Implant/Device Interoperability: Establishment of a National Database

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Implant/Device Interoperability: Establishment of a National Database

Workforce Analysis

Implant/Device Interoperability: Establishment of a National Database

Introduction - At the current time, no national database/registry exists in the U.S. for orthopedic implants/pacemaker devices -Major Components of database:the processes involved in the implant manufacturing and implementation (process model); and the capabilities and resources required for the implant manufacturing and configuration.

END USERS-Interventional Cardiologists-Cardiologists-Physicians-Implant manufacturers-Stock MarketIMPACTED FROM SOLUTION-Patients-Physicians-Hospitals


Organizational ReadinessReflecting back on the diffusion of innovation theory, the end result of the implementation would be an organization which adopts to this new product. The organization is currently ready for this change, with some obstacles. These obstacles include reluctance to change, readiness for learning and changes in current routine. Careful analysis is to be conducted related to the costs of the implementation. The main preparation for a smooth transition consists of physician and registered nurse training on database access. The previously mentioned safety stars would become familiar with the model and manufacturer of the devices, as well as how to upload patient specific data as soon as a new implant is inserted. This process would warrant the use of a barcode for error reduction. For those patients that have previously implanted devices, they can visit their physicians office and provide them with implant specific information. If for example a patient looses this data, the database can then be accessed to find resources related to implants and their specific characteristics.

Functional Analysis Ready access to data pertaining to a patient’s cardiac and/or orthopedic implant will be available anywhere in the U.S. Consequently, proper care can be rendered to maximize patient outcomes. A barcode scanning system will be used. Once a patient receives an implant, the card they receive relays implant specific information by the use of a barcode. The card is to be scanned into the system by RN or physician. In the operating room, barcode scanning computers are already available, minimizing extra costs. A confirmation will be delivered to both the physician and patient that data was input into the system. The program database will be available online, as well as on the hospitals current EMR system.

Solution A database system was designed at Royal Sussec County Hospital in Brighton, UK. This database held the personal and pacing details of pacemaker patients. The trial first incorporated a standalone personal computer for 12 months. Pacemaker patient database has since been redesigned and implemented as an intranet-based system. It was successful and user friendly.A second user-friendly database was created to disseminate information about the hazards involved in investigating patients with implantable medical devices with MR techniques. The searchable catalogue currently has 352 entries. Searches can be done on any piece of information relating to the device. This is particularly useful in the common situation where a full device description is unavailable. Entries are divided into 20 categories, including Aneurysm Clips, Pacemakers, Eye Implants and Stents. If patients are not listed in the database, the following techniques can be used to find information: directly contacting the manufacturer, requesting a written confirmation of MR safety and/or MR compatibility ,searching manufacturer and distributor websites for downloadable Product Information Sheets, searching the academic literature for information regarding safety,identifying a patient who has had an X-ray examination with the implant in place, which allows us to ascertain that the device contains no metal components, testing a sample of the device with hand-held magnet and/or in the magnetic field in the scanning room.It is important to note that these procedures can be time consuming.

Planning Implementation/Testing The testing of the device/implant interoperability software will incorporate active testing techniques by including personnel that would be involved in the care of patients with implants and devices, as well as manufacturing personnel and engineers. The active testing will involve a complete overview of software and integration, a step-by-step walk through by IT personnel and active question and answer sessions. The syntax, format and compatibility of the software will be tested within the organization early to recognize glitches and any other problems within the software. The focus of the software will be to recognize and organize data pertaining to each implant/device without causing confusion within the system and allowing the user to navigate at ease. After the active testing, the software will be implemented within organizations that come in contact with these implant/devices and eventually the interoperability will reach across the nation.


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