2006N-0292
  
  Unique Device Identification
  


  
  
  


  
  FDA Comment Number : 
  
  EC21
  




  
  Submitter : 
  
  Ms. susan bushard
  
  Date & Time: 
  
  09/26/2006 01:09:41
  




  
  Organization : 
  
  River Falls Area Hospital
  




  
  Category : 
  
  Health Professional
  




  
  Issue Areas/Comments 
  


  
  


  
   Developing a System of Unique Device Identifiers (UDI)

  		


  
  


  
  




  
  At what level of packaging (that is, unit of use) should UDIs be 
  


  
  




  
   Question 7

o Packaging should be by the box for small items that are stored in operating rooms and may be used in multiple units such as suture or staples. Items that are singly packaged in a box such as gynecare balloon ablation tubing is used singly for a single patient. This would have the UDI on the individual item.



  		


  
  


  
  


  
  


  
  


  
  


  
  




  
  Have you implemented some form of UDI in your product line? 
  


  
  




  
   Question 5

o We are totally manual here in this rural hospital. I look forward to better identification of items that we use.



  		


  
  


  
  


  
  




  
  How should a unique device identification system be developed?
  


  
  




  
   Question 1 

o Equipment used with disposables: the equipment UDI should identify the disposables that can be used with the machine. Therefore if there is a recall, the machine is identified as well as the disposables with the lot numbers. 

o Suture should be specified by the box as unit of use rather than the individual suture pack. Additionally there are some types of sutures that are never used in some parts of the body. For example, a non absorbable suture is never used on the ureters as the suture will cause problems in ureter function. Alternatively non-absorbable suture is always used on the coronary arteries and aorta because these structures are under a pressure load and one doesnt want the suture to absorb before healing is complete. Manufacturers should provide some detail to the end user about these issues. Online access works just fine for this

o There are some products that have disposable parts and reusable parts. As with a machine that has disposables as part of the function, instruments that are reprocessed and have disposables attached for the procedure should be specific.

o Attributes for machine devices that have a long life expectancy should include the following:

  Manufacturer, make, model

? Size, length if applicable, quantity of unit, serial number, lot number if applicable, date of manufacture, disposables that are used with the device if applicable

o Attributes for devices that are non-disposable but are considered instruments that are reprocessed and may or may not have accompanying disposables:

  Manufacturer, make, model

? Size, length if applicable, quantity of unit, serial number, lot number if applicable, date of manufacture, reprocessing data i.e., steam sterilization, ethylene oxide sterilization, steris or sterrad sterilization. Identity of any disposables that are used with the item.



  		


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  












  
  Should unique device identifiers be considered for all devices? 
  


  
  




  
   Question 6

o Unique device labels should be on all items. For example, it is possible for a laparoscopic device to fall apart in a patient. Having a radiofrequency identifier on items used inside a patient will reduce the incidence of foreign object retention. Raytec sponges (often called 4 by 8s) do have a radio opaque strip in each sponge. The sponge shows up on x-ray however if it is left in the patient, unless an x-ray is taken, the sponge is not discovered until the patient has symptoms. If there was a way to wave a wand over the patient at the end of the procedure, we could determine whether there was an object left in the patient. 



  		


  
  


  
  


  
  


  
  


  
  


  
  


  
  


  
  




  
  What are the barriers for establishing unique device 
  


  
  




  
   Question 4

o Barriers to implementation is the time it takes to put together a system that is standard throughout the industry. Manufacturers must meet to generate ideas that help all meet deadlines.



  		


  
  


  
  


  
  


  
  




  
  What are the incentives for establishing a uniform, standardized 
  


  
  




  
   Question 3

o Incentives for hospitals are ease of dealing with inventory and recalls. Incentives for manufacturers is ease of dealing with recalls as hospitals have better information about who the device was used on.



  		


  
  


  
  


  
  


  
  




  
  What should be the role, if any, of FDA in the development and 
  


  
  




  
   Question 2

o Any standardization that manufacturers take on must be mandatory in order to prevent problems with implementation in the hospital setting. It gets difficult to have several different systems in place for inventory and use.



  		


  
  


  
  


  
  


  
  




  
  What solutions have you developed or could be developed for 
  


  
  




  
   Question 8

o I cant answer however would be willing to be part of a larger group to brainstorm the issues.