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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 -
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 -
Diagnostic and Interventional Radiology... Jul 2018Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular... (Review)
Review
Cardiovascular devices and hemodynamic monitoring systems continue to evolve with the goal of allowing for rapid clinical intervention and management. Cardiovascular devices including the CardioMicroelectromechanical (CardioMEMS) device, implantable loop recorder, and right ventricular (RV) leadless pacemaker are now widely used for treatment and monitoring of advanced cardiac conditions, as many of these devices have been shown to significantly improve patient outcomes. Additionally, hemodynamic monitoring devices have shown utility in monitoring patients with aortic aneurysms after endovascular aortic repair (EVAR) for early detection of Type I and Type II endoleaks. There is limited published data regarding the imaging features of these devices. As these devices become more widely used, it is important for radiologists to become familiar with the normal imaging features and potential complications. The goal of this review is to summarize the data regarding the use of leadless cardiovascular devices including the CardioMEMS device, implantable loop recorder, and RV leadless pacemaker, and to present cases demonstrating their utility and normal imaging features.
Topics: Equipment Design; Equipment and Supplies; Humans; Monitoring, Physiologic; Pacemaker, Artificial; Radiography; Tomography, X-Ray Computed
PubMed: 30091710
DOI: 10.5152/dir.2018.17462 -
Pharmacoepidemiology and Drug Safety Sep 2019Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system.... (Review)
Review
PURPOSE
Recent public health safety issues involving medical devices have led to a growing demand to improve the current passive-reactive postmarket surveillance (PMS) system. Various European Union (EU) national competent authorities have started to focus on strengthening the postmarket risk evaluation. As a consequence, the new EU medical device regulation was published; it includes the concept of a PMS Plan.
METHODS
This publication reviewed Annex III Technical Documentation on PMS and Annex XIV Part B: Postmarket clinical follow-up from the new Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices.
RESULTS
The results of the PMS activities will be described in the PMS plan and will be used to update other related documents. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device.
CONCLUSIONS
The PMS plan may serve as a thorough tool for the benefit-risk evaluation of medical devices. If properly developed and implemented, it will function as a key player in the establishment of a new framework for proactive safety evaluation of medical devices.
Topics: Device Approval; Equipment and Supplies; European Union; Feasibility Studies; Product Surveillance, Postmarketing; Risk Assessment
PubMed: 31318470
DOI: 10.1002/pds.4859 -
BMJ (Clinical Research Ed.) May 2016To investigate the regulatory approval of new medical devices. (Review)
Review
OBJECTIVE
To investigate the regulatory approval of new medical devices.
DESIGN
Cross sectional study of new medical devices reported in the biomedical literature.
DATA SOURCES
PubMed was searched between 1 January 2000 and 31 December 2004 to identify clinical studies of new medical devices. The search was carried out during this period to allow time for regulatory approval.
ELIGIBILITY CRITERIA FOR STUDY SELECTION
Articles were included if they reported a clinical study of a new medical device and there was no evidence of a previous clinical study in the literature. We defined a medical device according to the US Food and Drug Administration as an "instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."
MAIN OUTCOME MEASURES
Type of device, target specialty, and involvement of academia or of industry for each clinical study. The FDA medical databases were then searched for clearance or approval relevant to the device.
RESULTS
5574 titles and abstracts were screened, 493 full text articles assessed for eligibility, and 218 clinical studies of new medical devices included. In all, 99/218 (45%) of the devices described in clinical studies ultimately received regulatory clearance or approval. These included 510(k) clearance for devices determined to be "substantially equivalent" to another legally marketed device (78/99; 79%), premarket approval for high risk devices (17/99; 17%), and others (4/99; 4%). Of these, 43 devices (43/99; 43%) were actually cleared or approved before a clinical study was published.
CONCLUSIONS
We identified a multitude of new medical devices in clinical studies, almost half of which received regulatory clearance or approval. The 510(k) pathway was most commonly used, and clearance often preceded the first published clinical study.
Topics: Academies and Institutes; Clinical Studies as Topic; Cross-Sectional Studies; Device Approval; Equipment and Supplies; Health Care Sector; Humans; Prostheses and Implants
PubMed: 27207165
DOI: 10.1136/bmj.i2587 -
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 -
Annals of Surgery Jan 2022To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0).
OBJECTIVE
To extend the IDEAL framework for device innovation, IDEAL-D, to include the preclinical stage of development (stage 0).
BACKGROUND
In previous work, the IDEAL collaboration has proposed frameworks for new surgical techniques and complex therapeutic technologies, the central tenet being that development and evaluation can and should proceed together in an ordered and logical manner that balances innovation and safety.
METHODS
Following agreement at the IDEAL Collaboration Council, a multidisciplinary working group was formed comprising 12 representatives from healthcare, academia, industry, and a patient advocate. The group conducted a series of discussions following the principles used in the development of the original IDEAL framework. Importantly, IDEAL aims for maximal transparency, optimal validity in the evaluation of primary effects, and minimization of potential risk to patients or others. The proposals were subjected to further review and editing by members of the IDEAL Council before a final consensus version was adopted.
RESULTS
In considering which studies are required before a first-in-human study, we have: (1) classified devices according to what they do and the risks they carry, (2) classified studies according to what they show about the device, and (3) made recommendations based on the principle that the more invasive and high risk a device is, the greater proof required of their safety and effectiveness before progression to clinical studies (stage 1).
CONCLUSIONS
The proposed recommendations for preclinical evaluation of medical devices represent a proportionate and pragmatic approach that balances the de-risking of first-in-human translational studies against the benefits of rapid translation of new devices into clinical practice.
Topics: Equipment Design; Equipment Safety; Equipment and Supplies; Humans; Risk Assessment; Translational Research, Biomedical
PubMed: 33856386
DOI: 10.1097/SLA.0000000000004907 -
European Journal of Clinical... Nov 2017Despite considerable efforts, healthcare-associated infections (HAIs) continue to be globally responsible for serious morbidity, increased costs and prolonged length of... (Review)
Review
Despite considerable efforts, healthcare-associated infections (HAIs) continue to be globally responsible for serious morbidity, increased costs and prolonged length of stay. Among potentially preventable sources of microbial pathogens causing HAIs, patient care items and environmental surfaces frequently touched play an important role in the chain of transmission. Microorganisms contaminating such high-touch surfaces include Gram-positive and Gram-negative bacteria, viruses, yeasts and parasites, with improved cleaning and disinfection effectively decreasing the rate of HAIs. Manual and automated surface cleaning strategies used in the control of infectious outbreaks are discussed and current trends concerning the prevention of contamination by the use of antimicrobial surfaces are taken into consideration in this manuscript.
Topics: Animals; Bacteria; Cross Infection; Decontamination; Disinfectants; Disinfection; Equipment and Supplies, Hospital; Fungi; Humans; Parasites; Viruses
PubMed: 28647859
DOI: 10.1007/s10096-017-3042-4 -
JAMA Health Forum Jan 2022
Topics: Computer Communication Networks; Equipment and Supplies; Electronic Health Records; Systems Integration
PubMed: 36218857
DOI: 10.1001/jamahealthforum.2021.4313 -
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