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Suit Alleges Devices Faulty, FDA Standards Violated
The United States filed a complaint on June 25 in Federal Court to seize and condemn allegedly faulty patient lift devices being stored by Moving Solutions Inc., in Downers Grove, IL. The lifts, manufactured in Denmark and distributed in the United State by Moving Solutions, are mechanical sling-like devices used to lift and move patients from one place to another, as from a bed to a wheelchair. Approximately 850 of these patient lifts have been distributed to hospitals, nursing homes and private homes throughout the United States. According to the lawsuit and reports received by the FDA, one patient has died and another was seriously injured when the bolt that supports the hanger bar and the patient sling broke, dropping the patients. Moving Solutions allegedly failed to report the patient death to the FDA and violated the FDA's Quality System regulations by lacking procedures to handle complaints, and failing to verify that servicing of the product met specified requirements.
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The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
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