Introduction of Compulsory Bar Coding of Medical Devices in the US?

M

MIREGMGR

#11
(...) do we need to apply for a barcode with the FDA?
I'm not aware that the FDA currently issues or certifies barcodes or any other specific product identifiers for particular medical-device applications. They do have rules, and format expectations, for pharma and biomedical barcode applications...but even there they are not an issuer of specific identifiers, to the best of my knowledge. See http://www.fda.gov/oc/initiatives/barcode-sadr/fs-barcode.html.

As far as I know, the 2001-2003 barcode initiative petered out and isn't currently considered to be reasonably achievable as a regulatory matter. I believe broad barcode requirements also were downgraded by JCAHO several years ago from a proposed mandate to a recommendation, after the difficulties and costs of effective implementation became more apparent.
 
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T

Thomas Dwyer

#12
Turkey is currently the only country, but USA and Japan soon to follow, 2010(?). I believe the GTIN-13 is acceptable format for devices. Japan is likey to have a twist, but I have no details on the exact requirment for Japan. See the GS-1 or HBIC web sites.
 
T

Thomas Dwyer

#14

Proposed regulatory language for implementation of the
Unique Device Identification (UDI) provisions that were enacted by the
Food & Drug Administration Amendments Act of 2007

1. Medical device manufacturers and remanufacturers shall standardize and adopt a Unique Device Identification (UDI) for systems or major components that comprise the system, and components that are sold as “finished devices,” and any accessories as defined in 21CFR1010. The UDI shall consist of: the enterprise identifier number, designating manufacturer’s name/address, part number/model number, serial number or lot number if appropriate. The UDI format shall be standardized so that it can be used globally. Product attributes such as the following information should NOT be placed on the UDI, but instead should be put on the labeling (Instructions for Use and/or device) of the device, or on its packaging:

§ Date of manufacture (place on product label)
§ Indication if the product is sterile
§ Packaging information
§ Safety information relevant to the specific device, such as: contains latex, PCB, PVC, mercury, or if the device is considered to be a biological, chemical or nuclear hazard, should be placed on the product label


The above attributes are only needed to be disclosed at the point of use of the device.

MITA supports the use of Global Medical Device Nomenclature (GMDN), however MITA would like to emphasize that the ongoing efforts to “clean up” the codes and make the use of the GMDN system free of charge to manufacturers is absolutely necessary for industry to capitalize on the benefits of the GMDN system.

2. The technology which is utilized by medical device manufacturers to meet the UDI requirements of this regulation shall be selected by the medical device firm. The UDI shall be human readable and machine readable where appropriate. When bar coding is selected as the technology solution, then the standard format shall comply with global harmonization requirements.

3. A “refurbished” medical device means a device having the same performance specifications as the original device. For “refurbished” medical devices, the original UDI shall be retained or replaced with an identical UDI on the appropriate system or component.

4. A “remanufactured” medical device means, as defined in 21CFR 820.3 (w), “a device that has significantly changed the safety or performance specifications or intended use of the original device.” A new UDI shall be placed on this device and tracked by the firm which performed the remanufacturing of the medical device in changing its specifications.

5. Software that is sold as a finished device shall be tracked by one UDI based on the name and version of the software. The UDI number shall be embedded into the software or user manual and shall be accessible to the user.



6. All products produced on or after 24 months following the effective date of this regulation shall have an UDI number.

7. An assessment shall be performed by FDA no less than biannually to regularly and periodically monitor and measure the effectiveness of the UDI system.

8. A publicly accessible UDI database shall contain the following information: identification of manufacturer, product name, model number, and expiration date. Not all of these fields shall be applicable to all medical device manufacturers.
 
M

MIREGMGR

#15
I believe that particular statement is part of a communication from MITA (MITAHealth.org) to FDA, representing MITA's goals regarding UDI. As a child-organization of CMMS tasked with decreasing CMMS's reimbursement costs via information-technology initiatives, it's natural that MITA would be an advocate of UDI. There are some clear mission differences between CMMS and FDA, though.

We do know that GHTF, which has participation by some of the FDA's more regulatory-activist senior device personnel, is thinking about UDI. But, there are a number of conflicts between the MITA proposal and what might be desired in nations with different regulatory-policy legal bases and ISO 13485-related regulatory systems. As far as I know, it remains a core goal of UDI that it be Universal, therefore all of the GHTF participants would have to sign off on a UDI implementation before it could go forward. I'd think that would entail UDI bumping into the same regulatory-mission-differentials that have caused the FDA to not actually make much progress toward harmonization so far.

Certainly no system will be implemented calling for mandatory utilization of the GMDN system until such access is legally freely available. And, I'm not aware that any work has started on resolving what might be significant disruptions for manufacturers who have based legacy device regulatory-stance decisions on the FDA's existing product code system if a new classification system were introduced.

I'm not aware that the FDA has directly acted to "start the ball rolling" regarding UDI adoption. There are many stakeholders other than MITA who would be expected to have input. As far as I know, the FDA itself has not asked for comments yet, or given an indication that it has a specific timetable or agenda for any such introduction. If I'm wrong on that and there is a specific FDA action pending, I'd like to know about it.
 
L

Laurie Anderson

#17
We joined GS-1, and now have a GTIN-13 number. I understand FDA is leaning this way for medical devices in USA, Japan is also developing similar requirements.
Ditto Thomas, but there is every indication this may not be adequate in the future.
In our case anyway.

Laurie Anderson
 

rthompson

Starting to get Involved
#19
Re: Introduction of Compulsory Bar Coding of Medical Devices in Turkey

Thomas - is 20K what GS-1 charges to set you up with a company prefix? I was not able to readily find the costs on their website.
Thanks!
 
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