Medical Device Recalls – a Prevention Strategy
Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles has been a regulatory consultant for over 20 years and has published numerous white papers on the subject. His firm works with both domestic and international clients designing solutions for complex regulatory, Lean, training, and documentation issues.
In a recent study, the FDA has reported a 95% increase in medical device recalls over a nine year period ending in 2017 attributable to a variety of reasons. Whatever the reason, medical device recalls are expensive and most importantly carry significant risk to the health and safety of patients.
The increase indicates serious failures in the processes and controls designed to ensure reliability, safety, and effectiveness of the recalled devices. As medical devices become more complex and software components become more critical to device functioning, the need for proactive risk prevention becomes more and more evident.
The rough breakdown of medical device failures is 60% residing with the product specification and only 30% of the errors in the components themselves. This rough breakdown indicates that most of the problems are referred to as management errors – caused by faulty systems, processes, and conditions. A failure of procedures and execution. In other words, management failure.
- Explain the structure of an effective medical device recall prevention strategy
- Explain how recalls can be prevented at each stage of medical device design and development
- Preventing recalls during specification writing
- Preventing recalls during early design
- Preventing recalls during the detail design phase
- Designing for Prognostics to protect patients
- Preventing recalls during production validation
- Preventing software design recalls
- Preventing supply chain quality defects to avoid recalls
- Preventing recalls using a verification process
- Preventing recalls using the design validation process Role of management in preventing recalls
- Innovative methods useful in preventing recalls
Course Level - Intermediate
Who Should Attend
- Medical Device Industry
- Technicians, and other personnel involved in product development
- Quality assurance, or regulatory affairs that require a basic understanding of the regulatory submissions process.
Why Should Attend
The webinar will provide an overview and a foundation for further learning concerning preventing recalls during specification writing, risk assessment and risk management, preventing recalls during the early design and the detail design phases of development, and preventing recalls during validation, verification, and software design.
The secret to preventing medical device recalls is to implement and follow basic practices for specifications and design control, design for process reliability, production validation and design validation using accelerated life tests. This webinar is about controlling safety risk from specification writing to device retirement – control throughout the product’s life cycle.