Guide for recalling medical devices (GUI-0054): Distribution records

On this page

• Keeping distribution records
• Distribution record requirements
• Checklist for distribution records

Keeping distribution records

The process that a manufacturer, importer or distributor follows to create and keep distribution records will vary depending on their sales, accounting and shipping procedures.

Keeping records may involve a number of procedures and personnel. Your establishment must indicate the records you will use to identify the location of affected products during a recall.

Records can be paper-based or electronic. They should be stored in a way that will protect their integrity. For example, you could consider backing up your electronic records regularly and storing paper copies in a different location.

Distribution record requirements

There are 5 distribution record requirements in the regulations.

Section 52 states:

1. The manufacturer, importer and distributor of a medical device shall each maintain a distribution record in respect of each device.
2. Subsection (1) does not apply to
   1. a retailer or
   2. a health care facility in respect of a medical device that is distributed for use within that facility

Manufacturers, importers and distributors must create and keep a distribution record for each medical device they distribute, including those that are given out as:

• gifts
• samples
• donations
• rental units
• "loaner" units
• demonstration units

Depending on your company's activities, you may require different procedures for tracking various distribution activities (for example, sales versus rentals).

Retailers, including drug stores and department stores, do not have to keep distribution records of devices they sell.

Health care facilities do not have to keep distribution records if they distribute solely within their regional health authority. Health care facilities include:

• hospitals
• clinics
• groups of facilities forming 1 corporate entity

You have to keep records if you distribute medical devices outside your regional health authority or corporate entity.

You do not have to keep records if you distribute medical devices to patients, as this is considered a retail activity.

Section 53 states:

The distribution record shall contain sufficient information to permit complete and rapid withdrawal of the medical device from the market.

Your procedures for distribution records should specify:

• how to record customer and device details for each sale
• what format the records should be in (for example, paper, electronic), including any software programs to be used to keep the records
• where information is stored and how it is accessed

When you receive a product, create a record that includes:

• enough detail to identify the device, including:
  • name
  • device identifier
  • model number
  • catalogue number (if different from the identifier)
• control number or lot number
  • date received
  • number of units received
• name of the person or company who supplied the device

When you distribute or ship a product, your record should include:

• enough detail to identify the device, including:
  • name
  • device identifier
  • model number
  • catalogue number if different from the identifier
  • control number or lot number
• date shipped to consignee
• number of units shipped
• name and address of the consignee

Note: The client contact information (contact name, phone and fax numbers, email address) in your records system should be accurate and maintained for when notifying the client of a recall.

Section 54 states:

1. The distribution record maintained by a manufacturer of an implant shall also contain a record of the information received on the implant registration cards forwarded to the manufacturer from a health care facility pursuant to section 67.
2. The manufacturer of an implant shall update the information referred to in subsection (1) in accordance with any information received from the health care facility or the patient.

If you manufacture an implant listed in Schedule 2 of the regulations, you must:

• include in its distribution record the information forwarded to you from a health care facility when they complete an implantation (as per section 67)
• update the record with any further information you receive from the health care facility or the patient

These requirements apply to the following select group of implantable devices defined as implants in Schedule 2:

• heart valves
• annuloplasty rings
• active implantable device systems, including:
  • all models of implantable pacemakers and leads
  • all models of implantable defibrillators and leads
  • artificial hearts
  • implantable ventricular support systems
  • implantable drug infusion systems
• devices of human origin, including:
  • human dura mater
  • wound coverings containing human cells

Section 55 states:

The manufacturer, importer and distributor shall retain the distribution record maintained in respect of a medical device for the longer of:

1. the projected useful life of the device and
2. 2 years after the date the device is shipped

Make sure your written procedures show the specific length of time you will keep records (for example, in years). The manufacturer usually determines the projected useful life of a device.

It is not enough to repeat the text of section 55 in your written procedure. You must specify an amount of time based on the nature of devices you distribute. You may also:

• specify different times for keeping paper and electronic records or
• indicate that you will keep all records indefinitely

Section 56 states:

Distribution records shall be maintained in a manner that will allow their timely retrieval.

Keep distribution records so they can be easily retrieved (regardless of where they are physically located). In most cases, you should be able to retrieve records within 1 to 2 business days. You may need time to access records from archived databases. Identify this as part of your recall strategy.

If you change the software program you use to keep records, make sure you:

• can still access records generated by your previous program or
• have alternate means of accessing those records (for example, through paper copies)

Checklist for distribution records

Use this checklist to help you:

• assess your procedures for creating and maintaining distribution records
• check that you are meeting the distribution record-keeping requirements in sections 52 to 56 of the regulations

Creating a distribution record

• Our company has identified triggers for distributing products. They may include:
  • receipt of purchase orders from clients
  • rental or lease agreements
  • requests for demonstration units, loaner units and samples
• We have described any forms or logs used to collect this information in our written procedures, and copies or templates are attached as applicable.
• We identify which staff members are responsible for recording distribution records.
• If we collect information electronically, we have described the electronic system and how to back up data in our procedures.

What to include in a distribution record

These requirements come from section 53 of the regulations.

• Our distribution records include customer information.
• Our distribution records include device information.

Maintaining distribution records

These requirements come from section 55 of the regulations.

• We have specified in our procedures how long our company will keep distribution records for medical devices. This time period is adequate to cover the device's longest projected lifespan.
• We have expressed this time period (for example, in years) or have indicated that the records will be kept indefinitely.
• We understand that keeping records in archived format is acceptable if we are able to retrieve the records quickly.

Retrieving distribution records

This requirement comes from section 56 of the regulations.

• We have specified in detail how to retrieve distribution records during a recall in our written procedures.