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Re: [IP] Re: pump-for-sale issues

On 27 Jul 00, at 14:56, Keith Johnson wrote:

> Recently Sherry warned, regarding someone offering to sell a MiniMed 508:
> > It is illegal to sell prescription only products to anyone.
> > Since pumps are a prescription only medical device, you could be
> > criminally charged.  Just wanted to give a heads up on this.
> True, true. 

Not exactly correct - used equipment is generally excluded from 
the prescription requirement.  The law covers new equipment and 
manufacturers - but even then there isn't much enforcement on 
medical equipment because most of the effort is spent on tracking 
down doctors and pharmacies who are selling drugs under the counter.

The used pump market is extrememly small too, so it's not even on
the regulatory radar...  Years ago I worked in a medical supply business, 
selling the old MediJector devices.  They required a prescription too, 
but all that happened to them was that they were filed with the sales 
records because neither the manufacturer nor government really cared
about durable medical equipment.  I was told that it was the kind of
equipment that the regulators figured if you wanted it you really needed

The pump manufacturers are attempting to limit their liability and comply
with the law when they require a prescription to refurbish or transfer
the warranty for the pump.

> Which brings up an interesting point. The CDEs at the diabetes
> center I frequent tell me they've been getting folks walking in off the
> street with pumps in hand, wanting the CDE team to help them set everything
> up.

Which pump and how many?  There are doctors who know a little about the
pump who will write a prescription and then the patient is on their own to 
get set up and going.  

> Anyway, the team is considering doing a study of pumpers they've helped get
> started, to find out how successful they were, and how that correlated with
> their attitudes toward diabetes and pump management. They hope to set up
> more effective criteria for deciding who should go on the pump. I know, it
> should be available for anyone, but you and I _know_ there are some folks
> who just shouldn't even start. My center generally insists they take their
> advanced diabetes management class (an excellent one-week workshop), or the
> equivalent, before they start a pump.

Unfortunately, these one-week workshops are beyond the means of many 
people and insurance companies tend to frown on them too.  They'd much 
rather you spend thirty minutes with a CDE who primarily works with Type 
II diabetics and knows nothing about pumps because it's much cheaper...  
When I started on the intensive MDI protocol my doctor sent me to 
Louisville to spend a week in Humana University Hospital for their advanced 
diabetes managment training (this was about fifteen years ago).  If I had 
taken the money my insurance company spent on that one week and invested 
it in Microsoft stock I'd be quite wealthy now...  and the cost of those types
of training programs hasn't declined since then.  

Rev. Randall Winchester
WD4HVA (email @ redacted)
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