Cardiac Device Advisory Workflow With Clinic Feedback Tracking
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Solution Overview
Problem
Existing systems face challenges in efficiently managing and tracking cardiac implantable electronic device (CIED) advisories, as care providers struggle with complex patient records and manufacturers are unaware of the downstream impacts of their advisories, leading to delayed and inefficient updates.
Innovation Solution
A cardiac device advisory management platform that receives and processes advisory notifications from manufacturers, integrates them into clinic workflows, and provides actionable indicators for clinicians to manage patient populations, enabling timely updates and tracking of advisory actions.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Loss of time
If advisory notifications are manually tracked and distributed through traditional channels, then manufacturers can issue advisories, but the dissemination is delayed (6-8 weeks) and manufacturers remain unaware of downstream impacts
Solution Approach 1:
The system performs preliminary actions by automatically distributing advisories to clinics immediately upon issuance, and proactively tracking the downstream impacts before the traditional 6-8 week delay occurs. The automated distribution system is pre-configured to push notifications to affected clinics, eliminating the manual delay.
Solution Approach 2:
The system implements feedback mechanisms where clinic actions and patient status changes are automatically reported back to manufacturers in real-time. This creates a closed-loop information flow that provides manufacturers with immediate visibility into downstream impacts, such as which clinics are affected and what actions are being taken.
2Reliability
If care providers use complex patient records systems to manage advisories, then comprehensive patient data can be stored, but the complexity makes it difficult to easily manage and track advisories
Solution Approach 1:
The system extracts advisory management functionality from the complex general-purpose patient records system into a dedicated automated advisory management module. This separate module specifically handles advisory notifications, tracking, and status updates, simplifying the interface and workflow for advisory-specific tasks while maintaining integration with the broader patient records system.
Solution Approach 2:
The system implements self-service capabilities where the automated platform performs routine advisory management tasks without requiring manual intervention from care providers. The system automatically distributes advisories, tracks clinic actions, updates patient statuses, and generates reports, reducing the operational burden on clinicians while maintaining reliable record-keeping.
3Ease of manufacture
If manufacturers issue advisories without automated tracking, then advisories can be released, but manufacturers are ill-equipped to gather information on downstream impacts and work required
Solution Approach 1:
The automated advisory management platform serves as an intermediary between manufacturers and the downstream distribution network. It receives advisories from manufacturers, automatically distributes them to affected clinics, and collects feedback on implementation. This intermediary system bridges the information gap, providing manufacturers with detailed data on downstream impacts without complicating the advisory issuance process.
Data Source
AI summary
Systems and methods include a cardiac device advisory management platform to receive and distribute data related to advisory notification(s) for an implanted cardiac device. Advisory notification data includes a device identifier and/or a lead identifier corresponding to the advisory notification. Upon receiving the advisory notification data, the clinic matches the device identifier and/or the lead identifier with patient data for patients enrolled with the clinic. One or more action indicators for various workflow procedures are generated and presented at a clinic user interface (UI) of the clinic device. Clinician inputs are received via the clinic UI to perform steps in response to the advisory notification, such as reviewing patient information, scheduling an in-office visit, and/or sending a notification to a patient device. A clinic behavior analysis is performed on the clinician inputs to generate information regarding the impact of the advisory notifications on the clinic workflow procedures.


