Patient compatibility of devices
Patient compatibility of devices
- Author(s): R. Dickinson
- DOI: 10.1049/ic:20060300
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- Author(s): R. Dickinson Source: IET Seminar on Biocompatible Materials, 2006 p. 73 – 95
- Conference: IET Seminar on Biocompatible Materials
- DOI: 10.1049/ic:20060300
- ISBN: 0 86341 752 3
- Location: London, UK
- Conference date: 26 Oct. 2006
- Format: PDF
This paper discusses the patient compatibility of medical devices. A device is said to be patient compatible if it meets the regulatory requirements of safety, functionality and is according to the Annex 1 of the European Medical Device Directive. As it is accepted that medical devices constitute a risk, the benefits of the device should outweight the risks. The risk should be minimised hence a risk management programme must be undertaken. The relevance of device encapsulation is also discussed. If some materials are not biocompatible, they must be covered or encapsulated. A case study on an intravascular ultrasound (IVUS) coronary catheter is presented.
Inspec keywords: biomedical ultrasonics; catheters; encapsulation; health and safety; risk analysis
Subjects: Sonic and ultrasonic applications; Patient diagnostic methods and instrumentation; Sonic and ultrasonic radiation (medical uses); Sonic and ultrasonic radiation (biomedical imaging/measurement)
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