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Pediatrics May 2021Children with medical complexity (CMC) are commonly assisted by medical devices, which family caregivers are responsible for managing and troubleshooting in the home....
OBJECTIVES
Children with medical complexity (CMC) are commonly assisted by medical devices, which family caregivers are responsible for managing and troubleshooting in the home. Optimizing device use by maximizing the benefits and minimizing the complications is a critical goal for CMC but is relatively unexplored. In this study, we sought to identify and describe workarounds families have developed to optimize medical device use for their needs.
METHODS
We conducted 30 contextual inquiry interviews with families of CMC in homes. Interviews were recorded, transcribed, and analyzed for barriers and workarounds specific to medical device usage through a directed content analysis. We used observation notes and photographs to confirm and elaborate on interview findings.
RESULTS
We identified 4 barriers to using medical devices in the home: (1) the quantity and type of devices allotted do not meet family needs, (2) the device is not designed to be used in locations families require, (3) device use is physically or organizationally disruptive to the home, and (4) the device is not designed to fit the user. We also identified 11 categories of workarounds to the barriers.
CONCLUSIONS
Families face many barriers in using medical devices to care for CMC. Our findings offer rich narrative and photographic data revealing the ways in which caregivers work around these barriers. Future researchers should explore the downstream effects of these ubiquitous, necessary workarounds on CMC outcomes toward developing interventions that optimize device use for families.
Topics: Caregivers; Child; Child, Preschool; Equipment and Supplies; Female; Home Care Services; Humans; Male; Middle Aged
PubMed: 33926988
DOI: 10.1542/peds.2020-019513 -
Hand Clinics May 2020The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned... (Review)
Review
The medical device industry has long been subject to criticism for lack of price transparency and minimal regulations surrounding device approval, which have functioned as barriers to providing quality and cost-effective care. Recent health care reforms aimed at overcoming these barriers, including improving market approval regulations, increasing postmarket surveillance, and using comparative effectiveness research, have drastically changed industry practices. These reforms have also prompted increasingly cost-aware health care practices, which have encouraged new trends in medical device innovation such as frugal innovation and deinstitutionalization. This article explores the challenges faced by industry, physicians, and patients in light of these reforms.
Topics: Comparative Effectiveness Research; Consumer Product Safety; Device Approval; Equipment Design; Equipment and Supplies; Government Regulation; Health Care Reform; Industry; Inventions; Medical Device Legislation; Orthopedics; Taxes; United States; United States Food and Drug Administration
PubMed: 32307056
DOI: 10.1016/j.hcl.2020.01.008 -
International Journal of Radiation... Jun 2017To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation...
PURPOSE
To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety.
METHODS AND MATERIALS
Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions.
RESULTS
There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001).
CONCLUSIONS
Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
Topics: Brachytherapy; Chi-Square Distribution; Databases, Factual; Equipment and Supplies; Linear Models; Medical Device Recalls; Product Surveillance, Postmarketing; Radiation Oncology; Radiotherapy Planning, Computer-Assisted; Software; Statistics, Nonparametric; Time Factors; United States; United States Food and Drug Administration
PubMed: 28463163
DOI: 10.1016/j.ijrobp.2017.02.006 -
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 -
Clinical Microbiology Reviews Apr 2004The number of indwelling medical devices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce... (Review)
Review
The number of indwelling medical devices is escalating, and an increasing proportion of device-related infections are being caused by Candida spp. Candida spp. produce biofilms on synthetic materials, which facilitates adhesion of the organisms to devices and renders them relatively refractory to medical therapy. Management of device-related Candida infections can be challenging. Removal of the infected device is generally needed to establish cure of Candida infections of medical devices. However, since the pathogenesis of Candida bloodstream infection is complicated, more studies are necessary to determine the role of catheter exchange in patients with both gastrointestinal tract mucositis and indwelling catheters. The medical and economic impact of these infections is enormous.
Topics: Biofilms; Candida; Candidiasis; Equipment and Supplies; Humans
PubMed: 15084500
DOI: 10.1128/CMR.17.2.255-267.2004 -
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 -
Advances in Skin & Wound Care Jun 2018To examine the prevalence and characteristics of medical device-related pressure injuries (MDR PIs) in a large, generalizable database.
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.
Topics: Databases, Factual; Equipment and Supplies; Health Surveys; Humans; Pressure Ulcer; Prevalence; Retrospective Studies; Surveys and Questionnaires
PubMed: 29782417
DOI: 10.1097/01.ASW.0000532475.11971.aa -
Antimicrobial Resistance and Infection... May 2021Healthcare-associated infections (HAIs) are a significant cause of morbidity and mortality in hospitalized patients. Water in the environment can be a source of... (Review)
Review
BACKGROUND
Healthcare-associated infections (HAIs) are a significant cause of morbidity and mortality in hospitalized patients. Water in the environment can be a source of infection linked to outbreaks and environmental transmission in hospitals. Water safety in hospitals remains a challenge. This article has summarized available scientific literature to obtain an overview of outbreaks linked to water-containing hospital equipment and strategies to prevent such outbreaks.
METHODS
We made a list of water-containing hospital equipment and devices in which water is being used in a semi-closed circuit. A literature search was performed in PubMed with a search strategy containing the names of these medical devices and one or more of the following words: outbreak, environmental contamination, transmission, infection. For each medical device, we summarized the following information: the function of the medical device, causes of contamination, the described outbreaks and possible prevention strategies.
RESULTS
The following water-containing medical equipment or devices were identified: heater-cooler units, hemodialysis equipment, neonatal incubators, dental unit waterlines, fluid warmers, nebulizers, water traps, water baths, blanketrol, scalp cooling, and thermic stimulators. Of the latter three, no literature could be found. Of all other devices, one or more outbreaks associated with these devices were reported in the literature.
CONCLUSIONS
The water reservoirs in water-containing medical devices can be a source of microbial growth and transmissions to patients, despite the semi-closed water circuit. Proper handling and proper cleaning and disinfection can help to reduce the microbial burden and, consequently, transmission to patients. However, these devices are often difficult to clean and disinfect because they cannot be adequately opened or disassembled, and the manufacturer's cleaning guidelines are often not feasible to execute. The development of equipment without water or fluid containers should be stimulated. Precise cleaning and disinfection guidelines and instructions are essential for instructing healthcare workers and hospital cleaning staff to prevent potential transmission to patients.
Topics: Cross Infection; Disease Outbreaks; Disinfection; Equipment Contamination; Equipment and Supplies, Hospital; Humans; Infection Control; Water Supply
PubMed: 33971944
DOI: 10.1186/s13756-021-00935-6 -
ALTEX 2021Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this...
Monocyte activation tests (MAT) are widely available but rarely used in place of animal-based pyrogen tests for safety assessment of medical devices. To address this issue, the National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods and the PETA International Science Consortium Ltd. convened a workshop at the National Institutes of Health on September 18-19, 2018. Participants included representatives from MAT testing laboratories, medical device manufacturers, the U.S. Food and Drug Administration's Center for Devices and Radiologic Health (CDRH), the U.S. Pharmacopeia, the International Organization for Standardization, and experts in the development of MAT protocols. Discussions covered industry experiences with the MAT, remaining challenges, and how CDRH's Medical Device Development Tools (MDDT) Program, which qualifies tools for use in evaluating medical devices to streamline device development and regulatory evaluation, could be a pathway to qualify the use of MAT in place of the rabbit pyrogen test and the limulus amebocyte lysate test for medical device testing. Workshop outcomes and follow-up activities are discussed.
Topics: Animal Testing Alternatives; Animals; Endotoxins; Equipment and Supplies; Monocytes; Pyrogens; Rabbits; Toxicity Tests
PubMed: 33452530
DOI: 10.14573/altex.2012021 -
Clinical and Translational Science Oct 2014Medical devices are often introduced prior to randomized-trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include...
BACKGROUND
Medical devices are often introduced prior to randomized-trial evidence of efficacy and this slows completion of trials. Alternative regulatory approaches include restricting device use outside of trials prior to trial evidence of efficacy (like the drug approval process) or restricting out-of-trial use but permitting coverage within trials such as Medicare's Coverage with Study Participation (CSP).
METHODS
We compared the financial impact to manufacturers and insurers of three regulatory alternatives: (1) limited regulation (current approach), (2) CSP, and (3) restrictive regulation (like the current drug approval process). Using data for patent foramen ovale closure devices, we modeled key parameters including recruitment time, probability of device efficacy, market adoption, and device cost/price to calculate profits to manufacturers, costs to insurers, and overall societal impact on health.
RESULTS
For manufacturers, profits were greatest under CSP-driven by faster market adoption of effective devices-followed by restrictive regulation. Societal health benefit in total quality-adjusted life years was greatest under CSP. Insurers' expenditures for ineffective devices were greatest with limited regulation. Findings were robust over a reasonable range of probabilities of trial success.
CONCLUSIONS
Regulation restricting out-of-trial device use and extending limited insurance coverage to clinical trial participants may balance manufacturer and societal interests.
Topics: Costs and Cost Analysis; Device Approval; Equipment and Supplies; Health; Humans; Insurance; Insurance Coverage; Models, Economic; Product Surveillance, Postmarketing
PubMed: 25185975
DOI: 10.1111/cts.12199