Life Support: Current Use

by Food and Drug Administration (FDA)

(Page 2 of 2)

Today, as many as 1.5 million Americans a year use ventilators, according to the June 1998 issue of Respiratory Care, a journal of the American Association for Respiratory Care.

Ventilators help premature babies breathe until their lungs are more fully developed and help patients recovering from the effects of anesthesia and sedatives given before and during surgery. Patients with heart disease whose failing hearts cause fluid buildup in the lungs, accident victims, and other people with emergency health needs also may need ventilators. These patients usually need a ventilator for about seven to 10 days.

Some patients, such as actor Christopher Reeve, depend on ventilators long term to perform all their breathing. If otherwise healthy and not bedridden, these people use portable ventilators, which allow them to be free of the confines of a health-care facility or their homes.

Because long-term portable ventilator users are interested in ventilators that fit in more easily with their lifestyles, manufacturers say they are continually striving to improve portable units by making them lighter, smaller, and able to operate longer on a single battery than current models.

Newer models also may offer built-in telemedicine capabilities. These ventilators gather information on patients' respiratory function and transport it, over computer and other telecommunications lines, to health-care providers at distant sites. Care-givers are then able to assess and provide care to these patients without actually seeing them in person. This also aids in reducing medical costs.

Though ventilators clearly benefit so many people, mechanical ventilation is not without problems. The risk of infection, particularly in a health-care setting, is high for ventilator-assisted patients. Also, ventilators can injure patients' lungs when used incorrectly. And the machines themselves can fail. According to adverse event reports made to FDA between 1996 and 1998, failures in the audio and visual alarm systems were the most frequently reported ventilator problems. However, according to a study in the November 1998 journal Chest, ventilator failure in the home is uncommon, and, when it does occur, nearly all problems can be resolved at home by replacing, repairing or readjusting the unit or re-educating the care-giver. Among 189 reports of home ventilator failure cited by the study, only one required a hospital stay.

Less serious is a problem with skin irritation from the masks of the noninvasive ventilators. This problem can interfere with patients' willingness to use the ventilators, thus preventing patients from getting the level of care they need, says Leon Narem, director of marketing for Puritan Bennett's portable ventilators.

FDA Regulation

Since at least 1993, in response to the 1990 Safe Medical Devices Act, FDA has required manufacturers of life-supporting devices, such as continuous ventilators, to keep track of these devices. Then, if serious problems develop, the devices can be located easily. Specifically, ventilator manufacturers must track their products through the distribution chain and provide FDA with information on their locations within 10 working days. The manufacturer must maintain the tracking information for the useful life of the device, periodically auditing the data and tracking method to ensure accuracy.

Also, health-care facilities and manufacturers are required to report to FDA any deaths and serious injuries believed to have been caused by a ventilator or any medical device.

In 1996, FDA strengthened manufacturing standards for ventilators and other higher-risk medical devices. Manufacturers now are required to incorporate a set of checks and balances into their design phases, similar to those used in the automotive, aerospace and defense industries.

Under these standards, manufacturers must establish preproduction performance requirements for new ventilators — for example, by ensuring that device components are compatible with each other and by performing risk analyses.

Because ventilators, like other medical devices, can be affected by electromagnetic interference, FDA requires respiratory devices such as ventilators to meet rigorous guidelines for electromagnetic compatibility before they can be approved. This allows the devices to operate accurately despite the presence of electromagnetic waves from other sources.

FDA also has taken steps to ensure that medical devices that incorporate or employ computer systems or microprocessor controls do not malfunction as a result of the date change to the year 2000. FDA has reminded all medical device manufacturers to assess the function of their products on the market, identify those at risk, and inform their customers of potential problems related to the date change. The concern is that the devices will misread data by misinterpreting the last two digits in 2000 as 1900. (For more information about FDA and the "Y2K" problem, visit FDA's Website at www.fda.gov and select the "Year 2000" button.)

FDA's intent with this and other regulatory measures is to make ventilators and other medical devices not only safer to use but more effective, as well.

For Reeve, advances in technology and strengthened regulations have made it possible for him to live as nearly normal a life as possible. He has been able to stay on a TV movie set for as long as 14 hours a day, travel around the country to address university graduates at commencement ceremonies, and speak at various charitable functions for spinal cord research.

As he explained during a CNN Interactive interview in May: "Either you vegetate and look out the window, or you get busy and try to effect change. And the second, of course, appeals to me a lot more."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.