From: Marty Leighton [mjleighton@attbi.com]
Sent: Thursday, August 29, 2002 2:37 PM
To: fdadockets@oc.fda.gov
Subject: Docket # 00D-53 e-comment

To whom it may concern at FDA:



SUBJECT: DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0053]


Determining Hospital Procedures for Opened-But-Unused, Single-Use 
Medical Devices; Request for Comments and Information




Dear Sir or Madam:



I cannot comment on hospital practice relative to opened-unused-single-use-medical-devices. 



However I can provide you with  text excerpted from section 6.4 of ISO 14969,  Draft Guidance to The Application of  ISO 13485:200X,  which has been supplied to ISO TC 210 WG1. 

I sit on ISO TC 210 as a member and US observer expert. 



I think that this guidance being given to the medical devices industry should be similarly applied in hospitals because when (or if) a hospital chooses to repackage and re-sterilize they then assume the responsibilities of the OEM organization and are respectively subject to applicable QSR.



The underlined text (below) is guidance supplied in consideration of ISO 13485:200X clause 6.4 b).  That clause currently reads, "If appropriate, special arrangements shall be established and documented for the control of used product in order to prevent contamination of other product, the manufacturing environment or personnel. "



And now, from the proposed ISO 14969 draft guidance;



If an organization accepts returned product in any condition for any purpose, special arrangements need to be established and documented for the control of used product in order to prevent contamination of other product, the manufacturing environment or personnel. These special arrangements should also include measures to ensure that, if the returned product is returned to stock for resale, its package integrity has been maintained  and or if repackaged, is equivalent to new product.

 

Examples of special arrangements are:

 

o   Special identification as “used product” upon receipt by the organization

 

o   Special handling cleaning and decontamination procedures especially for product which may have been used and is invasive and or used to channel or store blood or other body fluids or tissues. This includes devices or accessories, which may have come into contact with these types of devices or bodily constituents.

 

o   Special re-work, re-pair or refurbishment procedures inclusive of resultant product specifications and verification means

  a.. Special traceability means and records
End guidance:

Sincerely yours,

Martin J. Leighton

      Martin J. Leighton
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     E-mail: mjleighton@attbi.com