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Risk management
Published in Marie B. Teixeira, Design Controls for the Medical Device Industry, 2019
A risk/benefit analysis should include a review of clinical data and scientific literature on the medical benefits of the use of the device to determine if the overall benefit outweighs the overall risk. FDA’s guidance document “Factors to consider regarding benefit-risk in medical device product availability, compliance, and enforcement decisions” indicates that the extent of benefit of a device may be assessed by considering: The impact the device may have on patient health and clinical management;The degree to which patients will experience the treatment benefit or the effectiveness of the device;The likelihood that the device will effectively treat or diagnose the patient’s disease or condition;How long the benefit is expected to last;The value patients place on use of the device;The benefit of the device to health-care professionals or caregivers in patient care; andWhether the device addresses needs that are otherwise unmet by other devices or therapies.
Product Liability and Accident Investigations
Published in Paul H. King, Richard C. Fries, Arthur T. Johnson, Design of Biomedical Devices and Systems, 2018
Paul H. King, Richard C. Fries, Arthur T. Johnson
Unlike the negligence suit, in which the focus is on the defendant’s conduct, in a strict liability suit, the focus is on the product itself. The formulation of strict liability states that one who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer or to his property if the seller is engaged in the business of selling such a product, and it is expected to and does reach the user or consumer without substantial change to the condition in which it is sold. Therefore, the critical focus in a strict liability case is on whether the product is defective and unreasonably dangerous. A common standard applied in medical device cases to reach that determination is the risk–benefit analysis—that is, whether the benefits of the device outweigh the risks attendant with its use.
European Union: Medical Device Regulatory System
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
The risk/benefit analysis is the basis to be conducted to ensure a high level of protection of health and safety: Its purpose is to assess the acceptable risks when weighted against benefits to the patient. The risk reduction is then the elimination or mitigation as far as possible of the risks for a safe design and construction. It addresses protection measures to be taken and information to be provided the user and patient for each residual risk.
Ethical Aspects of Translating Research with Human Pluripotent Stem Cell Products into Clinical Practice: A Stakeholder Approach
Published in The New Bioethics, 2020
Clemens Heyder, Solveig Lena Hansen, Claudia Wiesemann
Clinical research has been regulated internationally since the Declaration of Helsinki, first published in 1964. A careful risk-benefit analysis is one of the major ethical requirements, particularly for innovative research with considerable potential for harm. The Guidelines for Stem Cell Research and Clinical Translation of the ISSCR (2016) maintain that researchers must provide a ‘systematic appraisal of evidence supporting the intervention’ (3.3.2.1) and ‘anticipate a favourable balance of risks and benefits’ (3.3.2.2) before starting a trial. Moreover, a stem cell-based intervention ‘must aim at ultimately being clinically competitive with or superior to existing therapies or meet a unique therapeutic demand’ (3.3.2.4). Usually, risk-benefit analyses are carried out cooperatively by researchers, clinicians and sponsoring companies and approved by institutional review boards. Yet, in stem cell research, both risks and benefits are still highly speculative.