City University Consortium for Health Care Applications and Public Policy
Vision:
To support advancements and applications of information technology in healthcare management through implementation of Prognostics and Health Management (PHM) technology. Medical devices and solutions should be made available to consumers in a cost efficient manner with good reliability.
Mission:
To advocate the reliability and safety of medical devices and systems through proven PHM techniques and continual improvement from existing knowledge. Through collaboration and education to promote quality healthcare, we endeavor to provide quality assurance and promote change to facilitate members improve on their processes and practices to maximize competitiveness and operational excellence.
Policy:
The Consortium for Health Care Applications and Public Policy under the direction of Prof Michael Pecht, has been working with the Food and Drug Administration (FDA) in helping companies improve their design for reliability and qualification processes and in helping the FDA improve their process of evaluating and regulating products, including medical devices. However, such practices are still not globally practiced or enforced. Thus, a Consortium is needed to provide a resource-base for companies (and government organizations) to be educated, as well to provide a facility to conduct research on medical reliability and safety issues and to establish best practices and assessment techniques for the regulatory agencies and for medical device manufacturers.
Reliability assurance is a critical issue because failure of medical devices while in use can affect the life and safety of users. Depending on the modes of failure, a device can cause various types of hazards. Safety includes protection from all types of potential hazards that can be caused from the use of a device, e.g., mechanical, electrical, radiation, chemical, thermal and biological. For example, the mode of failure of a carotid stent can be the detachment of its tip from the delivery system, which can cause serious injury to the patient. The mode of failure of a transilluminator can be overdose (or high intensity) of infra – red rays which is a source of radiation hazard and is equally unsafe for the user. Even a tongue depressor can break leading to a serious injury. Such failures can also potentially lead to lengthy and costly legal proceedings.
Effectiveness pertains to the ability of a medical device to demonstrate clinically significant results . An unreliable device can either reduce the effectiveness of a device to unacceptable levels or completely make a device ineffective. For example, pacemakers are used to treat conditions of arrhythmia in patients. Failure of the pacemaker to generate the appropriate voltage pulse when required will make it ineffective and can aggravate the problem of the patient leading to death. Failure of a blood glucose monitor to accurately measure blood glucose levels will make it ineffective in serving its purpose and can lead to serious health concerns due to faulty diagnosis.
For new devices, the FDA should require the manufacturers to submit information about their reliability capability at an early stage in the device review process, i.e., during the investigational device exemption (IDE) application process. For devices that are already on the market, the FDA should monitor adverse event reports and recalls associated with devices, or use PMA supplements to identify manufacturers with a need for reliability capability assessment. Manufacturers can either conduct reliability capability assessment of their organization by themselves or utilize the services of third party organizations to evaluate their reliability capability, and provide assessment results to the FDA. The Consortium will maintain a database of available of third party organizations for this purpose by region.
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