Philips Health­care sus­pends pro­duc­tion at Ohio fa­cil­ity

Modern Healthcare - - REGIONAL NEWS - — Chuck Soder, Crain’s Cleve­land Busi­ness

Philips Health­care tem­po­rar­ily has sus­pended pro­duc­tion at its med­i­cal imag­ing fa­cil­ity in High­land Heights, Ohio, while it works to im­prove its qual­ity con­trol pro­cesses.

Philips stopped pro­duc­tion vol­un­tar­ily, but the shut­down was prompted by process-re­lated is­sues that federal reg­u­la­tors iden­ti­fied dur­ing a re­cent in­spec­tion, ac­cord­ing to a state­ment Philips e-mailed to Crain’s Cleve­land Busi­ness.

How­ever, “there is no in­di­ca­tion” that those is­sues have af­fected the safety of the med­i­cal imag­ing ma­chines made at the fa­cil­ity, ac­cord­ing to the state­ment. Philips makes CT scan­ners and molec­u­lar imag­ing ma­chines in High­land Heights.

“Our cus­tomers can re­main con­fi­dent in the safety of our prod­ucts,” the com­pany said in the state­ment.

The U.S. Food and Drug Ad­min­is­tra­tion has pre­vi­ously chided Philips’ High­land Heights fa­cil­ity for fail­ing to meet stan­dards the agency sets for med­i­calde­vice man­u­fac­tur­ing pro­cesses.

The FDA in 2011 sent Philips a warn­ing let­ter point­ing out sev­eral flaws in the pro­cesses that the fa­cil­ity used to pre­vent and cor­rect man­u­fac­tur­ing prob­lems that could arise.

Philips did ad­dress those prob­lems, ac­cord­ing to an­other let­ter the FDA sent in 2012. In that let­ter, how­ever, the FDA promised to keep an eye on the fa­cil­ity.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.