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Medical Equipment

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.

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Medical Equipment

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  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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