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Journal of Wound Care Feb 2020
Topics: Consensus Development Conferences as Topic; Equipment and Supplies; Humans; Practice Guidelines as Topic; Pressure Ulcer
PubMed: 32058852
DOI: 10.12968/jowc.2020.29.2.77 -
Systematic Reviews Mar 2015Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting... (Review)
Review
BACKGROUND
Medical devices have improved the treatment of many medical conditions. Despite their benefit, the use of devices can lead to unintended incidents, potentially resulting in unnecessary harm, injury or complications to the patient, a complaint, loss or damage. Devices are used in hospitals on a routine basis. Research to date, however, has been primarily limited to describing incidents rates, so the optimal design of a hospital-based surveillance system remains unclear. Our research objectives were twofold: i) to explore factors that influence device-related incident recognition, reporting and resolution and ii) to investigate interventions or strategies to improve the recognition, reporting and resolution of medical device-related incidents.
METHODS
We searched the bibliographic databases: MEDLINE, Embase, the Cochrane Central Register of Controlled Trials and PsycINFO database. Grey literature (literature that is not commercially available) was searched for studies on factors that influence incident recognition, reporting and resolution published and interventions or strategies for their improvement from 2003 to 2014. Although we focused on medical devices, other health technologies were eligible for inclusion.
RESULTS
Thirty studies were included in our systematic review, but most studies were concentrated on other health technologies. The study findings indicate that fear of punishment, uncertainty of what should be reported and how incident reports will be used and time constraints to incident reporting are common barriers to incident recognition and reporting. Relevant studies on the resolution of medical errors were not found. Strategies to improve error reporting include the use of an electronic error reporting system, increased training and feedback to frontline clinicians about the reported error.
CONCLUSIONS
The available evidence on factors influencing medical device-related incident recognition, reporting and resolution by healthcare professionals can inform data collection and analysis in future studies. Since evidence gaps on medical device-related incidents exist, telephone interviews with frontline clinicians will be conducted to solicit information about their experiences with medical devices and suggested strategies for device surveillance improvement in a hospital context. Further research also should investigate the impact of human, system, organizational and education factors on the development and implementation of local medical device surveillance systems.
Topics: Biomedical Technology; Equipment and Supplies; Humans; Medical Errors; Product Surveillance, Postmarketing
PubMed: 25875375
DOI: 10.1186/s13643-015-0028-0 -
Journal of Tissue Viability Feb 2018Costs for the prevention and management of pressure ulcers have increased significantly with limited published advice from health and social care organisations on...
BACKGROUND
Costs for the prevention and management of pressure ulcers have increased significantly with limited published advice from health and social care organisations on seating and preventing pressure ulcers. At the request of the UK Tissue Viability Society the aim of the publication was to develop a practical guide for people, carers and health and social care professionals on how the research and evidence base on pressure ulcer prevention and management can be applied to those who remain seated for extended periods of time.
METHODS AND FINDINGS
The evidence base informing the guidelines was obtained by applying a triangulation of methods: a literature review, listening event and stakeholder group consultation. The purpose was to engage users and carers, academics, clinicians, inspectorate and charities, with an interest in seating, positioning and pressure management to: gather views, feedback, stories, and evidence of the current practices in the field to create a greater awareness of the issue.
CONCLUSION
The new guidelines are inclusive of all people with short and long-term mobility issues to include all population groups. The document includes evidence on where pressure ulcers develop when seated, risk factors, best possible seated position and what seat adjustments are required, the ideal seating assessment, interventions, self-help suggestions and key seating outcomes. The updated TVS CPGs have been informed by the best available evidence, the insights and wisdom of experts, stakeholders and people who spend extended periods of time sitting.
Topics: Equipment and Supplies; Guidelines as Topic; Humans; Posture; Pressure Ulcer; Tissue Survival
PubMed: 28919021
DOI: 10.1016/j.jtv.2017.09.006 -
German Medical Science : GMS E-journal 2022The goal of this review was to identify decision-analytic modeling studies in early health technology assessments (HTA) of high-risk medical devices, published over the... (Review)
Review
OBJECTIVE
The goal of this review was to identify decision-analytic modeling studies in early health technology assessments (HTA) of high-risk medical devices, published over the last three years, and to provide a systematic overview of model purposes and characteristics. Additionally, the aim was to describe recent developments in modeling techniques.
METHODS
For this scoping review, we performed a systematic literature search in PubMed and Embase including studies published in English or German. The search code consisted of terms describing early health technology assessment and terms for decision-analytic models. In abstract and full-text screening, studies were excluded that were not modeling studies for a high-risk medical device or an in-vitro diagnostic test. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram was used to report on the search and exclusion of studies. For all included studies, study purpose, framework and model characteristics were extracted and reported in systematic evidence tables and a narrative summary.
RESULTS
Out of 206 identified studies, 19 studies were included in the review. Studies were either conducted for hypothetical devices or for existing devices after they were already available on the market. No study extrapolated technical data from early development stages to estimate potential value of devices in development. All studies except one included cost as an outcome. Two studies were budget impact analyses. Most studies aimed at adoption and reimbursement decisions. The majority of studies were on in-vitro diagnostic tests for personalized and targeted medicine. A timed automata model, to our knowledge a model type new to HTA, was tested by one study. It describes the agents in a clinical pathway in separate models and, by allowing for interaction between the models, can reflect complex individual clinical pathways and dynamic system interactions. Not all sources of uncertainty for in-vitro tests were explicitly modeled. Elicitation of expert knowledge and judgement was used for substitution of missing empirical data. Analysis of uncertainty was the most valuable strength of decision-analytic models in early HTA, but no model applied sensitivity analysis to optimize the test positivity cutoff with regard to the benefit-harm balance or cost-effectiveness. Value-of-information analysis was rarely performed. No information was found on the use of causal inference methods for estimation of effect parameters from observational data.
CONCLUSION
Our review provides an overview of the purposes and model characteristics of nineteen recent early evaluation studies on medical devices. The review shows the growing importance of personalized interventions and confirms previously published recommendations for careful modeling of uncertainties surrounding diagnostic devices and for increased use of value-of-information analysis. Timed automata may be a model type worth exploring further in HTA. In addition, we recommend to extend the application of sensitivity analysis to optimize positivity criteria for in-vitro tests with regard to benefit-harm or cost-effectiveness. We emphasize the importance of causal inference methods when estimating effect parameters from observational data.
Topics: Humans; Technology Assessment, Biomedical; Equipment and Supplies
PubMed: 36742459
DOI: 10.3205/000313 -
Wound Management & Prevention Mar 2021Medical device-related pressure ulcers/injuries (MDRPU/Is) are a serious concern in health care.
BACKGROUND
Medical device-related pressure ulcers/injuries (MDRPU/Is) are a serious concern in health care.
PURPOSE
To develop and assess the psychometric testing of a questionnaire to measure nursing students' attitudes about the care and prevention of MDRPU/Is.
METHODS
Based on a review of the literature, a 26-item questionnaire was developed; face validity was assessed by ten (10) nursing students. The modified Lawshe's model was used, and both the content validity index (CVI) and content validity ratio were calculated. Items with a CVI more than 0.63 were retained. The minimum optimal CVI for the new instrument was 79%. Qualitative assessments were performed by 10 experienced faculty members. One-hundred-and-eighty seven (187) nursing students participated in the construct validity testing of the 11-item questionnaire. The Kaiser-Meyer-Olkin test of sampling adequacy and Bartlett's test of sphericity were performed. Following analysis of the main components and the varimax rotation, the factor analysis was determined. Internal consistency (Cronbach's alpha) and test-retest were determined using Pearson's correlation and intraclass correlation coefficient to evaluate reliability.
RESULTS
During the face validity phase of the initial 26 items, 7 items had impact scores less than 1.5. After calculating the CVI and content validity ratio for all items, 8 items did not achieve the desirable score. After performing exploratory factor analysis on the remaining 11 items, the Kaiser-Meyer-Olkin test value was 0.789, and Bartlett's test of sphericity was 0.0001, which was statistically significant. Internal consistency of items (Cronbach's alpha of 0.77) showed that all items had a high correlation. The reliability of test-retest was significant using an intraclass correlation coefficient of 0.75 and Pearson's correlation coefficient of 0.86 at P < .005.
CONCLUSION
In this sample of nursing students, the Attitude Towards Medical-device Related Pressure Ulcers/Injuries Questionnaire was valid and reliable. Studies including licensed clinicians are needed to confirm these results.
Topics: Attitude of Health Personnel; Equipment and Supplies; Humans; Pressure Ulcer; Psychometrics; Reproducibility of Results; Students, Nursing; Surveys and Questionnaires
PubMed: 33788773
DOI: No ID Found -
Journal of Biomedical Informatics May 2019Similarly to what already established and implemented in the United States, the concept of the Unique Device Identification (UDI) system has been introduced with the...
BACKGROUND AND OBJECTIVES
Similarly to what already established and implemented in the United States, the concept of the Unique Device Identification (UDI) system has been introduced with the European Regulations for medical devices MDR (EU) 2017/745 and in-vitro diagnostic medical devices IVDR (EU) 2017/746 and it is on the way to become a worldwide standard. The aim of this work was to provide a possible approach for the implementation of UDI and traceability in Europe for standalone software medical devices according to lifecycle and quality system standards.
METHODS
The key points of the UDI regulation were determined and analyzed in order to identify the main issues related to the manufacturing of software medical devices and, in particular, labeling, privacy aspects, UDI assignment criteria, and international standards compliance.
RESULTS
An approach for the management of each key point was suggested, resulting in different levels of implementation for UDI and traceability.
CONCLUSIONS
Among the various types of medical devices, software is an increasingly large reality with very specific characteristics that must be taken into consideration. All the relevant aspects for the implementation of the UDI should be taken into consideration to combine safety and feasibility in order to effectively pursue the traceability of these medical devices.
Topics: Equipment and Supplies; Privacy; Software
PubMed: 30878617
DOI: 10.1016/j.jbi.2019.103150 -
International Wound Journal Mar 2019The incidence rate of patients developing pressure ulcers associated with medical device use is underreported in Korea. This study aims to determine clinical nurses'...
The incidence rate of patients developing pressure ulcers associated with medical device use is underreported in Korea. This study aims to determine clinical nurses' perceived importance and performance towards medical device-related pressure injury prevention. A total of 620 nurses from seven hospitals attending continuing education programmes in Korea responded to self-administered questionnaires. Data were collected from March to December 2017 on a 4-point-Likert scale on nurses' perceived importance and performance for prevention of medical device-related pressure ulcer (MDRPU). Secondary data analysis was performed through reported pressure injury incidence, and questionnaire data were analysed using descriptive statistics, t-test, and anova. The overall rates of hospital-acquired pressure ulcers and MDRPU were 16.9% and 0.8%, respectively. The proportion of MDRPU was 5.02%. Its perceived importance (3.56 ± 0.48) was also higher than prevention performance (3.13 ± 0.90) among nurses. Education level and participation in pressure injury management training was found to enhance prevention performance by nurses. Therefore, informational and educational programmes based on clinical practice are necessary for clinical nurses to focus on perceived importance and performance towards prevention of medical device-related pressure injury and pressure ulcer care.
Topics: Adult; Attitude of Health Personnel; Critical Care Nursing; Equipment and Supplies; Female; Humans; Male; Middle Aged; Nursing Staff, Hospital; Pressure Ulcer; Republic of Korea
PubMed: 30793861
DOI: 10.1111/iwj.13023 -
International Wound Journal Jun 2015Medical device related pressure ulcers (MDR PUs) are defined as pressure injuries associated with the use of devices applied for diagnostic or therapeutic purposes... (Review)
Review
Medical device related pressure ulcers (MDR PUs) are defined as pressure injuries associated with the use of devices applied for diagnostic or therapeutic purposes wherein the PU that develops has the same configuration as the device. Many institutions have reduced the incidence of traditional PUs (sacral, buttock and heel) and therefore the significance of MDR PU has become more apparent. The highest risk of MDR PU has been reported to be patients with impaired sensory perception, such as neuropathy, and an impaired ability for the patient to communicate discomfort, for example, oral intubation, language barriers, unconsciousness or non-verbal state. Patients in critical care units typify the high-risk patient and they often require more devices for monitoring and therapeutic purposes. An expert panel met to review the evidence on the prevention of MDR PUs and arrived at these conclusions: (i) consider applying dressings that demonstrate pressure redistribution and absorb moisture from body areas in contact with medical devices, tubing and fixators, (ii) in addition to dressings applied beneath medical devices, continue to lift and/or move the medical device to examine the skin beneath it and reposition for pressure relief and (iii) when simple repositioning does not relieve pressure, it is important not to create more pressure by placing dressings beneath tight devices.
Topics: Bandages; Equipment and Supplies; Global Health; Humans; Incidence; Pressure Ulcer
PubMed: 23809279
DOI: 10.1111/iwj.12111 -
Drug Delivery and Translational Research Oct 2018Gastritis is an inflammation of the gastric mucosa. In this study, we investigated the efficacy of a medical device, Esoxx®, based on hyaluronic acid and chondroitin... (Randomized Controlled Trial)
Randomized Controlled Trial
Gastritis is an inflammation of the gastric mucosa. In this study, we investigated the efficacy of a medical device, Esoxx®, based on hyaluronic acid and chondroitin sulfate on gastritis-related upper abdominal pain/discomfort and endoscopic features. Fifty patients, affected by gastritis, were randomised to receive the medical device or placebo. The primary endpoint was the medical device efficacy on upper abdominal pain/discomfort associated with gastritis and measured by Visual Analogue Scale (VAS). The secondary endpoints were the efficacy of the medical device on gastritis-related mucosal erosions, blood oozing, and hyperemia (redness)/edema, as assessed by endoscopy, and the patients' rating of their compliance with the treatments. A significant reduction in VAS pain was observed in the treatment group after a 5-week treatment, if compared with placebo (p < 0.001). In summary, administration of a medical device, based on hyaluronic acid and chondroitin sulfate, improves gastritis-related upper abdominal pain/discomfort and decreases mucosal erosions, blood oozing, and hyperemia (redness)/edema at 5-week follow-up in patients affected by gastritis.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Anecdotes as Topic; Child; Chondroitin Sulfates; Double Bind Interaction; Endoscopy, Digestive System; Equipment and Supplies; Female; Gastritis; Humans; Hyaluronic Acid; Male; Middle Aged; Pain; Random Allocation; Retrospective Studies; Treatment Outcome; Young Adult
PubMed: 29796851
DOI: 10.1007/s13346-018-0531-7 -
Diagnostic and Interventional Radiology... May 2020Radiographs of the abdomen and pelvis are routinely obtained as a standard part of clinical care for the abdomen and pelvis. Brisk advances in technology over the last... (Comparative Study)
Comparative Study Review
Radiographs of the abdomen and pelvis are routinely obtained as a standard part of clinical care for the abdomen and pelvis. Brisk advances in technology over the last few decades have resulted in a multitude of medical devices and materials. Recognizing and evaluating these devices on abdominal and pelvic radiographs are critical, yet increasingly a difficult endeavor. In addition, multiple devices serving different purposes may have a similar radiographic appearance and position causing confusion for the interpreting radiologist. The role of the radiologist is to not only identify accurately these medical objects, but also to confirm for their accurate placement and to recognize any complications that could affect patient care, management or even be potentially life threatening. An extensive online search of literature showed our review article to be the most comprehensive work on medical devices and materials of the abdomen and pelvis, and in this second part of our two-part series, we discuss in depth about the neurologic and genitourinary devices seen on abdominal and pelvic radiographs.
Topics: Abdomen; Catheters; Equipment and Supplies; Female; Foreign Bodies; Humans; Implantable Neurostimulators; Male; Pelvis; Radiography; Radiography, Abdominal; Radiologists; Stents; Urogenital System
PubMed: 32209503
DOI: 10.5152/dir.2019.19391