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

Id. d’épisode : 1000653215129

GUID : c66ee754-0b72-4446-9136-c60a04a6bfff

Date de publication : 22/4/2024 à 15:41:37