An analysis of medical device-related errors: prevalence and possible solutions

Author:

Ward James R,Clarkson P John

Publisher

Informa UK Limited

Subject

Biomedical Engineering,General Medicine

Reference59 articles.

1. MEDICAL DEVICES AGENCY, 1998, Medical Devices Agency annual report and accounts, 1997 — 1998. (London: Medical Devices Agency).

2. US FOOD AND DRUG ADMINISTRATION, 2002, Office of Health and Industry Programs FY2001 annual report. (Rockville, MD: Food and Drug Administration).

3. US FOOD AND DRUG ADMINISTRATION, 1999, Managing the risks from medical product use: creating a risk manage-ment framework. Report to the US Food and Drug Administration Commissioner from the task force on risk management. (Rockville, MD: Food and Drug Adminis-tration).

4. MELDRUM, S. J. 1998, Where do I look for good ideas for my new device? In Medical equipment industry-potential for growth, edited by A. Murray (London: Institution of Electrical Engineers), pp. 17 — 20.

5. US FOOD AND DRUG ADMINISTRATION, 1995, Instructions for completing form 3500A with coding manual for form 3500A. (Rockville, MD: Food and Drug Administration).

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