How to Manage a Medical Device Recall Efficiently and Effectively

Recall means the correction or removal of a device for human use where FDA finds that there is a reasonable probability that the device would cause serious, adverse health consequences or death. It is an action taken to address a problem with a medical device that violates FDA law. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company. A recall sometimes means that the medical device needs to be checked, adjusted, or fixed. If an implanted device (for example, a pacemaker or an artificial hip) is recalled, it does not always have to be removed. When an implanted device has the potential to fail unexpectedly, companies often tell doctors to contact their patients to discuss the risk of removing the device compared to the risk of leaving it in place. FDA classifies medical device recalls into three categories, representing the potential risk to public health: Class I, II, and III.

Areas Covered in the seminar:

• Create and use a recall operational procedure and what should it contain.
• Understand what are effectiveness checks.
• What happens in a medical device recall.
• Learn why a recall is either a correction or a removal depending on where the action takes place.
• Understand why is required for the recall strategy as expected by FDA.
• Medical device recall authority and guidance.
• Depth of recall and using a viable, sustainable and effective strategy.
• Understand why the documentation and paper trail are so critical and termination of a recall.

Who will benefit:

This webinar will provide valuable assistance and guidance to medical device firms that are either going through or preparing to go through a recall and want to understand the strategy and expectations of a recall and FDA’s involvement. The employees who will benefit include:

• All levels of Management for all departments and those who desire a better understanding
• QA/QC/Compliance/Regulatory Affairs
• Marketing & Sales
• Engineering/Technical Services
• Consultants
• Operations and Manufacturing

Instructor Profile:
David R. Dills, Indpendent Regulatory & Compliance Consultant, departed PAREXEL Consulting in July 2008 due to service line organizational change. Prior to joining the consultancy Mr. Dills has provided independent consultative services in various capacities from pre-marketing to post-marketing within the technical, quality, regulatory affairs and compliance arena to pharmaceutical, Class I/II/III medical devices, in vitro diagnostics and biologics/biotech companies with an emphasis on establishing sustainable compliance systems. Through his work, Mr. Dills has been affiliated within the life sciences industry for more than nineteen years with increasing responsibilities in QA/Quality Systems, Regulatory Affairs/Compliance, and Corporate/Operations Management and previously employed on behalf of globally recognized device manufacturers and service providers.

Key areas of focus include product development and commercialization strategies, regulatory classifications, applications and submissions, regulatory and clinical consulting, rapid regulatory crisis response, involved in consent decree/CIA activities, improve and remediate quality management systems and documentation, inspection readiness preparedness for manufacturers and serves in an Expert Witness capacity for a third party. Mr. Dills has prepared and executed effective paths to obtaining approvals, worked effectively across functions for overall corporate compliance, and aligned GxP compliance in a fashion that supports a company’s business strategies and goals.

Key areas of focus also include product development and commercialization strategies, regulatory classifications, applications and submissions, rapid regulatory crisis response, and inspection readiness preparedness for manufacturers. He adds business value to device companies by providing strategic and tactical solutions that facilitate the achievement of regulatory milestones. The focus is on planning, implementation, and training for all phases of the regulatory review and approval process, and on minimizing delays due to regulatory noncompliance.

He has a proven track record and an accomplished regulatory professional working not only with several Notified Bodies and FDA/CDRH/ODE representatives but also international regulatory bodies in Japan, EU, Australia, Canada and other locales. He has worked on and currently working on several J-STED files and Ninsho Certification, IDEs, PMAs and 510(k) submissions and applications, as well as serving on teams related to clinical trials development and deploying sustainable and proven strategies.

Mr. Dills areas of interest and expertise include executing process validation, supplier qualification, training, internal/due diligence audits, policy/procedure development, PM, risk management/assessment, ISO 9001/13485/14971, MDD 93/42/EEC, CE Marking, remediation, GxPs, SW Validation/IT Network, MDR/AE/product complaints, design/change control, CAPA, PMA, IDE, 510(k), NDA and e-CTD/CMCs submissions, interfacing with international regulatory bodies, QSIT and PAI Inspections, product registration, J-STED/Ninsho activities, and training.

Mr. Dills currently serves on the Faculty Advisory Board for the Pharmaceutical Training Institute and Editorial Advisory Boards for Software Quality Professional and the Institute of Validation Technology (IVT), publisher of the Journal of GXP Compliance and Journal of Validation Technology. He serves on the Readers’ Board for Medical Device & Diagnostic Industry and Medical Product Manufacturing News and was nominated and accepted for inclusion into the 2005-2006 Strathmore’s Who’s Who of Professionals. Mr. Dills has authored and published validation, regulatory and compliance-related articles, commentaries and technical guides, and is an accomplished global industry presenter.

Mr. Dills’ academic degrees include Environmental Science and Biology. He currently serves as Advisor for the ASQ’s Section 1506 and as a former Chair and Co-Chair and is an active member of the Biomedical Division, RAPS, PDA, ISPE, and other industry working groups.

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