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- Legal and Policy Approaches 5
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- Technologic Approaches 2
- Device-related Complications 10
- Medical Complications 4
- Medication Errors/Preventable Adverse Drug Events 8
- Surgical Complications 2
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Health Care Providers
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Search results for "Department of Health and Human Services (HHS)"
- Department of Health and Human Services (HHS)
- Governmental Reporting
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.
AHRQ National Scorecard on Hospital-Acquired Conditions Updated Baseline Rates and Preliminary Results 2014–2017.
Rockville, MD: Agency for Healthcare Research and Quality; January 2019.
Hospital-acquired conditions (HACs) represent a significant source of preventable harm to patients. The Centers for Medicare and Medicaid Services financially penalizes hospitals with increased numbers of HACs through the Hospital-Acquired Condition Reduction Program. This policy of nonpayment has prompted hospitals to focus significant resources on preventing HACs. This AHRQ report found a reduction in HACs from 99 per 1000 acute care discharges to 86 per 1000 discharges between 2014 and 2017, representing a decrease in 910,000 HACs and savings of $7.7 billion. Declines in certain HACs such as adverse drug events and Clostridium difficile infections were noted to be more significant as compared to others. A past WebM&M commentary highlighted the clinical significance of HACs and described an incident involving a patient who developed a pressure ulcer while in the hospital.
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.
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.
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.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 2015. Report No. OEI-01-13-00400.
A widely-reported meningitis outbreak in the United States uncovered quality and safety issues associated with the use of compounded sterile preparations. This publication describes an analysis of five accreditation organizations and their ability to provide oversight and inspection of Medicare hospitals that contract with compounding entities. The authors offer recommendations to help hospitals determine if their compounded sterile preparations contracts ensure products are prepared safely for use, including targeted training for surveyors related to compounding and improved contracting processes.
Avery L, Bennett R, Brinsley-Rainisch K, et al. Atlanta, GA: Centers for Disease Control and Prevention; October 9, 2018.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; July 2012. Report No. OEI-06-09-00092.
This report built on earlier research to examine rates of adverse events reported to state-level reporting systems compared with hospital data. It found that, even in states with required hospital reporting of adverse events, only about one in nine events is reported to the state. Because few of the events were found in each hospital's incident reporting system, the investigators concluded that the low rate of reporting was likely due to hospital failure to identify events rather than hospitals failing to report known events.
Lucado J, Paez K, Elixhauser A. HCUP Statistical Brief #109. Rockville, MD: Agency for Healthcare Research and Quality; April 2011.
Wright S. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; January 5, 2010. Report No. OEI-06-09-00360.
Journal Article > Commentary
Common formats allow uniform collection and reporting of patient safety data by patient safety organizations.
Clancy CM. Am J Med Qual. 2010;25:73-75.
Tools/Toolkit > Fact Sheet/FAQs
FDA Consumer Health Information. Silver Spring, MD: US Food and Drug Administration; February 27, 2009.
This fact sheet provides information for consumers about how to report adverse drug events and product complaints to the US Food and Drug Administration (FDA) through the Consumer Complaint Reporting system and MedWatch.
Levinson DR. Washington, DC: US Department of Health and Human Services, Office of the Inspector General; December 2008. Report No. OEI-06-07-00471.
The Tax Relief and Health Care Act of 2006 mandated that the Office of Inspector General (OIG) report to Congress a series of analyses with the first related to understanding the issues around hospital-based adverse events. This related and simultaneously released report identifies and describes state reporting systems and how they utilize the captured information. The report concludes that as of January 2008, 26 states had reporting systems in place, 23 states used the data to hold individual hospitals accountable, and 18 states reported using the data to promote learning and develop prevention strategies. A past AHRQ WebM&M perspective discusses the role of state reporting systems in advancing patient safety.
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.
Tools/Toolkit > Fact Sheet/FAQs
Center for Drug Evaluation and Research, US Food and Drug Administration.
This Web site provides information on and access to quarterly reports and an interactive dashboard of medication-related incidents culled from FDA's Adverse Event Reporting System (FAERS) database and identifies potential safety issues.
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.
Office of the Inspector General. Washington, DC: US Department of Health and Human Services; September 2006. Report No. OEI-09-04-00350.
This report presents findings from an investigation into the reporting of and response to restraint and seclusion-related deaths.