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- Technologic Approaches 2
- Device-related Complications 7
- Identification Errors 1
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- Medication Errors/Preventable Adverse Drug Events 9
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Health Care Providers
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Search results for "Press Release/Announcement"
- Press Release/Announcement
- Error Reporting
National Quality Forum.
Patient safety organizations collect data across various systems and states. This announcement calls for review of the current beta version of the common formats developed to provide a standardized method to collect and report incident data to patient safety organizations. The current comment period is of open duration.
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.
Silver Spring, MD: US Food and Drug Administration; April 9, 2019.
Efforts to address the opioid epidemic range from regulation to changes in pain management. This safety announcement raises awareness of potential harms associated with rapidly decreasing the dose of or discontinuing opioids for patients who may be physically dependent on the medication. It also announces a requirement regarding changes to prescribing information for opioids to provide expanded guidance on how to safely taper doses. Health care providers should discuss tapering plans with patients and provide ongoing monitoring and support.
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.
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.
Agency for Healthcare Research and Quality and the Institute for Healthcare Improvement.
Preventable patient harm is a global public health concern. This announcement highlights a new partnership initiative co-led by the Agency for Healthcare Research and Quality and the Institute for Healthcare Improvement. The committee was formed in response to a call to coordinate a national plan and set of priorities for patient safety improvement efforts across public health and medical care communities.
NHS Improvement. London, UK: National Health Service.
Organizational processes to investigate adverse care incidents play an important part in generating the learning needed for improvements. This announcement sought multidisciplinary insights regarding how to revise the Serious Incident Framework (2015), currently used by the National Health Service, to enhance reporting and investigation processes.
Institute for Safe Medication Practices.
Request for comments on the proposed measures and 2020 targets for the National Action Plan for Adverse Drug Event Prevention: inpatient and outpatient measures for reduction of adverse drug events from anticoagulants, diabetes agents, and opioid analgesics.
Federal Register. Washington, DC: Office of Disease Prevention and Health Promotion, US Department of Health and Human Services. October 20, 2016;81:72594-72595.
National attention has focused on efforts to address adverse drug events. This call for comments seeks insights regarding revisions to a 2014 action plan that highlighted how to reduce adverse drug events associated with anticoagulants, diabetes agents, and opioids. These proposed updates involve measures to apply in both the inpatient and outpatient environments to track adverse drug events. The opportunity to submit written comments is now closed.
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.
Federal Register. Rockville, MD: Agency for Healthcare Research and Quality. February 18, 2014;79:9214-9215.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 21, 2011.
This announcement reports the recall of several mislabeled products, including the commonly used anticoagulant warfarin.
Washington, DC: National Quality Forum; June 13, 2011.
This publication announces the 2011 National Quality Forum update of 2010 never events. The opportunity to provide open comment of the 29 serious reportable events, which includes 4 new events, has now passed.
Horsham, PA. Institute for Safe Medication Practices.
These educational programs with the Institute for Safe Medication Practices (ISMP) are for clinicians who wish to expand their practical knowledge of medication error prevention. The application deadline for the 2019–2020 fellowships is June 30, 2019.
Washington, DC: National Quality Forum; September 2009.
This announcement provides background on the proposed 2010 effort to revise and expand the National Quality Forum list of never events.
Shuren J. Federal Register. October 23, 2008;73:63153-63157.
This announcement invites field review of proposed information elements to be included in a Food and Drug Administration portal designed to collect drug- and product-related adverse event reports. The comment collection period is now closed.
The John D. and Catherine T. MacArthur Foundation. September 23, 2008.
Through his work, Peter Pronovost, a critical care physician and professor at Johns Hopkins University School of Medicine, has inspired culture change by devising evidence-based clinical practices that save lives and improve patient safety. The MacArthur Foundation has selected him as a 2008 Fellow and recipient of a $500,000 "genius grant."
Federal Register. February 12, 2008;73:8112-8183.
These proposed rules seek to support the implementation of portions of the Patient Safety and Quality Improvement Act of 2005 including how entities are defined as a patient safety organization (PSO) and how PSOs will collect and protect safety incident data. The comment period on the proposed rules is now closed.
MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 13, 2007.
This announcement describes a fatal overdose of a protease inhibitor in an infant and discusses how to prevent such occurrences.