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Agency Information Collection Activities: Proposed Collection; Comment Request, "Hospital Survey on Patient Safety Culture Comparative Database.''

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Agency for Healthcare Quality and Research. Fed Register. June 3, 2022;87: 33795-33796.

Surveys are recognized tools to inform hospitals of the current status of their safety culture. This notice calls for public comment on the intention of the Agency for Healthcare Research and Quality to launch the Hospital Survey on Patient Safety Culture Comparative Database data collection process. The deadline for submitting comments on this notification is August 2, 2022.

Fellowship in Diagnostic Excellence.

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Society to Improve Diagnosis in Medicine.

Diagnostic error is garnering increased attention as a key area of focus in patient safety improvement. This fellowship program for physicians who have completed their residency will provide the opportunity to build expertise in enhancing diagnostic safety. The application process for the 2022-2023 program is now closed.

Agency information collection activities: National Healthcare Safety Network (NHSN); comment request.

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Zirger JM, Centers for Disease Control and Prevention. Fed Register. September 27, 2021;86:53309-53312.

Tracking healthcare-associated infection (HAI) data aids in national, regional, and organizational design of HAI improvement efforts. This notice calls for public comment on the continuation of the National Healthcare Safety Network HAI information collection process. The comment period closes November 26, 2021.

Letter to Health Care Providers: Safe Use of Surgical Staplers and Staples.

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US Food and Drug Administration. October 7, 2021.

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 updated 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.

Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.

Delays in treatment due to device misuse or design flaws can result in patient harm. This recall announcement highlights the omission of instructions describing a distinct device feature that, if a surgeon is unaware of it, reduces emergent umbilical vein catheter placement safety. Two deaths have been reported due to problems with the device.

Use purple bracelets or wristbands only for do not resuscitate status - letter to industry.

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Bethesda, MD: Food and Drug Administration; August 16, 2021.

Lack of standardization in processes, devices, and colors contributes to errors and patient harm. This letter to industry calls for medical device manufactures to use standard colors for patient identification wristbands to minimize confusion regarding do-not-resuscitate status.

FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; August 20, 2021.

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: flexible bronchoscopes and updated recommendations for reprocessing.

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Silver Springs, MD: US Food and Drug Administration: June 25, 2021.

Incomplete reprocessing of reusable flexible endoscopes can result in nosocomial infection. This announcement highlights recent guidance to improve the safe reuse of bronchoscopes with a focus on scope design, sterile processing, and infection control program management.

Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; May 4. 2021.

Anesthesia medications can be high risk should dosing errors occur. This company announcement reports a recall of two lots of anesthetics that have been mislabeled to mitigate the potential for patient harm due to misinformation.

AHRQ Safety Program for Methicillin-Resistant Staphylococcus Aureus Prevention. Request for Proposal Comment.

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Agency for Healthcare Research and Quality. May 3, 2021. Fed Register. 2021;86(83):23366-23369.

This notice announces a call for comments on an information collection project drawing from the Comprehensive Unit-based Safety Program (CUSP). This project will support the implementation of targeted hospital-acquired infection improvement initiatives in intensive care units, long term care and surgical environments to reduce the prevalence of methicillin-resistant Staphylococcus aureus (MRSA). The process for submitting comments is now closed.

Using ventilator splitters during the COVID-19 pandemic--letter to health care providers.

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Silver Spring, MD: Division of Industry and Consumer Education, US Food and Drug Administration; February 9. 2021.

Lack of access to ventilators during the COVID-19 crisis has necessitated care compromises to support multiple patients. This situation can reduce the effectiveness of monitoring patients on shared devices and introduce other challenges. This communication provides insights to enhance the safety of multiple-patient ventilator use.

Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; February 3. 2021.

Recalls of medical products due to labeling errors are an established proactive safety strategy. This announcement highlights an anticoagulant packaging mistake that could result in dosing errors.

Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 27, 2021.

Labeling mistakes in the pharmaceutical production cycle can remain undetected until the affected medication reaches a patient. This alert reports a recall of a neuromuscular blocker for use in surgery due to it being mislabeled as a medication to increase blood pressure.

FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; January 15, 2021.

Vinca alkaloid misadministration is a persistent problem that results in patient harm and death. This alert raises awareness of label changes that aim to mitigate accidental spinal administration of the high-alert chemotherapy agent by supporting infusion bag administration only.

Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers.

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US Food and Drug Administration: November 3, 2020.

False-positive results contribute to patient and family discomfort and harm. This announcement shares information for clinicians to improve the reliability of the COVID-19 testing process and highlights government- and staff-level actions to support effective testing.

FDA advises health care professionals and patients about insulin pen packaging and dispensing.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 13, 2020.

Insulin use errors are common despite their heightened potential for patient harm. This announcement highlights labeling and storage practices to reduce dispensing and administration errors associated with individual insulin pen use.

Dangerous wrong-route errors with tranexamic acid.

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National Alert Network for Serious Medication Errors. Bethesda, MD: American Society of Health-System Pharmacists and Institute for Safe Medication Practices. National Alert Network. September 9, 2020.

This announcement highlights container confusion as a contributing factor for accidental spinal injection of tranexamic acid. Storage, purchase, and preparation recommendations are shared to minimize errors with this medication.

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. July 23, 2020.

Accidental misuse of prescription opiates for pain can result in addiction, overdose and death. This announcement outlines new federal labeling requirements for opiates and treatments for opioid use disorder. The FDA calls for health care professionals to educate patients about naloxone when prescribing opioid medications to improve the safety of patients taking opiates.

Northeastern University Hospital Surge Capacity Planning Model: Bed, Ventilator, and PPE 1-30 Day Demand.

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Rockville, MD; Agency for Healthcare Research and Quality: 2020.

The COVID-19 pandemic is placing surge demand and strain on health organizational, department, and unit-level capacity and personnel. This announcement features a prototype tool as a model for health systems to evaluate hospital-specific demand for medical and intensive care unit beds and the needed equipment to equip staff to keep patients safe during shifting conditions associated with providing care during an emerging crisis.

FDA alerts health care professionals to the temporary absence of warning statement on the vial caps of two neuromuscular blocking agents.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. June 2, 2020.

Neuromuscular blocking agents are high alert medications that can severely harm patients if used incorrectly. This announcement alerts clinicians to the absence of warning statements on two types of paralyzing agents, as well as to steps to minimize mistaken use.

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