Showdown with FDA over pistol for seniors

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Could a pistol qualify as a medical device? That’s what Matthew Carmel, inventor of the Palm Pistol, believes.

He is considering appealing a decision by the Food and Drug Administration, which found that his weapon—designed specifically for seniors and disabled people to use in self-defense—does not have a medical function. That finding eliminates the possibility for those over 65 to receive reimbursement from Medicare for purchasing the gun.

Well, surprise, surprise. Can you imagine the government paying for the use of firearms among the elderly? As if long-term care facilities don’t have enough headaches. (I can just picture administrators patting down new admissions for this contraband …)

I have to agree with the government on this call. Still, it appears the FDA didn’t handle the case in the most professional manner. While the FDA never approved the device, it allowed the manufacturer to register and list the product in the FDA’s electronic database on Dec. 2. Then, when it determined the product was not a medical device, it canceled the registration.

A spokeswoman from the FDA reportedly said that Carmel got some bad advice from an agency representative.

“Who is suffering?” Carmel asked, referring to the registration cancellation. “The seniors and the disabled.”

Carmel, an instructor with the National Rifle Association, said that he created the gun after seeing how difficult it was for older people and those with disabilities to handle traditional firearms. Unlike a typical weapon, the Palm Pistol uses the thumb for firing instead of the index finger. Use of the thumb mitigates “lateral muzzle drift,” which is one of the factors of inaccurate fire, according to Carmel’s Web site

While the gun is not in production yet, it has been classified as a standard “pistol,” according to the Bureau of Alcohol, Tobacco, Firearms and Explosives, Carmel said. It likely will be chambered for the .38 special/ .357 magnum cartridge. Carmel is unaware of any other type of firearm that is geared to seniors, disabled people and those with limited manual dexterity.

Carmel believes that the elderly and disabled, who are more vulnerable to attacks than other populations, are entitled to such a tool to defend themselves. And they should be covered for it, he says. "Medical indications” for use of the weapon include: arthritis; peripheral neuropathy caused by chemotherapy, infection, traumatic injury or diabetes; multiple sclerosis; carpal tunnel syndrome; and side effects of certain medications, the Web site says.

It might be possible to convince me that the gun would be a plausible candidate for Medicare coverage, except for one minor point: It can kill people. And that does not sound like it works to further the health of older Americans to me.

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Daily Editors' Notes

McKnight's Daily Editors' Notes features commentary on the latest in long-term care news and issues. Entries are written by Editorial Director John O'Connor, Editor James M. Berklan, Senior Editor Elizabeth Newman and Staff Writer Marty Stempniak.