What are the responsibilities of recovery establishments that contract the cleaning and sterilization of recovery instruments (equipment)?
In order to demonstrate that cleaning and sterilization of recovery instruments performed by a contract facility are appropriate, the recovery establishment should: • obtain and approve the procedures, and review the records of cleaning and sterilization per § 1271.200; • establish and maintain verification procedures under § 1271.210 for any instruments cleaned and sterilized for you by a facility under contract, agreement or other arrangement; and • have the procedures and records available for review on inspection. Establishments that only clean and sterilize recovery instruments (equipment) under contract, agreement, or other arrangement to a registered recovery establishment are not required to register, because this function is not considered a manufacturing step.
