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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 -
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 -
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 -
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 -
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 -
Indian Journal of Medical Ethics 2019The report by the International Consortium of Investigative Journalists (ICIJ) on the international medical device industry adds to the growing documentation of health...
The report by the International Consortium of Investigative Journalists (ICIJ) on the international medical device industry adds to the growing documentation of health scandals in India in recent years. A comprehensive picture emerges of manufacturers selling untested products at usurious rates; criminally negligent doctors and medical establishments; and a regulatory system focused on the industry's growth with little regard for patient safety.
Topics: Equipment and Supplies; Ethics, Business; Ethics, Medical; Government Regulation; Humans; Industry; Patient Safety
PubMed: 30919806
DOI: 10.20529/IJME.2019.002 -
Journal of Diabetes Science and... Jul 2018
Topics: Computer Security; Diabetes Mellitus; Equipment Safety; Equipment and Supplies; Humans; Medical Device Legislation; Wireless Technology
PubMed: 29575925
DOI: 10.1177/1932296818763634 -
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 -
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 -
BMC Medical Informatics and Decision... Sep 2020Modern healthcare devices can be connected to computer networks and many western healthcare institutions run those devices in networks. At the same time, cyber attacks...
BACKGROUND
Modern healthcare devices can be connected to computer networks and many western healthcare institutions run those devices in networks. At the same time, cyber attacks are on the rise and there is evidence that cybercriminals do not spare critical infrastructure such as major hospitals, even if they endanger patients. Intuitively, the more and closer connected healthcare devices are to public networks, the higher the risk of getting attacked.
METHODS
To asses the current connectivity status of healthcare devices, we surveyed the field of German hospitals and especially University Medical Center UMCs.
RESULTS
The results show a strong correlation between the networking degree and the number of medical devices. The average number of medical devices is 25.150, with a median of networked medical devices of 3.600. Actual key users of networked medical devices are the departments Radiology, Intensive Care, Radio-Oncology RO, Nuclear Medicine NUC, and Anaesthesiology in the group of UMCs. In the next five years, the usage of networked medical devices will increase significantly in the departments of Surgery, Intensive Care, and Radiology. We detected a strong correlation between the degree of connectivity and the likelihood of being attacked.The survey answers regarding the cyber security status reveal a lack of security basics in some of the inquired hospitals. We did discover successful attacks in hospitals with separated or subsidiary departments. A fusion of competencies on an organizational level facilitates the right behavior here. Most hospitals rated themselves predominantly positively in the self-assessment but also stated the usefulness of IT security insurance.
CONCLUSIONS
Concluding our results, hospitals are already facing the consequences of omitted measures within their growing pool of medical devices. Continuously relying on historically grown structures without adaption and trusting manufactures to solve vectors is a critical behavior that could seriously endanger patients.
Topics: Computer Communication Networks; Computer Security; Equipment and Supplies; Germany; Health Facilities; Hospitals; Humans; Radiography; Radiology; Risk Assessment; Security Measures
PubMed: 32993623
DOI: 10.1186/s12911-020-01259-y