Friday, 2 March 2012

The Life Critical System: How a Manufacturer Ensures the Reliability of a Breathing Machine

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One of the most common concerns patients have about using a breathing machine is its reliability. Users and family members crave assurance that such a system will perform even during loss of electrical power. This is especially important to those who have hospitalized family members who rely on a breathing machine to keep them alive.

A breathing machine is any device which is used to mechanically move air into and out of the lungs. This device literally takes breaths for patients who are physically incapable of doing it themselves.

Most people think of a "breathing machine" as a complicated, digitized device. Indeed, modern breathing machines are marvelous, computerized machines that can perform complex tasks to exact specifications. They are fully programmable and customizable to any given set of conditions.

However, anything that performs the task of taking breaths also falls under this definition. This includes the "primitive," simple bag valve mask.

The bag valve mask is exactly what it sounds like: a heavy plastic bag attached to a face mask. A valve allows for passage of air in and out of the bag. The bag is operated by squeezing it, literally, by hand.

The bag valve mask is often used in mass emergency situations during a disaster. Bag valve masks can be transported by the hundreds right to the site of a disaster.

No power supply is needed, and no specialized training is required to administer the bag valve mask. This type of breathing "machine" was used on scores of patients during disasters like 9/11 and Hurricane Katrina.

Obviously it would be highly impractical, inefficient and downright dangerous to rely solely on bag valve masks to sustain the lives of hospitalized patients. This is why hospitals rely on complex digital breathing machines.

They have two major uses in hospitals. One is for helping an anesthetized patient to breathe during surgery. The other is to treat patients whose bodies, for various reasons (such as respiratory failure), cannot perform the movements necessary for breathing.

These devices literally keep patients alive, and therefore must be absolutely guaranteed to perform. They must be capable of running under the most adverse of circumstances, including an extended power failure. Therefore, the breathing machine is classified as a "life critical system."

A "life critical system" is defined as any system whose failure would lead to death or serious injury to a patient, serious equipment damage or environmental harm. Life critical systems are not limited to medical or anesthesia supplies. They include a range of systems from circuit breakers and fire sprinklers all the way to nuclear reactors.

Manufacturers of life critical systems must engineer such systems in a manner that renders them virtually fail safe. It means anticipating every possible event that could cause the system to fail and putting aversion methods in place.

It also means putting systems in place that will override potential emergency situations. Some of these situations include temporary or long term loss of power and computer malfunctions.

Another measure that is used to ensure a patient's safety while on a breathing machine is an alarm function. Alarms notify caregivers whenever a potential danger situation is encountered, such as a cut to power. The alarm notifies caregivers that a switch is being made from electrical to battery power.

These are all intrinsic measures. Extrinsic measures are also employed when using a life critical system like a breathing machine. Such measures include a protocol regarding supervision by medical personnel while a patient is on the system. For example, an anesthesiologist must be present and monitoring a patient at all times while on a breathing machine during surgery.

Jessie Flesner is a freelance writer in New Albany, Indiana. She writes widely about the health care industry with a concentration in the surgical field. She is an expert at procuring anesthesia supplies and breathing machine solutions.

View the original article here

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