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Critical Care Nursing Clinics of North... Dec 2020Medical device-related pressure injuries result from use of medical devices, equipment, furniture, and everyday objects in direct contact with skin and because of... (Review)
Review
Medical device-related pressure injuries result from use of medical devices, equipment, furniture, and everyday objects in direct contact with skin and because of increased external mechanical load leading to soft tissue damage. The resultant pressure injury generally mirrors the pattern or shape of the device. The nurse and clinician must be hypervigilant of increased risk of pressure injuries with the use of these devices. This article provides evidence-based information regarding the most common devices that cause pressure injuries in adults and describes current best evidence-based prevention strategies. Evidence-based prevention strategies are key to minimizing the harm devices can cause.
Topics: Compression Bandages; Drainage; Equipment and Supplies; Evidence-Based Practice; Humans; Intubation, Intratracheal; Pressure Ulcer
PubMed: 33129412
DOI: 10.1016/j.cnc.2020.08.004 -
Toxicologic Pathology Apr 2019Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must... (Review)
Review
Thorough morphologic evaluations of medical devices placed in or near the nervous system depend on many factors. Pathologists interpreting a neurologic device study must be familiar with the regulatory framework affecting device development, biocompatibility and safety determinants impacting nervous tissue responses, and appropriate study design, including the use of appropriate animal models, group design, device localization, euthanasia time points, tissue examination, sampling and processing, histochemistry and immunohistochemistry, and reporting. This overview contextualizes these features of neurologic medical devices for pathologists engaged in device evaluations.
Topics: Animals; Biocompatible Materials; Equipment Design; Equipment Safety; Equipment and Supplies; Humans; Materials Testing; Medical Device Legislation; Nervous System; Pathologists
PubMed: 30599801
DOI: 10.1177/0192623318816685 -
Irish Journal of Medical Science May 2019Trends in medical technology patents provide an objective comparison of research and development between countries and over time. An analysis of these trends can... (Review)
Review
INTRODUCTION
Trends in medical technology patents provide an objective comparison of research and development between countries and over time. An analysis of these trends can benchmark innovation within Ireland in a worldwide context. By identifying and examining leading countries, domestic educational, infrastructural, regulatory and fiscal planning may be optimised.
MATERIALS AND METHODS
Published data filing and granting reports from the two major patent offices (United States Patent and Trademark Office (USPTO) and European Patent Office (EPO)) were analysed.
RESULTS
USPTO statistics demonstrated an 83.1% decrease in the overall number of medical device patents filed over the 10-year period, from 2005 (n = 1092) to 2015 (n = 185). Conversely, there was a 166% increase in the number of medical device patents granted over the same period. EPO applications in the field of medical technology represented the single largest industry category. The proportion of patents granted of Irish origin have increased from 0.7 (n = 22) to 0.9% (n = 73) over 10 years. Switzerland ranks first for medical device patents granted per head of population by the EPO, with Ireland ranking 5th. Ireland's medical device patents have increased dramatically per head of population, from 4.1 per million in 2012, to 15.3 in 2016. Israel has the highest number of USPTO patents granted per head of population, with Ireland ranking 5th.
CONCLUSIONS
Ireland demonstrates high levels of medical technology patent filing per head of population, reflecting the importance of this industry. However, both Switzerland and Israel demonstrate dominance amongst smaller nations, and serving as benchmarks for national planning.
Topics: Equipment and Supplies; Humans; Ireland; Patents as Topic; United States
PubMed: 30099715
DOI: 10.1007/s11845-018-1880-4 -
Drug Safety Feb 2020We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional."... (Review)
Review
We propose the following definition of a medical device: "A contrivance designed and manufactured for use in healthcare, and not solely medicinal or nutritional." Current regulatory classifications of medical devices are complex and designed primarily for regulators. We propose a simpler classification, based on (1) the site of application of the device, (2) the time scale of its use, and (3) whether it has an external power source. The regulation of medical devices is less well developed than the regulation of medicinal products, which it could follow more closely. In particular, devices that incorporate medicines should be required to meet the same regulatory standards as medicinal products. This would remove the anomaly that some delivery systems that incorporate medicines are classified as devices while other similar systems that deliver the same medicines are classified as medicinal products. Some improvements might also result from more widespread use of registries, such as those used for prosthetic joint replacements. Registries would allow both a prospective examination of the performance of high-risk devices and a retrospective analysis when signals from other sources of information suggest problems. Those who apply for a marketing authorization for a new device should have to assure regulators of its quality of manufacture, safety, and efficacy before licensing. Even the most straightforward device should be shown to be useable in practice. Trials on patients, or at least simulations of use in the real world, should be practicable for most devices.
Topics: Equipment Safety; Equipment and Supplies; European Union; Humans; Medical Device Legislation; United States
PubMed: 31845212
DOI: 10.1007/s40264-019-00878-3 -
Journal of Wound Care Jun 2019
Topics: Consensus; Equipment and Supplies; Humans; Pressure Ulcer
PubMed: 31166859
DOI: 10.12968/jowc.2019.28.6.315 -
Infection Control and Hospital... Aug 2000
Topics: Catheterization; Disposable Equipment; Equipment Reuse; Equipment and Supplies, Hospital; Humans; Infection Control; Needles; Sterilization
PubMed: 10968713
DOI: 10.1086/501792 -
JAMA Internal Medicine Mar 2021
Topics: Device Approval; Equipment and Supplies; Product Labeling; United States; United States Food and Drug Administration
PubMed: 33325986
DOI: 10.1001/jamainternmed.2020.7797 -
Toxicologic Pathology Apr 2019Lymph nodes and associated lymphatics filter extracellular fluid and lymph to maintain tissue-fluid balance and detect distant tissue injury. Examination of regional... (Review)
Review
Lymph nodes and associated lymphatics filter extracellular fluid and lymph to maintain tissue-fluid balance and detect distant tissue injury. Examination of regional draining lymph nodes (RDLs; lymph nodes that drain the route of article dosing) is an important step in detecting immunotoxicity and other associated changes during general toxicology studies. Similarly, evaluation of RDLs is often a key component of evaluating medical devices. Nonclinical medical device studies can present challenges for RDL evaluation, due to the wide variety of tissues and organs that are implanted with devices, the potential for wear debris/degradation products, and the likely disruption of normal lymphatic drainage by surgical procedures. This article discusses concepts for consideration when designing a nonclinical medical device study that includes the macroscopic evaluation, collection, histologic processing, microscopic assessment, and documentation of findings within RDLs. References describing RDLs for common implantation sites are reported, as are considerations for specific tissues and species commonly used in medical device biocompatibility and functional testing.
Topics: Animals; Equipment Safety; Equipment and Supplies; Lymph; Lymph Nodes; Research Design
PubMed: 30411668
DOI: 10.1177/0192623318811075 -
Expert Review of Medical Devices Jun 2016With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products... (Review)
Review
INTRODUCTION
With the aging of the post-war baby boomer generation, the increasing demands for healthcare are driving the growth of medical industry and development of new products in order to meet the immense needs from the aging population. However, medical devices are designed to maintain the health and safety of people, therefore, medical devices are undergoing rigorous management by competent health authorities in all countries. In recent years, Asian countries have been reforming their regulations and standards for medical devices with substantial changes.
AREAS COVERED
The study is a summary of the framework of medical device regulations in Asian countries, including Asian Harmonization Working Party (AHWP), Japan, China, Taiwan, South Korea, India and Singapore. Expert commentary: Asian countries are constantly reforming their medical device regulations. The emergence of brand-new technology and quality management issues arose by global manufacturing have imposed difficulties in harmonizing and reaching consensus between countries. The third-party conformity assessment system for medical devices can reduce the costs for competent health authorities and shorten the review time, which could facilitate the feasibility of harmonization of medical device regulations.
Topics: Asia; Equipment and Supplies; Humans; Medical Device Legislation
PubMed: 27136699
DOI: 10.1080/17434440.2016.1184970 -
Journal of Medical Engineering &... 2014The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as... (Review)
Review
The paper provides an introduction to the regulatory landscape affecting a particular category of medical technology, namely standalone software-sometimes referred to as 'software as a medical device'. To aid the reader's comprehension of an often complex area, six case studies are outlined and discussed before the paper continues to provide detail of how software with a medical purpose in its own right can potentially be classified as a medical device. The reader is provided an appreciation of how to go about classifying such software and references to support the developer new to the field in locating detailed regulatory support documents and contact points for advice.
Topics: Device Approval; Equipment and Supplies; Europe; Government Regulation; Internationality; Software
PubMed: 26415828
DOI: 10.3109/03091902.2015.1088087