Original language of petition: English
Petition to the Government of Canada
- Diabetes and sight loss are closely connected;
- Canada has one of the highest rates of diabetic retinopathy (25.1% of people living with diabetes), which is the fourth leading cause of sight loss in Canada, and the leading cause of sight loss in working-age adults;
- An estimated 750,000 Canadians live with the condition;
- People living with diabetes and sight loss often rely on insulin pumps for their diabetes treatment, like their sighted peers;
- Individuals living with diabetes and sight loss live independent lives but are unable to safely and independently use insulin pumps due to the lack of accessibility features and visual cues on the device;
- Health Canada does not assess accessibility as part of the approval process for medical devices, which jeopardizes device efficacy and patient safety, and creates further barriers for people who are blind or partially sighted; and
- Insulin pump manufacturers have issued public warnings (called contraindications) advising people with sight loss to avoid using insulin pumps, citing safety concerns.
Government response tabled
Response by the Minister of Health
Signed by (Minister or Parliamentary Secretary): Adam van Koeverden
The Food and Drugs Act (the Act)and its Medical Devices Regulations (the Regulations) set out the scope of Health Canada’s authority for the approval process for new medical devices, including insulin pumps. Health Canada’s Health Products and Food Branch (HPFB) is responsible for pre-market review of insulin pumps in compliance with the Act and Regulations.
Health Canada is committed to facilitating access to Insulin pumps to all Canadians, including populations such as individuals who are blind, deafblind, and partially sighted. HPFB is responsible for the approval process of insulin pumps and operates within the scope and mandate of its regulatory authority.
Under sub-section 11(1) of the Regulations “A medical device […] shall not, when used for the medical conditions, purposes or uses for which it is manufactured, sold or represented, adversely affect the health or safety of a patient, user or other person, except to the extent that a possible adverse effect of the device constitutes an acceptable risk when weighed against the benefits to the patient and the risk is compatible with a high level of protection and safety”. In order to assess an application against this requirement, Health Canada’s pre-market reviews of devices include the assessment of device safety in relation to the medical conditions, purposes or uses for which it is manufactured, sold or represented. This includes consideration of the intended target population for a given device. As such, Health Canada’s review evaluates evidence from usability testing to ensure the device can be used safely by the target population. In this usability testing, patients are asked to try to complete important device tasks, and the manufacturer confirms these tasks can be done safely without introducing errors.
Health Canada cannot compel manufacturers to develop or seek to market a device specific to a user group. It is the manufacturer’s responsibility to determine the intended target population for their devices. In the case that the manufacturer makes a claim that the device is accessible to certain patient populations, Health Canada would assess the data available to support that claim, including usability testing. However, if the manufacturer does not make a claim that the device is accessible to certain patient populations, Health Canada does not have the authority to require the manufacturer to produce evidence, revise their intended use or labelling, or redesign their device to make it accessible to special populations.
Section 10 of the Regulations requires that a “medical device shall be designed and manufactured to be safe”, and if certain risks cannot be eliminated, to “provide, with the device, information relative to the risks that remain”. For example, if an inability or reduced ability to visually confirm information provided by an insulin pump presents an unacceptable risk to the patient, it is the manufacturer’s responsibility to take steps to eliminate or mitigate this risk, in compliance with section 10 of the Regulations. If a manufacturer has determined that it is not possible to eliminate the risk if a person with sight loss uses that insulin pump (i.e., the device design is inherently unsafe for use by people with sight loss), one of the manufacturer’s responsibilities is to provide information with the device relative to the risk (i.e., label the limitations of the device). This is the reason why a manufacturer might include a warning in the device labelling advising that users must have adequate vision to allow safe use of the device.
Health Canada’s responsibility in the pre-market review of insulin devices is to ensure that the manufacturer has provided sufficient analysis of the risks associated with their device and has complied with section 10 for any such risks. This includes ensuring that a manufacturer has eliminated risks where possible and that a manufacturer provides adequate information about the risks that cannot be eliminated, including statements of warning or contraindications, in the device labelling. Although Health Canada may request additional warnings or contraindications be added to a device’s label based on the evidence provided or known risks associated with the technology, Health Canada generally does not request a manufacturer remove particular warnings or contraindications that the manufacturer has identified are necessary or relevant for the safe use of their device.
After medical devices are licensed for sale, the Department monitors them for safety, effectiveness, and quality. This includes monitoring devices through recalls, as well as incident reports from consumers, manufacturers, health care providers and other sources. The Department follows up and takes appropriate action, as required. This can range from requesting a label change, controlling distribution, recalling the device, or even suspending a medical device licence. While the Department does not regulate the practice of medicine, if warranted, Health Canada may communicate about the risk of devices on the market.
Health Canada has engaged in outreach with associations representing those with sight loss. In 2020 and 2021, the Department met with the Canadian National Institute for the Blind (CNIB) to discuss issues related to insulin pumps and persons with sight loss. In March 2022, the Department also engaged with key manufacturers of insulin pumps to share the concerns related to accessibility of these devices for people living with diabetes and sight loss.
Health Canada welcomes the submission of medical device applications for devices that are accessible to underserved patient populations and that have eliminated, as far as possible, risks associated with the use of the device. When an application is received, Health Canada will undertake the review in a timely manner in accordance with its service standards. Health Canada offers medical device priority reviews for a device that provides a significant benefit-risk improvement over existing licensed devices or responds to an unmet urgent health need. The first application for an insulin pump designed to be used safely and effectively by persons with sight loss would, therefore, meet Health Canada’s criteria for priority review since it addresses an accessibility need, which may lead to a shorter time to market for these devices.
Finally, through the special access program for medical devices, health care professionals can access custom-made and unlicensed devices for patients under their care when conventional therapies have failed, are unavailable or are unsuitable to treat a patient.
- Open for signature
- November 2, 2022, at 11:25 a.m. (EDT)
- Closed for signature
- March 2, 2023, at 11:25 a.m. (EDT)
- Presented to the House of Commons
March 6, 2023 (Petition No. 441-01164)
- Government response tabled
- April 19, 2023
Member of Parliament
Only validated signatures are counted towards the total number of signatures.
|Province / Territory
|Newfoundland and Labrador
|Prince Edward Island