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- Education and Training 4
- Error Reporting and Analysis 5
- Human Factors Engineering 6
- Legal and Policy Approaches 2
- Research Directions 1
- Technologic Approaches 4
- Device-related Complications 6
- Medical Complications 3
- Medication Errors/Preventable Adverse Drug Events 5
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Search results for "Food and Drug Administration (FDA)"
- Epidemiology of Errors and Adverse Events
- Food and Drug Administration (FDA)
Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors.
Brigham and Women's Hospital, Harvard Medical School, Partners HealthCare. Silver Spring, MD: US Food and Drug Administration; December 15, 2015.
Electronic prescribing, considered an opportunity to reduce medication errors, has been linked to problems unique to technology use. This white paper discusses the results of a multi-hospital effort to develop a process and tools to collect and analyze data related to search, display, and workflow issues associated with computerized provider order entry. The authors offer recommendations to enhance the safety of electronic prescribing, including standardizing drug names, minimizing the number of alerts, and designing better search functions.
Journal Article > Study
Magill SS, O'Leary E, Janelle SJ, et al; Emerging Infections Program Hospital Prevalence Survey Team. N Engl J Med. 2018;379:1732-1744.
Health care–associated infections (HAIs) are a key cause of preventable harm in hospitals. Successful programs to avert HAIs include the comprehensive unit-based safety program to reduce catheter-related bloodstream infections and the AHRQ Safety Program for Surgery to prevent surgical site infections. This survey of 12,299 patients at 199 hospitals on a single day enabled researchers to estimate the prevalence of HAIs in the United States. In 2015, 3.2% of hospitalized patients experienced an HAI, a 16% decrease compared to a similarly derived estimate in 2011. The most common HAIs were pneumonia and Clostridium difficile infections, while the biggest reductions were in urinary tract and surgical site infections. This data emphasizes the importance of identifying strategies to combat pneumonia in nonventilated patients, which remains common and less well-studied than other HAIs. A past PSNet perspective discussed the history around efforts to address preventable HAIs, including federal initiatives.
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.
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.
FDA Drug Safety Communication: FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2018.
Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 11, 2017.
Hazards in the magnetic resonance imaging environment can result in patient harm. This announcement raises awareness of inaccuracies and disruptions that may affect the safety of patients with implantable infusion devices who undergo an MRI exam. The statement recommends that patients inform their care team and carry an implant card with information about the implanted device to prevent these problems.
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.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; September 17, 2015.
Use of incompletely cleaned medical devices has been linked to health care–associated infections. Drawing from reports submitted to the FDA regarding infections related to reprocessed flexible bronchoscopes, this announcement offers recommendations to enhance the reliability of scope sterilization methods.
FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam).
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; May 20, 2015.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 25, 2015.
The practice of using multi-dose insulin pens, meant for single patient use only, among multiple patients has been linked to health care–associated infections. This announcement outlines federal labeling requirements to raise awareness of the risks associated with this practice to prevent misuse of the devices.
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning.
FDA Safety Communication. Silver Spring, MD: US Food and Drug Administration; February 23, 2015.
Design limitations and production pressure may contribute to insufficient sterilization of complicated medical devices between uses. This announcement raises awareness of risks associated with inadequate cleaning of duodenoscopes that surfaced after a cluster of nosocomial infections at Ronald Reagan UCLA Medical Center.
Legislation/Regulation > Government Resource
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications.
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration; February 11, 2015.
Tools/Toolkit > Fact Sheet/FAQs
Silver Spring, MD: United States Food and Drug Administration; October 31, 2014.
Studies have shown that pharmacist involvement can prevent medication errors. To help patients take their medications safely, this consumer update discusses pharmacists as participants in a government drug information center and reveals the top five questions submitted along with their corresponding answers.
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.
MedWatch Safety Alert, FDA Drug Safety Communication. Silver Spring, MD: US Food and Drug Administration; August 2, 2010.
This announcement reports on numerous errors in which an oral medication, nimodipine, was administered intravenously and describes how such errors occur.
Journal Article > Study
Adolescent use of insulin and patient-controlled analgesia pump technology: a 10-year Food and Drug Administration retrospective study of adverse events.
Cope JU, Morrison AE, Samuels-Reid J. Pediatrics. 2008;121:e1133-e1138.
This study examined more than 1600 medical device adverse event reports and categorized the frequency and cause of each event. The authors conclude that the adolescent population warrants special consideration when using device technology and a greater understanding of the safety problems that face this patient group.
Journal Article > Study
Follow-up study of medication errors reported to the Vaccine Adverse Event Reporting System (VAERS).
Varricchio F, Reed J, and the VAERS Working Group. South Med J. 2006;99:486-489.
The investigators analyzed medication errors submitted to a national database to assess whether they were true errors, the reasons for these errors, and responses to the errors.
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.