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 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.

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.

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.

Medical Equipment Training

• Employees using medical equipment must have training and be able to demonstrate competency in the use of the piece of equipment.