Is the open system legal and safe?
Yes, it is legal if it is FDA approved. The safety of the unit depends on the operations of the unit. If the therapist allows the client to self insert the speculum or allows the client to operate the equipment, this is a very un-safe and illegal practice. This is covered in the CFR’s Part 21 Sections 800-1200. In which 801.109 clearly identifies the law. The therapist must be trained to insert and operate the equipment. This is done by the manufacturer or an approved school of the manufacturer. One must understand that each type of equipment is different, and a therapist must be trained on each unit they use.
