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

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

• Discuss the impact of FDAs consumer protections
  on patient safety
• Describe the Medical Device Reporting Regulation
  as a model for patient safety
• Identify criteria for FDAs 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

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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
• FDAs consumer protections are in place to
• safely bring new products to market, and
• to ensure that safe and effective products
  remain on the market

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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

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FDAs Basic Responsibilities
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FDAs 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

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FDAs Basic Responsibilities

• Integrity Assurance
• Enforcement
• Fraud
• Bad Manufacturing Practices
• Bad Clinical Practices

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FDAs Basic Responsibilities

• Science-Based Regulatory Decisions
• Evidence
• Clinical Trial Data
• Post-market Adverse Event Experience Data
• Standards

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FDAs 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

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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?

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Mid-Product Life Cycle

• 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

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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

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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
FDC Act, Section 201(h).
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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

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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)
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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.
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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)
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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

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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
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What is a User Facility?

• Hospitals

• Ambulatory Surgical Centers

• Nursing Homes

• Outpatient Diagnostic Facilities

• Outpatient Treatment Facilities

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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
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What is a Manufacturer?

• Defined to include
• Domestic Manufacturers
• Foreign Manufacturers
• Repackagers / Relabelers
• Component Manufacturers
• Hospitals Reprocessing
• Single-Use Devices

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