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The American Journal of Bioethics : AJOB Aug 2020
Topics: Commerce; Equipment and Supplies; Ethics, Business; Health Care Sector; Humans; Marketing
PubMed: 32757913
DOI: 10.1080/15265161.2020.1782643 -
Globalization and Health Jul 2018This study characterized the landscape of commercially available medical devices specifically designed for use in low-income countries (LICs). (Review)
Review
BACKGROUND
This study characterized the landscape of commercially available medical devices specifically designed for use in low-income countries (LICs).
METHODS
A state-of-the-art review of peer-reviewed publications, patents, global health databases, and online resources was performed. The criteria established for a health technology's inclusion in the study were: it met the definition of a medical device; it was designed and developed to address one of the top ten causes of death in LICs, Millennium Development Goal (MDG) 4, or MDG 5; and there was evidence of its commercialization.
RESULTS
Analysis identified 134 commercialized devices exclusively designed for use in LICs. More than 85% of devices were designed to address infectious diseases or child or maternal health (MDG 4 or 5, respectively). None of the identified devices addressed prevention of noncommunicable diseases (NCDs). Only 8% of devices were designed for use in primary health facilities by non-physician health providers.
CONCLUSION
There is a significant mismatch between the projected global burden of disease due to NCDs and the relevant number of commercialized medical devices designed specifically for use in LICs. A limited number of commercialized devices were designed for use by non-physician health providers. These findings suggest the need for medical devices targeting NCDs in LICs and design processes that consider the broader context of design and engage stakeholders throughout all phases of design.
Topics: Communicable Diseases; Developing Countries; Equipment Design; Equipment and Supplies; Humans; Noncommunicable Diseases
PubMed: 29973232
DOI: 10.1186/s12992-018-0355-8 -
Paediatric Respiratory Reviews Sep 2020There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these... (Review)
Review
There are significant logistical challenges to providing respiratory support devices, beyond simple oxygen flow, when centres run out of supplies or do not have these devices at all, such as in low resource settings. At the peak of the COVID-19 crisis, it was extremely difficult to import medical equipment and supplies, because most countries prohibited the medical industry from selling outside of their own countries. As a consequence, engineering teams worldwide volunteered to develop emergency devices, and medical experts in mechanical ventilation helped to guide the design and evaluation of prototypes. Although regulations vary among countries, given the emergency situation, some Regulatory Agencies facilitated expedited procedures. However, laboratory and animal model testing are crucial to minimize the potential risk for patients when treated with a device that may worsen clinical outcome if poorly designed or misused.
Topics: Betacoronavirus; COVID-19; Continuous Positive Airway Pressure; Coronavirus Infections; Device Approval; Education, Professional, Retraining; Equipment Design; Equipment and Supplies; Humans; Medical Device Legislation; Noninvasive Ventilation; Pandemics; Personnel Staffing and Scheduling; Pneumonia, Viral; Respiration, Artificial; Respiratory Distress Syndrome; Respiratory Insufficiency; SARS-CoV-2; Spain; Ventilators, Mechanical
PubMed: 32690356
DOI: 10.1016/j.prrv.2020.06.015 -
Orthopaedics & Traumatology, Surgery &... Feb 2016Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the... (Review)
Review
Patient safety requires speedy detection of any medical device malfunction; this is known as "materials vigilance". It entails the need to be able to trace back the life-long pathway of a device; this is "traceability". European regulations enact free circulation of medical devices throughout the European Union, with each member state being responsible for safety within its own territory. Medical devices are divided into 3 categories of increasing risk. CE marking mandatory for medical devices distributed within the EU, and count as market authorizations. They are delivered with 5-year validity by what is known as a "notified body". Health authorities are responsible for monitoring the market and any incidents. New regulations are presently being drawn up to improve efficiency and transparency. Materials vigilance is founded on mandatory declaration of medical device incidents. At local level, it comprises local reporters responsible for informing the National Health Products Safety Agency (Agence nationale de sécurité du médicament et des produits de santé [ANSM]) of any incidents and taking all necessary precautions. At national level, the ANSM assesses the safety, efficacy and quality of healthcare products; it centralizes and assesses materials vigilance reports and takes the requisite decisions. Materials vigilance is further organized at the European and international levels, to harmonize legislation regarding medical devices. Traceability is intended to rapidly identify medical device bearers in case of product recall. Each center is to organize the traceability of its devices; manufacturers' obligation of traceability ceases with the healthcare establishment or user. CE marking involves strict labeling rules to ensure safety of use. A change in the organization of traceability is presently underway, in the form of international Unique Device Identifiers, with harmonized label data, barcodes and standardized terminology. A European and later international database will be set up. The objective is to make Unique Device Identifiers mandatory within the EU by 2017.
Topics: Equipment Failure; Equipment and Supplies; European Union; Humans; Patient Safety; Product Labeling; Prostheses and Implants; Reference Standards
PubMed: 26822532
DOI: 10.1016/j.otsr.2015.05.013 -
Environmental Microbiology Sep 2018The use of medical devices in modern medicine is constantly increasing. Despite the multiple precautionary strategies that are being employed in hospitals, which include... (Review)
Review
The use of medical devices in modern medicine is constantly increasing. Despite the multiple precautionary strategies that are being employed in hospitals, which include increased hygiene and sterilization measures, bacterial infections on these devices still happen frequently. Staphylococci are among the major causes of medical device infection. This is mostly due to the strong capacity of those bacteria to form device-associated biofilms, which provide resistance to chemical and physical treatments as well as attacks by the host's immune system. Biofilm development is a multistep process with specific factors participating in each step. It is tightly regulated to provide a balance between biofilm expansion and detachment. Detachment from a biofilm on a medical device can lead to severe systemic infection, such as bacteremia and sepsis. While our understanding of staphylococcal biofilm formation has increased significantly and staphylococcal biofilm formation on medical devices is among the best understood biofilm-associated infections, the extensive effort put in preclinical studies with the goal to find novel therapies against staphylococcal device-associated infections has not yet resulted in efficient, applicable therapeutic options for that difficult-to-treat type of disease.
Topics: Biofilms; Equipment and Supplies; Humans; Staphylococcus
PubMed: 29633455
DOI: 10.1111/1462-2920.14129 -
Value in Health : the Journal of the... Jul 2019The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate... (Review)
Review
The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable." In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies. With a focus on regulatory science, the MDIC has been assessing how to apply real-world evidence (RWE) regulatory science to medical devices. A key goal of this project is to review the history of RWE regulatory science, define terms, and explain why and how RWE is being considered across the total product life cycle, including regulatory assessment. Unique considerations of real-world data for in vitro diagnostics are also taken into account. We envision that these activities will help ensure a high level of rigor and integrity of RWE necessary for regulatory use cases and demonstrate where RWE can be successfully used for regulatory decision making. The ISPOR, FDA, and MDIC are providing the needed leadership in ensuring that diverse stakeholders share a meaningful voice in determining RWE use and, by so doing, are improving the quality and efficiency of care, enhancing health outcomes, and addressing broader societal concerns of reducing health disparities and costs.
Topics: Device Approval; Equipment Safety; Equipment and Supplies; Evidence-Based Medicine; Government Regulation; Health Policy; Humans; Interdisciplinary Communication; International Cooperation; Patient Safety; Policy Making; Product Surveillance, Postmarketing; Public-Private Sector Partnerships; Risk Assessment; Terminology as Topic; United States; United States Food and Drug Administration
PubMed: 31277820
DOI: 10.1016/j.jval.2019.03.020 -
Journal of Medical Microbiology Nov 2017Surface microtopography offers a promising approach for infection control. The goal of this study was to provide evidence that micropatterned surfaces significantly...
PURPOSE
Surface microtopography offers a promising approach for infection control. The goal of this study was to provide evidence that micropatterned surfaces significantly reduce the potential risk of medical device-associated infections.
METHODOLOGY
Micropatterned and smooth surfaces were challenged in vitro against the colonization and transference of two representative bacterial pathogens - Staphylococcus aureus and Pseudomonas aeruginosa. A percutaneous rat model was used to assess the effectiveness of the micropattern against device-associated S. aureus infections. After the percutaneous insertion of silicone rods into (healthy or immunocompromised) rats, their backs were inoculated with S. aureus. The bacterial burdens were determined in tissues under the rods and in the spleens.
RESULTS
The micropatterns reduced adherence by S. aureus (92.3 and 90.5 % reduction for flat and cylindrical surfaces, respectively), while P. aeruginosa colonization was limited by 99.9 % (flat) and 95.5 % (cylindrical). The micropatterned surfaces restricted transference by 95.1 % for S. aureus and 94.9 % for P. aeruginosa, compared to smooth surfaces. Rats with micropatterned devices had substantially fewer S. aureus in subcutaneous tissues (91 %) and spleens (88 %) compared to those with smooth ones. In a follow-up study, immunocompromised rats with micropatterned devices had significantly lower bacterial burdens on devices (99.5 and 99.9 % reduction on external and internal segments, respectively), as well as in subcutaneous tissues (97.8 %) and spleens (90.7 %) compared to those with smooth devices.
CONCLUSION
Micropatterned surfaces exhibited significantly reduced colonization and transference in vitro, as well as lower bacterial burdens in animal models. These results indicate that introducing this micropattern onto surfaces has high potential to reduce medical device-associated infections.
Topics: Animals; Cyclophosphamide; Equipment Contamination; Equipment and Supplies; Prostheses and Implants; Rats; Surface Properties
PubMed: 28984233
DOI: 10.1099/jmm.0.000600 -
Wound Management & Prevention Nov 2023The attitudes of nurses should be measured using valid and reliable tools to develop effective nursing care strategies for the prevention of medical device-related...
BACKGROUND
The attitudes of nurses should be measured using valid and reliable tools to develop effective nursing care strategies for the prevention of medical device-related pressure injuries and to organize necessary training programs.
PURPOSE
This study was planned to conduct the Turkish validity and reliability study of the Attitude towards Medical Device-Related Pressure Ulcers/Injuries Questionnaire (MDRPU/I Questionnaire (the English-language version)) in nurses.
METHODS
This methodological study included 134 nurses working in hospitals of different sizes and characteristics (public hospitals, training and research hospitals, and university hospitals) in Turkey. The validity and reliability of the Attitude Towards Medical Device-Related Pressure Injuries (MDRPI Questionnaire (the Turkish-language version)) Questionnaire were tested using language validity, content validity, face validity, construct validity, and reliability analyses.
RESULTS
The final version of the questionnaire had a content validity index of 98.03%, sufficient construct validity, and a Cronbach α value of 0.92 for the total questionnaire.
CONCLUSIONS
The Turkish version of the MDRPI Questionnaire is valid, reliable, and suitable for measuring the attitudes of nurses in Turkey toward the prevention and care of medical device-related pressure injuries.
Topics: Humans; Hospitals, University; Language; Pressure Ulcer; Reproducibility of Results; Surveys and Questionnaires; Turkey; Equipment and Supplies; Attitude of Health Personnel
PubMed: 38090951
DOI: 10.25270/wmp.22099 -
Journal of Medical Economics 2023Strategies focus on securing the competitiveness of medical device corporations by strengthening their organizational capabilities, which, in turn, ensure their...
AIMS
Strategies focus on securing the competitiveness of medical device corporations by strengthening their organizational capabilities, which, in turn, ensure their continuous development. This study aims to investigate both management strategies and organizational culture, which may affect the performance of these companies, and analyzes the influence of education and training investment.
MATERIALS AND METHODS
We used data from the 3rd to 6th Human Capital Corporate Panel surveys by the Korea Research Institute for Vocational Education and Training as well as data from the Korea Information Service and 6,112 workers and 260 companies were analyzed. For the analysis, management strategy and organizational culture were set as independent variables, and corporation performance was set as the dependent variable. Additionally, investment in education and training was set as a control variable between the independent and dependent variables. Corporate performance was analyzed by dividing into organizational satisfaction and organizational commitment.
RESULTS
Differentiation strategy and innovative culture had a positive (+) effect on organizational satisfaction, while cost leadership strategy and hierarchical culture had a negative (-) effect. On the other hand, in the case of interaction with education and training investment, cost leadership strategy and hierarchical culture had a positive (+) effect, while differentiation strategy and innovation culture had a negative (-) effect. In organizational commitment, innovation culture had a positive (+) effect, and hierarchical culture had a negative (-) effect. In the case of interaction with investment in education and training, only the hierarchical culture had a positive (+) effect.
CONCLUSIONS
The innovation culture positively influenced the performance of medical device companies. Furthermore, cost leadership strategy, hierarchical culture, education and training investment improved the corporate performance of these companies. To enhance corporate performance, these companies should create an innovation culture and invest in education and training in accordance with the organizational culture.
Topics: Organizational Culture; Equipment and Supplies
PubMed: 37300440
DOI: 10.1080/13696998.2023.2224168 -
Globalization and Health Aug 2017Forty to 70 % of medical devices and equipment in low- and middle-income countries are broken, unused or unfit for purpose; this impairs service delivery to patients and... (Review)
Review
BACKGROUND
Forty to 70 % of medical devices and equipment in low- and middle-income countries are broken, unused or unfit for purpose; this impairs service delivery to patients and results in lost resources. Undiscerning procurement processes are at the heart of this issue. We conducted a systematic review of the literature to August 2013 with no time or language restrictions to identify what product selection or prioritization methods are recommended or used for medical device and equipment procurement planning within low- and middle-income countries. We explore the factors/evidence-base proposed for consideration within such methods and identify prioritization criteria.
RESULTS
We included 217 documents (corresponding to 250 texts) in the narrative synthesis. Of these 111 featured in the meta-summary. We identify experience and needs-based methods used to reach procurement decisions. Equipment costs (including maintenance) and health needs are the dominant issues considered. Extracted data suggest that procurement officials should prioritize devices with low- and middle-income country appropriate technical specifications - i.e. devices and equipment that can be used given available human resources, infrastructure and maintenance capacity.
CONCLUSION
Suboptimal device use is directly linked to incomplete costing and inadequate consideration of maintenance services and user training during procurement planning. Accurate estimation of life-cycle costing and careful consideration of device servicing are of crucial importance.
Topics: Costs and Cost Analysis; Developing Countries; Equipment and Supplies; Health Resources; Humans; Income
PubMed: 28821280
DOI: 10.1186/s12992-017-0280-2