United States of America. An executive summary of the AFDA Workshop on Minimizing Medical Products Errors - A Systems Approach” held on 8 January 1998 is available on the Internet at: http://www.gov/oc/workshops/mederrorsum.htm.
The ISMP presented “Failure Mode and Effects Analysis (FMEA) - A Way to Eliminate Medical Product Related Errors”. FMEA is a systematic process of understanding how and where errors might actually occur during the development phase of the product.
The ISMP made the following recommendations:
The FDA should establish minimum standards for systematic pre-launch safety testing of labelling, packaging, and brand names using practitioners and persons with expertise in failure mode and effects analysis.
The FDA should require companies to certify that required testing has been done, prior to product launch, to assure safer labelling, packaging, naming and instructions for product use.
The FDA should ask companies to provide, upon request, documentation to indicate how the testing was done, and their determination that the product was free from significant flaws or that any revealed problems were resolved.
Reference: ISMP Medication Safety Alert! Vol. 3, Issue 18, 9 September 1998.