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

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: gregory.austin@eci-rx.com

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