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

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

2. Objectives • Discuss the impact of FDA’s consumer protections on patient safety • Describe the Medical Device Reporting Regulation as a model for patient safety • Identify 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 problem • Create a model for patient safety

3. FDA, Medical Devices, and Patient Safety • 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: • 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: • 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. FDA’s Basic Responsibilities • Risk 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 Assurance • Enforcement • Fraud • Bad Manufacturing Practices • Bad Clinical Practices

8. FDA’s Basic Responsibilities • Science-Based Regulatory Decisions • Evidence • 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? • Device, Pharmaceutical, Biological? • Combination product? • Prototype • What makes the product new? • Biomaterials • Design • Indication? • What is already known? • i.e. does the product leach, oxidize?

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

12. Late Product Life Cycle • Product Marketing • Promotion and Advertising • Truthful Labeling • Commercial Use • Unforeseen problems • Device Failures • Product re-design • Obsolescence • Use and End-of-Life Considerations • Customer complaints and complaint investigation • Use errors • Failure analysis • Adverse 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 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: - device failure - improper / inadequate design - device malfunction - manufacturing (problems) - use error - labeling (problems)

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

17. Malfunction The failure of a device to meet its performance specifications or otherwise perform as intended. A malfunction is reportable: when itis 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 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 Manufacturers • Foreign Manufacturers • Repackagers / Relabelers • Component Manufacturers • Hospitals Reprocessing • Single-Use Devices

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