Antimicrobial and Anti-Biofilm Medical Devices: Public Health and Regulatory Science Challenges

2017 ◽  
pp. 37-65 ◽  
Author(s):  
Yi Wang ◽  
Geetha Jayan ◽  
Dinesh Patwardhan ◽  
K. Scott Phillips
Keyword(s):  
Public Health ◽  
Medical Devices ◽  
Regulatory Science

scholarly journals Regulation EU 2017/745 on medical devices – implementation analysis in Portugal by the distributors

2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
H Vilaça
Keyword(s):  
Public Health ◽  
Medical Devices ◽  
Stakeholder Involvement ◽  
Implementation Process ◽  
Regulatory Framework ◽  
Theory And Practice ◽  
Structured Interviews ◽  
Public Health Action ◽  
Study Implementation ◽  
Implementation Analysis

Abstract The Regulation responds to legislation failures in the European regulatory framework on medical devices (MD), which in turn led to public health issues. Two media scandals triggered the final actions on the elaboration of this EU Regulation, which was already being thought off in a context of fast MD development, and on the commitment of member-states to harmonize legislation in order to better manage resources. This Regulation is expected to address detected gaps, and contribute to the protection of European citizens' health by ensuring high quality and safety of MD, through advocating for more transparency, vigilance, and traceability. A technique to evaluate policies is the implementation analysis, as it links theory and practice. By understanding it, it is possible to ascertain if, in fact, the Regulation will contribute, as proposed, to improve public health. The implementation analysis framework I developed can be used in other countries affected by this Regulation, and may even be extrapolated to other scenarios. Entry into force 25/05/17.Full application 05/20. This qualitative study uses document analysis and semi-structured interviews to collect data, and literature review to frame the situation and to study implementation analysis. The questions are: identify the facilitators and resistance points of the implementation; explore perceptions of the Portuguese MD distributors; understand the policy implementation pathway; and have a picture of the implementation status in Portugal. The results can be summarized as: implementers are interested in complying with the Regulation; there is stakeholder involvement in policy making and throughout the implementation process; the main points of resistance, difficulties and the facilitators are identified; and the Regulation is being implemented according to the timelines. The public health action brought by the policy is that each economic operator is an active actor on vigilance and patient safety across MD lifecycle. Key messages If we are interested in the extent to which a particular polity is able to solve the problems with which it is confronted, we need to study the way in which the law is executed in practice. Focus on the effective implementation of the new regulatory framework on medical devices to protect patients and ensure it addresses new and emerging challenges.

scholarly journals Medicines Counterfeiting in Africa: A View from Zimbabwe

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000017 ◽  
Author(s):  
Shingai D. Gwatidzo ◽  
Petronella K. Murambinda ◽  
Zivanai Makoni
Keyword(s):  
Public Health ◽  
Public Education ◽  
Medical Devices ◽  
Quantitative Data ◽  
Regulatory Authority ◽  
Medicinal Products ◽  
Street Vendors ◽  
Qualitative And Quantitative ◽  
Leading Role ◽  
Control Authority

With the sprouting of unregulated outlets on the streets of Zimbabwe, common questions that are raised include: (i) what is the Medicines Control Authority of Zimbabwe (MCAZ) doing about these street vendors? and (ii) is the law against unregulated markets and proliferation of substandard and falsified (SF) medicines being actively enforced? There is no doubt that this is a new challenge for MCAZ because of the risks involved with SF medicines. Notwithstanding the rather strong regulatory framework for the regulated market that the MCAZ has major control over, and its demonstrable regulatory prowess over the last 20 years as a National Medicines Regulatory Authority (NMRA), MCAZ is increasingly challenged to take a leading role in addressing this rising phenomenon. MCAZ has attempted to address the problem through collaboration with the Zimbabwe Republic Police (ZRP), public education and inspections by port officials at ports of entry. However, the problem still persists. A general lack of concrete qualitative and quantitative data on the commonly encountered SF medicinal products on the Zimbabwe market is another major issue. This is evidently a multi-layered problem and as the Shona adage goes “chara chimwe hachitswanye inda” (loosely translated “one thumb cannot crush all lice”), there is need for engaging local and regional partners in a bid to fulfil the MCAZ's mandate of protecting public health by ensuring medicines and medical devices intended for sale and distribution in Zimbabwe, are safe, effective and of good quality.

PROBLEMS RELATED TO FIRST AID EQUIPMENT: ORGANIZATIONAL AND LEGAL ASPECT

2020 ◽  
Vol 66 (5) ◽  
pp. 10-10
Author(s):  
L.I. Dezhurny ◽  
◽  
A.Yu. Zakurdaeva ◽  
Keyword(s):  
Public Health ◽  
Russian Federation ◽  
Medical Devices ◽  
First Aid ◽  
Health Protection ◽  
Federal Law ◽  
Ministry Of Health ◽  
The Russian Federation ◽  
State Registration ◽  
Public Health Protection

The article examines organizational and legal problems related to state registration, production, procurement and use of medical devices for first aid. The study significance is accounted for by the need to find solutions to problems related to equipping first aid activities with medical devices, which is becoming extremely important for the modern Russian society. Moreover, a comprehensive study of these issues has not been undertaken so far. The purpose of the study is to develop a set of proposals of an organizational and legal nature to improve quality of medical devices for first aid and equipping all potential participants of first aid delivery with such devices. To eliminate the problem of low equipment of potential participants of first aid delivery with the means of delivery, the composition of first-aid kits, packs, sets, and packages for all categories of participants have to be approval by the Ministry of Health of the Russian Federation. The authors also propose organizational and legal measures to improve interdepartmental and intradepartmental cooperation in this direction with the Russian Ministry of Health playing the coordinating role. The authors have also identified the need for improving the procedure for state registration of the production of first aid devices either though amending the Federal Law "On the Basics of Public Health Protection in the Russian Federation" regarding the provision that first-aid kits, packs, sets, and packages equipped with medical devices registered in the prescribed manner are not subject to state registration. As an alternative, the authors propose amendments and additions to the Rules of the state registration of medical devices, providing for a simplified state registration of first-aid kits, packs, sets, and packages. In addition, the authors name arguments in favor of improving the clinical trial procedure for first aid medical devices and propose changes to Article 38 of the Federal Law “On the Basics of Public Health Protection in the Russian Federation” in terms of eliminating the problems of legal techniques in the definition of the term “medical device” regarding first aid. Keywords: First aid; first aid kits; first aid equipment; medical devices.

20. EU health law

2020 ◽  
pp. 643-672
Author(s):  
Tamara K Hervey
Keyword(s):  
Public Health ◽  
Medical Devices ◽  
Human Tissue ◽  
Healthcare Professionals ◽  
Health Law ◽  
Eu Law ◽  
Patient Mobility ◽  
The Law

This chapter examines EU law on health. Specifically, it discusses the law governing patient mobility; healthcare professionals; healthcare institutions; medical devices and pharmaceuticals; blood, organs, and human tissue; and public health.

Strategies for antimicrobial peptide coatings on medical devices: a review and regulatory science perspective

2020 ◽  
Vol 41 (1) ◽  
pp. 94-120 ◽  
Author(s):  
Mehdi Kazemzadeh-Narbat ◽  
Hao Cheng ◽  
Rosa Chabok ◽  
Mario Moisés Alvarez ◽  
Cesar de la Fuente-Nunez ◽  
...  
Keyword(s):  
Antimicrobial Peptide ◽  
Medical Devices ◽  
Regulatory Science ◽  
Peptide Coatings

scholarly journals Positive impacts of Covid-19 pandemic to strengthen National Health Defense

2021 ◽  
Vol 24 ◽  
pp. 562-570
Author(s):  
Widyati Widyati ◽  
I Dewa Ketut Kerta Widana
Keyword(s):  
Public Health ◽  
National Health ◽  
Medical Devices ◽  
Raw Materials ◽  
Health Sector ◽  
National Health System ◽  
Healthcare Sector ◽  
National Defense ◽  
Medical And Healthcare ◽  
Positive Impacts

During the past one and a half year, we all have faced the COVID-19 pandemic. In national defense perspective, COVID-19 Pandemic could be viewed as a non-military threat to national defense. The COVID-19 pandemic is a wake-up call that improves our awareness on the necessity to be fully independent and self-sufficient in health sector. So far, we have been complacent with the ease of importing raw materials for medicines and medical devices. Thus, the advent of the COVID-19 pandemic has made us aware to reduce Indonesia’s high dependence on import of health and medicine goods. Despite of the losses and prolonged sadness brought by the COVID-19 pandemic, there are also positive impacts for this nation as the result of the COVID-19 pandemic. One of the impacts on the National Health System is the strengthening and involvement of all levels of society and the apparatus in dealing with COVID-19 pandemic, which can be seen in the prevention, detection, and orderly response to COVID-19. Adjustment of public health service capacity is also carried out very swiftly to respond the pandemic situation. Another indicator is seen in the financing of medical and healthcare sector that was able to rapidly finding sources of funding for a very sharp increase in public health needs. Meanwhile, Human Resources capacity development appears to be very prominent as seen from the rapid improvement of training and research in medical and healthcare competences. No less important is the pharmaceuticals and medical devices sectors that are more determined to improve their independence and self-sufficiency in terms of drugs and vaccines raw materials. Independent raw materials provision for drugs and vaccines has an important value in the national economy and strengthening national security in the public health sector.

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