Regulatory bodies and their roles associated with medical devices and wound dressings

2019 ◽  
pp. 423-461 ◽  
Author(s):  
R. Rathinamoorthy ◽  
S. Rajendran
Keyword(s):  
Medical Devices ◽  
Wound Dressings ◽  
Regulatory Bodies

scholarly journals Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

2020 ◽  
Author(s):  
Sara Takahashi ◽  
Kiyotaka Iwasaki ◽  
Haruki Shirato ◽  
Mami Ho ◽  
Mitsuo Umezu
Keyword(s):  
United States ◽  
Medical Devices ◽  
Large Scale ◽  
The United States ◽  
Priority Review ◽  
Regulatory Body ◽  
Scientific Papers ◽  
Alternative Measures ◽  
Regulatory Bodies ◽  
Further Development

Abstract Further development of medical devices for children is required in Japan, but the development of such devices is delayed compared to that of medical devices for adults. Herein, we investigated policies for advancing the development of pediatric medical devices in Japan and the United States. Considering the achievements of each policy, we proposed a strategy to promote further development of pediatric medical devices in Japan. We investigated policies for supporting the development of pediatric medical devices and approved cases in Japan and the United States by searching contents of websites of regulatory bodies and other related administrations, and scientific papers. We found the main six policies in Japan and nine main policies in the United States for the development of pediatric medical devices. In the United States, various measures have initiated mainly in the 2000s, while in Japan, the main measures have been in place since 2013. Similarities were found in both countries, such as subsidies for application fees and research and development expenses, exemption of requirements for regulatory approval, and priority review and consultation by the regulatory body. Our study revealed that there are similarities in initiatives by both countries. To promote further development of pediatric medical devices in the future, improvements to expediting the review process to approval by the regulatory body, global development, and implementation of alternative measures to ensure the efficacy and safety of the device instead of large-scale clinical trials should be anticipated through cooperation among industry, government, and academia.

scholarly journals Design of Hack-Resistant Diabetes Devices and Disclosure of Their Cyber Safety

2016 ◽  
Vol 11 (2) ◽  
pp. 198-202 ◽  
Author(s):  
Jonathan Sackner-Bernstein
Keyword(s):  
Risk Assessment ◽  
Operating Systems ◽  
Medical Devices ◽  
Cyber Security ◽  
State Of The Art ◽  
Security Testing ◽  
Cyber Safety ◽  
Regulatory Bodies ◽  
Recognition And Response ◽  
Inform Decision Making

Background: The focus of the medical device industry and regulatory bodies on cyber security parallels that in other industries, primarily on risk assessment and user education as well as the recognition and response to infiltration. However, transparency of the safety of marketed devices is lacking and developers are not embracing optimal design practices with new devices. Achieving cyber safe diabetes devices: To improve understanding of cyber safety by clinicians and patients, and inform decision making on use practices of medical devices requires disclosure by device manufacturers of the results of their cyber security testing. Furthermore, developers should immediately shift their design processes to deliver better cyber safety, exemplified by use of state of the art encryption, secure operating systems, and memory protections from malware.

The Legislation and Regulation of Medical Devices

2021 ◽  
pp. 177-194
Keyword(s):  
European Commission ◽  
Medical Devices ◽  
Product Safety ◽  
Regulatory Environment ◽  
New Approach ◽  
Legislative History ◽  
The Core ◽  
Regulatory Bodies ◽  
The Impact ◽  
The Eu

This chapter outlines the laws that govern the manufacture and supply of medical devices in the EU and UK, both multi-faceted and internationally well-regarded legislative regimes. It contextualises these laws within the broader framework of the EU’s new approach to product safety legislation, in which these medical devices regimes were established. It discusses the core principles and fundamental statutory concepts under the EU and UK legislation that have been reinforced and improved upon over forty years of legislative history. Recent legislative change and the impact of Brexit is discussed in detail in that regard. The chapter also describes the regulatory environment in which Europe’s substantial medical devices industry operates, an industry which is estimated by the European Commission in 2019 as being comprised of 500,000 different types of medical devices and worth €100 billion. An outline of key regulatory bodies and functions is also provided.

scholarly journals Analysis of the effect of ionizing radiation on the properties of bulk nonwoven material

2021 ◽  
Vol 2124 (1) ◽  
pp. 012024
Author(s):  
M S Lisanevich ◽  
R Yu Galimzyanova ◽  
V V Ivanov
Keyword(s):  
Ionizing Radiation ◽  
Medical Devices ◽  
Dose Range ◽  
Nonwoven Material ◽  
Breaking Load ◽  
Static Field ◽  
Wound Dressings ◽  
Radiation Sterilization ◽  
Nonwoven Materials ◽  
Wide Range

Abstract At the moment, there is a wide range of bulky nonwovens for various purposes on the market. One of the important areas of using such materials is healthcare. In particular, bulky nonwoven materials are intended for the manufacture of wound dressings, evacuation kits for newborns. Disposable medical devices of this kind are usually subjected to radiation sterilization. As is known from earlier studies, radiation sterilization significantly affects the performance of nonwovens. In this regard, for nonwoven materials for medical use, an important characteristic is the stability of indicators after exposure to radiation sterilization. As a result of the study of bulk nonwovens Holofiber ® after radiation radiation in the dose range from 20-60 kGy, there were no significant changes in operational performance. The stiffness increased by an average of 3-10%. The stiffness indicators after ionizing radiation according to GOST 24684 also meet the requirements. The value of electrification increased due to an increase in the static field under the action of ionizing radiation. It is worth noting that the values of electrification are within the norm established by GOST 32995. The breaking load varies from 1-5%. Thus, non-woven materials Holofiber ® PROFI, article P 35191, Holofiber ® SOFT, article P 5197, Holofiber ® SOFT, article P 5200 are recommended for the production of medical devices.

scholarly journals Use of wound dressings to enhance prevention of pressure ulcers caused by medical devices

2013 ◽  
Vol 12 (3) ◽  
pp. 322-327 ◽  
Author(s):  
Joyce Black ◽  
Paulo Alves ◽  
Christopher Tod Brindle ◽  
Carol Dealey ◽  
Nick Santamaria ◽  
...  
Keyword(s):  
Medical Devices ◽  
Pressure Ulcers ◽  
Wound Dressings

Taking Temperature — A Review of European Union Regulation in Nanomedicine

2009 ◽  
Vol 16 (3) ◽  
pp. 249-269 ◽  
Author(s):  
Geert van Calster ◽  
Joel D'Silva
Keyword(s):  
European Union ◽  
Medical Devices ◽  
Medical Diagnosis ◽  
Regulatory Regime ◽  
The European Union ◽  
Medicinal Products ◽  
Regulatory Bodies ◽  
Potential Impact ◽  
Change Health Care ◽  
Regulatory Challenges

AbstractNanomedicine, the application of nanotechnology to healthcare offers numerous improvements to medical diagnosis, drug delivery, therapy and implants. The potential impact of nanomedicine is foreseen radically to change health care; however it also challenges existing perceptions, dynamics and standards relating to ethics, safety and governance. This paper introduces the emerging field of nanomedicine and then proceeds to detail the current regulatory framework and regulatory bodies in the European Union relating to medicinal products, medical devices, biologics and therapies. This is followed by a detailed analysis of two nanomedical applications in the context of regulatory challenges. The paper concludes with a discussion of the adequacy of the current regulatory regime in Europe and where problems are likely to arise as nanomedicine evolves.

scholarly journals The state of artificial intelligence-based FDA-approved medical devices and algorithms: an online database

2020 ◽  
Vol 3 (1) ◽  
Author(s):  
Stan Benjamens ◽  
Pranavsingh Dhunnoo ◽  
Bertalan Meskó
Keyword(s):  
Artificial Intelligence ◽  
Medical Devices ◽  
De Novo ◽  
Online Database ◽  
Medical Technologies ◽  
The Us ◽  
Open Access Database ◽  
Regulatory Bodies ◽  
Premarket Approval ◽  
Insight Into

Abstract At the beginning of the artificial intelligence (AI)/machine learning (ML) era, the expectations are high, and experts foresee that AI/ML shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of AI/ML in daily clinical practice are numerous, especially regarding the regulation of these technologies. Therefore, we provide an insight into the currently available AI/ML-based medical devices and algorithms that have been approved by the US Food & Drugs Administration (FDA). We aimed to raise awareness of the importance of regulatory bodies, clearly stating whether a medical device is AI/ML based or not. Cross-checking and validating all approvals, we identified 64 AI/ML based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any AI/ML-related expressions in the official FDA announcement. The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%), and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine/General Practice respectively. We have launched the first comprehensive and open access database of strictly AI/ML-based medical technologies that have been approved by the FDA. The database will be constantly updated.

The state of artificial intelligence-based FDA-approved medical devices and algorithms: An online database (Preprint)

2020 ◽  
Author(s):  
Bertalan Mesko ◽  
Stan Benjamens ◽  
Pranavsingh Dhunnoo
Keyword(s):  
Artificial Intelligence ◽  
Medical Devices ◽  
De Novo ◽  
Online Database ◽  
Medical Technologies ◽  
Open Access Database ◽  
Regulatory Bodies ◽  
Premarket Approval ◽  
Insight Into ◽  
The U.S

BACKGROUND At the beginning of the artificial intelligence (A.I.) era, the expectations are high, and experts foresee that A.I. shows potential for diagnosing, managing and treating a wide variety of medical conditions. However, the obstacles for implementation of A.I. in daily clinical practice are numerous, especially regarding the regulation of these technologies. OBJECTIVE Therefore, we provide an insight into the currently available A.I.-based medical devices and algorithms that have been approved by the U.S. Food & Drugs Administration (FDA). We aimed to raise awareness about the importance of regulatory bodies, clearly stating whether a medical device is A.I.-based or not. METHODS Cross-checking and validating all approvals, we identified 64 A.I.-based, FDA approved medical devices and algorithms. Out of those, only 29 (45%) mentioned any A.I.-related expressions in the official FDA announcement. RESULTS The majority (85.9%) was approved by the FDA with a 510(k) clearance, while 8 (12.5%) received de novo pathway clearance and one (1.6%) premarket approval (PMA) clearance. Most of these technologies, notably 30 (46.9%), 16 (25.0%) and 10 (15.6%) were developed for the fields of Radiology, Cardiology and Internal Medicine / General Practice respectively. CONCLUSIONS We launched the first comprehensive and open access database of strictly A.I.-based medical technologies that have been approved by the FDA. The database will be constantly updated. 

scholarly journals A Pharmacological and Toxicological Profile of Silver as an Antimicrobial Agent in Medical Devices

2010 ◽  
Vol 2010 ◽  
pp. 1-16 ◽  
Author(s):  
Alan B. G. Lansdown
Keyword(s):  
Medical Devices ◽  
Soft Tissues ◽  
Protein Complexes ◽  
Systemic Circulation ◽  
Biologically Active ◽  
Wound Dressings ◽  
Metallic Silver ◽  
Toxicological Profile ◽  
The Central Nervous System ◽  
Silver Sulphide

Silver is used widely in wound dressings and medical devices as a broad-spectrum antibiotic. Metallic silver and most inorganic silver compounds ionise in moisture, body fluids, and secretions to release biologically active . The ion is absorbed into the systemic circulation from the diet and drinking water, by inhalation and through intraparenteral administration. Percutaneous absorption of through intact or damaged skin is low. binds strongly to metallothionein, albumins, and macroglobulins and is metabolised to all tissues other than the brain and the central nervous system. Silver sulphide or silver selenide precipitates, bound lysosomally in soft tissues, are inert and not associated with an irreversible toxic change. Argyria and argyrosis are the principle effects associated with heavy deposition of insoluble silver precipitates in the dermis and cornea/conjunctiva. Whilst these changes may be profoundly disfiguring and persistent, they are not associated with pathological damage in any tissue. The present paper discusses the mechanisms of absorption and metabolism of silver in the human body, presumed mechanisms of argyria and argyrosis, and the elimination of silver-protein complexes in the bile and urine. Minimum blood silver levels consistent with early signs of argyria or argyrosis are not known. Silver allergy does occur but the extent of the problem is not known. Reference values for silver exposure are discussed.

Antibacterial Applications of Silver Nanoparticles

2013 ◽  
Vol 754 ◽  
pp. 131-142
Author(s):  
Rani M. Pattabi ◽  
Manjunatha Pattabi
Keyword(s):  
Escherichia Coli ◽  
Staphylococcus Aureus ◽  
Medical Devices ◽  
Ag Nanoparticles ◽  
Wound Dressings ◽  
Poly Vinyl Alcohol ◽  
Streptococcus Pneumonia ◽  
Overwhelming Evidence ◽  
Antiviral Activities ◽  
Vast Range

A brief review on the antimicrobial application of Ag nanoparticles (AgNP) is presented. Ag in nanoform is considered less toxic than Ag+ ions and hence, a considerable amount of research has been carried out on the antibacterial, antifungal and antiviral activities of Ag nanoparticles. Poly (vinyl alcohol) (PVA) stabilized AgNPs provide overwhelming evidence on their potency against Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pneumonia etc. A recent study using biostabilized AgNPs have shown their efficacies against a vast range of bacteria. The antibacterial activity of AgNPs has also resulted in the development of wound dressings and medical devices. Some results on the antifungal activities exhibited by them are also highlighted.

Sign in / Sign up

Export Citation Format

Share Document