- UHF reading needs no contact and no line of sight. One study measured 64.0 s against 190.4 s for barcodes on 41 instruments, with an experienced team.
- Reading 100% of the instruments inside a closed box is not possible. To guarantee 100%, the instruments are laid on a non-metallic table and read one by one.
- The tag has proven resistance to more than 1500 autoclave cycles at 134 °C.
- Several studies use high-frequency RFID. A UHF architecture needs its own validation of reading, proximity to metal and sterilization.
Article
RFID in sterile processing: what can and cannot be read
UHF reading identifies instruments without contact and without line of sight, but the result depends on how the instruments are laid out.
What UHF reading does
SureKits tags are RAIN RFID UHF Gen2, with 96 bits of EPC memory and GS1 EPC encoding. The instrument tag measures 5 mm x 1.8 mm x 1.3 mm and is read from 10 cm to 3 m, depending on the type of instrument.
Reading needs no contact and no line of sight. A Datamatrix engraved on the instrument is read one at a time, with the mark facing the reader, while RFID reads several items at once on the table. In a test with 41 instruments, RFID took 64.0 s and the barcode 190.4 s, with an experienced team. [2]
Why a closed box is not read in full
The metal of the box and of the piled instruments themselves disturbs radio reading. That is why reading 100% of the instruments inside a closed box is not possible.
The published numbers point the same way. In a test with 125 instruments, the full count happened in 2 of 4 tests, and in the other two 124 of 125 were detected. During surgeries, a study with 15 patients recorded 95% detection on a single pass and 100% cumulative, with electrocautery interference. [6] That result does not equal a complete reading on every pass.
How to guarantee 100%
A reliable count is made with the instruments spread on a non-metallic surface. In practice, this is solved in four ways:
- Non-metallic table. The instruments are laid on the table and read one by one, outside the box.
- ID50 collector. Identix handheld UHF RFID collector, used over the table in the operating room, in decontamination or in the supply room.
- DR-max reading table. Identix table for decontamination and assembly in the CME. The count can also be done by passing one or more instruments over it.
- Basket and load. The baskets that carry the instruments through the washer and sterilization also get a tag, and the basket is identified together with the load.
The tag and CME cycles
The proven resistance of the instrument tag exceeds 1500 autoclave cycles at 134 °C, and it withstands ultrasound and thermal disinfection. The tags go through laboratory tests, including compression and corrosion with accelerated aging on test specimens.
The tag and its method of application are patented so that it does not come off, which reduces the risk of a retained foreign object. Baskets and containers have their own tag, 50 mm x 15 mm x 3 mm, read from 2.5 m.
What high-frequency studies are worth for UHF
Several published studies use high-frequency RFID, at 13.56 MHz. SureKits uses UHF, and a UHF architecture needs its own validation of reading, proximity to metal and sterilization.
That applies to the numbers cited in this text. They show that counting time can drop with RFID in each setup studied, and they do not guarantee the same value at another hospital. The prudent path is to measure on the hospital's own kits and with its own team.
How to start
The hospital can start with simple counting using Identix RFID collectors and grow from there. The readings go to the CME software it already uses, through integration. SureKits handles identification and reading and is not CME management software.
Tags are applied at the hospital itself, without taking instruments out of the institution: no transport cost and no surgeries cancelled because of the application. RFID and Datamatrix work together, and the hospital can keep its own coding even if it does not follow GS1 or UDI.
There is no need to put RFID on every instrument at once. Coverage grows at the pace of the budget and the CME's priorities.
What is not proven yet
- Clinical outcomes. There is no robust study attributing to individual RFID on instruments a reduction in surgical site infection, mortality, retained objects or cancelled surgeries.
- 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.
- The manual count stays. AORN treats RFID as an aid to counting. None of the studies justifies dropping the manual count from the protocol without validation and approval by the hospital. [21]
- Brazilian rule. RDC 15/2012 requires the traceability of processing, including sterilization batches, and does not require individual RFID per instrument. [20]
Frequently asked questions
Can all the instruments in a closed box be read?
No. The metal of the box and of the instruments disturbs the reading. To guarantee 100%, the instruments are laid on a non-metallic table and read one by one.
Does the tag withstand the autoclave?
Yes. The proven resistance exceeds 1500 autoclave cycles at 134 °C, and the tag withstands ultrasound and thermal disinfection.
Do the RFID studies apply to UHF?
Several use high frequency. A UHF architecture needs its own validation of reading, proximity to metal and sterilization.
Do I have to send instruments out of the hospital?
No. Tags are applied at the hospital itself, without taking instruments out of the institution.
Does RFID replace Datamatrix?
It depends on the instrument. If it already has a Datamatrix, the two complement each other. If it has no marking, RFID gives it an identity without outside engraving.
Does SureKits replace my CME software?
No. It handles RFID identification and reading and integrates with the CME software the hospital already uses.
Sources
- 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
- Yamashita K, Kusuda K, Ito Y, et al. Evaluation of Surgical Instruments With Radiofrequency Identification Tags in the Operating Room. Surg Innov. 2018;25(4):374-379. doi.org/10.1177/1553350618772771
- Anvisa. Resolução RDC nº 15, de 15 de março de 2012, arts. 24 a 26. anvisalegis.datalegis.net
- Cochran K. Guidelines in Practice: Prevention of Unintentionally Retained Surgical Items. AORN J. 2022;116(5):427-440. doi.org/10.1002/aorn.13804
Want to test reading in your CME?
Tell us about your instrument flow and we will design a simple start with counting.