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 - 7 of 7 Results

Use of recalled devices in new device authorizations under the US Food and Drug Administration's 510(k) pathway and risk of subsequent recalls.

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Kramer DB, Yeh RW. JAMA. 2023;329:136-143.

The Food and Drug Administration (FDA) plays an important role in ensuring the safety of medical devices. In this cross-sectional study, researchers identified a high risk of future Class 1 FDA recall (the most serious recall designation, indicating serious risks to patient safety) among previously authorized devices (predicates) with prior Class 1 recalls.

Using proactive risk assessment (HFMEA) to improve patient safety and quality associated with intraocular lens selection and implantation in cataract surgery.

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DeRosier JM, Hansemann BK, Smith-Wheelock MW, et al. Jt Comm J Qual Patient Saf. 2019;45:680-685.

Researchers used failure mode and effects analysis to examine intraocular lens implantation. They report uncovering many potential failure modes or safety vulnerabilities and extensive variation in how this procedure is conducted. The authors recommend standardization, changes to equipment and workflows, and quality assurance through direct observation in order to enhance safety.

Quality, Value, and Patient Safety in Orthopedic Surgery.

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Azar FM, ed. Orthop Clin North Am. 2018;49(4):A1-A8,389-552.

Quality and value have intersecting influence on the safety of health care. Articles in this special issue explore key principles of safe orthopedic care for both adult and pediatric patients. Topics covered include leadership's role in implementing sustainable improvement, postsurgery patient education as a safety tactic, and the impact of surgical volume on safe, high-quality care.

Interference between CT and Electronic Medical Devices.

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Center for Devices and Radiological Health; CDER; Food and Drug Administration; FDA.

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.

Coming Undone: Failure of Closure Device

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WebM&M Case September 1, 2007

A man underwent coronary angiography; one stent was placed and bypass surgery was scheduled for 4 days later. He developed bleeding at the catheter site and returned to the hospital. A CT scan revealed a large retroperitoneal hematoma, which was repaired surgically. While in the hospital awaiting the delayed bypass surgery, the patient had a cardiac arrest and died.

Shelhigh, Inc. implantable medical devices.

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Food and Drug Administration; FDA

This announcement alerts health care providers and consumers to potential contamination of medical devices from one manufacturer.

Quality of Care in Cranial Implant Surgeries at James A. Haley VA Medical Center, Tampa, Florida.

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Washington, DC: VA Office of Inspector General; April 10, 2006. OIG Report No. 06-01642-126.

This report shares the results of an inspection into two mistakes at a Veterans Affairs (VA) health facility involving appropriate sterilization of implantable medical devices.

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