Is Implantable Device Reform Almost Here?
It’s not always an easy question for a consumer to answer, yet it comes up for more people than you might think. In the case of certain heart defibrillators, for example, consumers with defective devices run the risk that their device will either deliver an unnecessary jolt of electricity—akin to being hit across the chest with a baseball bat—or, worse, simply fail, potentially leading to cardiac arrest and death. Unfortunately, more than a few implantable devices have become defective. An …
Clinical Trials: Will Older Patients Finally Be Adequately Represented?
Would you want your doctor to prescribe a drug even though she did not know how it would affect you? Of course not. But this is exactly what happens all too often with older patients, given that many drugs and other therapies have not been tested on people beyond a certain age. In fact, one study found that 72% of clinical trials excluded patients due to age. With older adults being so underrepresented in clinical trials, clinicians often don’t know …
Hearing Aid Prices are Coming Down: Is Now the Time to Consider Getting One?
When my parents got into their 80s, sometimes I thought they were arguing because they were shouting. Then I realized they were just having trouble hearing each other. Unfortunately, this went on for some time because they did not have hearing aids. They said hearing aids were too expensive. Expense may soon become less of an issue for would-be purchasers. Recently, the Food and Drug Administration (FDA) approved the first hearing aid for sale over-the-counter (OTC). Allowing OTC sales of …
Regulatory Reform Options for Implantable Devices
In 2011, some widely used implantable heart defibrillators, designed to correct potentially fatal irregular heart rhythms, developed cracked insulation on their high-voltage electrical wires. The result was that in some cases they caused severe shocks, and even deaths. Consumers with the defective implants had to decide whether to undergo dangerous surgery to replace the device or simply monitor it. Until the defective device is replaced, consumers run the risk that it will deliver an unnecessary high-voltage jolt of electricity—described as …
More Price Transparency Needed for Implantable Devices
Implantable devices, such as hip replacements and heart valves, are a central part of medical treatment today. Americans receive about 370,000 cardiac pacemakers and about 1 million total hip and knee replacements per year. Despite how common the use of implantable devices is, little information is publicly available on the prices paid for these devices in the United States. Limited information about prices and performance of many implantable devices has raised concerns that providers, consumers and insurers may be paying …
Are You in the Hospital or Not?
If you think you are having a stroke, you’ll probably go to the nearest ER. But will the hospital admit you? After you have been checked into the ER, the doctor may instead put you under “observation,” especially if it is unclear whether you have had a stroke, a fainting spell or something else. What is observation status? It’s an outpatient designation used to monitor patients during periods of medical uncertainty. Rather than being formally admitted as inpatients, patients in …
