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Surgical instrument traceability: what RDC 15 requires and how RFID helps

Every sterile processing department has to trace what it processes, but tracing the box and tracing each instrument give different answers. Here is what the rule requires, what individual RFID adds and what the literature has measured.

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Published on November 7, 2026 · 8 min read

In short
  • Anvisa RDC 15/2012 requires traceability of processing, including sterilization batches. It does not require individual RFID on each instrument.
  • Tracing by box tells you where the box has been. Tracing each instrument tells you the history of each piece: where it went, in which surgeries it was used and through how many reprocessing cycles.
  • Studies with RFID on instruments measured faster counting and leaner kits. Each result holds for the arrangement of that study, not for any hospital.
  • There is still no robust study attributing fewer infections, fewer retained items or fewer breakages to individual RFID.

What RDC 15 requires

Anvisa RDC 15, of March 15, 2012, requires traceability of the processing of health products, including sterilization batches. That is the floor: the hospital must be able to show where the material has been.

The rule deals with the traceability of batches and does not require individual RFID identification on each instrument. Using individual RFID is a choice for those who want to go beyond the batch and know the history of each piece. [20]

Tracing by box or by instrument

Tracing by box or batch tells you where the box has been. Tracing each instrument tells you the history of each piece: where it went, in which surgeries it was used, through how many cleaning and sterilization cycles it passed and when it failed or was repaired.

For that, the RFID tag provides the identity, and each reading records which instrument, where and when. The rules and the full history stay in the sterile processing software and the hospital systems.

What individual RFID adds

With the identity of each instrument, the sterile processing department and clinical engineering can:

  1. Plan maintenance. Today, an instrument is usually replaced when it fails, sometimes in the middle of surgery. With the history of uses and cycles, inspection, sharpening and swap-out can be planned.
  2. Decide purchases from real use. Knowing which instruments are used, how often and in which surgery also shows what is left over and can leave the standard kit, always with the approval of the surgeons and the department.
  3. Investigate events. When a sterilization indicator fails or a batch is suspect, the infection control question is: which instruments, in which boxes, used on which patients? With individual identification, the answer comes from a record rather than a reconstruction.

What has already been measured with RFID

These results come from studies that used RFID on surgical instruments. Each one holds for the arrangement of that study.

  1. Counting 41 instruments. RFID 64.0 s against barcode 190.4 s, with an experienced team. Observed result. [2]
  2. Leaner kit (Duke, breast surgery). 25 of 62 instruments were removed from the kit (40.3%), and none of the 25 was requested in the next 10 surgeries. Implemented and measured. [7]
  3. Scissors service life (Japan). With records of 34,390 surgeries in 15 specialties between 2013 and 2017, it was possible to estimate the service life of 136 pairs of scissors: the probability of failure passed 50% after 169 uses and 80% after 224. It is a study of one center and one type of instrument, and the statistical fit was weak. [9]

What is still not proven

The list below comes from the Evidence and ROI page.

  1. Clinical outcomes. There is no robust study attributing to individual RFID on instruments a reduction in surgical site infection, mortality, retained items or canceled surgeries.
  2. Losses and breakage. There is also no demonstration of a causal reduction in losses, repairs or breakage. History data allow service life to be studied, but do not prove that alerts reduced breakage.
  3. Different technology, different result. Several studies use high-frequency RFID. A UHF architecture requires its own validation of reading, proximity to metal and sterilization.
  4. Manual counting stays. AORN treats RFID as an aid to counting. None of the studies justifies abolishing manual counting from the protocol without validation and approval by the hospital. [21]

How to start without complicating things

The hospital can start with simple counting using the Identix RFID collectors and grow from there.

The tags are applied at the hospital itself, without taking instruments out of the institution: no transport cost and no surgeries canceled for the application. Reading 100% of the instruments inside a closed box is not possible. To guarantee 100%, instruments are read one by one, laid on a non-metallic table.

SureKits delivers the identification and the reading: the tag on each instrument, the reading equipment and the record of which piece was read, where and when. This data feeds the sterile processing software and the hospital systems, which keep the full history. SureKits is not sterile processing management software and integrates with what the hospital already uses.

Frequently asked questions

Does RDC 15 require RFID?

No. RDC 15/2012 requires traceability of processing, including sterilization batches, but does not require individual RFID on each instrument.

What is the difference between tracing the box and tracing the instrument?

Tracing the box tells you where it has been. Tracing the instrument tells you the history of each piece: where it went, in which surgeries it was used and through how many reprocessing cycles.

Is SureKits sterile processing software?

No. SureKits is the RFID identification and reading layer and integrates with the sterile processing software the hospital already uses, which keeps the history and applies the rules.

Can all instruments inside the box be read?

Reading 100% inside a closed box is not possible. To guarantee 100%, instruments are read one by one, on a non-metallic table.

Do instruments have to leave the hospital to receive the tags?

No. The application is done at the hospital itself, without taking instruments out of the institution.

Does RFID reduce infections or instrument losses?

There is no robust study attributing that to individual RFID. What the literature measured was faster counting, checked assembly and leaner kits.

Sources

  1. Anvisa. Resolução RDC nº 15, de 15 de março de 2012, arts. 24 a 26. anvisalegis.datalegis.net
  2. Kusuda K, Yamashita K, Morishita E, et al. Comparison of Reading Times of RFID-Tagged and Barcode-Engraved Surgical Instruments. J Surg Res. 2024;304:121-125. doi.org/10.1016/j.jss.2024.09.087
  3. Olivere LA, Hill IT, Thomas SM, Codd PJ, Rosenberger LH. Radiofrequency Identification Track for Tray Optimization: An Instrument Utilization Pilot Study in Surgical Oncology. J Surg Res. 2021;264:490-498. doi.org/10.1016/j.jss.2021.02.049
  4. 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
  5. Cochran K. Guidelines in Practice: Prevention of Unintentionally Retained Surgical Items. AORN J. 2022;116(5):427-440. doi.org/10.1002/aorn.13804

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