SureKits
Individual traceability: every instrument with its own history
When each instrument has its own identity, the CME, infection control and purchasing decide with data. We explain what that allows, what the literature has shown and where the limits are.
What individual traceability is
Tracking by box or by batch says where the box has been. Tracking each instrument tells the history of each piece: where it went, in which surgeries it was used, through how many reprocessing cycles it passed and when it failed or was repaired.
The RFID tag gives the identity, and each reading records which instrument, where and when. The rules and the full history live in the CME software and the hospital’s systems, which SureKits integrates with.
Where it is
In which box, in which room, at which step of the cycle.
What it went through
In which surgeries it was used and through how many cleaning and sterilization cycles.
What state it is in
When it was inspected, repaired or taken out of use.
The difference: "where is the box?" gives way to "what is the history of this piece?".
Preventive maintenance: predict before it breaks
Today, an instrument is generally replaced when it fails, often in the middle of surgery. With the history of uses and cycles of each piece, the CME and clinical engineering can plan inspection, sharpening and renewal.
One study shows the way. At a Japanese center, records from an RFID traceability system, covering 34,390 surgeries in 15 specialties between 2013 and 2017, made it possible to estimate the service life of 136 scissors. The probability of failure passed 50% after 169 uses and 80% after 224.
Benefits
Fewer surprise failures during surgery, scheduled inspection and sharpening, and data to take up with the instrument supplier.
Limits
It is one center and one type of instrument, and the statistical fit was weak. The study does not show that alerts reduced breakage.
Care
Use limits vary by type, brand and way of use. They must be defined and validated by the CME and clinical engineering, never automatic.
Demand forecasting and supply
Knowing which instruments are used, how often and in which kind of surgery turns purchases and restocking into decisions based on real use.
Real use also shows what is left over: instruments that are almost never used can leave the standard kit. In the Duke study, 25 of 62 instruments in a kit were withdrawn after clinical validation. See the Evidence and ROI page.
Benefits
More precise purchases and restocking, right-sized kits and less reprocessing of pieces nobody uses.
Limits
The history reflects the period measured. Changes in team, technique or case mix alter use, and a sufficient sample is needed.
Care
Every withdrawal of an instrument from a kit goes through approval by surgeons and the CME.
Infection control: tracing contamination events
When an event happens, such as a failed sterilization indicator, a suspect batch or an exposure of patients, the infection control question is: which instruments, in which boxes, used on which patients? With individual identification, the answer comes from a record, not from a reconstruction.
The literature shows the cost of not knowing. In a CDC review of 19 incidents in which patients were exposed to instruments potentially contaminated by prions, the contaminated sets could not be identified in 11 of the 19 hospitals (58%). In several, there were many neurosurgical sets, and every patient operated on in the period had to be notified.
Benefits
Faster investigation, notification limited to those really exposed and a record for audit.
Limits
Traceability does not prevent contamination and a reading does not prove sterility. It depends on reading at every step and on keeping instruments within their sets.
Care
Linking instrument to patient creates personal data. Handling must follow the LGPD and hospital rules.
Tracing does not replace cleaning and sterilizing well. It lets the hospital know, in minutes, how big a problem is.
Prion diseases and discarding instruments
Prions resist the usual cleaning and sterilization processes. That is why instruments used on high-risk tissue (brain, spinal cord and eye) of patients with suspected or confirmed Creutzfeldt-Jakob disease call for specific decontamination protocols, or discard.
International recommendations include immersion in sodium hydroxide followed by autoclaving, quarantine while the diagnosis is not settled and, for delicate instruments that do not withstand those processes, treating them as single-use. When the sets used cannot be identified, the CDC review suggests treating all neurosurgical sets with the protocol, particularly those that went through fewer than 10 cycles.
Transmission through instruments is rare. The CDC review reports six cases, from the late 1950s to 1976, linked to contaminated neurosurgical instruments and electrodes, and no known case in ophthalmologic procedures.
What individual identification allows
Finding at once the instruments of a suspect case, quarantining them, counting each one’s cycles and recording decontamination or discard, piece by piece.
What it does not do
It does not decide the discard nor define the protocol. That decision belongs to infection control and the clinical direction, following the current rule and Anvisa guidance.
Limit of the evidence
We found no study showing that individual tracking reduces infections. NICE lists the cost-effectiveness of keeping sets traceable as a subject for research.
In extreme situations, individual identification spares the hospital from discarding everything because it does not know which piece was used.
Benefits and problems, side by side
An honest view helps decide. These are the gains and the difficulties that the literature and practice point to.
| Topic | Benefit | Problem or limit |
|---|---|---|
| Maintenance | Plan inspection, sharpening and renewal by real use | Use limits need validation; one study at one center |
| Demand | Purchases and kits based on use | Depends on a sufficient sample and clinical approval |
| Infection control | Fast investigation and limited notification | Needs reading at every step; patient data call for the LGPD |
| Prions | Find, isolate and record the discard, piece by piece | It does not decide the protocol; no study of impact on infections |
| Technology | Fast reading, no line of sight | Metal and closed boxes limit reading; the tag must withstand reprocessing |
| Adoption | Data that does not exist today | Investment, routine change and staff training |
What SureKits delivers
SureKits delivers identification and reading: the tag on each instrument, the Identix reading equipment and the record of which piece was read, where and when. That data feeds the CME software and the hospital’s systems, which keep the full history and apply infection control rules.
Sources
The numbers and recommendations cited come from these sources. Always check the rule and the guidance currently in force at your hospital and from Anvisa.
- Belay ED, Blase J, Sehulster LM, Maddox RA, Schonberger LB. Management of Neurosurgical Instruments and Patients Exposed to Creutzfeldt-Jakob Disease. Infect Control Hosp Epidemiol. 2013;34(12):1272-1280. doi.org/10.1086/673986
- Rutala WA, Weber DJ. Guideline for Disinfection and Sterilization of Prion-Contaminated Medical Instruments. SHEA, 2010. doi.org/10.1086/650197
- Yoshikawa T, Kimura E, Akama E, et al. Prediction of the Service Life of Surgical Instruments from the Surgical Instrument Management System Log Using Radio Frequency Identification. BMC Health Serv Res. 2019;19:695. doi.org/10.1186/s12913-019-4540-0
- NICE. Reducing the risk of transmission of Creutzfeldt-Jakob disease (CJD) from surgical instruments used for interventional procedures on high-risk tissues. www.nice.org.uk/guidance/htg535
- Olivere LA, Hill IT, Thomas SM, Codd PJ, Rosenberger LH. Radiofrequency Identification Track for Tray Optimization. J Surg Res. 2021;264:490-498. doi.org/10.1016/j.jss.2021.02.049
- WHO. Infection Control Guidelines for Transmissible Spongiform Encephalopathies. WHO/CDS/CSR/APH/2000.3, 2000. www.who.int/publications/i/item/WHO-CDS-CSR-APH-2000.3
Want to discuss your case?
Tell us how the CME and infection control work today and we will show what individual traceability changes in practice.