RE: [Histonet] FDA approved recyclers

From:"Lee & Peggy Wenk"

Going to put in my 2 cents, which may not be too accurate.

The FDA (Food and Drug Administration) covers topics that relate to Food and
Drugs and medical devices that go INTO a HUMAN BEING, and anything else that
touches these foods and drugs and medical devices that could effect a
person's health.

So as far as "recycling" would go, the FDA would be concerned about food or
drugs that were being gathered after NOT being used and "recycled" for reuse
(think of drugs after expiration date, or that had already been given to a
patient and returned back to pharmacy). The FDA is also concerned about the
plastic that goes around the food and drugs, as I remember they were
concerned about new "recycled" plastic that the food and drugs are packaged
in, and whether recycled plastic emit anything that would compromise the
food or drugs and make it a health hazard.

I know the FDA was concerned about medical devices (artificial hips, pace
makers, etc.) being removed from people, cleaned up, and "recycled" for use
in another person.

As for a xylene/alcohol/formalin recylcer - I personally think this is out
of the jurisdication of the FDA. The equipment itself does not go inside a
person, nor is the intended use of these chemicals that are being recycled
intended to human consumption. Neither the recycler nor the chemicals are
intended for human USE.

On the other hand, 
- OSHA has lots laws about chemical exposure to people that would apply
- EPA would be concerned if the recycled chemicals got into the atmosphere
or the water, and care about the proper disposal of waste
- CAP has checklist questions for safety and use of equipment, electricity,
chemicals, disposal, etc. that would apply.
- I've never read the GLP, put I'm certain they have similar rules about
chemicals and equipment.
- Local fire marshals and the hospital's insurance company may have their
own concern, especially as to where the recycler is positioned - but this is
for scenarios of catching on fire and explosions.

If someone knows of the FDA's concern in recycling chemicals in the
laboratory, please inform HistoNet. Thanks.

Peggy A. Wenk, HTL(ASCP)SLS
William Beaumont Hospital
Royal Oak, MI 48073

-----Original Message-----
[] On Behalf Of Rene J Buesa
Sent: Thursday, February 22, 2007 12:50 PM
To: Mrosla, Tina M;
Subject: Re: [Histonet] FDA approved recyclers

  I also used a B/R recycler for more than 10 years, we were inspected
frequently in our hospital and we were never told of a FDA requirement.
  If that information cost you any money, ask for your money back!
  René J.

"Mrosla, Tina M"  wrote:
We were just informed that some hospitals don't recycle xylene, alcohol, or
formalin because solvent recyclers are not approved by the FDA for use in
hospitals. Is this true? 
We have a B/R Procycler 9700 that we have been using for 5 years. Does
anyone know anything about this recycler and FDA approval?

Tina Mrosla, HTL (ASCP)
St. Joseph's Hospital
Healtheast Care System
fax 232-4543

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