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U.S. Department of Health and Human Services

Radiation-Emitting Products

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Infection Control

Policy Guidance Help System logo

Citation:

900.12(e)(I3)(i), (ii), (iii). Infection control. 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:

(i) Comply with all applicable Federal, State, and local regulations pertaining to infection control; and

(ii) Comply with the manufacturer’s recommended procedures for the cleaning and disinfection of the mammography equipment used in the facility; or

(iii) If adequate manufacturer’s recommendations are not available, comply with generally accepted guidance on infection control, until such recommendations become available.

Questions:
  1. What infection control procedures are required under MQSA?
  2. What criteria will FDA use to determine that facilities meet the MQSA requirements for infection control?
  3. We clean the mammography unit between each patient. Do we still have to document (through the use of logs or charts) cleaning after the equipment comes in contact with blood or other potentially infectious materials?
  4. We use our mammography unit for interventional procedures as well as for routine mammography. Since interventional procedures are currently excluded from regulation, what should we be doing to document that proper infection control procedures have been performed?
  5. We use our mammography unit solely for interventional procedures. Since interventional procedures are currently excluded from regulation, what are we required to do with respect to infection control procedures?
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