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Search results for "Food and Drug Administration (FDA)"
- Food and Drug Administration (FDA)
US Food and Drug Administration. March 8, 2019.
Errors of commission during complex procedures can contribute to patient harm. Drawing from an analysis of medical device reports submitted to the Food and Drug Administration, this announcement seeks to raise awareness of common adverse events associated with surgical staplers and implantable staples. User-related problems include opening of the staple line, misapplied staples, and staple gun difficulties. Recommendations include ensuring availability of various staple sizes and avoiding use of staples on large blood vessels.
FDA Safety Communication: caution when using robotically-assisted surgical devices in women's health including mastectomy and other cancer-related surgeries.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 28, 2019.
This announcement seeks to raise awareness of the potential risks associated with the use of robotic-assisted surgical devices in mastectomies or cancer-related care. Recommendations for patients who may seek to have robotically assisted surgery include asking about their surgeon's experience with these procedures and discussing benefits, risks, and alternatives regarding available treatment options with their health care provider. Suggestions for health care providers include completing specialized training on procedures they perform. A WebM&M commentary described the challenges and benefits associated with robotic surgery.
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; November 14, 2018.
This safety announcement raises awareness of pump failures, dosing errors, and other potential safety issues associated with implanted pumps. Recommendations to enhance safety include review of medication labeling to select appropriate medicines and concentrations as well as open discussions with patients about risks associated with pump and medication options.
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.
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.
Silver Spring, MD: US Food and Drug Administration; September 29, 2018.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. May 29, 2018.
Surgical fires can result in patient harm. This announcement provides information about causes of surgical fires and reviews FDA recommendations to prevent them, such as presurgery fire risk assessment, promoting team communication, and fire management planning. A WebM&M commentary discussed common sources of operating room fires and how to reduce risks.
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.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; September 20, 2016.
Highlighting how aging affects medication absorption that may lead to complications, this fact sheet offers recommendations for older patients to follow instructions, maintain a medication list, be aware of drug interaction potential, and perform an annual review of medications with clinicians to help them take prescriptions safely.
Web Resource > Government Resource
Rockville, MD: Center for Devices and Radiological Health, US Food and Drug Administration. April 12, 2016.
This website alerts clinicians and patients to risks for patient harm associated with implanted electronic medical devices, such as insulin infusion pump and pacemakers, when x-rays are used during CT examinations.
Rockville, MD: Center for Drug Evaluation and Research, US Food and Drug Administration; April 2016.
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 Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 4, 2016.
This announcement alerts prescribers to differences in two oral formulations of the same medication that can lead to dosing errors. The FDA suggests that clinicians specify dosage form, strength, and frequency on prescriptions for this drug to reduce the risk of patient harm and recommend that pharmacists follow up with prescribers if such information is missing.
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.
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 Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor).
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; July 30, 2015.
Look-alike and sound-alike drug names can contribute to confusion and result in medication errors. To raise awareness of potential wrong-patient errors due to similarity between two proprietary names, this announcement describes near misses with the drugs at the prescribing and dispensing stage and suggests clinicians use the generic names for the medications to reduce risk of patient harm.
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff.
Federal Register. Washington, DC: US Department of Health and Human Services. Baltimore, MD: Food and Drug Administration. July 9, 2015;80:39440-39441.