Medical Devices
Medical Devices – Making a difference in people's livesWhat is a medical device? When many people think of medical devices, they think of expensive machines in hospitals or clinics, like a magnetic resonance imaging (MRI) system. But the actual definition is much broader. The Food, Drug, and Cosmetic Act defines a medical device as an instrument, machine, implant, or diagnostic test that helps diagnose a disease or cure, treat, or prevent disease. Medical devices can range from thermometers to artificial hearts to at-home pregnancy test kits.
Although some of the earliest medical devices (e.g. bandages), have retained their same basic form and function, the complexity and use of medical devices have increased exponentially over the past 50 years. Devices are more sophisticated, more dependable and more convenient. Patient care has improved dramatically as a result of these changes. The following examples illustrate advances that have been made in medical technology in just the last few years.
• Heart defibrillators have progressed from large, bulky external pumps to small external machines to totally implantable devices -- about the same size as a pacemaker of a few years ago.
• Open-heart surgery once required for coronary artery disease has been largely replaced by less invasive techniques such as balloon angioplasty, insertion of cardiovascular stints, laser ablation of plaque and minimally invasive surgery.
• "Artificial" skin for burn victims is now available.
• Many major surgical procedures (e.g., removal of the gall- bladder) have been replaced with laparoscopic procedures that require only small incisions. This "revolution" alone has dramatically reduced hospital stays and recuperation is much faster.
• New devices have been developed to do needle biopsy of breast abnormalities without general anesthesia or major surgery.
• Many diagnosis devices now can be used at home -- e.g., testing for blood clotting, pregnancy, cholesterol, glucose.
• Improvements to anesthesia systems have reduced risks to patients several-fold.
• New imaging systems (PET and MRI) provide a dramatic improvement in image quality, information content and analysis.
• Cemented joint replacement for hips have given way to better functioning, more durable replacements not just for hip problems but for nearly every joint in the body.
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