Eliot L. Ostrow November 2005 Rev 0.0

1. IHE ElectrophysiologyEmergent/Urgent Implantable Rhythm Control Device (IRCD) Identification and Programming Eliot L. Ostrow November 2005 Rev 0.0

2. IRCD Emergency Room Problem Statement • Patients with implantable rhythm control devices (IRCDs, i.e., pacemakers and implantable cardioverter defibrillators) often present in emergency situations to physicians with no knowledge of the patient or of the specific device implanted (pacemaker or ICD, manufacturer, model number, etc). Frequently, the patient cannot identify the specific device either. This is a problem, particularly in cases where the nature of the emergency presentation requires immediate reprogramming of the IRCD (e.g., disabling shock therapies in an ICD delivering inappropriate shocks), because only the appropriate programmer from the appropriate device manufacturer can communicate with the IRCD. IHE EP

3. IRCD Emergency Room Problem Statement • At present, the clinician has three alternative ways to attempt to identify the IRCD: • X-ray the device, locate and decipher the ID tag • Contact technical services at each manufacturer of IRCDs and request that they query their patient registry to see if the patient has one of their devices • Attempt to interrogate the IRCD with each of the available programmers until one is found that will successfully communicate with the IRCD • Each of these alternatives is time-consuming, and a faster, simpler way to identify and program the IRCD in an emergency situation is highly desirable. IHE EP

4. IRCD Emergency Room-Potential Approaches • Universal programmer-A single programmer that could identify, interrogate, and program all pacemakers and ICDs, regardless of manufacturer • Universal IRCD interrogation and emergency programming functions-Each manufacturer’s programmer would have the capability to identify other manufacturers’ devices, retrieve limited information, and perform emergency programming (e.g., stat VVI, disabling of tachycardia therapies, etc.) • Universal IRCD identification in programmers-All programmers would have the ability to ID other manufacturers’ devices • Universal IRCD identification via incorporation of non-traditional technologies (e.g., RFID tags) into IRCDs IHE EP

5. IRCD Emergency Room-Potential Approaches • Unfortunately, each of the aforementioned approaches is beyond the current purview of IHE because they would require universal standards for device interrogation, programming, and/or identification that do not exist at the present time. • In addition, intercompany IRCD/programmer interrogation and/or programming is fraught with technical, legal, and business pitfalls that are not likely to be easily overcome • An approach using something like RFID tags would only work for newer devices with the technology incorporated, so would not present a universal solution for many years. IHE EP

6. IRCD Emergency Room-Proposed Approach • It would be within the purview of IHE to facilitate the development of a database system that would allow clinicians, in an emergency, to enter patient information and retrieve device identification information that would allow the correct programmer to be accessed without trial and error. IHE EP

7. IRCD Emergency Room Scenario • A patient presents to the emergency department of a community hospital in atrial fibrillation, as a result of which he has received, and continues to receive, inappropriate shocks from his ICD. The patient is unknown to the E.D. physician, does not know what type of IRCD he has, and does not carry his manufacturer-issued ID card. • The physician, after placing a magnet on the ICD to inhibit further shock delivery, logs into a password protected ACC-operated Internet website, acknowledges the HIPPA requirements for emergency access to patient information, enters the patient’s last name and Social Security number, and requests device information. After a brief wait, the manufacturer’s name and device model number are displayed on the screen. The physician logs out of the Website, retrieves the appropriate manufacturer’s programmer, and proceeds to interrogate the ICD and reprogram it as required. IHE EP

8. IRCD Emergency Room Profile Diagram IHE EP

9. IRCD Emergency Room Profile Actors • Patient Identification Databases-Databases maintained by each IRCD manufacturer, containing subset of complete patient registration databases with information required to match patient and device identification data • Query Engine-Processes request for information, queries Patient Identification databases, and collects results of query • Physician Portal-Website that manages access to query engine, accepts patient identification input, and displays query results IHE EP

10. IRCD Emergency Room Transactions • Transmission of entered patient information-Passage of clinician-input patient identification to query engine • Request for patient/device match-Query engine queries patient identification databases for device information associated with input patient identification data • Database search-Patient identification database searches for patient/device match in response to query, reports results back to query engine • Query response-Query engine sends query results to physician portal for display IHE EP

11. Phased Approach • Short Term • Implementation of steps to facilitate web-based databasing approach to IRCD identification • Mid-Term • Exploration of feasibility of RFID or similar approach • If feasible, request standards development • Long Term • Explore technical, legal, business feasibility of universal interrogation and/or universal emergency programming • If feasible, request standards development IHE EP

12. Open Issues • Is there a way to make the database approach to device identification HIPPA compliant? • Is there an interest on the part of ACC, HRS, AMA, or a similar organization to sponsor a web-based approach? IHE EP