Medical
devices such as blood test kits, diagnostic imaging equipment, and
heart valves are used to diagnose, treat, mitigate, and prevent
diseases and medical conditions. Medical devices play an important role
in all stages of the delivery of quality health care. The manufacture
and sale of medical devices are subject to the Food and Drugs Act and
the Medical Devices Regulations. According to the Food and Drugs Act, a
medical device is defined as “any article, instrument,
apparatus or contrivance, including any component, part of accessory
thereof, manufactured, sold or represented for use in human beings and
animals for:
- the diagnosis, treatment,
mitigation or prevention of a disease, disorder or abnormal physical
state, or its symptoms,
- restoring, correction or
modifying a body function or the body structure,
- diagnosis of pregnancy, or
- care during pregnancy and
at, and after birth of the offspring, including care of the offspring,
and includes a contraceptive device but does not include a drug.
Medical devices are largely based on technology. As advances are made
in technology, the number of devices and their complexity will
increase.
The public has limited control
over the risks and benefits to which they are exposed. Ultimately, they
must trust others, such as health care professionals and manufacturers
of therapeutic products, to provide safe and effective services and
products.
Health care professionals play a
significant role in helping to ensure the continued safety of medical
devices for the public and they are often the first to become aware of
an adverse event related to a device. This makes them the most
important source of information on adverse events. When this
information comes to their attention, they have a professional
responsibility to pass it on to the manufacturer and/or the federal
government. Their failure to warn can result in liability on their part
in addition to the traditional reasons relating to negligent
prescription, administration and use of medical devices.
The legal responsibilities of
the medical devices industry are outlined in the Medical Devices
Regulations. These Regulations place significant responsibility on the
industry to do all it can to protect the health and safety of the
public. Information on manufacturer liabilities is set out in our
product liability section. The circumstances relating to products
liability are of relevance and application to medical device liability.
In recent years, courts have
held that in some circumstances public authorities could be found to
owe a duty of care to certain persons. In cases where a public
authority did not exercise diligence, the public authority may be found
negligent and liable to those injured by that negligence.
Medical device claims are
advanced when an adverse event incident occurs that has led to patient
or user injury. It can be caused by failure of the device or improper
use due either to human error or to inadequate labeling or directions.
If you have been seriously
injured or suffer disability as a result of a defective medical device
such as:
- cardiac pacemakers
- catheters
- contact lenses
- dental care products
- implanted electrical leads
- laser surgical tools
- orthopedic implants
- orthopedic surgical tools
- heart valves
- Sulzer hip and/or knee
implant devices
- joint hip and knee implants
from various other manufacturers
- Guidant Ancure Enograft
devices
- temporomandibular implant
- TMJ implant
- glucose monitor
- laser eye surgery
- collagen
- insulin pump
- stent
then contact us if you wish to explore your legal rights and determine
whether you are entitled to advance a claim. |
