DELIVERING FAST EFFICIENT SPONGE DETECTION SITUATE DELIVERY SYSTEM

The Situate Delivery System The Situate delivery system is a powerful delivery room safety tool, designed as an adjunct to manual counting techniques, that helps detect missing sponges within seconds. The user-friendly interface offers on-screen prompts to ensure compliance and clearly indicates the presence or absence of remaining sponges.

LABOR & DELIVERY THE DATA ON RETAINED FOREIGN OBJECTS

RFOS IN VAGINAL DELIVERY A SENTINEL EVENT Healthcare Protocol: The Joint Commission categorizes the unintended retention of a foreign body after a vaginal delivery as a sentinel event. This categorization requires healthcare organizations to conduct a root cause analysis and to develop a corrective action plan designed to reduce the probability of a repeat occurrence. 1. Ins'tute for Clinical Systems Improvement (ICSI). Preven'on of uninten'onally retained foreign objects during vaginal deliveries. Healthcare protocol. Bloomington (MN): Ins'tute for Clinical System Improvement (ICSI); 2012 Jan. 34 p.

RFO INCIDENCE VAGINAL DELIVERY 22% of all retained sponges are left in the vagina. 1. Gawande AA, Studdert DM, Orav EJ, Brennan TA, Zinner MJ. Risk Factors for Retained Instruments and Sponges after Surgery. New England Journal of Medicine 2003;348(3):229 235.

RETAINED SPONGES IN VAGINAL DELIVERIES Potential causes 1. Protocol execution is challenging 2. No counting protocol in place 50 Contributing Factors to RSI in L&D 1 Methods of Count Protocol 1 40 30 20 No Count Protocol 29% AORN 31% 10 0 Quality/Design of L&D Count Protocol Execution of L&D Count Protocol Angle/Depth of sponge in vaginal canal Other ACOG 39% Other 1% Not a Factor Possible Factor Strong Factor In the majority of instances, the facility reported there was no policy for wound sweep or counting sponges/gauze used during vaginal delivery and subsequent repair of episiotomy or tearing. Since the sponge/gauze is used to dam the flow of blood, it may be placed higher in the vagina and not be visible following the suturing. 2 1. Labor & Delivery Project: VOC Research. Market Research. RF Surgical Systems, Dec 2013. 2. Quality & Safety Winter 2011, Vol. 5, No. 1, p. 4

LABOR & DELIVERY MEETING THE CHANGING PROCEDURAL NEEDS

MEETING THE CHANGING PROCEDURAL NEEDS! Supports lithotomy position - Situate Delivery System is designed for scanning of patients in lithotomy position! Patient-friendly design - If the patient is conscious, they can observe the detection procedure taking place - Design of the wand may appear intrusive to new mother and infant! A flexible solution - Hospital can design protocol anytime from when the delivery is completed to when the new mother is recovering Detection Area for Vaginal Delivery

SITUATE DETECTION TECHNOLOGY 101 WHAT IS IT? HOW DOES IT WORK?

THE POWER OF DETECTION The Situate system is a proprietary technology, developed as an adjunct to manual counting techniques, to overcome the difficulty of finding a surgical sponge in vivo and in the surrounding operating room. The Situate System advantage Situate Detection Technology has three unique features that make it a solution for the L&D Suite: 1 2 3 Low energy radio frequency Unlike conventional RFID technologies, low frequency maintains its signal strength through dense tissue, blood and bone as well as near metal, making it an optimal solution for in vivo detection. 1,2 Environmental compatibility Situate Detection Technology filters the electrical noise found in modern L&D suites and meets the IEC; medical electrical equipment general requirements for basic safety for electromagnetic compatibility. Extended reach Complementing scanning components allow for detection outside the patient and across the L&D suite itself. 1. Steelman et al 2001, Amer J Surg 2. Rivera et al. ASSIST - Automated System for Surgical Instrument and Sponge Tracking, 2008 IEEE International Conference on RFID The Venetian, Las Vegas, Nevada, USA April 16-17, 2008

SITUATE DETECTION TECHNOLOGY IN THE OPERATING ROOM Innovation: New 3-coil array design utilizes the coupling principle RF Tag embedded in sponge/ gauze/towel Eliminates the need to move the scanner in a pattern to achieve proper alignment with the RF Tag

SITUATE DELIVERY SYSTEM PLATFORM OVERVIEW

SYSTEM OVERVIEW Situate Delivery System Situate Console Situate Delivery Scanner Situate Premium Cotton

SITUATE DELIVERY SCANNER! Portable scanner that detects and helps locate sponges! Orb design is less obtrusive to conscious patient! Merges functional advantages of the wand and mat of the Situate Detection System into a single L&D-specific configuration Delivery Scanner is used as an adjunct to manual counting

SITUATE CONSOLE, MODEL 200 LD-V Workflow Guidance, Recordkeeping, and Device Control User-friendly interface that delivers real-time feedback and data capture Interactive Graphical User Interface Patient Scan Static Mode Room Scan Dynamic Mode 1. On-screen prompts that guide compliant workflow 2. Allows OR staff to reconcile inaccuracies before case closure, preventing readmissions 3. Unique confirmation codes for convenient EMR entry

DELIVERY STAND Portable for ease of transport across multiple Labor & Delivery suites! Provides storage for the Situate Delivery Console and Delivery Scanner Base Area (secure attachment of Situate Console) Holster (storage for Situate Delivery Console)

SCANNING/ DETECTION MODES OF OPERATION & SCANNING STEPS

SCANNING: 3 EASY STEPS (PATIENT SCAN SHOWN) Step 1: Position the Delivery Scanner in contact or within 1 of the pubic bone Step 2: Press Start on the touch screen Step 3: If scan is clear, record the confirmation number after the scan completes (~35 secs) Note: If detection occurs, re-count, search, re-scan until scan is clear.

MODES OF SCANNING Situate Delivery System has 2 scanning modes: Patient Scan Static Mode Room Scan Dynamic Mode! Scan takes approximately 15 seconds to complete! Delivery Scanner is held in a stationary position in contact or within 1 of the pubic bone (no movement required)! Scan alerts user immediately if a RF tagged disposable (gauze, sponge or towel) is within 8 of the Delivery Scanner! Hospital staff moves the Delivery Scanner around the surrounding area of the Labor & Delivery suite in search of the sponge

PATIENT SCAN SCREENS Patient Scan Static Mode optimizes the user experience because the scanner is held in place and no motion pattern is required Prior to Scan While Scanning Progress bar Progress bar shows the status of the scan. Lets hospital staff know how long before the scan finishes (~ 15 seconds).

ROOM SCAN SCREENS Room Scan Dynamic Mode enables scanning for missing sponges for faster count verification within the Labor & Delivery Suite Prior to Scan While Scanning Alleviates the hospital staff from unnecessarily searching through a disposal container unless a missing RF Tagged sponge/gauze has been detected ahead of time.