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Medical Equipment. Safe Medical Devices Act (SMDA) Hospitals must report to the FDA an event, when it is suspected that a defective product and/or malfunctioning.

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Presentation on theme: "Medical Equipment. Safe Medical Devices Act (SMDA) Hospitals must report to the FDA an event, when it is suspected that a defective product and/or malfunctioning."— Presentation transcript:

1 Medical Equipment

2 Safe Medical Devices Act (SMDA) Hospitals must report to the FDA an event, when it is suspected that a defective product and/or malfunctioning equipment contributed to serious injury or to the death of a patient. If you are involved in such an event, please report immediately to your supervisor and complete an Occurrence Screen for Risk Management.

3 Broken Medical Equipment Immediately take out of service Report to your supervisor Complete the information on the Orange Equipment Repair Tag. Your supervisor will see that it is taken for repair.

4 Medical Equipment Inspection Must be performed on all incoming equipment, including physician equipment. Make sure all inspected equipment has a Biomed sticker attached. If the inspection date is over one year, bring down to Biomed.

5 Medical Equipment Training Employees using medical equipment must have training and be able to demonstrate competency in the use of the piece of equipment.

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