How To Prevent And Fix PAINFUL Medical Device Recalls with Debbie Church

BioTalk Unzipped

Podcast Show Notes: “How To Prevent And Fix PAINFUL Medical Device Recalls with Debbie Church”

• Host: Gregory Austin
• Guest: Debbie Church, Regulatory Senior Manager, Enhanced Compliance Inc. (ECI)

In this Bonus Episode (EP11) you get to watch a recording from a previous LinkedIn Live show discussing the methods, strategies, and techniques you can use to prevent and remediate Medical Device Recalls.

Introduction

• Gregory Austin, Business Development Lead for Enhanced Compliance Inc. (ECI), welcomes listeners to the BioTalk Unzipped podcast’s LinkedIn Live session.
• Special guest: Debbie Church, Regulatory Senior Manager at ECI, with over 25 years of experience in the medical device industry.

DISCUSSION HIGHLIGHTS

1. Trends in Medical Device Recalls

• Austin highlights the increasing trend in medical device recalls over recent years.

• Data from the FDA website shows a steady rise: 33 recalls in 2020, 62 in 2023, and 23 in Q1 of 2024.
• Questions why these recalls continue to increase?
  

2. Reasons for Recalls

• Church elaborates on the reasons behind medical device recalls.
• Discusses the consequences of changes leading to unintended outcomes.
• Highlights the importance of having robust post-market surveillance programs to handle complaints effectively.

3. Costs Associated with Recalls

Financial Costs: Direct expenses, legal and regulatory costs, and reputation damage.

• Operational Costs: Rework, redesign, and supply chain disruptions.
• Innovation Impact: Delayed innovation and competitor advantage.
• Patient Safety and Trust/Brand: Potential patient harm and loss of trust.
• Stock Price Impact: Share price decline after major recall events.

4. Quality Improvement Initiatives

• Church shares examples of successful quality improvement initiatives.
• Discusses FDA’s updated cybersecurity guidance and improvements in Quality Management Systems (QMS) and Corrective and Preventive Actions (CAPA) procedures.

5. Reporting Process and Regulatory Collaboration

• Walks through the process of reporting a medical device recall to regulatory authorities.
• Explores how regulators collaborate with industry stakeholders to improve the effectiveness of recalls and prevent future issues.

Conclusion

• Austin summarizes the discussion, emphasizing the multifaceted costs of medical device recalls.
• Highlights the importance of robust post-surveillance programs, quality control, and proactive prevention measures.
• Invites listeners to reach out for further assistance or questions.

Contact Information:

Gregory Austin: [e-mail]

https://www.linkedin.com/in/gregoryaustin1/

Debbie Church, Sr. Manager of Regulatory Compliance, ECI

https://www.linkedin.com/in/debbie-kidder-church-b921a169/

Enhanced Compliance Inc.

https://eci-rx.com

#MedicalDevices #Recalls #QualityAssurance #RegulatoryCompliance