1. External Defibrillators: Recalls, Inspections, and the Quality System Regulation Melissa Torres Office of Compliance December 15, 2010

2. 2 Overview Recalls –Definitions –Analysis of external defibrillator recalls Common Quality System (QS) regulation deficiencies identified in recalls and inspections. –Purchasing Controls and Acceptance Activities –Design Controls –Corrective and Preventive Action (CAPA)

3. 3 What is a Recall? Voluntary action taken by a firm to address a problem with a device that violates FDA law, such as: –returning devices to recalling firm –performing a field repair or modification –modifying device labeling –notifying patients of a problem –advising physicians to monitor patients for health issues Effective method to remove or correct consumer products from the market place.

4. 4 How to Determine if you have a Medical Device Recall Removal –Physical confiscation from where the device is used or sold, to some other location for repair, modification, adjustment, relabeling, destruction, or inspection. –A removal is not part of regularly scheduled maintenance! Correction –On site activities which can include repair, modification, adjustment, relabeling, destruction, inspection, or patient monitoring.

5. 5 Recall Analysis 70 voluntary recalls conducted by manufacturers of external defibrillators from January 2005 – November 2010. –17 were classified as Class I –50 were classified as Class II –1 was classified as Class III –2 were safety alerts FDA has seen an increase in the amount of recalls. *Recall analysis only includes product code MKJ – Automated External Defibrillator.

6. 6 External Defibrillator Recall Trends * 2010 data only includes recalls classified between Jan.- Nov. 2010

7. 7 Quality System (QS) Regulation 21 CFR 820 Provides framework of basic requirements for medical device manufacturers to follow to ensure that devices are adequately designed and manufactured. Manufacturers must develop a Quality System (QS) commensurate with the: –Risk presented by the device; –Extent of the activities to be carried out; –Complexity of the device and manufacturing processes; and –Size and complexity of manufacturing facility.

8. 8 What are Purchasing Controls? 21 CFR 820.50 Requirements for manufacturers to ensure that purchased or received product and services from suppliers, contractors, and consultants conform to specified requirements. –Evaluation and selection of suppliers –Control over suppliers –Records of acceptable suppliers –Purchasing data

9. 9 What are Acceptance Activities? 21 CFR 820.80 Requirements for manufacturers to ensure that received, in-process, and finished devices are tested and accepted based on established requirements and specifications. –Receiving –In-process –Final

10. 10 Purchasing Controls and the Link to Acceptance Activities Manufacturers must establish an appropriate mix of assessment and receiving acceptance to ensure products and services are acceptable for their intended uses...... The extent of incoming acceptance activities can be based, in part, on the degree to which the supplier has demonstrated a capability to provide quality products or services. Preamble to the 1996 QS Regulation, Comments #99 and #106

11. 11 What is Unique About Medical Devices? Wide range in type of supplied products and services. –Raw materials, components, software, laboratories, sterilizers, etc. Wide range in complexity in supplied products. –From components to finished devices. Wide range in risk associated with supplied products and services. –Same supplied product or service may have different risks based on use. –Same supplier may have different risks for different supplied product or service.

12. 12 Why is FDA Concerned about Purchasing Controls? There is an increased importance of purchasing controls for both quality attributes as well as product specifications. –Increase in outsourcing of critical components and manufacturing of entire devices. –Increasing recalls and product problems associated with purchased components and devices.

13. 13 Purchasing Controls: Most Commonly Identified Deficiencies Inappropriate evaluation of suppliers. Changes to the components without notification to the manufacturer. Problems with the manufacturing of a component/subassembly. Inadequate incoming acceptance activities to detect nonconformities. Inadequate or lack of process validation activities at the supplier.

14. 14 What are Design Controls? 21 CFR 820.30 Requirements for manufacturers to control the design and development process through procedures and processes to assure that devices meet user needs, intended uses, and specified requirements. Design and Development Planning Design Input Design Output Design Review Design Verification Design Validation Design Transfer Design Changes Design History File

15. 15 Design Controls It is up to a firm to decide what design tools and practices they will employ. The QS regulation focuses on the general procedures and processes used to design the devices.

16. 16 Design Controls: Most Commonly Identified Deficiencies Problems with the initial design of the device. Inadequate verification/validation of design changes (including changes in the actual design, process, testing, labeling, etc.) prior to implementation. Inadequate software validation. Inadequate risk analysis/management.

17. 17 What is Corrective and Preventive Action? 21 CFR 820.100 Requirements for manufacturers to –Collect and analyze information. –Identify and investigate existing and potential product and quality problems. –Take appropriate, effective, and comprehensive corrective and/or preventive actions.

18. 18 Corrective and Preventive Action: Most Commonly Identified Deficiencies “Fix on Fail” - Fixing individual devices through servicing activities as they fail rather than correcting a group of known defective devices. Inadequate analysis of data sources including evaluation of servicing activities within the CAPA system to identify potential trends that may be a recall situation. Inadequate investigations to determine the cause of nonconformities.

19. 19 Servicing Activities What is considered by a manufacturer to be routine servicing and preventive maintenance must be defined up front in the design control process. If the servicing and maintenance being performed are not defined and documented as expected actions, then it is considered to be a correction to the device. Service records should be analyzed in the CAPA system. [21 CFR 820.100(a)(1)]

20. 20 References 21 CFR Part 820 –http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsear ch.cfm?CFRPart=820http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsear ch.cfm?CFRPart=820 Preamble to the QS Regulation Final Rule –http://www.fda.gov/downloads/MedicalDevices/DeviceRegulation andGuidance/PostmarketRequirements/QualitySystemsRegulati ons/MedicalDeviceQualitySystemsManual/UCM122806.pdfhttp://www.fda.gov/downloads/MedicalDevices/DeviceRegulation andGuidance/PostmarketRequirements/QualitySystemsRegulati ons/MedicalDeviceQualitySystemsManual/UCM122806.pdf CDRH Learn –http://www.fda.gov/Training/CDRHLearn/default.htmhttp://www.fda.gov/Training/CDRHLearn/default.htm Device Advice –http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan ce/default.htmhttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidan ce/default.htm

21. 21 References, cont. GHTF Quality Management System – Medical Devices – Guidance on the Control of Products and Services Obtained from Suppliers –http://www.ghtf.org/documents/sg3/sg3final-N17.pdfhttp://www.ghtf.org/documents/sg3/sg3final-N17.pdf GHTF Implementation of Risk Management Principles and Activities Within a Quality Management System –http://www.ghtf.org/documents/sg3/sg3n15r82005.pdfhttp://www.ghtf.org/documents/sg3/sg3n15r82005.pdf GHTF Quality management system - Medical Devices - Guidance on corrective action and preventive action and related QMS processes - Draft –http://www.ghtf.org/sg3/sg3-proposed.htmlhttp://www.ghtf.org/sg3/sg3-proposed.html

22. 22 Thank You!