The Food and Drug Administration is proposing to classify medical washers and medical washer-disinfectors as class II medical devices. In a notice in last Thursday's Federal Register, the FDA said it has classified several generic washers by regulation; medical washers and medical washer-disinfectors intended for general medical purposes have not been classified by regulation and are therefore considered as unclassified devices.

The new proposal refers to washers that are used to clean and dry surgical instruments, and decontaminate or disinfect anesthesia equipment, hollowware and other medical devices. After considering public comments on the proposed classification, the FDA said it would publish a final regulation classifying the devices. Comments can be submitted by May 8 at www.fda.gov/dockets/ecomments. An FDA panel said that the risk associated with the washers include infections, failure to properly clean medical devices and exposure of patient and healthcare users to chemical residues.