The Burden of Medical Device Alerts and Recalls | Key Takeaways

Recall management remains challenging for healthcare providers, as the number of hazard alerts involving medical devices, pharmaceuticals, and other products continues to increase. From cybersecurity vulnerabilities involving complex medical technologies, to sterility issues with various consumables, to shortages across the industry, managing product recalls and corrections becomes more complex every year. 

An analysis of 2022 data from the ECRI Alerts Workflow system, which facilitates efficient recall and technology risk management for medical equipment, supplies, and pharmaceuticals, highlights the scale of the challenge that providers are facing:

Large volume of alerts and recalls 

In 2022, the number of ECRI medical device alerts and related recalls kept pace with the prior year; however, reports from providers point to a higher volume of impacted units and increased burden on the provider. The 2022 alerts breakdown as follows:

• 1,923 total medical device alerts – 62% of these were related to supplies, while the rest were related to capital equipment
• 636 alerts related to pharmaceuticals
• 546 alerts related to food products

As an indicator of risk, ECRI assigns a priority level to each alert to help members prioritize. In 2022:

• 5% of device alerts were classified as “critical,” indicating the potential for serious injury or death
• 77% were classified as “high” priority,” indicating the potential for serious injury, temporary illness, or harm
• 18% were classified as “normal priority,” based on regulatory or other risks that are unlikely to cause injury or illness

Multiple technologies affected

Medical device alerts classified as “critical” priority included a range of technologies, with specific types being represented multiple times:

• Several alerts related to cardiac circulatory assist units, which are used to improve blood circulation in patients with a debilitated heart
• Multiple alerts involved infusion pumps, which remain a common device affected by recalls and corrections
• As in previous years, issues involving continuous positive airway pressure and bi-level continuous positive airway pressure technologies continued to arise
• COVID tests continue to be a hot topic, as inaccurate or unapproved tests continue to cause issues for patients

High-profile medical device recalls

In addition to the many alerts that require review and the diverse group of technologies affected, healthcare providers experienced several high-profile recalls that garnered much industry attention:

• Recalls involving Philips continuous positive-airway pressure devices and ventilators, stretching back to 2021, continue to be a big issue in 2022
• Contamination and resulting shortages of infant formula placed a large burden on providers and parents
• A production disruption of GE Healthcare Omnipaque (Iohexol) and Visipaque (Iodixanol) contrast media led to shortages and diagnostic imaging delays

Recall management best practices

With the large volume of recalls shown above and the complexities of recall management and supply chain sourcing, management of recalled medical devices, pharmaceuticals, and food products remains a complex problem for healthcare providers. To ensure the safety of patients and staff, providers should have appropriate resources and technologies working seamlessly together for more effective and efficient recall management. Some best practices are as follows:

• Ensure that recall notifications are being received and distributed in a timely fashion
• Confirm that recall information is properly communicated to all organizational stakeholders
• Make sure that staff takes appropriate action to isolate affected products to help keep patients safe
• Validate that proper information is communicated back to the manufacturer to close the recall loop. Track all recalls to closure and record actions taken for regulatory compliance and audit
• Incorporate reporting and related dashboards to support quarterly updates and to confirm complete enterprise-wide recall compliance

Learn how ECRI can help you ensure the removal of harmful products before they reach the patient and reduce the time spent on recalls by 50% to 90%.