In­sulin pumps have most re­ported prob­lems in FDA data­base

The Standard Journal - - LOCAL - By Hol­brook Mohr and Mitch Weiss,

When Polly Var­nado’s 9-year-old daugh­ter was di­ag­nosed with Type 1 di­a­betes, it didn’t take long for the fam­ily to hear about in­sulin pumps.

In Septem­ber 2012, the girl picked out a pur­ple one — her fa­vorite color.

Over the next seven months, she pro­ceeded to be hos­pi­tal­ized four times in a McComb, Mis­sis­sippi med­i­cal cen­ter with high blood su­gar. But when Var­nado asked about all her daugh­ter’s prob­lems, she said, her doc­tor blamed user er­ror.

“They said it wasn’t the in­sulin pump, it was my daugh­ter,” said Var­nado, who be­came a reg­is­tered nurse so that she could bet­ter care for the girl.

When it comes to med­i­cal de­vices, none have had more re­ported prob­lems over the last decade than in­sulin pumps, a prod­uct that’s used by hun­dreds of thou­sands of di­a­bet­ics around the world, many of them chil­dren.

Col­lec­tively, in­sulin pumps and their com­po­nents are re­spon­si­ble for the high­est over­all num­ber of mal­func­tion, in­jury and death reports in the U.S. Food and Drug Ad­min­is­tra­tion’s med­i­cal de­vice data­base, ac­cord­ing to an As­so­ci­ated Press anal­y­sis of reports since 2008.

In terms of in­juries alone, in­sulin pumps were sec­ond only to metal hip re­place­ments, whose prob­lems with metal shav­ings in the body caus­ing dam­age to bone and tis­sue and other is­sues, have been well-doc­u­mented and widely re­ported.

By con­trast, prob­lems with in­sulin pumps largely have flown un­der the radar.

Med­i­cal de­vice com­pa­nies and many ex­perts say in­sulin pumps are safe de­vices that can help di­a­bet­ics lead more nor­mal lives. They blame user er­ror for most re­ported prob­lems, not­ing that the pumps are com­pli­cated de­vices re­quir­ing spe­cial train­ing for pa­tients.

The FDA notes that “di­a­betes is a dan­ger­ous dis­ease, and peo­ple with di­a­betes who rely on in­sulin are at higher risk.” The agency said it “has played a crit­i­cal role helping to iden­tify and ad­dress safety con­cerns for de­vices ... in­clud­ing push­ing man­u­fac­tur­ers to im­prove the safety of their de­signs.”

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