More and more Canadians are using self-test medical kits to monitor their health. Considered medical devices, these kits can provide benefits, but they can also be risky.
Context
Technological advances, Canadians can make their own tests to include:
* Diagnose a physical condition: the home pregnancy test is a good example;
* Monitor disease: this type of test used to monitor various health and whether treatment should be rectified, for example, the blood glucose test allows people with diabetes monitor their blood sugar;
* Identify a disease or health problem: these kits can detect various health problems or illnesses in people who appear healthy. For example, one can use this type of test to measure cholesterol or triglyceride. The results can then make choices that reduce the risk of heart disease.
Couple looking at the results of a pregnancy test
Some benefits of medical self-diagnosis kits are obvious. They can help you to play an active role in monitoring or improving your health. They are in the privacy of your home. Often they can get quick results, even in minutes.
However, health and disease are complex issues. It is important to remember that medical self-diagnosis kit is no substitute for a health care professional. The self-test medical kits are useful when used as part of an integrated treatment under the supervision of a healthcare professional.
Safety and effectiveness of medical self-diagnostic kits
The kits are self-diagnostic medical devices and, as such, must be approved by Health Canada before being offered in Canada. The approval from Health Canada ensures that the product is safe and effective when used as directed. It is important to ensure that Health Canada has approved the product. See More ... for information on how to proceed.
Risks associated with self-test medical kits
Some companies market and sell self-test medical kits on the Internet or by mail. In some cases, it is possible that the product offered is not registered in Canada. If you send money to a company that is not trustworthy, you may receive a faulty product or receive nothing. A defective test may indicate a health problem does not exist or, worse, it could fail to detect an existing problem.
Pharmacists taking drugs
Legitimate companies use legal channels to distribute their products. It is likely that a kit unapproved (whether purchased from a foreign or domestic) is not in conformity with Canadian safety and effectiveness.
While the kit is approved by Health Canada, the results may not be 100% accurate. The results can be misleading if the user did not follow the storage instructions and use. Sometimes, for reasons of economy, people cut in two test strips in order to double the time or they combine some parts from different kits. If you alter the contents of a package, it is possible that the results are erroneous.
Also, if you do not see a qualified health care professional, you may misinterpret the results and change your treatment or lifestyle without good reason. Interpretation of results should always be part of a complete medical check.
Reducing risks
The following steps will help you reduce the risks associated with self-diagnostic kits:
Remember that medical self-diagnosis kit can replace a qualified health. It is best to use these tests as part of an integrated approach to health, under the supervision of a qualified health care.
With the purchase of a kit:
* Buy the kit from a reliable source. If you are unsure, ask a health professional.
* Make sure the product is approved by Health Canada (see Further information below). Remember, if you use a kit unapproved, it is possible that the test is not reliable because it is not subject to Canadian standards.
* Check for an expiration date on the package.
Be sure to read and follow the storage instructions, otherwise the result may be wrong.
Before using the test:
* Read the label and instructions carefully. ¬ Make sure you understand what you need to do and follow the instructions exactly.
* Make sure you know the limitations of the test, the meaning of warnings and error messages. Make sure you know what if it fails.
After the test:
Label of a bottle of pills
* Remember that the results are not 100% accurate. They should always be assessed in the context of your overall health, along with a qualified health professional.
* Do not take any decision and do not make radical changes to your treatment before you talk with your healthcare professional.
* Consult your doctor if you feel ill or worried, or if the test instructions recommend.
* Report any problem with a self-test medical kits to medical devices Inspectorate of Health Canada, 1 800 267-9675 (toll free in Canada). Health Canada monitors reported problems, your call will help ensure that medical devices sold in Canada are safe and effective.
Health Canada's Role
Medical devices, including medical self-diagnostic tests, must be approved by Health Canada before being imported and sold in Canada. The Medical Devices Regulations require that all medical devices imported and sold in Canada are safe, effective and manufactured to quality standards. This requires an appraisal of medical devices (before approval) and a post-marketing surveillance of adverse events (after approval).
For more information ...
You can report a problem with medical device at the site of the Branch Inspectorate Health Products and Food
For more information, visit the following web pages:
* Medical
* To find out if a medical test Class II, III or IV is approved by Health Canada, search the database of the Ministry medical intruments. If the instrument you are looking for is not on the list, check if a similar instrument was approved by typing the generic name (eg blood pressure) in the name field of the instrument. If there are similar instruments approved, the approval requirement also applies to the one you are looking for. You can also send questions by email at homologation_instruments@hc-sc.gc.ca or by fax at 613 957-6345
* Notice, warnings and recalls for medical devices
* Your Health - Purchase of medical equipment on the Internet
* Problem Reporting for Medical Devices by health facilities, the medical professionals and other users
* Your Health, drug list
Medical self-diagnostic kits
