2006N-0292
  

  
Unique Device Identification
  


  

  

  


  

  
FDA Comment Number : 
  

  
EC19
  



  

  
Submitter : 
  

  
Ms. Marian Robinson
  

  
Date & Time: 
  

  
09/19/2006 10:09:32
  



  

  
Organization : 
  

  
Baxa Corporation
  



  

  
Category : 
  

  
Device Industry
  



  

  
Issue Areas/Comments 
  


  

  


  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 Safety in the provision of healthcare must be a collaborative effort between manufacturers, regulators and providers.  My concern with sweeping legislative change is that it is often done reactively and that haste can cause onerous requirements to be placed on industry that no one is willing to pay for.  My recommendation is that this issue be carefully reviewed to ensure that whatever requirements are placed on manufacturers actually provide utility on the provider side, that is that hospitals and alternate care sites actually have a way of using whatever UDIs are required and that this is not just another empty requirement.  One of the key issues in this is that there is no defined standard for what type of UDIs should be used in the care setting and how they might be implemented in a way that actually results in quality care.  At the end of the day, setting forth a requirement makes no change in the provision of care and patient safety unless it is accompanied by procedural and provider changes that support it.  The recent legislation to require bar code labeling at the pharmaceutical manufacturers does little to ensure that the right drug gets to the right patient, since any drug that is not provided ready to use must be handled, placed in an administration container or device and re-labeled.  That's where the safety ends.  The proposed UDI legislation has the earmarks of the same hollow promise.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  



  

  
 Implementing Unique Device Identifiers

  


  

  


  

  



  

  
How should the UDI and its associated minimum data set be 
  


  

  



  

  
 At this point, there are standards set for identifying devices (Baxa Corporation uses UPNs, for example).  However, these standards typically are used only at the wholesaler/inventory level.  Without standardization at the point of care it doesn't make a lot of sense to mandate UDIs.  The real goal is to improve patient safety and reduce errors.  There has to be a comprehensive and integrated solution for this to make any sense.

  


  

  


  

  


  

  



  

  
Should a UDI be based on the use of a specific technology 
  


  

  



  

  
 It is more important that the technology be implementable at the bedside than that it be required from the onset.  The focus should be on standardization -- can this data actually be used in practical application -- and not on requiring a specific implementation.  The issue of flexibility is important given the wide range of device types available today.

  


  

  


  

  


  

  


  

  
Should the UDI be both human readable and encoded in an 
  


  

  



  

  
 I like the option of including human readable and automation in identifiers as this provides a good cross-check in the event that technology fails to work properly.  At some point, however, automatic technology may be so fail-safe that this is no longer necessary.  For devices that are implanted or used long-term separate from their packaging (IV lines, PICC lines, etc.) I think there is real value in having a UDI on the device itself.



That said, any technology choice must be affordable.  You would not want this requirement to be so expensive or difficult that it stifled future product development in this area.

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
What is the minimum data set that should be associated with a 
  


  

  



  

  
 I don't believe it is possible to implement a minimum data set at the device level if there is no standard data set at the provider level -- that is, no standard of care at the patient bedside that determines what data must be part of the UDI.