Opening Statement to the Standing Committee on Health
Health CanadaRegulation of Medical Devices
(Chapter 2 - March 2004 Report of the Auditor General)
29 April 2004
Sheila Fraser, FCA
Auditor General of Canada
Madam Chair, thank you for the opportunity to discuss the results of our audit
of Health Canada's Medical Devices Program, Chapter 2 in the March 2004 Report.
With me today is Linda Anglin, the Director responsible for this audit.
The federal government, as federal regulator, has a legislated responsibility
that is outlined in the Food and Drugs Act to protect the health and safety
of Canadians. Protecting Canadians from risks related to medical devices is the
responsibility of Health Canada under the Act and the Medical Devices Regulations.
The goal of Health Canada's Medical Devices Program is to ensure that medical
devices available in Canada are safe, effective, and of high quality. Health Canada
has developed a regulatory framework to assess the safety and effectiveness of
medical devices through a balance of quality system requirements, pre-market activities,
and post-market activities.
Medical devices play an important role in the delivery of health care. They
include diverse products such as surgical masks, blood test kits, diagnostic imaging
equipment, joint implants, and heart valves. Modern health care relies more and
more on these devices to diagnose, treat, mitigate, and prevent diseases and certain
medical conditions. Canadians spend $5 billion on medical devices annually.
Our audit examined how the department manages the risks and benefits related
to medical devices, whether it identifies weaknesses in the Program and takes
action to address them, and measures and reports the results achieved by the Medical
Devices Program.
In conducting our audit, we reviewed the 1992 report issued by the Medical
Devices Review Committee and the Development Plan for an Improved Medical Devices
Regulatory Program prepared by Health Canada in response to that report. We also
reviewed documents from consultations with stakeholders that took place before
the introduction of the Medical Devices Regulations. We examined Health Canada's
activities to carry out its responsibilities. We made comparisons with the medical
devices programs in the United States and the United Kingdom and Health Canada's
Drug Program. Finally, we considered the impact of the Medical Devices Program's
human and financial resources on Health Canada's ability to adequately carry out
its responsibilities.
While Health Canada has made progress in important aspects of managing risks
related to medical devices before they are authorized for sale, we concluded that
it needs to better monitor the continued safety of medical devices once they are
in use. We found that as a result of gaps in its Medical Devices Program, the
Department does not have a comprehensive program to protect the health and safety
of Canadians from risks related to medical devices, even though it committed to
such a program over a decade ago. Its failure to deliver such a program compromises
Health Canada's ability to protect health and safety, which could translate into
a growing riskrisk of injury and liability.
More specifically, our audit found that Health Canada requires a more proactive
inspection program once products are on the market to verify compliance with the
Medical Devices Regulations. It needs a better approach to managing risks related
to the sale of unlicensed medical devices.
Health Canada also needs to improve its post-market surveillance system to
provide timely, accurate, and complete information about adverse events after
devices are in use and once safety concerns are identified, they must be better
communicated to those who need this information.
Further, the Department needs to address the risks posed by the reuse of single-use
medical devices.
Health Canada also needs to ensure that Canadians have timely access to all
available medical devices. While it is important that Health Canada take the necessary
time to properly evaluate a device for safety and therapeutic effectiveness, delays
in authorizing licences deny Canadians timely access. As such, Health Canada needs
to ensure that devices are authorized within the performance targets. The Department
also needs to consider activities that would allow it to benefit from international
regulatory co-operation.
Although Health Canada has been aware of the gaps and weaknesses in its Medical
Devices Program for some time, it has made limited effort to address them. Limited
financial and human resources and limited progress in advancing international
regulatory co-operation prevent the Department from addressing these gaps and
weaknesses. This, in turn, prevents it from delivering the Medical Devices Program
as it is designed.
While elements of the Program are acceptable, significant shortfalls indicate
that the current Medical Devices Program is not sustainable over the long term.
It is expected that medical devices will become increasingly complex and that
the medical devices industry will grow in size and importance. Gaps and weaknesses
that exist raise concerns about how Health Canada will manage the Program in the
future.
As a result, we recommended that Health Canada make a choice: either provide
adequate human and financial resources to deliver the Program as designed, or
redesign the Program and the Medical Devices Regulations to manage risks in a
way that calls for fewer resources.
Madam Chair, I am pleased to report that the Department has accepted all of
our recommendations. The Committee may wish to ask the Department about the specific
actions it intends to take to address our recommendations as well as timelines
for implementation. I encourage your committee to review Health Canada's progress
by requesting regular updates from the Department and following up on any remaining
gaps and weaknesses.
This concludes my opening statement. We would be pleased to answer any questions.
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