A facility that handles tissue implants or organ transplants should have:
(1) a policy for dealing with product recalls.
(2) a means of tracking the location and disposition of a product at all times
Actions upon receipt of a recall notice:
(1) Date and time that the notice was received and all actions taken subsequently.
(2) Determine if the recalled product was received at the facility.
If the product has been received:
(3) Determine the product's disposition: in storage, implanted, sent elsewhere.
(4) Create a recall file where all information is placed. This information must be available for at least 10 years and in some cases indefinitely.
(5) Follow the instructions of the recalling facility.
(6) Notify any agencies (FDA, State Health Department, other) as required by law.
(7) If a problem adversely affecting a patient is detected then notify those involved in managing risk (risk management, lawyer, insurance carrier).
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Disposition
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Immediate Action
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in inventory
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quarantine product
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implanted
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notify physician (see below)
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shipped elsewhere
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notify receiving facility
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discarded or destroyed
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document how and when
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If the physician cannot be notified, then an attempt should be made to reach the patient. If the patient is unable to receive the information then a parent, guardian or family member should be contacted.
