Ethics of medical device safety
| Autor: | Timothy J Kriewall |
|---|---|
| Rok vydání: | 2009 |
| Předmět: |
Flexibility (engineering)
medicine.medical_specialty Equipment Safety Process (engineering) Computer science business.industry Biomedical Engineering Usability Equipment Design Risk analysis (engineering) Equipment and Supplies Backup Emergency medicine New product development Ethical dilemma medicine Humans Product (category theory) business Engineering design process General Dentistry |
| Zdroj: | Journal of long-term effects of medical implants. 18(2) |
| ISSN: | 1050-6934 |
| Popis: | How safe is safe? The design intent of a medical device is to off er maximum flexibility, and low-cost and fail-safe features. Easily said, these requirements are difficult to deliver in a litigious society where performance standards are uncommon. Medical device manufacturers face challenges as they strive to offer the ultimate in product safety and keep the price affordable for the technology deployed, while making the usability of typically complex products common sense for the operator. As microprocessors are able to assist designers in providing intelligent, multifunctional systems, care must be taken during the design process to balance technological ability with intuitive use. The medical device development process requires rigor that is not often taught to biomedical engineers. Ethical product development requires a process that will be described in this paper using as an example the development of a recent cardiopulmonary perfusion system. However, the same techniques are germane to implantable devices such as cochlear implants. All engineering product development requires trade-off decisions considering how much is too much and how much is too little. Biomedical engineering faculty need to present this ethical dilemma to their students and give them the tools to help decide. However, in the final analysis, the operator of any medical product or installer of any medical device holds the primary responsibility for understanding how to use the system or install the implant in normal use as well as emergent or special situations; the technology is his or her backup in performing the medical professionals primary job. |
| Databáze: | OpenAIRE |
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