FDA in­fu­sion pump ini­tia­tive ad­dresses safety con­cerns

Modern Healthcare - - Late News -

The Food and Drug Ad­min­is­tra­tion launched an in­fu­sion pump safety ini­tia­tive aimed at ad­dress­ing sev­eral se­ri­ous and life-threat­en­ing prob­lems re­ported to the agency in re­cent years. They in­clude soft­ware de­fects, me­chan­i­cal fail­ure and in­ad­e­quate user­in­ter­face de­signs. Ac­cord­ing to FDA of­fi­cials, 87 in­fu­sion pump re­calls took place be­tween 2005 and 2009, and the agency has re­ceived more than 56,000 re­ports of ad­verse events over the past five years in con­nec­tion with in­fu­sion pumps. Those re­ports in­clude more than 500 deaths. As a part of the new safety ef­fort, the FDA has is­sued new man­u­fac­turer draft guid­ance and has also sent a let­ter in­form­ing in­fu­sion pump de­vice­mak­ers that they may need to con­duct ad­di­tional risk as­sess­ments to sup­port ap­proval of new or mod­i­fied pumps. The FDA will hold a pub­lic work­shop May 25-26, to dis­cuss ways to im­prove in­fu­sion pump safety.

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