Patient safety related to the use of medical devices: a review and investigation of the current status in the medical device industry

2013 ◽  
Vol 58 (1) ◽  
Author(s):  
Norman Geissler ◽  
Trevor Byrnes ◽  
Wolfgang Lauer ◽  
Klaus Radermacher ◽  
Susanne Kotzsch ◽  
...  
Keyword(s):  
Patient Safety ◽  
Medical Device ◽  
Medical Devices ◽  
Current Status ◽  
Medical Device Industry ◽  
Device Industry

The Bioengineering Design Forum

1997 ◽  
Vol 11 (2) ◽  
pp. 116-119 ◽  
Author(s):  
Patrick J. Prendergast
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Medical Device Industry ◽  
Industry Collaboration ◽  
University Industry ◽  
Device Industry

The author assesses the results of the Bioengineering Design Forum – a collaboration between university researchers, clinicians and industry in Ireland. The aim of the Forum is to initiate, develop and bring to a successful conclusion R&D collaborations that lead to new or improved medical devices. By laying down certain operating procedures for the Forum, an effective ‘meeting ground’ has been developed which serves the objectives of both university engineering departments and the medical device industry in a unique way. The purpose of this paper is to relate our experiences of the Forum; they may be useful to others who would like to attempt similar initiatives in other fields. The author also describes the results that may be expected from this kind of university–industry collaboration in practice.

scholarly journals Innovation and Design: Pollution Prevention Opportunities in Medical Device Design

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
J. Becker ◽  
C. Zimmer ◽  
K. Larson
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Chlorinated Solvents ◽  
Pollution Prevention ◽  
Cost Savings ◽  
The United States ◽  
Medical Device Industry ◽  
Potential Cost ◽  
Environmental Considerations ◽  
Device Industry

A wide variety of materials and chemicals are used in the development, production, cleaning, packaging, sterilization and shipment of medical devices. Some of these materials are used in large quantities and are often a source of waste. Some materials, such as poly vinyl chloride (PVC) plastics, have toxicity concerns. Additionally, many chemicals including chlorinated solvents and ethylene oxide are carcinogenic or highly toxic and can be detrimental to the environment and public health. While the medical device industry is highly regulated in the United States by the Food and Drug Administration, new green initiatives in the European Union are modifying the regulatory oversight of chemicals, materials, and their manufacture. In addition, hospitals are working to reduce waste and pollution as part of their operations and are increasingly asking vendors to assist them. Minimizing waste and pollution associated with medical devices can improve a company's environmental performance and save money. The primary focus in medical device manufacturing is patient safety and compatibility. Environmental considerations, which can include potential cost savings, are often overlooked in the design and process development phases. Numerous pollution prevention and energy efficiency options exist for medical device manufacturers. These options can be integrated into the development, design and process protocols, and engineering change orders when designing a new product or improving an existing part. By having a process design evaluation plan that includes environmental considerations, companies can effectively manage the creation of waste streams, toxicity of material inputs, and process efficiencies as a mechanism at both the front-end and the duration of the product line. These options often cut costs and can help reduce current and prospective regulatory burdens. The Minnesota Technical Assistance Program (MnTAP) at the University of Minnesota has been assisting businesses with pollution prevention and cost savings for 25 years. MnTAP's engineers and scientists have worked with the medical device industry to reduce the quantity of packaging and waste associated with cardiac catheters, reduce the use of toxic cleaning solvents, minimize the use of PVC, and research safer disinfection and sterilization methods. This poster includes case studies of the above mentioned projects, an overview of less toxic sterilization methods, and tools for medical device manufacturing that meet FDA requirements, but reduce waste and toxicity during production and use.

scholarly journals Brief Talking about the Development of Medical Device Industry in China

2019 ◽  
Vol 2 (4) ◽  
pp. 24
Author(s):  
Yiling Bao
Keyword(s):  
Health Care ◽  
Medical Device ◽  
Medical Devices ◽  
Living Standards ◽  
Policy Support ◽  
Continuous Development ◽  
Medical Device Industry ◽  
Aging Society ◽  
China’S Economy ◽  
Device Industry

With the continuous development of China's economy and the improvement of Chinese’ living standards, people's awareness of health care has gradually increased, so the demand for medical devices products is also strengthen. In addition, China is gradually entering an aging society and policy support for the medical device industry. China's medical device industry is developing rapidly.

Software-Related Recalls: An Analysis of Records

2013 ◽  
Vol 47 (6) ◽  
pp. 514-522 ◽  
Author(s):  
Lisa K. Simone
Keyword(s):  
Public Health ◽  
Medical Device ◽  
Medical Devices ◽  
Medical Device Industry ◽  
Industry Sector ◽  
Medical Device Safety ◽  
Device Industry

Public and internal databases were examined to evaluate software-related recalls in the medical device industry sector. In the analysis of recalls reported from 2005 through 2011, 19.4% of medical device recalls are related to software. This paper includes analysis results, challenges faced in determining the causes, and examples and trends in software-related recalls. This information can be useful in enhancing our understanding of why medical devices fail, and it can help to improve medical device safety, and patient and public health.

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