As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host documents obtained by the Freedom of Information Act (FOIA). POGO has long investigated issues related to public health, and today's document shows how FOIA can be used to make important information available to the public. Read more about POGO's plans for Sunshine Week here.
Invacare Corporation, a manufacturer of medical beds, failed to take adequate corrective action even after receiving complaints that their beds allegedly caused multiple consumer deaths, according to a Food and Drug Administration (FDA) inspection report dated August 2010.
The document is part of a broader set of FDA inspection reports in the Los Angeles and Florida districts that POGO obtained via Freedom of Information Act (FOIA) request. Inspections by FDA can be triggered—as in this case—if the agency receives consumer complaints that a medical device is unsafe.
The inspection report states that Invacare “failed to take corrective action in response to reports of entrapment involving Invacare medical beds sometimes resulting in death.”
In one of many complaints to the firm outlined in the document, an Invacare bed and bed rail was allegedly involved in a bed entrapment death of an 11-year-old child—but, despite the death involving its product, Invacare did not get pertinent information such as the bed model number, patient size, and whether there was a history of entrapment with that particular model of bed rail.
In another case, an 18-year-old patient with cerebral palsy fell from an Invacare bed and suffocated—but Invacare did not determine the “most likely root cause” of the accident.
In a third case, a patient was found deceased with her head entrapped in the bed rail—but the firm did not determine if bed rail dimensions put the patient at an increased risk of death.
There were several more cases of death outlined in the report, as well as multiple complaints about sparks coming out of bed control boxes. The FDA sent a letter of warning to Invacare on December 15, 2010, asking the firm to investigate and determine the causes of violations of FDA regulations observed by agency investigators, and to take prompt action to correct the violations. The letter didn’t see much coverage in the media at the time, but one medical equities analyst called it “more egregious than a typical warning letter,” adding that “Most are resolved quietly without much attention, with no impact on the company or its stock. But every once in a while you get a very tough warning letter.”
POGO called Invacare to get an update on what amends the firm has made in response to the FDA’s inspection.
“We’re making progress, it’s not something that happens overnight” said Lara Mahoney, Invacare Director of Investor Relations and Corporate Communications. “We’re staying in touch with FDA, and doing our best to do the right things and make sure that we’re in compliance with FDA regulations.”
The FDA has received hundreds of reports of injuries related to hospital, nursing home, and home care beds. Between 1985 and 2009, the agency received reports of 803 incidents of patients being caught, trapped, entangled, or strangled in beds with rails. These incidents involved 480 deaths.
Dana Liebelson is POGO's Beth Daley Impact Fellow.