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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.

An 18-month-old girl presented to the Emergency Department (ED) after being attacked by a dog and sustaining multiple penetrating injuries to her head and neck. After multiple unsuccessful attempts to establish intravenous access, an intraosseous (IO) line was placed in the patient’s proximal left tibia to facilitate administration of fluids, blood products, vasopressors, and antibiotics.  In the operating room, peripheral intravenous (IV) access was eventually obtained after which intraoperative use of the IO line was restricted to a low-rate fluid infusion.

Rockville, MD: Agency for Healthcare Research and Quality; April 2022.

Healthcare-associated infections can result in significant morbidity and mortality. Developed by AHRQ, this customizable, educational toolkit uses the Comprehensive Unit-based Safety Program (CUSP) and other evidence-based practices to provide clinical and cultural guidance to support practice changes to prevent and reduce central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) rates in intensive care units (ICUs). Sections of the kit include items such an action plan template, implementation playbook, and team interaction aids.
Nether KG, Thomas EJ, Khan A, et al. J Healthc Qual. 2022;44:23-30.
Medical errors in the neonatal intensive care unit threaten patient safety. This children’s hospital implemented a robust process improvement program (RPI, which refers to widespread dissemination of process improvement tools to support staff skill development and identify sustainable improvements) to reduce harm in the neonatal intensive care unit. The program resulted in significant and sustainable improvements to staff confidence and knowledge related to RPI tools. It also contributed to improvements in health outcomes, including healthcare-acquired infection.
McCleskey SG, Shek L, Grein J, et al. BMJ Qual Saf. 2022;31:308-321.
Catheter-associated urinary tract infection (CAUTI) prevention is an ongoing patient safety priority. This systematic review of economic evaluations of quality improvement (QI) interventions to reduce CAUTI rates found that QI interventions were associated with a 43% decline in infections.
Forrester JD, Maggio PM, Tennakoon L. J Patient Saf. 2022;18:e477-e479.
Healthcare-associated infections (HAIs) result in poorer patient outcomes and increased costs. The 2016 national data set of five common HAIs (surgical site infections, catheter- and line-associated bloodstream infections, catheter-associate urinary tract infections, ventilator-associated pneumonia, and Clostridioides difficile) was analyzed to create an estimated national cost. Clostridioides difficile was the most frequently reported; Clostridioides difficile and surgical site infections accounted for 79% of costs.
Fleisher LA, Schreiber M, Cardo D, et al. N Engl J Med. 2022;386:609-611.
The COVID-19 pandemic disrupted many aspects of health care. This commentary discusses its impact on patient safety. The authors discuss how the pandemic response dismantled strategies put in place to prevent healthcare-associated infections and falls, and stressors placed on both patients and healthcare workers directed attention away from ongoing safety improvement efforts. They argue that more resilience needs to be built into the system to ensure safety efforts are sustainable in challenging times.
Fakih MG, Bufalino A, Sturm L, et al. Infect Control Hosp Epidemiol. 2021;43:26-31.
Central line-associated blood steam infection (CLABSI) and catheter-associated urinary tract infection (CAUTI) prevention were an important part of patient safety prior to the COVID-19 pandemic. This study compared CLABSI and CAUTI rates in 78 hospitals during the 12-month period prior to the pandemic and the first 6 months of the pandemic. CLABSI rates increased by 51% during the pandemic period, mainly in the ICU. CAUTI rates did not show significant changes.
Sosa T, Mayer B, Chakkalakkal B, et al. Hosp Pediatr. 2022;12:37-46.
Many medications and medical devices can result in preventable harm in pediatric patients. This article describes one hospital’s efforts to implement explicit, structured processes and huddles to increase situational awareness regarding high-risk therapies among the care team and family members. After implementation, the percentage of electronic health record (EHR) alerts correctly describing high-risk therapies increased from 11% to 96%.
Rockville, MD: Agency for Healthcare Research and Quality.
In this annual publication, AHRQ reviews the results of the National Healthcare Quality Report and National Healthcare Disparities Report. This 2021 report highlights that a wide range of quality measures have shown improvement in quality, access, and cost.
Coldewey B, Diruf A, Röhrig R, et al. Appl Ergon. 2021;98:103544.
Medical devices without user-friendly interface designs may contribute to patient complications. This review explores problems in the use and design of mechanical ventilators that challenge safe use. The authors provide recommendations to product engineers to improve safe ventilator design.

Zipp R. Medical Tech Dive. October 18, 2021.

This article highlights systems influences that detract from the effectiveness of current methods of reporting recalled unsafe medical devices and raising awareness of recalls for clinicians, patients and families. Challenges highlighted include the use of paper-based notification systems and data reporting delays.

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.
Papaioannou AI, Bartziokas K, Hillas G, et al. Postgrad Med. 2021;133:524-529.
Incorrect use of medical devices can lead to unfavorable outcomes. In this study of 663 patients with asthma and/or chronic obstructive pulmonary disease (COPD), 41% demonstrated incorrect use of their inhaler. Incorrect use was more common among older patients and associated with more acute exacerbations.
Anderson E, Mohr DC, Regenbogen I, et al. J Patient Saf. 2021;17:316-322.
Burnout and low staff morale have been associated with poor patient safety outcomes. This study focused on the association between organizational climate, burnout and morale, and the use of seclusion and restraints in inpatient psychiatric hospitals. The authors recommend that initiatives aimed at reducing restraints and seclusion in inpatient psychiatric facilities also include a component aimed at improving organizational climate and staff morale.

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.
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.
Lalani C, Kunwar EM, Kinard M, et al. JAMA Intern Med. 2021;181:1217-1223.
Medical device-associated errors are common and often result in preventable patient harm. Based on medical device adverse event data reported to the FDA, this study used natural language processing to identify events not classified as deaths even though the patient died. Findings suggest that approximately 17% of medical device events that resulted in death were classified in other categories.