FDA orders company to recall automated endoscope reprocessors
The Food and Drug Administration (FDA) ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs) from health care facilities due to the firm’s continued violations of federal law and a consent decree entered with the company in 2007.
The FDA’s most recent inspection of Custom Ultrasonics' facility in April 2015 documented continued violations, including the inability to validate that the AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. In the months following the inspection, the FDA provided the company with an opportunity to correct inspection violations and requested additional validation data. Following a review of the company’s submissions, the agency determined that Custom Ultrasonics had not adequately addressed its continued violations, which could result in an increased risk of infection transmission to patients.
An estimated 2,800 AERs manufactured by Custom Ultrasonics are currently in hospitals and outpatient clinics throughout the United States. The FDA’s recall order applies to all Custom Ultrasonics AERs, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9.
Also this week:
CDC updates HAI prevention guide for outpatient settings
The Centers for Disease Control and Prevention has updated its “Guide to Infection Prevention for Outpatient Settings” and a companion checklist to be consistent with the Outpatient Settings Infection Control Assessment Tool.
DHS, HHS call for enhanced vigilance after Paris terrorist attacks
In the wake of the recent terrorist attacks in Paris, Health & Human Services sent out a notice from the Department of Homeland Security to the health care and public health community urging them to review their security plans with employees and revise where necessary. The notice detailed four action points for health care and public health officials to address, including the need to ensure proper functioning of emergency communications equipment.
FDA Class I Recall of G5 Ventilator by Hamilton due to faulty alarm
The Food and Drug Administration announced a Class I Recall of the G5 Ventilator V2.00 and V2.31. The notice states that the ventilator may stop working without sounding an alarm when the device operator presses the oxygen enrichment key to attach the ventilator mask to the patient.
OSHA seeks comment on Safety and Health Program Management Guidelines
The Occupational Safety and Health Administration is seeking public comment on an updated version of its voluntary Safety and Health Program Management Guidelines. The guidelines are intended to help employers establish health and safety management plans at their workplaces. Key principles include finding and fixing hazards before they cause injury or illness. The guidelines, first published in 1989, are being updated to reflect modern technology and practices.
