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- Epidemiology of Errors and Adverse Events
- Food and Drug Administration (FDA)
- Non-Health Care Professionals
Center for Devices and Radiological Health. Bethesda, MD: Food and Drug Administration, US Dept of Health and Human Services; 2006.
This document provides background on hospital bed injuries, identifies potentially dangerous design flaws, and offers assessment tools to reduce entrapment incidents.
Web Resource > Multi-use Website
Silverspring, MD: US Food and Drug Administration.
This Web site provides access to large publicly available datasets for adverse drug events to enable developers, researchers, and consumers to use this information when designing medication safety improvement plans or projects. Planned updates to this site include data on recalls and product documentation.
Journal Article > Study
Effect of US Drug Enforcement Administration's rescheduling of hydrocodone combination analgesic products on opioid analgesic prescribing.
Jones CM, Lurie PG, Throckmorton DC. JAMA Intern Med. 2016;176:399-402.
Improving the safety associated with opioid use is a major health policy priority. Investigators found that drug scheduling changes imposed by the US Drug Enforcement Administration (including tighter prescribing standards and prohibiting refills) led to major reductions in the prescribing and dispensing of hydrocodone combination analgesic products.
Journal Article > Commentary
U.S. Food and Drug Administration Precertification pilot program for digital health software: weighing the benefits and risks.
Lee TT, Kesselheim AS. Ann Intern Med. 2018;168:730-732.
Innovation is a valuable process in health care. However, when innovations are rapidly deployed, efforts to proactively identify and address safety concerns may fall short and lead to unintended consequences. This commentary describes a new program to expedite the review of digital health software and summarizes the benefits and potential harms that could result from the program.
Silver Spring, MD: US Food and Drug Administration; April 2018.
Reliable use of medical devices is an important contributor to safe health care delivery. This report describes the US Food and Drug Administration's plan to raise awareness of problems with devices in the field, develop new devices with better safety and cybersecurity protections, and enhance innovation and the product life cycle through regulation.