Tatyana Chorny answered a series of questions written by marcus evans before the forthcoming Medical Device Safety Monitoring and Reporting Conference, January 17-18, 2013 in Las Vegas, NV. Tatyana shares her thoughts on timely reporting and regulatory compliance.
What are the top 3 challenges faced when monitoring and reporting the safety of medical devices?
Tatyana Chorny: Medical device manufacturers face many challenges when it comes to reporting safety events to FDA, as well as Competent Authorities in global markets. Here’s the top 3 to consider:
• Proactively reporting safety incidents not related to product malfunction. This requires good justification as to why the device didn’t cause or contribute to the safety issue.
• Identifying and reporting previously reported malfunction. Monitoring and identifying the same root cause of malfunction requires very good monitoring and evaluation process.
• Timely reporting. With many sources of complaints for the global device manufacturer this still presents the biggest challenge.
Are there any trends that come to mind when managing reporting post-market product feedback?
TC: The FDA is strengthening the National System for Medical Devices Post-Market Surveillance, which presents the main trend in today’s post-market product feedback.
With emphasis on the new Unique Device Identifier, development of Automated Adverse Event Reporting and the ability to rapidly identify safety risk, Device Manufactures have to focus on the most effective and efficient product feedback management to address safety concerns, as well as continuous product quality improvement.
Have there been any major changes regarding regulatory requirements for quality data analysis?
TC: Statistical Analysis of Quality data have always been a challenge. What to look for? How to insure that appropriate statistical tools are used and horizontal analysis requirements are met? Far too often there’s a misuse of statistics by device manufacturers in an effort to minimize instead of address the problem. Such misuse of statistics would be a violation of regulations.
The new challenges are on the way with FDA calling for development and usage of new methods for evidence generation, quantitative decision analysis to evaluate benefits and risks, combining data from all data sources and refining processes for safety alerts generation.
What can attendees expect from your session?
TC: The goal of my presentation is to answer 3 questions:
• How to apply the Quality System Regulation requirements to the Post-Market Surveillance and Feedback Management System; in particular, to ensure product safety monitoring and timely reporting by utilizing a risk-based approach.
• How to use Service & Complaints data to ensure regulatory compliance and product quality improvement.
• How to use quality data trending to address safety concerns and improve Product Quality and drive NPS (Net Promoter Score) up.
Tatyana Chorny has MS in Computer Engineering and MBA from Case Western Reserve University and is known as Quality & Regulatory Expert in Medical Device Industry with diverse background in the new product development and system integration, process improvement, Quality and Regulatory Affairs and FDA Compliance.
At Philips, we simplify healthcare by focusing on the people in the care cycle – patients and care providers. Through combining human insights and clinical expertise, we aim to improve patient outcomes while lowering the burden on the healthcare system. Philips delivers advanced solutions for both healthcare professionals, to meet the needs of patients, and empowered consumers for affordable healthcare whether in hospital or at home.
For more information please contact Michele Westergaard, Senior Marketing Manager, Media & PR, Marcus Evans at 312-540-3000 ext. 6625 or Michelew@marcusevansch.com.
About the Medical Device Safety Monitoring and Reporting
This unique event will take place in Las Vegas, NV from January 17-18, 2013. Industry leaders attending this event will benefit from a dynamic presentation format consisting of workshops, panel discussions and case studies. Attendees will experience highly interactive conference sessions, 10-15 minutes of Q&A time after each presentation, 4+ hours of networking and exclusive online access to materials post-event.