OBJECTIVE:To examine the prevalence and characteristics of medical device–related pressure injuries (MDR PIs) in a large, generalizable database.
METHODS:This study is a retrospective analysis of the ...2016 International Pressure Ulcer Prevalence data. Data were limited to US and Canadian facilities. Facilities included acute care, long-term care, rehabilitation, long-term acute care hospitals, and hospice. Analysis included 102,865 adult patients; 99,876 had complete data and were the focus of the analysis and are reported in the results below.
RESULTS:The overall PI prevalence was 7.2% (n = 7189), and the facility-acquired prevalence was 3.1% (n = 3113). The prevalence of MDR PIs was 0.60% (n = 601), which included both mucosal and nonmucosal MDR PIs. In this study, 75% of MDR PIs were facility acquired, whereas non-MDR PIs were most commonly present on admission. Facility-acquired MDR PIs formed 3 days faster than facility-acquired non-MDR PIs (12 vs 15 days; P < .05). By stage, most MDR PIs were superficial (58% were Stage 1 or 2), 15% were deep-tissue PIs, and 22% were full-thickness PIs (Stage 3 or 4 or unstageable). The most common anatomic locations for MDR PIs were the ears (29%) and the feet (12%). The most common devices associated with MDR PIs were nasal oxygen tubes, 26%; other, 19%; cast/splints, 12%; and continuous positive airway pressure/bilevel positive airway pressure masks, 9%.
CONCLUSIONS:Because MDR PIs form faster than non-MDR PIs, timely proactive assessment and prevention measures are critical. Most MDR PIs occurred at the face and head region, and the ears specifically. The most common devices linked with MDR PIs were oxygen tubing and masks, making assessment and prevention efforts critical for patients who require those devices.
ObjectiveTo evaluate the clinical efficacy and effectiveness of using 3D printing to develop medical devices across all medical fields.DesignSystematic review compliant with Preferred Reporting Items ...for Systematic Reviews and Meta-Analyses.Data sourcesPubMed, Web of Science, OVID, IEEE Xplore and Google Scholar.MethodsA double-blinded review method was used to select all abstracts up to January 2017 that reported on clinical trials of a three-dimensional (3D)-printed medical device. The studies were ranked according to their level of evidence, divided into medical fields based on the International Classification of Diseases chapter divisions and categorised into whether they were used for preoperative planning, aiding surgery or therapy. The Downs and Black Quality Index critical appraisal tool was used to assess the quality of reporting, external validity, risk of bias, risk of confounding and power of each study.ResultsOf the 3084 abstracts screened, 350 studies met the inclusion criteria. Oral and maxillofacial surgery contained 58.3% of studies, and 23.7% covered the musculoskeletal system. Only 21 studies were randomised controlled trials (RCTs), and all fitted within these two fields. The majority of RCTs were 3D-printed anatomical models for preoperative planning and guides for aiding surgery. The main benefits of these devices were decreased surgical operation times and increased surgical accuracy.ConclusionsAll medical fields that assessed 3D-printed devices concluded that they were clinically effective. The fields that most rigorously assessed 3D-printed devices were oral and maxillofacial surgery and the musculoskeletal system, both of which concluded that the 3D-printed devices outperformed their conventional comparators. However, the efficacy and effectiveness of 3D-printed devices remain undetermined for the majority of medical fields. 3D-printed devices can play an important role in healthcare, but more rigorous and long-term assessments are needed to determine if 3D-printed devices are clinically relevant before they become part of standard clinical practice.
The deployment of artificial intelligence (AI) has the potential to make nuclear medicine and medical imaging faster, cheaper, and both more effective and more accessible. This is possible, however, ...only if clinicians and patients feel that these AI medical devices (AIMDs) are trustworthy. Highlighting the need to ensure health justice by fairly distributing benefits and burdens while respecting individual patients' rights, the AI Task Force of the Society of Nuclear Medicine and Molecular Imaging has identified 4 major ethical risks that arise during the deployment of AIMD: autonomy of patients and clinicians, transparency of clinical performance and limitations, fairness toward marginalized populations, and accountability of physicians and developers. We provide preliminary recommendations for governing these ethical risks to realize the promise of AIMD for patients and populations.
Improvements to the reliability and safety of medical devices are vital for healthcare systems. It is necessary to consider the user experience (UX) of patients and healthcare professionals at all ...the development stages of medical devices. Ergonomic design principles can also reduce the cost of medical device production. This study is a multilateral analytical literature review of UX and usability issues in healthcare and medical device design. The total number of literature sources presented is n = 88. The literature sources are classified according to the difference between UX and usability for various target products and services, including healthcare. The literature is reviewed with a focus on human-oriented aspects. This includes medical technology and device design, which are dependent on the user type, medical device scope, and area of use. A review of key medical device standards and regulation documents is presented. The main analysis methodologies for the UX and their advantages and disadvantages are discussed. The future challenges in healthcare and medical ergonomics are briefly highlighted. Above all, this study tried to examine the difference between usability and UX of general products and those of medical devices through the review of existing literature. Even standards do not reflect this well and need to be considered based on further research in academia and industry.
The obtained results will help medical-device designers and healthcare professionals understand the main medical-research trends and improve the design process. Additionally, they will be helpful for increasing the satisfaction level among medical-device users and reducing user risks.
•There is a lack of research on usability and user experience (UX) in the medial field.•We investigated the usability and UX of medical devices through a literature analysis.•The international standards for the usability of medical devices were analyzed.•The results provide a reference for how healthcare designers should handle usability.
This study investigates the benefits, limitations and awareness of using Real World Evidence and Real World Data for post-market clinical follow-up studies and clinical evaluation reports in the ...European Medical Device Regulations.
A mixed methods study was utilized with qualitative interviews and a quantitative survey.
The findings from the study demonstrate that in the case of the Medical Device Regulations, opportunities exist for manufacturers of legacy devices to conduct Real World Evidence studies to bridge gaps in clinical evidence. The primary value of Real World Evidence lies in its ability to provide an accurate and, therefore, more reliable measure of device safety and performance. As a measure of safety and performance, it supplements clinical evidence generated from pre and post-market clinical investigations, reducing the costs associated with these studies and supporting the manufacturer's benefit: risk conclusion.
This study provides insight into how the medical device industry could utilize Real World Evidence and have an initiative in the EU similar to the FDA-sponsored NESTcc partnership. This would aid medical device manufacturers in transitioning to the MDR clinical evaluation requirements and mitigate the impact on medical device availability in the EU.
Medical technologies present a huge potential in improving global health playing a key role toward achieving Sustainable Development Goal 3 by 2030. A number of clinicians, innovators, business ...entities and biomedical engineers among others have developed a number of innovative medical devices and technologies to address the healthcare challenges especially in Africa. Globally, medical devices clinical trials present the most acceptable method for determining the risks and benefits of medical device innovations with the aim of ascertaining their effectiveness and safety as compared with established medical practice. However, there are very few medical device clinical trials reported in Africa compared to other regions like USA, UK and Europe. Most of the medical device clinical trials reported in Africa are addressing challenges around HIV/AIDS, maternal health and NCDs. In this mini review, we report about some of the published medical device clinical trials in Africa PubMed and Google Scholar and their associated challenges.
The healthcare sector is struggling to become more environmentally friendly compared to other industries, evidently seen by the contribution to global emissions. These struggles have elicited some ...research on sustainable methods regarding the lifecycle of medical devices. Indeed, the World Health Organization (WHO) encourages the reuse of equipment and ethical donations, namely for the sake of the environment and sustainable global health. However, there is a lack of synthesis–multiple greener alternatives to the current healthcare system are developing without a connection to each other, hindering an increase in sustainability. Thus, there is a lack of global organization and standardization in medical equipment lifecycles. Inspired by the findings and guidelines of the Safe and Sustainable Medical Equipment Supply Subgroup (SASMES) of the International Rotary Fellowship of Healthcare Professionals, we created the Re-processing Medical Equipment: Rotarian Research Group for the Environment (Re-MERGE) to expand on these challenges. Re-MERGE follows the life cycle of medical devices in the United States of America through its initial stages of classification and various regulatory pathways, the middle stage of post-market requirements, and the end stage of disposal or donation and reprocessing. Our findings indicate that current medical device end-stages are inefficient, damaging to the environment, and burdensome to donation recipients; however, existing processes can provide improvements to medical device end-stage methods by drastically reducing environmental damage, improving healthcare globally, and increasing sustainability in the field. We identify that more research is needed to connect the implications of different medical device end stages. Additionally, we encourage the findings to be implemented to create more sustainable, effective methods of medical device disposal, donation, and reprocessing.
Electrostatic charging of hospital personnel and patients during various activities increases the risk of electrostatic discharge (ESD) malfunctions of medical devices and the likelihood of patients' ...adverse events. Therefore, the test level for ESD immunity of medical devices, specified in the IEC 60601-1-2 standard needs to reflect the reasonably maximum electrostatic voltages during usage. This study investigated the effects of material combinations and relative humidity on the body voltage while performing two routine clinical activities of lying down on a hospital bed and transferring to a bed using a sliding board. The peak body voltages in nearly 50% of the lying down experiments and 40% of sliding tests exceeded the test voltage level in the IEC 60601-1-2 standard (i.e., 15 kV). Using cotton blankets in lying down experiments and nylon sheets during sliding experiments resulted in 50% and 40% larger median than the median including all combinations, respectively. Sliding boards with antistatic coating reduced the peak body voltage by 24% on average, however, 33% of the tests still exceeded 15 kV. Based on the findings, recommendations are provided for healthcare facilities and medical device manufacturers to mitigate the risks of ESD malfunctions.
Market and Patent Analyses of Wearables in Medicine Mück, Julia E.; Ünal, Barış; Butt, Haider ...
Trends in biotechnology (Regular ed.),
June 2019, 2019-06-00, 20190601, Volume:
37, Issue:
6
Journal Article
Peer reviewed
Wearable medical devices (WMDs) will advance point-of-care diagnostics and therapeutics. This article analyses the market and patents for wearable devices. Activity monitors have the largest market ...share, and the intellectual property landscape is dominated by electronics corporations. However, the majority of these patents have not been realized in commercial products.
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