User Problem Reporting for Medical Devices (GUI-0060)

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Contact Information

Cover Letter

Our Mandate:
To promote good nutrition and informed use of drugs, food, medical devices and natural health products, and to maximize the safety and efficacy of drugs, food, natural health products, medical devices, biologics and related biotechnology products in the Canadian marketplace and health system.

Supersedes: January 2003

Date issued: January 14, 2011

Date of implementation: January 14, 2011

Disclaimer

This document does not constitute part of the Food and Drugs Act (Act) or its associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies. This document is not intended to provide legal advice regarding the interpretation of the Act or Regulations. If a regulated party has questions about their legal obligations or responsibilities under the Act or Regulations, they should seek the advice of legal counsel.

Table of contents

• 1.0 Introduction
  • 1.1 Purpose
  • 1.2 Background
  • 1.3 Scope
• 2.0 Definitions
• 3.0 Interpretation
  • 3.1 What is a Medical Device User Problem Report?
  • 3.2 Steps to follow when submitting a report
  • 3.3 What will happen after you submit your report?
• 4.0 Completing the Medical Device User Problem Report Form
  • 4.1 Where do I obtain the reporting form?
  • 4.2 To whom do I send the completed report?

1.0 Introduction

1.1 Purpose

The purpose of this guidance document is to assist medical device users, patients and other persons who experience a problem with a medical device, in submitting a user problem report to Health Canada.

User reporting (formerly known as voluntary problem reporting) is not intended for use by manufacturers, importers and distributors. Companies are expected to investigate reported problems according to their established problem investigation procedures and take appropriate corrective actions. Notification of Health Canada is only required when the mandatory problem reporting or the recall notification requirements of the  Medical Devices Regulations are met.

1.2 Background

Problem reporting is an essential element in the ongoing efforts of Health Canada to protect the health and safety of Canadians. Although only manufacturers and importers are required to report medical device problems under the mandatory reporting provisions of the Regulations, Health Canada encourages anyone purchasing, using or maintaining medical devices to report problems or concerns on a voluntary basis.

Generally, medical device problem reporting contributes to an increased level of medical device safety, effectiveness and quality. The report may set in motion a process by which Health Canada will verify that the device is in compliance with the Regulations and will assess the circumstances of the incident itself. This risk management process identifies problematic devices and works towards the prevention of the recurrence of medical device incidents. In accordance with the Compliance and Enforcement Policy (POL-0001), actions taken to correct the problem by either the company or Health Canada may include the following: issuance of public warnings and/or advisories to users of the device; product modifications; redesign; recalls; or improvements in directions for use. Failure of users of medical devices to notify the manufacturer and Health Canada could place at risk users elsewhere who are not aware of the problem.

The Medical Device User Problem Report Form (FRM-0029) is designed to collect the information used by Health Canada to assess the extent of the problem and the most appropriate response.

Most post-market device problems are experienced in a healthcare facility by the actual user of the device. Because device users understand the procedures and conditions under which the problem occurred, the user's description and perspective of the nature of the problem is invaluable to Health Canada.

1.3 Scope

This guidance document is directed to healthcare professionals, technical staff, administrators and the general public to assist in the reporting of medical device incidents, and also explains the types of problems that should be the subject of a user report.

2.0 Definitions

Incident: Any situation, including a complaint or enquiry, falling within the program areas of the Inspectorate, which has the potential to compromise the health and safety of Canadians, or violate the legislative requirements that the Inspectorate is responsible for enforcing.

Note: In the medical device area, incidents include problems or malfunctions with devices, as outlined in this guidance document (see section 3.1, below).

Note: Program areas of the Inspectorate include medical devices, drugs, biologics, among others.

Problem Report: An all-inclusive term used by the Inspectorate that encompasses reported actual or potential occurrences of device failure and other violations of the Food and Drugs Act and the Regulations. It includes a report of information to the Inspectorate which suggests that there is a reasonable probability that the use of, or exposure to, a medical device has lead to the death, or serious deterioration in the state of health, of a patient, user or other person or it is reasonable to believe that if it were to recur, could lead to the death, or serious deterioration of the state of health, of a patient, user or other person. A problem report also includes the report of information to the Inspectorate concerning the use of, or exposure to, a medical device that may have caused, or could cause, temporary deterioration in the state of health, of a patient, user or other person.

3.0 Interpretation

3.1 What is a Medical Device User Problem Report?

A Medical Device User Problem Report is any account of a problem or concern involving a medical device, which is forwarded to Health Canada at the discretion of the reporter. These reports include the following:

• actual problems, which have been detected during use;
• concerns about the safety of a device or about its ability to perform as claimed;
• deficiencies in the design of the device, defects arising from the manufacturing process, or deficiencies in labelling; or
• a contravention of a regulatory requirement, such as sale of a device without a device licence.

If you are unsure whether the product in question is a medical device, contact the nearest Operational Centre to determine the classification of the product. Contact information for each of the Operational Centres is listed in Section 4.2 of this document.

Healthcare professionals and the general public are urged to report all types of device problems or concerns to the device's manufacturer or distributor, as well as to Health Canada. User reports are assessed by Health Canada using risk management principles. Not all reports may warrant a compliance verification or an investigation. Even those that are not actioned directly, however, provide a basis for trend analysis. These reports assist in the identification of problems with individual devices, or classes of devices, which may, otherwise, go undetected.

3.2 Steps to follow when submitting a report

The steps for submitting reports to Health Canada using FRM-0029 are listed below. You may add additional pages if there is insufficient space on the form.

1. Obtain a copy of FRM-0029 as per Section 4.1;
2. Send the completed form to the appropriate Operational Centre listed in Section 4.2.

3.3 What will happen after you submit your report?

1. The Operational Centre will acknowledge receipt of your report and may request further information; and
2. The reporter will be advised whether the problem or concern was verified, and what, if any, actions were taken, as appropriate.

All problems or concerns are prioritized according to the risk to health presented, with those representing a higher risk being actioned first.

4.0 Completing the Medical Device User Problem Report Form

4.1 Where do I obtain the reporting form?

Although Health Canada accepts problem reports which are submitted in other formats than that found in the Medical Device User Problem Report Form (FRM-0029), our preference is that you submit your report using FRM-0029. This form prompts you for all of the required information to allow Health Canada to quickly and efficiently triage and action your report.

4.2 To whom do I send the completed report?

Your medical device user problem report may be submitted electronically, by mail, or by fax to the Operational Centre nearest you:

Atlantic
Atlantic Operational Centre
Suite 1625, 1505 Barrington Street
Halifax, NS   B3J 3Y6
Telephone: 902-426-2160 or 1-800-267-9675
Facsimile: 902-426-6676
E-mail: atl-med@hc-sc.gc.ca

Quebec
Quebec Operational Centre
1001 St-Laurent Street West
Longueuil, QC   J4K 1C7
Telephone: 450-646-1353 or 1-800-561-3350
Facsimile: 450-928-4105
Email: que-med@hc-sc.gc.ca

Ontario & Nunavut
Ontario Operational Centre
2301 Midland Avenue
Scarborough, ON   M1P 4R7
Telephone: 416-973-1600 or 1-800-267-9675
Facsimile: 416-954-4583
E-mail: ont-med@hc-sc.gc.ca

Manitoba, Saskatchewan
Manitoba & Saskatchewan Operational Centre
510 Lagimodiere Blvd.
Winnipeg, MB   R2J 3Y1
Telephone: 204-984-1341 or 1-800-267-9675
Facsimile: 204-984-2155
E-mail : ms-med@hc-sc.gc.ca

Alberta, Northwest Territories
Alberta Operational Centre
730 - 9700 Jasper Ave.
Edmonton, AB   T5J 4C3
Telephone: 1-800-267-9675
Facsimile: (780) 495-5551
E-mail: ab-med@hc-sc.gc.ca

British Columbia, Yukon
Western Operational Centre
4595 Canada Way, 4^th floor
Burnaby, BC   V5G 1J9
Telephone: 604-666-3350 or 1-800-267-9675
Facsimile: 604-666-3149
E-mail: woc-med@hc-sc.gc.ca