OF HOME USE MEDICAL DEVICES
Each year, Canadians spend millions of dollars on home use medical devices that they believe will restore them to good health and well being.
Unfortunately, some devices sold for home use are frequently promoted as miracle cures, with claims that are not scientifically verifiable. While the majority of these devices do not pose a direct hazard to the user, they can pose an indirect hazard if they cause a patient to delay seeking proper medical treatment. There can also be a direct economic loss to the user which can sometimes amount to several thousands of dollars.
Regulations Governing the Sale of Medical Devices
All medical devices sold in Canada must comply with the provisions of the Medical Devices Regulations, Food and Drugs Act.
These Regulations are administered by the Health Protection Branch of Health Canada and establish standards and conditions of sale with which the manufacturer must comply. Manufacturers must formally notify the Branch of each device they sell within 10 days of first sale, and must supply information concerning device identification and labelling. The manufacturer must also have evidence on file to substantiate the claimed benefits of the device, and is responsible for maintaining records of user complaints.
The Health Protection Branch promotes voluntary compliance by the medical device industry with the Food and Drugs Act and Medical Device Regulations, and maintains monitoring programs to ensure the safety and effectiveness of new and existing devices. However, in cases of non compliance, the Health Protection Branch has the responsibility to initiate investigations, and to undertake appropriate action, should a device be potentially harmful to human health.
In addition to administering and enforcing the Medical Device Regulations, the Branch provides information on medical devices to the general public, health professionals, and the medical devices industry through publications such as Health Protection Branch Issues, Surveillance, Information Letters, and Medical Devices Alerts.
The Health Protection Branch notification database contains information on almost 490,000 medical devices. Another 25,000 new devices appear on the Canadian market each year.
Given the enormous number and vast array of devices on the market, priority for regulatory action must be given to situations involving health risks. When there is no direct health risk, misrepresentation of the benefits of some home use medical devices is eventually addressed, but it may remain a problem for some time.
Public education, then, becomes the most effective way to increase awareness of the problem, and to assist the consumer to make informed choices about homeuse medical devices.
Examples of Misrepresented Devices
There are a number of questionable medical device/cures currently on the market. The following are examples of devices claimed to be beneficial to health, even though there is no scientific or medical evidence to support such claims.
The medical application of lasers has become increasingly popular in recent years. Medical lasers are used for surgical cutting and coagulation, and achieve their results by heating tissues to high temperatures, burning or vaporizing it.
However, some manufacturers promote lasers for cosmetic effects, such as removing wrinkles or "rejuvenating" the skin. These lasers emit light of a very low intensity, and are unlikely to have any effect on the skin, although they could possibly harm the eye, if used without eye protectors.
Some home use devices claim to generate beneficial ozone (sometimes also called "activated oxygen") to rejuvenate the skin or restore vitality. There are no legitimate medical benefits from exposure to ozone. It is illegal to sell or advertise a medical device which deliberately exposes humans to any amount of ozone.
These devices, also called air ecologizers, were popular about ten years ago but have recently faded from public attention.
They claimed benefits from the generation of negatively charged air ions. Some were marginally useful in removing smoke and dust from the air because they created electrostatic fields. The benefits of air ions have never been scientifically or medically confirmed. These devices are harmless as long as they don't generate ozone.
Pulsed Electromagnetic Field Devices
Most notable among the questionable devices are pulsed electromagnetic field devices. There has been a dramatic increase in their number and variety over the past 20 years.
Reputable scientific literature has substantiated the effectiveness of electromagnetic waves in promoting bone regrowth of non healing bone fractures, and there is good evidence for its application in wound healing and osteoporosis. Most importantly, these observations have been validated by scientific studies and extensive clinical investigations by qualified health care professionals, and have been reported in the appropriate medical literature.
Unfortunately, some devices claiming to use similar technology are also being promoted as effective treatment for almost every other type of ailment, including hypertension, diabetes, arthritis, problems of the liver and kidneys, chronic pain, AIDS, and even various forms of cancer. In fact, because there is no verifiable scientific or medical evidence, these claims are considered to be a misrepresentation of the benefits of the device, and are prohibited under the Food and Drugs Act.
What You, the Consumer, Can Do
Before purchasing any medical device for home use:
1) Consult your family physician or other health care professional. This will ensure that medical problems are treated promptly and properly, and not allowed to deteriorate to an untreatable state. By obtaining professional medical advice you may also save a considerable amount of money and avoid the potential disappointment of being misled.
2) Read the product label carefully, be well aware of the claims and the expected results.
3) Beware of home use devices that claim to treat a wide variety and range of ailments with cures that are quick, painless, simple and miraculous.
4) Beware of personal testimonials. In the majority of cases, testimonials have not been substantiated by scientific or medical evidence, and should not be accepted as valid evidence of a product's effectiveness.
Before purchasing a home use medical device, consult your doctor. Be wary of the aggressive, miracle cure type advertising, and most importantly, remember, if it sounds too good to be true, it most likely is!
February 21, 1994
(revised from July 5, 1991)
© Minister of Supply and Services, 1994