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In order to achieve precise risk control of medical devices, it is necessary to establish a scientific evaluation system throughout the entire life cycle of medical devices that focuses on risk identification and risk control. This study summarizes the medical device adverse event monitoring system of the US on regulatory agencies and regulatory law, adverse events reporting forms and time limits, adverse event database, adverse event report analysis and evaluation, as well as adverse event feedback and control. Furthermore, some examples are provided to illustrate the application of the MAUDE database in risk analysis, physical and mechanical performance research, and clinical evaluation of medical device registration and application materials.

Objectives: Experiences of difficulty (e.g., anxiety, difficult emotions) can occur during mindfulness practice. This study characterized the occurrence of such difficulties, defined as abnormal distress, dysregulation, or agitation, among high-suicide-risk participants during a mindfulness-based intervention. The study also evaluated whether mindfulness difficulties were associated with baseline differences or poorer outcomes during follow-up. Method: Participants (n = 50; mean age = 49 years, 84% male, 24% Latinx) were from the Mindfulness-Based Cognitive Therapy for Suicide Prevention (MBCT-S) trial. Occurrences of mindfulness difficulties were identified via systematic review of progress notes. Serious clinical outcomes (suicidal events, suicide attempts, and psychiatric hospitalizations) were tracked over 12 months follow-up. Participants experiencing difficulties during MBCT-S were compared to those who did not on baseline characteristics and serious clinical outcomes. Incidence density sampling and Cox proportional regression analyses tested whether experiencing difficulties during mindfulness increased the risk of subsequent serious clinical outcomes. Results: Eighteen percent of participants had difficulty during mindfulness practice, which mostly included experiences of anxiety or hallucinations. Those experiencing difficulty showed several diagnostic differences at baseline, but were not at significantly greater risk of a suicidal event, HR 0.62 (95% confidence interval [CI], 0.14–2.71) or an acute psychiatric hospitalization, HR 0.85 (95% CI, 0.19–3.82). There were no suicide attempts among the nine participants who experienced mindfulness difficulty, compared to five suicide attempts in those without mindfulness difficulty. Conclusions: Difficulties during mindfulness practice were common, but did not show increased risk of serious clinical outcomes in participants at high risk of suicide. Preregistration: This study reports findings from a secondary analyses of a randomized clinical trial that was preregistered at clinicaltrials.gov (NCT01872338). [ABSTRACT FROM AUTHOR]

Objective: Thoracic surgery carries significant risk of postoperative adverse events (AEs). Multiple international recording systems are used to define and collect AEs following thoracic surgery procedures. We hypothesized that a simple-yet-ubiquitous approach to AE documentation could be developed to allow universal data entry into separate international databases. Methods: AE definitions of the Canadian Association of Thoracic Surgeons (CATS) system and 4 international databases were matched and compared. This consisted of reviewing the definition of each AE as described by their respective database and assessing compatibility with the CATS system. We developed a single set of 4 drop-down menus to enable clear classification and facilitated data entry, using 3 single-select mandatory lists and 1 multiselect optional list classifying type and severity of these events. Results: The CATS data elements were harmonized (ie, perfect or good) with 100% (European Society of Thoracic Surgeons), 89% (Society of Thoracic Surgeons), 74% (Esophagectomy Complications Consensus Group), and 73% (National Surgical Quality Improvement Program) of respective data elements. The addition of 17 AEs and 2 complication modifiers to the CATS system was implemented to achieve complete harmonization. Consequently, 100% of AE data elements currently included in all 4 international databases are perfectly or well-harmonized with the revised 4-choice drop down menu. Conclusions: We describe a framework for a ubiquitously applicable approach to AE monitoring following thoracic surgery harmonized with AE definitions of all major thoracic international associations. Use of this AE collection framework allows for comprehensive evaluation of both the incidence and severity of all AEs after thoracic surgery along with quality indicators.

To produce a consensus list of the top 10 signs and symptoms suggestive of adverse drug events (ADEs) for monitoring in residents of long-term care facilities (LTCFs) who use antipsychotics, benzodiazepines, or antidepressants. A 3-round Delphi study. Geriatricians, psychiatrists, pharmacologists, general practitioners, pharmacists, nurses, and caregivers from 13 Asia Pacific, European, and North American countries. Three survey rounds were completed between April and June 2023. In Round 1, participants indicated their level of agreement on a 9-point Likert scale on whether 41 signs or symptoms identified in a systematic review should be routinely monitored. Participants considered signs and symptoms that reduce quality of life or cause significant harm, are observable or measurable by nurses or care workers, and can be assessed at a single time point. Round 1 statements were included in a list for prioritization in Round 3 if ≥ 70% of participants responded ≥7 on the Likert scale. Statements were excluded if ≤ 30% of participants responded ≥7. In Round 2, participants indicated their level of agreement with statements that did not reach initial consensus, plus amended statements based on Round 1 participant feedback. Round 2 statements were included in Round 3 if ≥ 50% of the participants responded ≥7 on the Likert scale. In Round 3, participants prioritized the signs and symptoms. Forty-four participants (93.6%) completed all 3 rounds. Four of 41 signs and symptoms reached consensus for inclusion after Round 1, and 9 after Round 2. The top 10 signs and symptoms prioritized in Round 3 were recent falls, daytime drowsiness or sleepiness, abnormal movements (eg, shaking or stiffness), confusion or disorientation, balance problems, dizziness, postural hypotension, reduced self-care, restlessness, and dry mouth. The top 10 signs and symptoms provide a basis for proactive monitoring for psychotropic ADEs. [ABSTRACT FROM AUTHOR]

Vancomycin is commonly used in outpatient parenteral antimicrobial therapy (OPAT) of Gram-positive infections. Therapeutic drug monitoring and adverse event monitoring pose a challenge. Outcome data of vancomycin in OPAT (vOPAT) are limited. The study aim was to report the safety and efficacy of a structured vOPAT program implemented in the University Hospitals Leuven. The program provides continuous elastomeric infusion of vancomycin at home with biweekly follow-up at the outpatient clinic. Demographics, clinical, biochemical and treatment parameters, target attainment parameters and clinical outcomes were recorded. An e-survey was conducted to assess patient satisfaction. Thirty-five vOPAT episodes in 32 patients were included. During 206 follow-up consultations, 203 plasma concentration measurements were registered with a median vancomycin plasma concentration of 22.5 mg/L (range 6.6–32.0). The majority of concentrations (68.5%) were within the therapeutic range (20.0–25.0 mg/L). Adverse event rates, including drug- (5.7%) and catheter-related (5.7%) events, were low. For 32 vOPAT episodes, a clinical cure rate of 100% was observed. All patients who completed the e-survey were satisfied with their vOPAT course. These findings show that a structured vOPAT program with rigorous follow-up provides safe and effective ambulatory treatment of patients with vancomycin in continuous infusion. [ABSTRACT FROM AUTHOR]

Background: Clinical guidelines recommend altering chemotherapy treatment by decreasing, delaying, or discontinuing dosing in patients who are experiencing chemotherapy-induced peripheral neuropathy. There are few data available on the clinical use of treatment alteration including the severity of CIPN at the time of treatment alteration. Methods: This was a retrospective analysis of patients receiving oxaliplatin on the NCCTG N08CB trial. Neuropathy severity was assessed at each cycle by clinicians and patients. Patients were classified as (1) completed treatment without alteration, (2) dose reduction or delay due to neuropathy, (3) discontinuation due to neuropathy, (4) discontinuation for other toxicity, or (5) discontinuation for another reason (5). Comparisons focused primarily on patients with alteration due to neuropathy (groups 2 and/or 3) compared with patients who completed treatment without alteration (group 1). Results: In 350 participants, 135 (39%) completed treatment without alteration, 70 (20%) had a dose reduction or delay due to neuropathy, and 35 (10%) discontinued early due to neuropathy. Clinician-assessed neuropathy severity was greater in patients at the time of dose reduction or delay compared with severity at the end of treatment in patients without alteration (p < 0.0001). Patient-reported neuropathy severity at cycle 4 was worse in patients who eventually had a reduction or delay as compared with patients who completed treatment without alteration (p = 0.017). Conclusions: Treatment alterations due to neuropathy are common in patients receiving oxaliplatin for colon cancer and are associated with clinician-assessed neuropathy severity. Rapid increases in patient-reported neuropathy severity indicate a potential need for monitoring and intervention. Trial Registration: Clinicaltrials.gov Identifier: NCT01099449 (NCCTG N08CB) [ABSTRACT FROM AUTHOR]

Vancomycin is commonly used in outpatient parenteral antimicrobial therapy (OPAT) of Gram-positive infections. Therapeutic drug monitoring and adverse event monitoring pose a challenge. Outcome data of vancomycin in OPAT (vOPAT) are limited. The study aim was to report the safety and efficacy of a structured vOPAT program implemented in the University Hospitals Leuven. The program provides continuous elastomeric infusion of vancomycin at home with biweekly follow-up at the outpatient clinic. Demographics, clinical, biochemical and treatment parameters, target attainment parameters and clinical outcomes were recorded. An e-survey was conducted to assess patient satisfaction. Thirty-five vOPAT episodes in 32 patients were included. During 206 follow-up consultations, 203 plasma concentration measurements were registered with a median vancomycin plasma concentration of 22.5 mg/L (range 6.6–32.0). The majority of concentrations (68.5%) were within the therapeutic range (20.0–25.0 mg/L). Adverse event rates, including drug- (5.7%) and catheter-related (5.7%) events, were low. For 32 vOPAT episodes, a clinical cure rate of 100% was observed. All patients who completed the e-survey were satisfied with their vOPAT course. These findings show that a structured vOPAT program with rigorous follow-up provides safe and effective ambulatory treatment of patients with vancomycin in continuous infusion.

To evaluate properties of psychotropic adverse drug event (ADE) monitoring tools intended for use in long-term care facilities. Systematic review. Adults aged 18 years and older in nursing homes and other long-term care facilities. Medline, CINAHL, Embase, and PsycInfo were searched from inception to August 2022 for studies reporting the development, validation, or application of tools to monitor psychotropic ADEs. Screening, data extraction, and quality assessment were performed independently by 2 authors. Each tool was assessed under the domains of test-retest reliability, interrater reliability, content validity, and construct validity. Eight studies that described 6 tools were included. Tools were developed in Wales (n = 2), United States (n = 1), Ireland (n = 1), Canada (n = 1), and Singapore (n = 1). Tools monitored 4 to 95 items related to antipsychotics (n = 6 tools), antidepressants (n = 4), benzodiazepines or hypnotics (n = 4), antiepileptics (n = 4), and dementia medications (n = 1). Tools commonly monitored sedation, tiredness, or sleepiness (n = 6), falls (n = 4), and tremor or extrapyramidal symptoms (n = 4). Tools were designed for application by nurses (n = 4), during family conferences (n = 1), and by general medical practitioners before repeat prescribing (n = 1). Two tools were reported to require 10 to 60 minutes to administer. Four tools were determined to have adequate content validity and 2 tools adequate interrater reliability. No tools reported test-retest reliability or construct validity. Six published psychotropic ADE monitoring tools are heterogeneous in design and intended application. Existing tools are predominately designed for application by nurses with or without direct involvement of the wider multidisciplinary team. Further research is needed into models of care that facilitate psychotropic ADE monitoring in the long-term care facility setting, and the extent to which application of specific tools is associated with reduced medication-related harm. [ABSTRACT FROM AUTHOR]

Objectives:Prescriptions of non-benzodiazepine sedative hypnotics, e.g. zolpidem, for insomnia in elderly subjects 80 years of age or older have markedly increased in the USA. However, a meta-analysis of the risks and benefits of hypnotics in older people reported the benefits associated with hypnotics use are outweighed by the risks. This study aimed to investigate the safety of zolpidem administration in extremely old elderly. Methods:The prevalence of adverse reactions to zolpidem was investigated in a subpopulation of participants in the Drug Event Monitoring project of the Japan Pharmaceutical Association. A total of 1011 (316 males and 695 females) zolpidem users, including 261 (25.8%) subjects 80 years of age or older without cognitive or mental complications, were eligible for the analysis. Results: The elderly and female patients were prescribed significantly lower doses of zolpidem than their counterparts. Adverse symptoms after the last prescription were reported by 60 (5.9%) subjects. The most common symptoms were impaired balance and/or falls (1.8%) and morning drowsiness (1.3%). The multiple logistic regression analyses showed that subjects 80 years of age or older were at lower risk of adverse symptoms (odds ratio 0.39, 95% confidence intervals: 0.17–0.88). Conclusion: Our findings in a real-world clinical setting suggest that low-dose zolpidem can be safely prescribed to subjects 80 years of age or older without cognitive or mental complications. [ABSTRACT FROM AUTHOR]

Electronic medical records are increasingly being leveraged to improve the efficiency and effectiveness of clinical trials. Reporting safety data and adhering to follow-up schedules are two challenges faced by study centers conducting a large number of clinical trials led by a single principal investigator. The Lenox Hill Electrophysiology Research Department collaborated with Northwell Health's informatics department to develop a live query accessing both inpatient and outpatient data. To demonstrate the efficacy of this approach we compared the compliance rate of adverse event reporting and patient follow-up visits between a clinical trial run using this approach and a clinical trial conducted prior to use. We compared the number of out of window visits, missed visits, missed assessments, subject drop out and number of late reported adverse events between both studies. The trial run using the described query method had a marked reduction in these categories. Leveraging available informatics resources have allowed for improved efficiency, accurate adverse even reporting and improved follow-up scheduling. [ABSTRACT FROM AUTHOR]

251 patients from 23 primary health care centres were recruited to a clinical trial in which either felodipine or placebo was added to baseline metoprolol treatment. Three methods of symptom reporting were used in 191 patients, namely two previously documented self-administered questionnaires and an adverse event monitoring system (spontaneous reports to treating physician). Higher frequencies of symptoms were seen with the questionnaires compared to spontaneous reporting. However, the overlap between the methods was moderate and they were found to complement one another. The questionnaires were completed twice during the study and the adverse event monitoring system was applied on five occasions. The rate of application had consequences for the ability of each method to detect transient, dose-related symptoms, e.g. headache and dizziness. Regardless of method, the possibility of detecting dose-related symptoms was enhanced when symptoms were measured not only during active treatment but also during a run-in or other baseline period, and both phases were considered in the analyses. [ABSTRACT FROM AUTHOR]

Background Human papillomavirus ( HPV) vaccines are currently utilised globally in national immunisation programmes. While evidence from clinical trials and epidemiological studies suggest that the HPV vaccines are both effective and safe, concerns about the safety of the vaccine and scientifically unproven associations with severe adverse events following immunisation have led to dramatic decreases in vaccine uptake in Japan and acceptance issues in other countries. Aim In Scotland, we utilised hospital admissions data to assess the impact of the HPV immunisation programme on the incidence of 60 diagnoses between 2004 and 2014 in both girls and boys; with boys acting as a comparator group. Methods Tabular and graphical outputs of the number of admissions, the incidence and the incidence ratio of 59 diagnoses were created to assess trends before and after the introduction of the HPV vaccine. Data linkage was utilised to investigate further the increase in Bell palsy diagnoses. Results Fifty-four diagnoses showed no change in incidence following the introduction of the national immunisation programme, and while small increases in incidence were observed for Bell palsy, coeliac disease, ovarian dysfunction, juvenile onset of type 1 diabetes, demyelinating disease and juvenile rheumatoid arthritis, none was statistically significant. Conclusions Consistent with previous evidence, we present disaggregate data that reiterate the safety of both HPV vaccines. [ABSTRACT FROM AUTHOR]

Vaccines save millions of lives per annum as an integral part of community primary care provision worldwide. Adverse events due to the vaccine delivery process outnumber those arising from the pharmacological properties of the vaccines themselves. Whilst one in three patients receiving a vaccine will encounter some form of error, little is known about their underlying causes and how to mitigate them in practice. Patient safety incident reporting systems and adverse drug event surveillance offer a rich opportunity for understanding the underlying causes of those errors. Reducing harm relies on the identification and implementation of changes to improve vaccine safety at multiple levels: from patient interventions through to organizational actions at local, national and international levels. Here we highlight the potential for maximizing learning from patient safety incident reports to improve the quality and safety of vaccine delivery.