Barack Obama Speaks Health Care Reform to the AMA. What about Defective Medical Devices?

June 17th, 2009 · No Comments

Defective medical products and devices are killing or disabling thousands of people in American hospitals every year. Thousands more die or are injured because of incompetence in handling products and/or operating the devices. Where is the outrage? Why hasn’t President Obama and congressional leaders mentioned anything about lethal medical products and devices in hospitals? Why hasn’t there been a public outcry for manufacturer recalls and other measures to protect the public? The simple answer to all of these questions is an absence of disclosure. The consumers are unaware of the fact that there is a lot of machinery in hospitals for every aspect of health care from diagnostics to treatment and any malfunction could cause injury and death. For example, during surgery the doctors use 50,000 volts of electric current to cauterize tiny blood vessels to stop the bleeding that occurs from making cuts with a scalpel and scissors. If the patient is not properly grounded, he or she will die by electrocution. If the ground wire is defective, or if the nurse forgets to plug it in, disaster strikes. Therefore, we need President Obama to speak out on all of the specifics of patient safety.

The three main problems with products and devices causing death or disability as reported by the Federal Government (CMS) are as follows:

Contaminated drugs, devices, or biologics
Misuse of devices
injecting air into the veins)

First, contamination of drugs, devices or biologics can occur at any point from manufacturing to end use. The process of preparing things like chemotherapy requires special techniques and the use of specialized equipment. The nurse or technician administering the substance has no way of knowing whether there is a contamination. However, all objects that must be sterile when used are sealed in tamper-proof containers or packages. The hospital personnel have to know that if there is any question about the seal, they cannot use that product and it must be returned to the manufacturer. Yet with all of the safeguards in place we still have unnecessary deaths and catastrophic illnesses occurring due to contamination. Therefore, while Congress is in this health care reform mode, Barak Obama needs to encourage its members to conduct hearings and consult with experts to find ways to prevent adulteration of medical products.

Second, the CMS has reported that use of devices for something other than for which it was designed or the incompetent operation of medical machines and equipment also kills thousands of people every year. Congress needs to include in its health care reform legislation strict mandates to forbid the misuse of any medical device and to require adequate training of any and all personnel who need to operate any medical device.

Third, the injection of air in the veins is a common occurrence even though it can be lethal. The way that intravenous tubes and bags are designed, whenever a nurse has to start an IV and connect it to a fluid bag there is invariably a column of air that has to be flushed out before it is hooked up to the patient. This may seem like a simple task, there are always pockets of air in the line. Most often nurses will let the air pass into the patient thinking that the amount is too small to cause a problem. On the contrary, research has shown that small amounts of air repetitively introduced into the veins by IV infusion has a detrimental cumulative effect because the air bubbles can get trapped in the large vessels near the heart with the gas pocket growing large as more air bubbles reach the area. The accumulated air can lead to severe neurologic injury, cardiovascular collapse, and death. Symptoms of shock can begin with only 50 cc of air being injected into a peripheral vein.

In conclusion, it is vital for President Barack Obama to lead his Congress to addressing the issues of all of the common dangers that every hospital patient in America faces. He can make a big dent in the ominous statistics if he would get Congress to start with the CMS list of “never-events” in a series of public hearings and work through setting safety standards with zero tolerance for non-compliance. For example, a simple act of requiring that hospital administrators keep all medical equipment in good working order or face criminal penalties would go a long way to saving thousands of lives.

Other Internet Media Sources:

Air embolism: the silent killer

Dangers of an Air Embolism

A Safe Amount of Air in an IV Line?

Monday April 6, 2009 Q; What amount of air is usually needed to …

central venous pressure

S600I/600IB Infusion Pump

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