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Quesenberry M. Patient Safety. 2022;4:6-9.
Medical devices intended to improve patient safety can unintentionally lead to patient harm. This patient safety alert draws attention to the risk of injury when hospital wheelchairs are used by staff, patients, or visitors who may not have training in safe use. Understanding the proper use of the wheelchair, particularly folding wheelchairs, is crucial to ensuring safety.
Serou N, Slight RD, Husband AK, et al. J Patient Saf. 2022;18:358-364.
Operating rooms are high-risk healthcare settings. This study reviewed serious surgical incidents occurring at large teaching hospitals in one National Health Service (NHS) trust. The authors outline several possible contributing factors (i.e., equipment and resource factors, team factors, work environment factors, and organizational and management factors) discuss recommendations for safer care.

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.
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%.
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; 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.

Cumberlege J. London, England, Crown Copyright. July 8, 2020.

Implicit biases are known to affect the safety of health care. This analysis of the National Health Service (NHS) found weaknesses in NHS’ consideration of and response to women’s medication and medical device concerns. Among the recommendations submitted to improve patient centeredness and respect for patients are the establishment of central yet independent authority to serve as the conduit to address patient concerns and improve system safety accountability.
ten Haken I, Ben Allouch S, van Harten WH. BMJ Qual Saf. 2021;30:380-387.
This cross-sectional study of home care nurses explored incident reports stemming from use of infusion therapy, parenteral nutrition, or morphine pumps. The majority of incidents resulted in no or mild harm. Most incidents were attributable to product failures, as well as organization of care (e.g., unclear tasks or responsibilities), human factors, and the environment.
Jeffrey Shuren, MD, JD is the Director of the Center for Devices and Radiological Health at the Food and Drug Administration. We spoke with him about the role of the Food and Drug Administration in ensuring the safety of medical devices.

FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. MedWatch Safety Alert. Silver Spring, MD: US Food and Drug Administration. March 24, 2020.

Device related errors reduce the safety of medications. This announcement highlights concerns associated with the use of epinephrine auto-injectors. Recommendations to address the problem include patient review of instructions and practice with the device to ensure its effective use in emergent situations.
Mohr H, Weiss M. Associated Press. November 27, 2018.
Usability issues, poor design, and lack of effective instruction hinder safe use of medical equipment. This news article reports on problems associated with ambulatory use of insulin pumps submitted to a Food and Drug Administration database.
Bach TA, Berglund L-M, Turk E. BMJ Open Qual. 2018;7:e000202.
Alarm fatigue limits the utility of physiologic monitoring devices intended to keep hospitalized patients safe. The authors conducted a literature review and interviewed experts to identify best practices to optimize device alarms. They present a step-by-step guide to alarm improvement that incorporates a human factors engineering approach.
Wright A, Ai A, Ash J, et al. J Am Med Inform Assoc. 2018;25:496-506.
Clinical decision support (CDS) includes electronic alerts that can prevent errors. Excessive or erroneous alerts may lead to alert fatigue or other unintended consequences. Researchers used a blend of qualitative methods such as interviews and quantitative data like alert rates to develop a taxonomy of CDS alert errors. The taxonomy includes the origin of the error, which most commonly occurred with introduction of a new decision support rule, and describes the underlying reason for the error, such as problems with new terms, conceptualization, and building the rule as intended. Errors could cause an alert to fail to appear for a relevant situation or could cause an irrelevant or erroneous alert to appear. Most errors came to light through reports from users. The authors recommend classifying CDS alert errors using this taxonomy so that safety efforts will be consistent and actionable.
A newborn with elevated total serum bilirubin (TSB) due to hemolytic disease was placed on a mattress with embedded phototherapy lights for treatment, but the TSB continued to climb. The patient was transferred to the neonatal ICU for an exchange transfusion. The neonatologist requested testing of the phototherapy lights, and their irradiance level was found to be well below the recommended level. The lights were replaced, the patient's TSB level began to drop, and the exchange transfusion was aborted.