EFHSS Questions and Answers - Question Q01134

We all have guidelines to follow for our work practices in CSSD. However, does the CSSD come under FDA reglations or do they need to have any kind of license to be able to carry out sterilization procedures within the hospital just like pharmacies or blood banks.
Wherever there are third party kind of arrangements for sterilization of single use items what type of licenses are required by them. What are the tests carried out by them as they are now considered as manufacturers of the items they resterilize.

Hi Neena,

Hospitals in the United States are accredited by the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) and follow the recommended standards of the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of Operating Room Nurses (AORN).

Sterilization of single use items by third party reprocessors are regulated under the FDA and as stated they are considered manufactureres of the items they sterilize. I do not know the specific tests each company performs on these items.

Don