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ECRI Alerts

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OVERVIEW

Automated recall and hazard management software for medical devices, supplies, drugs, and cybersecurity threats in healthcare.

ECRI Alerts, which includes the Alerts Guide and Alerts Workflow modules, is an enterprise-wide, web-based recall management system designed for healthcare organizations. It is a critical tool for ensuring patient safety, strengthening regulatory compliance, and improving operational efficiency in managing product recalls and hazards. The system aggregates approximately 3,000 safety and recall alerts per year from multiple international sources, including the FDA, Health Canada, MHRA, manufacturers, and ECRI's own investigations, often providing notifications days, weeks, or even months ahead of official regulatory notices.

Alerts Guide provides the foundational content, offering timely email notifications, advanced search and filtering capabilities, and the ability to generate PDF and Excel reports. It acts as a single source of truth for safety-related notifications across medical devices, supplies, drugs, biologics/blood, food, and equipment cybersecurity vulnerabilities.

Alerts Workflow builds on the Guide by transforming alerts into actionable, trackable tasks. It automates assignments, directs alerts to specific roles (e.g., supply chain, clinical engineering, IT, pharmacy, clinical departments), and facilitates real-time tracking and documentation of recall activities. This automation helps organizations achieve high compliance rates (reported over 95%) and ensures proper documentation for regulatory purposes. Key features include an 'Automatch' feature that scans and matches recalls directly with a facility's inventory, ECRI Exclusive Hazard Reports, and Micro-eLearning Modules for staff training.

RATING & STATS

Founded
1968

KEY FEATURES

  • Automated Recall Management (Alerts Workflow)
  • Aggregated Safety Alerts (Medical Devices, Drugs, Food, Supplies)
  • Cybersecurity Vulnerability Alerts
  • Early Warning Indicators (ahead of FDA)
  • Automated Inventory Matching (Automatch)
  • Customizable Dashboards and Filters
  • Compliance Tracking and Documentation
  • ECRI Exclusive Hazard Reports
  • Micro-eLearning Modules
  • PDF and Excel Reporting

PRICING

Model: enterprise
Available only to members of ECRI's advisory services (Health Devices System, Health Devices Gold, and SELECTplus) and requires a separate, non-public subscription/license fee.

TECHNICAL DETAILS

Deployment: cloud, saas
Platforms: web
🔌 API Available

USE CASES

Managing Medical Device and Pharmaceutical RecallsEnsuring Regulatory Compliance (e.g., FDA, MHRA)Improving Patient SafetyHealthcare Technology Risk ManagementStreamlining Supply Chain and Clinical Engineering Workflows

INTEGRATIONS

WorkdayoneSOURCE Document Management SystemAccruent TMS (Total Maintenance System)

COMPLIANCE & SECURITY

Security Features:
  • 🔒Cybersecurity Coverage

SUPPORT & IMPLEMENTATION

Support: email, phone, training
Target Company Size: medium, enterprise
TRAINING AVAILABLE

PROS & CONS

✓ Pros:
  • +Early warning on recalls (days/weeks/months ahead of FDA)
  • +Aggregates alerts from multiple international sources (single source of truth)
  • +Automated matching to inventory (Automatch) for focus on critical alerts
  • +Automated workflow, assignment, and tracking for high compliance (up to 95%+)
  • +Includes cybersecurity vulnerability alerts
✗ Cons:
  • -Pricing is not publicly disclosed (requires membership)
  • -No direct user reviews/ratings found on major platforms
  • -Requires membership in other ECRI advisory services

ABOUT ECRI

BROWSE SOFTWARE IN IMPLANT TRACKING AND RECALL MANAGEMENT