Patient Safety
Patient safety is the effort to prevent harm to people receiving medical care. It covers drug and device oversight, warnings and recalls, reporting systems, blood and vaccine safety, and hospital practices. The Food and Drug Administration, the Centers for Disease Control and Prevention, hospitals, manufacturers, and patients all share responsibility for spotting problems and acting on them.
People usually ask how to report a problem with a drug, device, or vaccine and what happens after a report. They want to know how recalls and safety alerts work, how emergency authorizations are used in a crisis, how regulators decide a product is safe enough, and what they can do to protect themselves.
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Referenced by Brookings, CNN, Forbes, Fox News, Pew Research, Snopes, The Hill and USA Today.
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All Articles on Patient Safety
Emergency Use Authorization: The FDA’s Crisis Playbook
When COVID-19 vaccines rolled out across America in December 2020, most people didn't realize they were receiving products that hadn't received full FDA approval.…
Medical Device Recalls: What Patients Need to Know
When your doctor tells you that a medical device inside your body has been recalled, the word itself can trigger panic. Images of products…
Understanding FDA Warning Letters and Safety Alerts
The Food and Drug Administration issues thousands of enforcement actions each year, from formal warning letters to urgent product recalls. These documents offer a…
A Guide to Blood Donation
Every two seconds, someone in the United States needs blood. That fact represents one of the most profound dependencies in modern medicine - our…
Vaccine Safety and VAERS: A Guide
Vaccine safety in the United States doesn't rely on a single checkpoint - it's protected by a comprehensive, multi-layered system that begins years before…
How Medical Devices Are Regulated—And What Patients Need to Know
From the simple tongue depressor in your doctor's office to the complex pacemaker that could save your life, medical devices shape modern healthcare. The…
Reporting Drug and Medical Device Problems to the FDA
When the FDA approves a new drug or medical device, it has passed rigorous safety tests. But those clinical trials only tell part of…