Contaminated product from field

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Hi there, From the ISO 13485: 2003 std. standpoint, there... - Feb 09, 2010 by Frank Albiter

Basically it states that you cannot have Field Returns in th... - Feb 09, 2010 by JAX

At a previous employer, we made a wearable medical device. W... - Feb 10, 2010 by davef

Frank Albiter

#61087

Contaminated product from field | 9 February, 2010

Hi there,

From the ISO 13485: 2003 std. standpoint, there is a special requirement which states: "The following requirements shall apply. d) If appropriate, special arrangements shall be established and documented for the control of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel (see 7.5.3.1).

So, the questions are: how to control potentially contaminated product returned from the field, and how to protect the personnel working with such products?

Could outsource be considered as a way to satisfy this one?

Thanks for your responses

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JAX

#61088

Contaminated product from field | 9 February, 2010

Basically it states that you cannot have Field Returns in the same area as Work In Process. You must have a way to clearly identify and seperate the two different types of product... In your ERP/MRP/ShopFloor/etc... as well as physically. The preferred method to handle this requirement is to create a "Customer Service Center" that handles all RMA's, Field Upgrades, etc...

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davef

#61095

Contaminated product from field | 10 February, 2010

At a previous employer, we made a wearable medical device. When a customer finished using the device, she/he returned it to the company. Then, the company refurbished the device and rented it to other customers.

Before it could be refurbished, it need to be cleaned / decontaminated of body fluids and other hazardous whatnot. So, the packaged device was not opened at receiving, but delivered to a control room / work cell where it was unhazmatted. After that, a standard work order was issued that allowed moving that product into the routine work flow.

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