument (tracing).
2. In the event of a patient acquiring an infection only attributed to their healthcare experience/treatment (HAI) then it is important to be able to determine whether reprocessing of RMD (tracing) played a part in the HAI.
[3. Accreditation requires these processes are in place because they are important aspects of safety and quality systems.]
Why is the confusion with terms?
Dentists traditional are more familiar with the term “batch control number” or “batch control indentification (BCI)” (AS 4815:2006). Using BCI, RMD are linked to a sterilization cycle batch (tracking) and if the RMD are used, then traced to a patient.
In newer AS/NZS 4187:2014 and National Standards (used in accreditation) the term “Traceability” is used instead of “tracking and tracing” or Batch Control identification. This is because traceability is no longer just concerned to items going through a steriliser “batch“, but include any RMD’s reprocessed in high level chemical disinfection system. Batch Control Identification is just considered a version of “traceability”.
Unfortuately ADA Guidelines for Infection Control (Third Edition) 2015 says that traceability has no place in dental practice!
Don’t misinterpret this statement.
The ADA guidelines make that statement about “traceability” ONLY because the ADA guidelines authors took a very specific view/interpretation of the meaning of “traceability”. In fact the ADA Guidelines fully supports the use of BCI, which is the form of traceability required by the standards for general dental practice.
The version of ‘Traceability‘ which is considered unnecessary by the ADA in dentistry involves high levels of instrument identification and high levels of tracing history. e.g. being able to trace individual instruments (laser or otherwise uniquely identified) each time they are used on patients and then each time they are reprocessed. Imagine the pointless data bloat if we traced the history of patient use and sterilisation cycles for each identifiable individual instrument, over a compulsory 7 year period. e.g. 10 instruments in your cons kit X 3 sterilisations per day X 3 patients treatment X 5 days per wk X 52 wks per year X each 7 years = 163800 individual records for one cons kit.
How traceable does traceability need to be?
“As a minimum, the traceability system shall be sufficient to enable the identification of a patient(s) where a nonconforming product has been used in an event that a recall is necessary.” [AS/NZS 4187:2014]
Procedures need to be in place to detect a nonconforming product before they are used on a patient.
A. What needs to be traced when we reprocess a RMD?
|AS 4815:2006||AS 4187:2014||ADA Guidelines||RACGP Standards!|
|R – Required
O- Optional but recommended
* Individually identifiable RMD if implantable and reprocessed
^ If undergoing high level chemical disinfection
# Semi-critical RMD are those that come into contact with mucous membranes or non-intact skin.
# Critical RMD are those that come into contact with the vascular system or sterile tissue and that shall be sterile at the time of use. e.g. surgical instruments.
! RACGP Standards for General Practice July 2017 (medical drs)
B. Where is the Traceability information recorded?
The Traceability system forms part of the release and quality assurance management of RMD. The system of traceability could vary depending on whether an electronic system or paper system is used.
Where to start
Any healthcare organisation who packages instruments can set up an extremely simple system for traceability and quality control.
A. Sterilisation log
All practices are required to keep a sterilisation log book. This can be a paper book; a paper log that is scanned into a computer; or an electronic logging system. The record requirements are the same in each case (see table). Each sterilisation load has a separate sterilisation load (or batch) number. This load number must be unique especially if you have more than one steriliser.
B. Recording information on the packaging of RMD’s
By recording the sterilisation cycle + date we have a link back to all the respective data on the sterilisation log for that cycle. The date helps us use the oldest pack first and if necessary an expiry date. The packaging staff member initals the pack so if the pack instruments are incorrect or nonconforming (not clean) then we can consult; educate and correct this process. The external chemical indicator allows the end user (dental practitioner) to check themselves as to whether the instruments went through the steriliser. The stage of examining and opening the package is a “release” phase in reprocessing and would be the responsibility of the operater or assistant.
(Est time to do this. 2 second with a self inking date and cycle stamp – cost $110 for 1000’s of prints)
C. Patient records
The steriliser cycle number is added into the patients records which will already include a date. This cycle information allows us to find the patient should a future recall of instruments from that particular sterilisation cycle occurs.
Time to do this: 2 seconds.
|Packages of RMD||Steriliser Log||Patient Record|
|Cycle Number||Cycle Number (unique)||Cycle Number|
|Date processed||Date processed||Date of use|
|Packing person||Load and release person/s|
|Contents * if not obvious due to packaging||Contents of load: RMD name or set and number|
|Chemical indicator||Parameters printout|
|Functional tests e.g. Bowie Dick/Helix|
Traceability can be simple or complex. You can trace each load or only critical instruments. The best, quickest and easiest system is one that is consistent for all instruments and staff at the practice.