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This document discusses using RFID tags to track surgical instruments for improved patient safety and quality management. It describes: 1) The estimated annual death toll from medical errors and the need for improved data management and automated tracking systems. 2) Problems with current surgical instrument management and the proposal to use RFID tags to allow computerized, burden-free tracking of instrument use, quality assurance, and which medical staff used each instrument. 3) Test results showing RFID tags can withstand repeated sterilization cycles and maintain functionality when attached to instruments.
![Results of the tests
? Durability test
Malfunction, No communication : 0
? Contamination Test
¡ú£Á£Ô£Ð Method£ºLuminescence test
Tag attachment section£º38.7¡À6.1 [RLU]
Box-rock section£º39.8¡À6.0 [RLU]
?Meet the standard of ¡°less than100RLU¡± by
Japanese Association for Operative Medicine
?No breakage or separation of RFID tag](https://image.slidesharecdn.com/13rfidsurgicalinstrumentsyamashita-121217201628-phpapp01/85/GS1-RFID-9-320.jpg)
![Load Test of RFID Tag
1
0.8
¼ÓˆR[kN]
Load [kN]
0.6
0.4
0.2
0
1 137 273 409 545 681 817
Ó‹œyµã
Measurement point
Test material : 6 surgical instruments
Load : 0.9kN(9kgf), 10000 Cycles
¡úbreakage, drop out, no communication £º 0](https://image.slidesharecdn.com/13rfidsurgicalinstrumentsyamashita-121217201628-phpapp01/85/GS1-RFID-10-320.jpg)
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- 1. Identification of Surgical Instruments with RFID Kazuhiko YAMASHITA Tokyo Healthcare University Division of Healthcare Informatics k-yamashita@thcu.ac.jp
- 2. TOKYO SKY TREE I wanna be a first climber! Spring ,2012 Can¡¯t wait! Completion 634m
- 3. Patient Safety & Quality Management - An urgent problem for Healthcare - Estimate of the death toll caused by medical errors ? 98,000 / year in US by IOM report ? 23,000 / year In Japan by a report sponsored by MoH ?Collection of accurate and quantitative data (data management) ?Automated system for physicians, nurses, medical workers, and patients ?Building Evidence for medical safety
- 4. Problem of management on surgical instruments Medical errors at clinical sites Social problem ?Rate of incidents that surgical instruments or sponge are left inside human bodies £º 1 / 10000 operation ?Frequency of errors in setting containers £º 2% How frequently is the instrument used? Is quality assured? To whom is it used? Management of those items by RFID Computerized data management of surgical instruments £¨user friendly, burden free£©
- 5. Ceramic RFID tag for surgical instruments Carved seal ID ?Frequency 13.56MHz ?Diameter 6 mm£¬ thickness 2mm ¢ÙApplicable to metals£¬¢ÚLow dilatability ¡ú low trouble rate£¬¢ÛRigid ¡úlow damage
- 6. Results of basic tests on RFID Tag 1.sterilization test (cycle test)¡ú50 tags 30 min, pressure 1.5 kgf/cm2£¬50 cycles ¡útrouble rate 0 % 200 ¡æ, heating time 300 hours 2. High temperature challenging test¡ú20 tags ¡útrouble rate: 0 % 3. Water and ultrasonic test¡ú80 tags 28 kHz, 150 W, 30 min, 30 cycles ¡útrouble rate: 0 % 4. High pressure test ¡ú 10 tags average pressure value 126.2kgf, 150 cycles ¡útrouble rate: 0 %
- 7. Durability & Contamination Tests at medical institute ? Durability test by washer-disinfector ¡ú77 surgical instruments, 31 cycles ? Durability test by autoclave ¡ú68 surgical instruments, 15 cycles ? Contamination test by ATP method ¡ú35 surgical instruments£¨A pair of scissors, 7 Mosquito Clamps, 27 Kocher Clamps£©£ºAfter contaminated by sheep blood, cleaned by a washer-disinfector ¡úComparing Tag attachment section and Box- rock section
- 8. Durability/Contamination Tests Instruments in a washing Setting in sterilization basket container Washer disinfector Autoclave
- 9. Results of the tests ? Durability test Malfunction, No communication : 0 ? Contamination Test ¡ú£Á£Ô£Ð Method£ºLuminescence test Tag attachment section£º38.7¡À6.1 [RLU] Box-rock section£º39.8¡À6.0 [RLU] ?Meet the standard of ¡°less than100RLU¡± by Japanese Association for Operative Medicine ?No breakage or separation of RFID tag
- 10. Load Test of RFID Tag 1 0.8 ¼ÓˆR[kN] Load [kN] 0.6 0.4 0.2 0 1 137 273 409 545 681 817 Ó‹œyµã Measurement point Test material : 6 surgical instruments Load : 0.9kN(9kgf), 10000 Cycles ¡úbreakage, drop out, no communication £º 0
- 11. Tag Reader/Writer The movement of the instruments can be monitored by Reader/Writer under spread No need of intentional board for surgical instruments. motion for reading
- 13. Operation Room The reader/writer is equipped under the spread board for surgical instruments
- 14. Data to be written in RFID ? In accordance with Steel Instrument 2D Symbol Marking Guideline & GS1 Spec. (EPCglobal in the future) ? Data Structure : to be based on ISO/IEC15418 GTIN-14 (AI) (AI) Serial No. (8 digit) 01 0 45 1234567 123 0 21 12345678 Global standard a master data Common serial number of surgical instrument
- 15. Actual use for human surgery
- 16. Actual use for human surgery
- 17. Summary ? Developed RFID Tag for surgical instruments ¡úChecked the basic performance of the tag attached to surgical instrument ? Developed a reader/writer for operation room and central supply. ? Developed a basis of software for collecting data
- 18. Effects of surgical instrument with RFID Surgical instruments manufacturer Traceability, assist of individual management Central supply room Maintenance, washing Setting container and sterilization Increasing set Build evidence on of container, surgical instruments For medical staff burden free and patient safety Checking, number of Counting instruments times, keeping quality before, during, after of surgery, depreciation operation A system can check automatically, burden free on instruments count, management of asset in hospital increase quality of operation Operating room
- 19. ¡°Insanity: Continuing to do the same thing and expecting different results.¡± - Albert Einstein Contact us. Kazuhiko YAMASHITA: k-yamashita@thcu.ac.jp