The PSNet Collection: All Content

The AHRQ PSNet Collection comprises an extensive selection of resources relevant to the patient safety community. These resources come in a variety of formats, including literature, research, tools, and Web sites. Resources are identified using the National Library of Medicine’s Medline database, various news and content aggregators, and the expertise of the AHRQ PSNet editorial and technical teams.

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Displaying 1 - 20 of 129 Results

Examples of Medical Device Misconnections.

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Food and Drug Administration. February 23. 2023.

Mismatches of medical device connectors are known factors in therapeutic agent administration failures, despite efforts to redesign equipment and minimize their occurrence. This series of case studies drawn from reports submitted to the Food and Drug Administration illustrates a variety of misconnection scenarios to demonstrate situations that have a range of potential for patient harm.

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; September 29, 2022.

Recalls of medications due to labeling errors are an established approach to minimize the potential for harm. This announcement highlights a labeling mistake with hypertension and antiplatelet medications that could result in dose omissions or bleeding risk.

Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff.

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Rockville, MD; US Food and Drug Administration: September 28, 2022.

Clinical decision support (CDS) systems must be reliable to be safe. This final guidance outlines CDS scope and software functions used to define their qualification as a device regulated by the US Food and Drug Administration.

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; May 18, 2022.

This guidance outlines design elements that reduce errors associated with medication labels. Improvements suggested include tall-man lettering use, look-alike / sound alike avoidance and abbreviation minimization.

Use duodenoscopes with innovative designs to enhance safety: FDA Safety Communication.

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Silver Spring, MD: US Food and Drug Administration; April 5, 2022.

The challenge of medical device sterilization has shifted the design of some products with disposable elements in order to reduce opportunities for human error that increase infection potential during reuse. The publication supports the complete adoption of disposable duodenoscopes or scope components as a safety measure.

Curated Libraries

Medication/Drug Errors

January 14, 2022

The medication-use process is highly complex with many steps and risk points for error, and those errors are a key target for improving safety. This Library reflects a curated selection of PSNet content focused on medication and drug errors. Included resources explore understanding harms from preventable medication use, medication safety...

Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication.

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MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration; October 12, 2021.

This announcement highlights the possibility of medication administration inaccuracy due to design characteristics of a low dose tip (LDT) syringe. Recommended cleaning methods and other actions for patients, families and clinicians are provided to protect dose precision when using these syringes.

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.

Accidental exposures to fentanyl patches continue to be deadly to children.

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Rockville, MD: US Food and Drug Administration; 2021.

To protect children and pets from accidental exposure to prescription medications, this consumer alert outlines the dangers of inappropriate storage and disposal of medication skin patches.

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.

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.

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Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. May 20, 2021.

Magnetic resonance imaging (MRI) suites harbor unique hazards that can harm patients, should process missteps occur. This report shares assessment steps to assure that medical devices are labeled appropriately to support their safe use in the MRI environment and encourages organizational reporting of problems encountered when testing device use.

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.

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.

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.

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.

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 7, 2020.

Nonprescription drugs are commonly associated with medication errors. This draft guidance seeks to provide a structure for industry to reduce instances of drug name confusion in nonprescription formulas of prescription medications. It describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency. The timeline for submitting comments is early February 2021.

Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry.

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Rockville, MD: US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research; December 2020.

Look-alike and sound-alike names weaken the safety of medication use. This guidance provides a structure for industry to reduce instances of drug name similarities and describes the US Food and Drug Administration (FDA) vetting process for drug names to improve naming actions prior to submission to the agency.

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