Tools for the Prevention of Retained Surgical Items

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2 Tools for the Prevention of Retained Surgical Items Verna C. Gibbs MD, FACS Professor - UCSF Dept of Surgery Surgeon - SFVAMC Director - NoThing Left Behind NoThing Left Behind

3 October 2004 NATIONAL SURGICAL PATIENT SAFETY PROJECT NoThing Left Behind

4 NoThing Left Behind Multi-stakeholder project Adoption of simple principles and if needed, technological adjuncts Development of an evidence base to inform policies and procedures that should be systematically applied Conduct research and clinical trials Individual site problem resolution NoThing Left Behind

5 GibbsVC, McGrath M, Russell T. The prevention of retained foreign bodies after surgery. Bulletin of the American College of Surgeons.

6 NEW POLICIES June JCAHO mandate: retained surgical item cases are a sentinel event An occurrence requires Root Cause Analysis (RCA) and reporting June 2006 Veterans Health Affairs - Prevention of Retained Surgical Items VHA Directive

7 PROGRESS 2007

8 PROGRESS

9 Retained Items: Instrument, Sharp, Sponge

10 PENNSYLVANIA

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12 RETAINED SPONGES Most common retained foreign body after surgery 22-85% of the time retention associated with correct sponge count Communication and Process of Care problem

13 RETAINED TOWEL Drapes NOT Dressings Different grade and quality of cotton No radiopaque marker Not included in the count Change practice or Purchase dressing quality towel with a marker Camazine, Contemp Surg 2005;61:398

14 TECHNOLOGY Primary focus of device industry is currently on sponges Electronic Article Surveillance (EAS) Two dimensional matrix labels (Barcode) RadioFrequency IDentification (RFID) Low frequency, hybrid versions, high frequency devices

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16 PLASTIC HANGING SPONGE COUNTERS Inexpensive system One sponge per pocket, Two sponges per pouch, Ten sponges per counter Blue radio-opaque marker visible Nurse initials counter when full of sponges MUST take final count from counters

17 ELECTRONIC ARTICLE SURVEILLANCE Fabian, Surgery 2005;137:298

18 TWO DIMENSIONAL DATA MATRIX LABEL (BARCODE) Sponges passed under reader and counted in at the beginning of case and then counted out at end of case Maintains line of sight, provides accuracy, FDA approved

19 SPONGE DETECTION RFID BUCKET RF WAND RFID ROOM Hardware Check in / Check out Scanners with receptacle Handheld Wand Multiple scanner and display system Handheld Wand Scanning / Counting Technology High Frequency (HF) Radio Frequency Identification (RFID) Low Frequency (LF) Electronic Article Surveillance (EAS) Very High Frequency Radio Identification Indicating Tags Unique ID and non-line of sight allows for detection and counting Binary response and non-line of sight allows for detection Unique ID pad on each item Multiple tag differentiation Built-in communication protocol handles many tags talking at once to be differentiated and counted Non-unique tags do not allow differentiation or counting Communication modules placed throughout room track tagged items Tag Safety / Security Measures Tags verified at check-in for function, proper quantity, and data integrity. Data encrypted to prevent counterfeit product. Not available with EAS technology Unknown

20 HYBRID RFID APPLICATION Passive tag without unique identifying signal (not a chip) Small tag fits many different sponges Visible and audible alert Yes/No signal

21 HYBRID RFID APPLICATION Disposable detecting wand Can scan garbage, receptacles in room Readout on console

22 Scan Procedure VERTICAL SCAN 6 passes, 3 seconds per pass 1. Position wand as close as possible parallel to body at Position With wand remaining parallel to body, move wand distally from Position 1 to Position Continue scanning through numeric sequence, at a rate of 3 seconds per pass. Passes 3 4 and 5 6 are performed with wand positioned on lateral sides of torso, parallel to the body. 4. Final pass w ill return w and from P osition 6 back to starting P osition 1.

23 Scan Procedure HORIZONTAL SCAN 10 passes, 3 seconds per pass 1. Place wand on lateral side of torso, parallel to body at Position With wand remaining parallel to body, move wand in arc to opposite lateral torso from Position 1 to Position Continue scanning through numeric sequence, at a rate of 3 seconds per pass. 4. Final pass will return wand from Position 6 back to starting Position 1.

24 CONSIDERATIONS Surgeon in control, no relying on the nurse Quick audible tone identifies sponges Small tag sewn into sponge, palpable Scanning process needs optimization Unknown capability in varying body sizes, different clinical situations Doesn t count the sponges

25 RFID TECHNOLOGY Used in millions of applications pet ID, gas purchases Passive RFID tags are microchips act as transponders Encapsulated and work with scanner

26 FIRST HUMAN TRIAL 28 RFID-tagged laparotomy pads placed in 8 patients during open abdominal procedures Handheld scanning wand passed over abdomen Sponges detected within 3-5 seconds 100% specificity and sensitivity Macario, Arch of Surgery 2006; 141:659

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28 BEST PRACTICE VS SMART PRACTICE Smart Sponges and SmartBucket device used to obtain electronic count = Smart Practice Hanging Counter Bags = Best Practice 30 cases, adult patients, anticipate >20 sponges will be used IRB Approval, patient written consent, nurses verbal consent OUT SCANNER IN SCANNER INVESTIGATIONAL DEVICE

29 RESULTS COUNTING OUT bucket interrogation 1355 SPONGES counted 160 times in 34 cases 1-18 times; 10 cases 2x, 4 cases >8x Every case count correct MANUAL count 7.9 MINS +/-15.5 mins DEVICE time 9 SECS +/-10 secs

30 CONSIDERATIONS NoThing Left Behind Investigational device, first clinical trial Good proof of principal, minimal risk and process development Accurately counts used sponges in very short time Minimizes handling of bloody sponges Bucket recently FDA approved

31 ClearCount SmartSponge System

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33 What is Veroscan? Systems Approach that Accurately counts and accounts for tagged consumables and tagged and untagged instruments Veroscan System and Technology: 1. RFID Correlating 2. Metal Detection 3. Scan Location and Guidance 4. ERP Integration Capable 5. Modular Upgradeable and Expandable

34 SAFER SURGERY NoThing Left Behind