Infection Control Policy

21 CFR 900.12(e)(13)  Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials.   This system shall specify the methods for documenting facility compliance with the infection control procedures established and shall:

§         Comply with all applicable Federal, State, and local regulations pertaining to infection control; and

§         Comply with the manufacturer's recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or

§         If adequate manufacturer's recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available. 

Comments:

The Infection control policy should include the following information: 

§         Name of the disinfectant used

§         Manufacturer recommendations for disinfectant

§         Copy of disinfectant reference material, for example: instructions for use

§         Step-by-step instructions on how to disinfect the mammography unit when contaminated with blood or other potentially infectious materials, for example: where to spray the disinfectant (on the cloth), and how long to leave the disinfectant on the unit, etc.

§         How to disinfect gross contamination (usually indicated on the disinfectant)

§         How disinfection will be documented and where (verification of disinfection is an MQSA requirement) 

Documentation of in-between patient cleaning is not a requirement of MQSA, but the written procedure for performing this task is required. 

It is advisable for ease during the inspection and for the facility employees, that these items be clearly stated and that a copy of the manufacturer’s recommendations be kept with the disinfection policy.

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