1. Patient Safety and Medical Devices Sonia Swayze, RN, MA, C and Suzanne Rich, RN, MA, CT

2. Objectives Discuss the impact of FDA’s consumer protections on patient safetyDiscuss the impact of FDA’s consumer protections on patient safety Describe the Medical Device Reporting Regulation as a model for patient safetyDescribe the Medical Device Reporting Regulation as a model for patient safety Identify criteria for FDA’s CDRH medical device adverse event report review and evaluationIdentify criteria for FDA’s CDRH medical device adverse event report review and evaluation Conduct an abbreviated medical device adverse event report review to identify a patient safety problemConduct an abbreviated medical device adverse event report review to identify a patient safety problem Create a model for patient safetyCreate a model for patient safety

3. FDA, Medical Devices, and Patient Safety FDA, Medical Devices, and Patient Safety Food and Drug Administration (FDA)Food and Drug Administration (FDA) –promotes the safe and effective use of medical devices, drugs, biologics, foods, and cosmetics through consumer protection programs FDA’s consumer protections are in place to:FDA’s consumer protections are in place to: –safely bring new products to market, and –to ensure that safe and effective products remain on the market

4. FDA at a Glance FDA is divided into 7 Centers, each with its own area of responsibility:FDA is divided into 7 Centers, each with its own area of responsibility: –Center for Medical Devices –Center for Drugs –Center for Biologics –Center for Food Safety and Applied Nutrition –Center for Toxicology and Research –Center for Veterinary Medicine –Center for Regulatory Operations

5. FDA’s Basic Responsibilities

6. Risk ManagementRisk Management –First human use (IND or IDE) –Safe Experimental use (product development) –Widespread Use (market approval) –Post-market Adverse Event Experience Evaluation

7. FDA’s Basic Responsibilities Integrity AssuranceIntegrity Assurance –Enforcement FraudFraud Bad Manufacturing PracticesBad Manufacturing Practices Bad Clinical PracticesBad Clinical Practices

8. FDA’s Basic Responsibilities Science-Based Regulatory DecisionsScience-Based Regulatory Decisions EvidenceEvidence –Clinical Trial Data –Post-market Adverse Event Experience Data –Standards

9. FDA’s Center for Devices and Radiological Health (CDRH) Mission CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and radiological products Vision Ensuring the health of the public throughout the Total Product Life Cycle

10. Total Product Life Cycle Early Product Life Cycle –Concept What is the product?What is the product? –Device, Pharmaceutical, Biological? –Combination product? –Prototype What makes the product new?What makes the product new? –Biomaterials –Design –Indication? –What is already known? i.e. does the product leach, oxidize?i.e. does the product leach, oxidize?

11. Mid-Product Life Cycle Pre-clinical EvaluationPre-clinical Evaluation –Are there critical performance specifications? –Standards – i.e. International Standards Organization. Clinical EvaluationClinical Evaluation –Use with final manufactured product or prototype? –Are there any unforeseen adverse events? Manufacturing EvaluationManufacturing Evaluation –controls – i.e., human factors, design, manufacturing process considerations Manufacturing for marketing and commercial useManufacturing for marketing and commercial use –Pre-approval FDA inspection –Supplier – component integrity –Consignees – user training and education –Promotion and Advertising –Labeled indications for use

12. Late Product Life Cycle Product MarketingProduct Marketing –Promotion and Advertising –Truthful Labeling Commercial UseCommercial Use –Unforeseen problems –Device Failures –Product re-design Obsolescence Obsolescence –Use and End-of-Life Considerations Customer complaints and complaint investigationCustomer complaints and complaint investigation –Use errors –Failure analysis Adverse event reportingAdverse event reporting

13. Device: Simply Defined * Item used for diagnosis, treatment or prevention of disease, injury or other condition that is not a drug, biologic or food. * Actual definition of a device can be found in FD&C Act, Section 201(h).

14. Medical Device Adverse Event Reporting A model for patient safetyA model for patient safety –Identification and reporting of adverse events involving medical devices, patients, and users –Information used to evaluate actual and potential problems with medical devices during use

15. What is an Adverse Event ? An event whereby a death or serious injury was, or may have been caused by a medical device. An event whereby a medical device was, or may have contributed to a death or serious injury. Includes events resulting from: Includes events resulting from: - device failure- improper / inadequate design - device malfunction- manufacturing (problems) - use error- labeling (problems)

16. Serious Injury results in permanent impairment / damage to body function / structure requires medical or surgical intervention to preclude permanent impairment / damage to body function / structure requires medical or surgical intervention to preclude permanent impairment / damage to body function / structure. Life-Threatening Injury or Illness

17. Malfunction The failure of a device to meet its performance specifications or otherwise perform as intended. A malfunction is reportable: when it is likely to cause or contribute to a death or serious injury if it were to recur. (Malfunctions are not required to be reported by User Facilities)

18. CDRH Reporting Programs Voluntary - MedWatch -Reporting by healthcare professionals and consumers -Report actual or potential product problems Mandatory -User Facilities -Report deaths and serious injuries -Manufacturers -Report deaths, serious injuries, and malfunctions

19. Mandatory Reporting User Facilities User Facilities required to report deaths and serious injuriesUser Facilities required to report deaths and serious injuries –1990 Safe Medical Device Act (SMDA) 11/28/90 –Effective date for User Facilities 11/28/91 –Effective date of Final Rule to implement MDR 7/31/96 MDR Regulation --------------- 21 CFR 803

20. What is a User Facility? Hospitals Ambulatory Surgical Centers Nursing Homes Outpatient Diagnostic Facilities Outpatient Treatment Facilities

21. Mandatory Reporting Manufacturers Manufacturers required to report deaths, serious injuries, and malfunctions –Initial Regulation requiring MDR reporting effective 12/13/84 –Reporting requirements revised by SMDA 1990 & 1992 Amendments effective 7/31/96 MDR Regulation --------------- 21 CFR 803

22. What is a Manufacturer? Defined to include: Domestic ManufacturersDomestic Manufacturers Foreign ManufacturersForeign Manufacturers Repackagers / RelabelersRepackagers / Relabelers Component ManufacturersComponent Manufacturers Hospitals ReprocessingHospitals Reprocessing Single-Use Devices

23. REPORTING TIMEFRAMES Deaths Serious Injury (if manufacturer unknown) manufacturer unknown) FDA User Facility Death and Serious Injury Manufacturer Deaths Serious Injury Malfunction