Policy Stat: Telephone Systems Failure Reporting Mechanisms SAFE MEDICAL DEVICES ACT This law is meant to protect patients and employees from medical devices or products that
may potentially cause serious injury, illness, or death by promptly reporting incidents to the
FDA.
What to do :
In a patient care incident, remove the equipment or supply.
Stabilize and treat the patient.
Notify the physician.
Notify the Risk Manager (or House Administrator after hours).
Complete a variance report with the identifying serial numbers or equipment
numbers.
Follow the specific procedure for drugs, supplies or equipment according to what is
involved in the event.
Drug Failure – Retain all packaging, syringes, inserts, serial numbers, and disposable
accessories. Notify the Pharmacy via a variance report and deliver the item to the pharmacy.
(Example of drug failure: Unit dose packaging received for your patient is empty, or
AddVantage product that will not activate.)
Supply Failure – Remove the item from use; retain all packaging and disposable
accessories, place in a biohazard bag and deliver to the office of Risk Manager. (Example:
After placing the patient to hemovac suction you note the hemovac drain will not maintain
suction. You note the drain appears to be defective.)
Equipment Failure - Attach and complete a variance report and a red “defective sticker”,
remove the equipment from service and sequester. Leave the equipment set-up as it was
when the incident occurred. Do not disconnect the electrical supply and save all items
connected to the equipment when the event occurred (fluids, tubing, etc).
Notify Clinical Engineering (Biomed) Department immediately that equipment was involved
