What criteria will FDA use to determine that facilities meet the MQSA requirements for infection control?
To meet the MQSA requirements for infection control, the facility must:
- provide written documentation that describes the infection control procedures used by the facility. If reference material is cited in the facility's description of its procedures, the facility must have a copy of the referenced material. The procedures used by the facility must comply with applicable Federal, State and local regulations as well as manufacturer's recommendations.
- have documentation (e.g., logs or charts) indicating that the infection control procedures were performed when the mammography equipment came into contact with blood or other potentially infectious materials. In those cases where there has not been an episode of contamination since the last inspection, the facility should make that clear to the inspector.