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Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital.

ABSTRACT: Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in the ICU at King Saud University Medical City completed a survey on medical devices and adverse events reporting and 198 reported experiencing an adverse event related to equipment failure. However, 195 nurses were unaware of an official national reporting system for reporting such events. It is important to develop a framework of safe operation of medical devices based on international standards. This reporting system should include the national patients' safety authorities, and should be anonymous, confidential, and non-punitive.

SUBMITTER: Alsohime F

PROVIDER: S-EPMC6812847 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital.

Alsohime Fahad F Temsah Mohamad-Hani MH Hasan Gamal G Al-Eyadhy Ayman A Gulman Sanaa S Issa Haytam H Alsohime Omar O

PloS one 20191024 10

Intensive care units (ICU) rely on multiple technical resources with extensive use of different medical devices, such as ventilators, vital sign monitors, infusion, and injection pumps. This study explored how ICU nurses approach adverse events related to medical devices in a single tertiary center and identify their level of awareness of the national reporting system for adverse events related to medical devices beside their source for risk information updates. Totally, 297 nurses working in th ...[more]

PMID: 31648228

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Project description:Dabigatran, an oral direct thrombin inhibitor, is FDA approved for the prevention of stroke in patients with nonvalvular atrial fibrillation. No agent exists for the reversal of dabigatran-related major bleeding. Prothrombin complex concentrate (PCC) has been studied in reversal but was not shown to affect the surrogate markers of bleeding such as the thrombin time, ecarin clotting time, or activated partial thromboplastin time (aPTT). Recombinant factor VIIa (rFVIIa) may provide benefit in patients with life-threatening or major bleeding; however, it has not been studied in dabigatran-related bleeding. PCC and rFVIIa are agents utilized at our institution for major bleeding in patients receiving anticoagulant therapy. Due to the high cost and thrombogenic risk of both rVIIa and PCC and lack of a clear reversal strategy, we reviewed the management of all reported cases of dabigatran-related bleeding.This was a retrospective chart review of patients admitted to UMass Memorial Medical Center with a bleeding event and also receiving dabigatran therapy.Eleven patients on dabigatran admitted for bleeding were identified. Seven were admitted for an intracranial hemorrhage (ICH) and four for a gastrointestinal hemorrhage (GIH). The baseline characteristics are as follows: mean age was 74.55 years (range, 63-89), and seven were male. Admission mean hemoglobin was 11.88 g/dl (range, 6.1-18), mean international normalized ratio (INR) was 2.2 (range, 1.1-7.1), and mean aPTT was 42.21 s (range, 36-81.4). Interventions received included fresh frozen plasma (n?=?6), platelets (n?=?3), packed red blood cells (n?=?4), rFVIIa (n?=?2), intravenous fluids (n?=?10), surgical intervention (n?=?3), and dialysis (n?=?2). No patients received PCC. Four patients survived in the ICH group, and four patients survived in the GIH group.Reversal strategies for dabigatran-related bleeding events at our institution are highly variable. Intracranial hemorrhage in patients on dabigatran was associated with 43 % mortality. Patients with severe dabigatran-related bleeding may benefit from a standardized approach to treatment.

Project description:An important challenge to spontaneous reporting system is underreporting. The sensitization and involvement of undergraduate medical students can reduce underreporting in pharmacovigilance program.To analyze the clinical characteristics and reporting quality of adverse drug reactions (ADRs) by undergraduate medical students in comparison with physicians' reporting.We sensitized the second professional year undergraduate medical students about pharmacovigilance and asked them to submit reports of ADR observed during their clinical posting from January to December 2015. We compared students' reports with those sent by physicians (Department of Medicine and Allied Branches, Paediatric, Obstetrics and Gynaecology) of our institute during the same time period. We included ADRs of "certain," "probable," or "possible" categories as per the World Health Organization causality definitions in analysis of both groups. We excluded "unlikely," "unclassified," and "unclassifiable" causality ADRs from the analysis due to questionable association of reactions with suspected drugs. We collected data of demographics, pattern of ADRs, causative drugs, seriousness, other clinical characteristics, and quality of reporting.We analyzed a total number of 176 students' reports having 269 ADRs and 143 physicians' reports covering 180 ADRs. The students predominantly reported ADRs of single drug suspect (84.09% vs. 43.35%), "probable" causality (63.94% vs. 21.11), and augmented type reactions (67.29% vs. 55%) than physicians. Both groups did not differ in reporting of serious reactions (6.25% vs. 9.09%). Students most frequently suspected gastrointestinal disorders (35.68%), whereas physicians most frequently reported skin and appendages disorders (41.11%). Students and physicians more commonly suspected ADRs due to systemic anti-infective (33.64%) and nervous system (42.07%) class of drugs, respectively. The quality analysis suggested no substantial difference in most domains of ADR reporting among both groups.Students' reported valuable and clinically relevant ADRs. Medical students should be exposed to ADR reporting during their clinical teaching posting and should be actively involved in pharmacovigilance program to improve detection rate.

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Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital.

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Reporting adverse events related to medical devices: A single center experience from a tertiary academic hospital.

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