Guide for recalling medical devices (GUI-0054): Defining a recall, documented processes

On this page

• Defining a recall
• Establishing and using documented processes
• Guidelines for writing procedures

Defining a recall

The Medical Devices Regulations (regulations) define "recall" as follows:

1. a recall ordered by the Minister under section 21.3 of the act or
2. any action taken by the manufacturer, importer or distributor of a medical device, after the device has been sold, to recall or correct the device, or to notify its owners and users of its defectiveness or potential defectiveness, after becoming aware that the device
   1. may present a risk of injury to health
   2. may fail to conform to any claim made by the manufacturer or importer relating to its effectiveness, benefits, performance characteristics or safety or
   3. may not meet the requirements of the act or these regulations

A recall may include:

• removing a medical device from the market
• instructing customers to stop using a medical device and destroying remaining units in stock
• doing an on-site correction of a medical device
• advising users of a device about a problem or potential problem
• supplying different labelling
  • may include updates to instructions or manuals

Establishing and using documented processes

You must document (electronically or on paper) your processes for maintaining distribution records and doing recalls (including recall reporting).

You may document each activity in a single procedure or use a number of procedures, depending on your quality system. If you use multiple procedures, you must be able to show that:

• all parts of the distribution record and recall process are represented
• your procedures are being followed

Documenting the recall and distribution record-keeping process

Your establishment's written procedures must:

• define key activities
• assign responsibilities
• describe steps taken from the start to the end of the process
• set out timeframes
• use a common format

There should be a timeframe for all activities described in your recall procedures, where appropriate. The timeframes should be based on the level of risk: the higher the risk, the shorter the timeframe for completing an action.

Be sure to specify timing for:

• notifying affected clients
• notifying Health Canada
• following up with anyone who does not respond to your recall notification

You may either set unique timeframes for each risk level or a single timeframe for all recalls based on the timing required for a high-risk recall.

Using written procedures

When your establishment initiates a recall or receives notification of a recall, use your step-by-step written procedures as follows:

1. Perform all steps in the procedure.
2. Ensure that each employee responsible for any step in the procedure:
   • has access to the procedure
   • understands their responsibility
   • is appropriately trained and qualified
   • receives support from management to ensure they follow procedure
3. Keep records as required.

To show that a third party will complete agreed-upon parts of the recall procedure, you might also:

• have a documented quality agreement that specifies roles and responsibilities and assures compliance with the regulations
  • for example, contacting affected customers and following up with non-responders
• have the third party sign and follow your written procedures

Guidelines for writing procedures

Follow these guidelines when writing procedures (for example, keeping distribution records or recall procedures).

Definitions: Your written procedures should include definitions for key terms used to describe the activities (for example, "recall").

Responsibilities: Assign overall responsibility for each procedure to a qualified individual with enough knowledge and authority to ensure it is effectively implemented.

Activities: Include detailed instructions about the steps involved in completing each activity.

Format: Your written procedures should follow a consistent format. Here is a sample format:

1. Purpose: Include a briefly stated reason for the procedure.
2. Scope: Define the situations, people or laws to which the procedure applies.
3. Responsibility: Define the units or people responsible for carrying out the procedure.
4. References: Include any useful references to:
   • corresponding chapters in your quality manual
   • applicable quality system standards
   • related procedures
   • federal regulations
5. Definitions: Include any relevant definitions (for example, for "recall").
6. Procedure: Describe the step-by-step actions that need to be taken. (This section may also be labelled "Instructions," "Actions" or "Methods.")
7. Documentation: List the kinds of records associated with the procedure, where these records are filed and how long you will keep them. (Or, you may state how long you will keep records in your procedures for data and documentation control.)
8. Distribution: Identify staff or departments within your company who will receive the procedure.
9. Revision sheet or table: Include:
   • revision level (for example, letter, number or combination)
   • date of the revision
   • effective date of the revision
   • a brief description of the change

You may also track revisions as part of your general documentation control procedures.

10. Attachments: Include all forms you will use to carry out the procedure (for example, a recall reporting form).