Philips recall: Senator pushes for answers

WASHINGTON – Sen. Richard Blumenthal, D-Conn., sent a three-page letter to Vitor Rocha, the CEO of Philips North America, on Aug. 24, asking him to answer seven questions, including, when does Philips expect to have repaired or replaced all impacted devices? 

Blumenthal writes that he has heard from constituents with concerns about the lack of information surrounding a recall of certain Philips CPAP devices and ventilators announced in June. 

“The current situation is untenable, unacceptable and must be immediately rectified,” he writes. “I look forward to reviewing your answers to these questions. In the meantime, I urge Philips to continue its outreach to impacted patients, immediately expedite its replacement and repair program, submit a mitigation plan with sufficient evidence to FDA for authorization and work to ensure that such a mass recall does not occur again in the future.” 

Blumenthal’s other questions: 

• How many devices have been impacted by this recall, and how many patients are believed to have been impacted by this recall? 
• What percentage of impacted patients have used the Philips established registration process to register a recalled device? Please also provide the total number of impacted patients who have registered. 
• How has Philips reached out to affected patients to alert them to this problem and how is Philips continuing to ensure all affected patients learn of this problem? 
• What percentage of impacted patients who have registered their device have received a response from Philips regarding their recalled device? Please also provide the total number of impacted patients who have received any response. 
• What percentage of impacted patients have had their recalled device repaired or replaced by Philips’ “comprehensive repair and replacement program”? Please also provide the total number of impacted patients who have had the issue completely resolved through replacement or repair. 
• When does Philips expect to submit a mitigation plan to FDA for authorization to permanently resolve this problem? If it has done so, has it provided FDA with sufficient evidence to show that the mitigation plan eliminates the product defect and the product is now safe and effective for use? 

Blumenthal asks for answers to his questions by Sept. 7.