Product Issues & Recall Process

This procedure applies to the Duke Enterprise.

Any employee, staff member, or credentialed provider in receipt of an external recall notice is to promptly notify DUHS Procurement and Supply Chain Management, and the Director of entity Clinical Risk Management of the content of the recall notice, providing a copy by fax or by e-mail. The notifying employee, staff member, or credentialed provider is to confirm receipt by the addressees of the forwarded information.

Any employee, staff member, or credentialed provider who becomes aware without recall notice of an actual or potential threat of adverse health consequences due to possible or known flaw in product design, or manufacture, contamination, or error in the supply chain is to promptly notify DUHS Procurement and Supply Chain Management and DUHS Risk Management, in the entity of the perceived threat and the circumstances of the identification of the product concern. The notifying employee, staff member, or credentialed provider is to confirm receipt by the addressees of the forwarded information.

Each clinical, administrative, and program unit, department and/or division will designate a recall contact person, to be listed with DUHS Procurement and Supply Chain Management and entity Pharmacy. It is the responsibility of each area to maintain accuracy of current listings and contact information. The contact list will be maintained in the web based recall tool. For external recall notices and for internal recall concerns, Procurement and Supply Chain Management will promptly:

• Evaluate the actual or probable FDA Class of the recall
• Identify the pertinent impacted departments
• Notify providers/responders
• If applicable, forward the pertinent information to the DUHS Quality and Safety Office for review. The Administrative Director will,
• Notify and assemble the Senior Recall Team as necessary to review pertinent information

The DUHS Senior Team will evaluate the information and identify immediate, short-term (1-2 weeks) and long-term (3 or more weeks) actions to be taken in response to the recall issue(s) under consideration. Areas such as Health Information Management, Procurement, Materials Management, Pharmacy and DHTS will provide technical support for recall efforts as needed.
Response measures can include, but are not limited to:

• Identification of impacted patients, if any
• Identification of impacted employees, staff, or providers, if any
• Development and implementation of a clinical response to the stated actual or potential medical problem/harm including patient record documentation and disposition of any associated patient costs
• Development and implementation of a communication plan and communications documents to assure consistent information is provided to the correct recipients, including providers
• Designation of a single or limited set of contact points with any manufacturer, distributor, or external agency involved in the recall
• Tracking and documentation of products returned to a manufacturer or distributor
• Tracking and documentation of costs associated with product revision and recall
• If required, as designated by the team, communication with PRMO to ensure billing reflects clinical events.

Standard tracking requirements at each entity will include the following:

• Pharmacy: Drug trade name, drug generic name, manufacturer, distributor, lot number
• Blood products: Type of product, unit numbers, supplier
• Implants: Type of product, manufacturer, distributor, lot number
• Equipment: Type of product, name of product, manufacturer, product number
• Other: All pertinent descriptive, ordering, and logistical information to provide for consistent identification across entities

Each entity will have a sub plan for recalls to channel into the DUHS procedure for consistent application across all entities.

Definitions

Recall

Removal or modification of products due to identified actual or potential harm to the user and/or recipient.

Recall Sources

Recall can be initiated externally by the FDA, the manufacturer, the distributor, or other knowledgeable or authoritative entities. Recall can be initiated internally by notification of safety or quality concern to the Senior Recall and Response Team (SRRT- “The Team”); The Senior VP for Clinical Affairs, the Chief Patient Safety Officer, DUHS Risk Management Director, the designated CMO, and the Chief of Staff.

FDA Classifications

Class I: Reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II: The use of or exposure to a violative product may cause temporary or medically reversible health consequences or where the probability of serious, adverse health consequences is remote.
Class III: The use of or exposure to a violative product is not likely to cause adverse health consequences.