Yes, these units will have to be replaced or modified to meet the regulations. The regulations require that effective October 28, 2002, the initial power drive compression must not exceed 45 pounds (200 newtons). The purpose of this requirement is to help prevent patient injury due to the use of excessive compression force. Units providing a maximum initial compression force of more than 45 pounds (200 newtons) are non-compliant after October 28, 2002. Compression forces greater than 45 pounds (200 newtons) are allowed in the fine adjustment mode.