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2004 March Report of the Auditor General of Canada
Exhibit 2.1—Medical devices are important to health care: The example of a patient with cardiovascular disease
Cardiovascular diseases are a leading cause of hospitalization in Canada. Statistics Canada has estimated a 36 percent increase each decade until 2026 in the number of hospitalizations for heart attack. Projections for caseload at the University of Ottawa Heart Institute are even more dramatic. Between 2003 and 2005, the Institute is projecting a 100 percent increase in defibrillator implants, and a 60 percent increase in pacemaker implants (both class IV medical devices).
A cardiac patient who needs a medical device like a stent or pacemaker may depend on over 400 devices, during non-invasive cardio exams, open heart surgery, and post-operative care. These devices are often highly complex, computerized machines, upon which the survival of a patient may depend.
For diagnosis, devices like a blood pressure monitor, diagnostic imaging equipment such as magnetic resonance imaging (MRI), or a stethoscope, would be used. If a patient needs a stent installed, some of the devices required would include an X-ray machine, an angiograph, catheters, a stent and balloon, and special monitors for temperature and pulse. If a patient needs a pacemaker, the surgery would involve at least 40 devices for anesthesia and between 100 and 200 devices for the surgery. Some examples include a fluoroscope to view the patient's heart and blood vessels, catheters, an array of special instrumentation, a bypass machine, ventilators, vaporizers, oxygenators, and multiple-infusion pumps. After surgery, a new set of devices are introduced for post-operative care.
Source: University of Ottawa Heart Institute