The Regulated Medical Waste Program is responsible for approving alternative technologies to treat regulated medical waste prior to their installation at healthcare facilities.
Upon installation of an approved technology, facilities must confirm through validation studies that operational parameters established by efficacy studies effectively treat medical waste at the installation site.
Manufacturers of alternative technologies are required to submit protocols for efficacy testing that must be approved prior to initiation of the studies.
These protocols should describe procedures that will be used to demonstrate the system's effectiveness in treating regulated medical waste.
Once protocols are approved, the manufacturer may initiate testing using the actual system and with biological indicators recommended by the Regulated Medical Waste Program.