Drug and Medical Devices Injuries

According to statistics from the Medication Safety Program, housed in the Division of Healthcare Quality Promotion in the United States Centers for Disease Control and Prevention, adverse drug events (ADEs) are a serious public health problem. It is estimated that:

  • 82% of American adults take at least one medication and 29% take five or more
  • 700,000 emergency department visits and 120,000 hospitalizations are due to ADEs annually
  • $3.5 billion is spent on extra medical costs of ADEs annually
  • At least 40% of costs of ambulatory (non-hospital settings) ADEs are estimated to be preventable

The numbers of adverse drug events will likely grow due to:

  • Development of new medications
  • Discovery of new uses for older medications
  • Aging American population
  • Increase in the use of medications for disease preventionI
  • ncreased coverage for prescription medications

The U.S. Food and Drug Administration is responsible for ensuring that a medical device meets regulatory standards for safety and effectiveness before it is made available in the market. They can range from simple tools, such as tongue depressors and bandages, to complex or life-saving equipment, such as pacemakers, magnetic resonance imaging machines, and heart–lung machines. Each year, approximately 4,000 new submissions of medical devices are made to the FDA for its approval. As the Institute of Medicine indicated in a 2011 report, in which it found that the current 510(k) process is flawed based on its legislative foundation:

The Federal Food, Drug, and Cosmetic Act (FFDCA) requires a "reasonable assurance of safety and effectiveness" before a device can be marketed, and the U.S. Food and Drug Administration (FDA) is responsible for enforcing this requirement. Devices that are deemed to have a moderate risk to patients generally cannot go on the market until they are cleared through the 510(k) process, named for Section 510(k) of the FFDCA. Some policymakers and patients have expressed concern about the ability of the 510(k) process to ensure that medical devices on the market are safe and effective.