Facilities that would like to use an approved alternative system to treat regulated medical waste are required to verify, through validation, that the system operates under parameters set by prior efficacy studies performed by the manufacturer of the system.
Information that needs to be submitted for review includes:
- Operation parameters
- Description of the protocols that will be used to validate operation of the system
Once these documents are approved by the Regulated Medical Waste Program, validation testing can be performed by the facility and data submitted for review by the program.
No alternative treatment system should be placed into operation prior to implementation of such operation plan, which should be designed to promote the safe and effective operation of the alternative system.
Any future modifications to the plan may require additional efficacy and/or validation testing.
A Checklist for Installation of Alternative Technologies is provided.