Strategies for Building an Effective Postmarket Surveillance Program

Transcription

1 Strategies for Building an Effective Postmarket Surveillance Program Sheila Hemeon-Heyer Vice President, Global Regulatory Affairs Boston Scientific Corporation MassMedic December 1, 2007

2 Why Postmarket Surveillance? The Goal Every marketed medical product is: Completely safe and effective for its intended use Manufactured under controlled conditions to meet appropriate specifications (product and labeling) Used in accordance with the product labeling (indications and instructions for use) The Reality Despite best efforts: All medical products carry some level of risk Premarket testing is conducted under controlled conditions and may not detect low frequency events Despite the best manufacturing controls, problems can result from errors (design, manufacturing, packaging, user) off-label use unanticipated risks PMS systems and tools help us meet the goal of assuring continued safety and performance/efficacy of marketed products 2 Copyright Boston Scientific Corporation 2006.

3 Challenges for a Global Postmarket Surveillance System Global regulatory requirements (QSR, ISO 13485, PAL) Same general requirements but different terminology, timelines, expectations Different types of products with different issues Low risk to high risk Permanent implants Combination products SUDs Capitol equipment Multiple facilities with both component and finished product manufacturing OEM and supplier issues Communication across various cultures, languages, timezones 3 Copyright Boston Scientific Corporation 2006.

4 Start with a Quality Culture Patient Safety Continual improvement Everyone trained in their roles and responsibilities to take a proactive approach Engrained Quality Culture Everyone is responsible for product quality 4 Copyright Boston Scientific Corporation 2006.

5 BSC Quality Policy 5 Copyright Boston Scientific Corporation 2006.

6 Management Involved at All Levels System Effectiveness Corporate Compliance Management Review Process Decisions/Actions Operational and Quality Data Flows Board of Directors Operating Committee Franchise/Business/Group/Operations Manufacturing / Sites/Distribution Ctr/Regions Plant Floor Management assures sufficient trained resources dedicated to sustaining and improving marketed products Quality/Compliance R&D Operations Regulatory Clinical/Medical Supply Chain Distribution Sales Marketing 6 Copyright Boston Scientific Corporation 2006.

7 Elements of an Effective PMS System Make it Right, Build Safety In Monitoring Systems to Identify Quality Issues Investigate & Analyze Quality Issues Communication with all Stakeholders Postmarket Surveillance and Action System Action (field action, CAPA, continuous improvement) Good Decisions Come from Good Data 7 Copyright Boston Scientific Corporation 2006.

8 Build Safety In Active Product Controls Self-Manufactured Products Process Control Controlled Returns Incoming Inspection Manufacturing Site Finished Good Inspection Distribution Center Active Final Release Market Externally Sourced Products Incoming Inspection Contractually Defined OEM Controls 8 Copyright Boston Scientific Corporation 2006.

9 Device Monitoring Tools Active PRO s CON s Post Market Studies (e.g., Condition of Approval) Defined protocol; complete data collection; monitored; etc. Can be difficult to get participation, practical size limitations Follow up of patients post-approval Longer term events on a well characterized and monitored patient population Limited patient population narrowly defined criteria may not represent real world experience Registries and tracking systems Larger numbers of patients, more real world experience Lower level of monitoring, varying levels of data and event verification Post-card or Survey of a defined patient sample Opportunity for larger sample of patients Depends on willingness of responders. Self selecting. Review of complaints. MDR reports, vigilance reports Ability to detect trends in reported adverse events over time and define corrective/preventative actions Fidelity of conclusions dependent on quality of complaint information Passive Use of existing databases (e.g., MedSun, NIH, VA, literature, etc.) Larger volume of data Varying definitions of events and data quality. Not linked or always accessible 9 Copyright Boston Scientific Corporation 2006.

10 Maximizing the Data From Postmarket Device Monitoring CRFs from PM studies & registries Complaint Call Centers Ask the right questions 10 Copyright Boston Scientific Corporation Who is providing information? What happened? Did the device malfunction? Was the patient injured? Was the AE (study) related to the device? Severity of injury? How resolved? Device lot or batch #? Had device reached its end-of-life? Was the device reprocessed? Is the device available for analysis? Information must be consolidated for complaint handling

11 Maximizing the Data From Postmarket Device Monitoring Code the complaint Evaluate for MDR/MDV reporting Do the right analysis Investigate device malfunction or packaging/labeling issue Mandatory examination and testing of returned device to determine root cause Trend complaints/aes by device and device family over defined time periods per units in field Thresholds for action based on premarket data, experience literature, risk 11 Copyright Boston Scientific Corporation 2006.

12 Maximizing the Data From Postmarket Device Monitoring Elevate quality or safety issues for potential field actions Open CAPAs to correct/prevent problems, improve products/processes Take action on the results Does information change product risk profile? Need for design or labeling changes? Look across product lines Include metrics, analysis, and actions in management review Communicate to stakeholders as appropriate new, significant risks product performance issues defects (products, packaging, labeling) 12 Copyright Boston Scientific Corporation 2006.

13 Complaint Handling One Global Process* <30 Calendar Days Customer/ BSC Employee CCC Report Complaint/ AE Open Complaint Request Product Return CCC Complaint Call Center CMC Complaint Management Center CIS Complaint Investigation Site MS Medical Safety DC Distribution Center Complete Initial Review Good Faith Effort for Info/Device (if necessary) Complete Follow-up Assessment(s) Close Complaint Reopen Complaint CMC Determine MDR/MDV Reportable Complete MDR/MDV Report Submit MDR/MDV Report Trending Mgmt Review MS Complete Medical review Investigate Complaint CIS Receive Returned Product from DC DC/Dispatch Center Receive Returned Product from Customer 13 Copyright Boston Scientific Corporation *Except newest acquisitions

14 PMS Field Actions PM Study Results Registry Information Complaint Trending Product Testing Quality Checks OEMs Product Inquiry Report (PIR) Quality Elevates quality issue Event description Investigation Root cause Medical Health Hazard Evaluation Regulatory Recommends field action/recall Field Action Execution Product Advisory Removal / correction Regulatory reporting Field Action Committee Senior level decision makers 14 Copyright Boston Scientific Corporation 2006.

15 PMS Risk Management Use FMEA Risk Analysis Product Risk Analysis Process FMEA Clinical Risk/Benefit Analysis Design FMEA Risk Mgt. Report Identify Unreasonable Risk Reduce/Eliminate Risk Product Risk Defines: Testing Rigor Acceptable levels of device failure Thresholds for Investigation 15 Copyright Boston Scientific Corporation 2006.

16 PMS CAPA How Often Does Complaint/AE Occur? Investigate Corrective or Preventive Action Necessary? Can a Correction Be Made? Is it feasible? Is it practical? What is the scope and severity of the problem? Implement solution Plan solution Verify effectiveness Discontinue? Design, manufacturing, labeling modification? Regulatory Submission? Training? Communication? 16 Copyright Boston Scientific Corporation 2006.

17 Communication CRM Product Performance Following the Health Rhythm Society Recommendations 17 Copyright Boston Scientific Corporation 2006.

18 Communication DES Late Stent Thrombosis Signals of potential Late Stent Thrombosis appeared only after 3 years of follow-up in > 3,000 patients (DES vs BMS) BSC brought this data to FDA s attention Subsequent communications to physicians through direct letters and scientific presentations LST is real but risk/benefit profile of DES still better than BMS Dec 7-8 FDA Panel Meeting: Welcome opportunity for controlled discussion of all data with common analysis and definitions 18 Copyright Boston Scientific Corporation 2006.

19 Continual Improvement Postmarket surveillance is integral to assuring product quality patient safety continual improvement of patient care Welcome FDA s Postmarket Transformation Initiative Issues outlined in PTLT Report mirror issues faced by industry Encourage continued collaboration between FDA and industry to assure solutions that facilitate efficient postmarket surveillance and optimum use of data without being overly burdensome 19 Copyright Boston Scientific Corporation 2006.

20 Thank You