20080130

Devices That Keep the Heart Beating

Heart devices such as pacemakers and defibrillators have extended and improved the lives of millions of people worldwide.

FDA approvals and oversight that make scientific and technological breakthroughs accessible have greatly expanded the number of people who can benefit from these devices.

FDA's Center for Devices and Radiological Health (CDRH) is responsible for ensuring the safety and effectiveness of all medical devices, including heart devices, sold in the United States.

Recent Actions and Approvals

Recent FDA actions and approvals related to heart devices include

* Comprehensive review of drug coated stents to address concerns about their safety. FDA has concluded that these stents are safe and effective when used within their labeled indication.
* Approval of the first totally implanted permanent artificial heart for humanitarian uses. The device is for patients with advanced heart failure involving both of the organ's pumping chambers, who are not eligible for a heart transplant, and who are unlikely to live more than a month without intervention.
* Approval of pacemakers that reduce severe heart failure symptoms by resynchronizing the pumping action of both heart chambers.
* Approval of new monitoring devices that allow implantable cardioverter defibrillators (ICDs) to transmit basic information about the patient and the device to physicians between office visits.

Types of Heart Devices

Through its "Heart Health Online" Web page at www.fda.gov/hearthealth/index.html, FDA offers consumers extensive information about a variety of heart devices.

These devices include

* Automated External Defibrillators (AEDs): Portable and automatic, these devices help restore normal heart rhythm to patients in cardiac arrest. They analyze heart rhythm and can help rescuers determine whether a shock is needed to restore a normal heartbeat.
* Cardiac Ablation Catheters: Long, thin flexible tubes that are threaded into or onto the heart, cardiac ablation catheters treat abnormally rapid heartbeats that cannot be controlled with lifestyle changes or medications. They work by modifying small areas of heart tissue that are causing abnormal heart rhythms.
* Cardiac Angioplasty Devices: These are long, thin, flexible tubes that are threaded into a heart blood vessel to open narrowed or blocked areas. They improve blood flow to the heart, reduce chest pain, and treat heart attacks.
* Cardiac Pacemakers: Small and battery-powered, pacemakers are implanted permanently into the body. Used when the heart beats too slowly or has other abnormal rhythms, they monitor the organ's electrical impulses and, when needed, deliver electrical stimuli to make it contract in a more normal tempo.
* Implantable Cardioverter Defibrillators (ICDs): These monitor heart rhythms and deliver shocks if dangerous rhythms are detected. Many record the heart's electrical patterns whenever an abnormal heartbeat occurs, allowing doctors to review the patterns. New monitoring devices allow ICDs to transmit basic information to physicians.
* Prosthetic (Artificial) Heart Valves: Used for replacing diseased or dysfunctional heart valves, these are available in two forms. Mechanical valves are made of man-made materials and can usually last a lifetime. Biological valves are made from tissue taken from animals or human cadavers.
* Stents: Small, lattice-shaped, metal tubes that are inserted permanently into an artery, stents help improve blood flow. Some contain drugs that reduce the chance that arteries will become blocked again.
* Ventricular Assist Devices (VADs): Mechanical pumps that help weak hearts pump blood adequately, VADs were originally intended for short-term use until donor hearts became available. Some are now used for long-term therapy in patients with severe heart failure who are not candidates for heart transplants.

Reporting Problems

If you're having problems with your heart device, or any other medical device, contact MedWatch, FDA's program for reporting serious reactions, product quality problems and product use errors regarding medical products. MedWatch can be found at www.fda.gov/medwatch/report/consumer/consumer.htm

Consumers can also call FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) for information about medical products.

The information provided should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed physician should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies.

Copyright Information: Public domain information with acknowledgement given to the U.S. National Library of Medicine.

Vital Facts About HIV Home Test Kits

Privacy and confidentiality are main factors that lead people to choose home testing kits to find out if they are infected with human immunodeficiency virus (HIV), which causes AIDS.

It is important that consumers know there is only one product currently approved by FDA and legally sold in the United States as a "home" testing system for HIV.

This product is a kit marketed as either "The Home Access HIV-1 Test System" or "The Home Access Express HIV-1 Test System." The kit is a home collection-test system that requires users to collect a blood specimen, and then mail it to a laboratory for professional testing. No test kits allow consumers to interpret the results at home.

Beware of False Claims

Numerous HIV home test systems that have not been approved by FDA are currently being marketed online and in newspapers and magazines.

Manufacturers of unapproved systems have falsely claimed that their products can detect antibodies to HIV in blood or saliva samples, and that they can provide results in the home in 15 minutes or less. Some have even claimed that their systems are approved by FDA or are manufactured in a facility that is registered with FDA.

FDA takes appropriate action against people or firms that sell unapproved and ineffective tests.

About the Approved Product

The FDA-approved Home Access System kits allow people to collect a blood sample. Using a personal identification number (PIN), they then mail the sample anonymously to a laboratory for testing. The PIN can then be used to obtain results.

The kits, manufactured by Illinois-based Home Access Health Corp., can be purchased at pharmacies, by mail order, or online. They only allow testing for the presence of antibodies of the virus known as HIV-1. They do not provide the ability to test for HIV-2, a less common cause of AIDS.

The Home Access System offers users pre- and post-test, anonymous and confidential counseling through both printed material and telephone interaction. It also provides the user with an interpretation of the test result.

Checking for Antibodies to HIV

Like most HIV tests, the approved Home Access testing system checks for the presence of antibodies to HIV that are produced once the virus enters the body. The rate at which individuals infected with HIV produce these antibodies differs.

There's a "window period" between the time someone is infected with HIV and the time the body produces enough antibodies to be detected through testing. During this time, an HIV-infected person will still get a negative test result.

According to FDA's Center for Biologics and Research (CBER), which regulates all HIV tests, detectable antibodies usually develop within two to eight weeks. The average is about 22 days.

Still, some people take longer to develop detectable antibodies. Most will develop antibodies within three months following infection. In very rare cases, it can take up to six months to develop detectable antibodies to HIV.

Rapid Tests: A Clinical Option

Consumers do have the option of taking a rapid test, some of which test for both HIV-1 and HIV-2. These tests are run where the sample is collected, and produce results within 20 minutes.

Because HIV testing requires interpretation and confirmation, rapid antibody tests are only approved and available in a professional health care setting, such as doctors' offices, clinics and outreach testing sites.

According to the Centers for Disease Control and Prevention (CDC), there are tests that look for HIV's genetic material directly, but these are not in widespread use. Tests using saliva or urine are also available, although not for "at-home" use.

If you are unsure whether a certain type of HIV test is FDA-approved, look for the test on the agency's list of at www.fda.gov/cber/products/testkits.htm. You can also contact CBER by phone at (800) 835-4709, or e-mail at OCTMA@CBER.FDA.GOV.

For More Information

Deciding If and When to Be Tested (CDC):
www.cdc.gov/hiv/topics/testing/resources/qa/be_tested.htm

The information provided should not be used during any medical emergency or for the diagnosis or treatment of any medical condition. A licensed physician should be consulted for diagnosis and treatment of any and all medical conditions. Call 911 for all medical emergencies.

Copyright Information: Public domain information with acknowledgement given to the U.S. National Library of Medicine.