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We are going to be coming to that sector’
Having launched a major regulatory initiative at hospitals that reprocess single-use medical devices, the Food and Drug Administration (FDA) is already leveling its sights at outpatient settings such as surgicenters and physician offices.
An FDA official recently clarified that only hospitals are subject to enforcement of the current regulations, but warned that other settings would be included in the future.
"The enforcement guidance that we put out applies only to acute inpatient hospitals — places where people go for overnight care," said Larry Kessler, ScD, director of the office of surveillance and biometrics in the FDA center for devices and radiological health.
"These guidance documents do not yet apply to surgicenters, outpatient diagnostic places, [and] doctors offices. We are aware reprocessing is being done in some of those outpatient settings. The FDA will be looking into those."
But even leaving such settings out of its current regulatory initiative does not tie the FDA’s hands should the agency chose to flex its enforcement muscle, he reminded. "While this enforcement guidance does not apply to them, technically all of the requirements of the FDA do apply," he said.
"We are not explicitly going to go into that setting at the moment, but surgicenters and doctors offices have to aware that we are going to be coming to that sector at some point during the future," Kessler pointed out. "I can’t tell you when or how that is going to play out, but if reprocessing is happening there, it has to happen with the same kind of care [as in] the hospital. We are trying to make devices safe for all patients — in- or outpatients."