Instrument modification hazardous; needle holder magnetization unrecognized; instrument cleaning technique vs. capacity

The modifications required removing a prong and shortening another. Since doing this I have been getting requests to have modifications made to other instruments and needles. From a legal perspective, the party that performs or allows for the alterations of any medical device becomes the manufacture...

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Veröffentlicht in:Healthcare Purchasing News 2020-05, Vol.44 (5), p.31-31
1. Verfasser: Taurasi, Ray
Format: Artikel
Sprache:eng
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Zusammenfassung:The modifications required removing a prong and shortening another. Since doing this I have been getting requests to have modifications made to other instruments and needles. From a legal perspective, the party that performs or allows for the alterations of any medical device becomes the manufacturer of said device and must comply with the US Food and Drug Administration (FDA) Good Manufacturing Regulations (GMP). GMP are the practices required in order to conform to the guidelines recommended by the agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
ISSN:1098-3716