Understanding UDI (Unique Device Identification)

[sonic85]

Hi Everyone,

This Thread is very informative. I think i came here little late.

I have been reading about the UDI rule and requirements. But I am little confused.

Why do we need a UDI now, can the serial # be used and considered to be sufficient?

are the current methods used by medical devices mfr to identify medical devices being considered ineffective?

what is the benefits of using UDI instead of serial #?

How medical devices mfr accepting and justifying the cost of the UDI implementation?

Hope someone here help out and shine some light on these questions. I do really appreciated .. thanks in advance

 

[MIREGMGR]

Why do we need a UDI now, can the serial # be used and considered to be sufficient?

are the current methods used by medical devices mfr to identify medical devices being considered ineffective?

what is the benefits of using UDI instead of serial #?

How medical devices mfr accepting and justifying the cost of the UDI implementation?

UDI is just an (eventually) globally standardized way of providing scanner-readability for existing, non-standardized-format, non-scanner-readable medical device identifying information so that end user organizations can more efficiently buy, receive, store and allocate to the cost account of a particular patient the various products and supplies they use.

A key goal is to move healthcare providers from having a huge overhead percentage, containing most of their expenditures on disposables and supplies, to having accurate allocation of exactly where all of those disposables and supplies were used. This better accounting for costs is regarded by many healthcare cost experts as an essential element of social and governmental projects to get healthcare costs under control.

If it's mandatory...and eventually it will be everywhere..."justification" by a particular manufacturer is unimportant. If you want to market medical devices, you conform to the regulations, including this one.

 

[Laura S]

Hi Everyone,

This Thread is very informative. <snip>

Hi Everybody. @MIREGMGR is correct - there is no option to bypass this regulation if your firm is a manufacturer of medical devices unless you have an incredibly good case for an exemption. Most companies do not have that option, therefore, they must comply.

Manufacturers of the first group of devices, the implantables and life-saving/life supporting classes of devices, just hit their required implementation date in September 2014. There are many lessons learned from this group of suppliers, including the realization of just how much work it really is to get to "UDI" on your product line. It's not just a new bar code format. There's much more that needs to be done.

 

[Mark Meer]

Why do we need a UDI now, can the serial # be used and considered to be sufficient? are the current methods used by medical devices mfr to identify medical devices being considered ineffective?

Setting aside manufacturer obligations for a moment (we can all agree UDI is mandatory), I still think this is a valid question by the OP.

It seems to me that any actual benefits lie only with products that are disposable or otherwise distributed in large quantities.

For your average "limited-devices-per-facility" devices however, I personally see no benefit. My feeling is that in cases where, for example, the serial number has to be referenced off such devices, the user will simply read it off the label as they always have, rather than running for their scanner...

 

[Ronen E]

UDI is just an (eventually) globally standardized way of providing scanner-readability for existing, non-standardized-format, non-scanner-readable medical device identifying information so that end user organizations can more efficiently buy, receive, store and allocate to the cost account of a particular patient the various products and supplies they use.

A key goal is to move healthcare providers from having a huge overhead percentage, containing most of their expenditures on disposables and supplies, to having accurate allocation of exactly where all of those disposables and supplies were used. This better accounting for costs is regarded by many healthcare cost experts as an essential element of social and governmental projects to get healthcare costs under control.

If it's mandatory...and eventually it will be everywhere..."justification" by a particular manufacturer is unimportant. If you want to market medical devices, you conform to the regulations, including this one.

Not diminishing cost considerations, I think that UDI is also important for post-market vigilance. It is most relevant for devices that by-nature are separated from their packaging / labeling, and normally wouldn't carry a label.

 

[MIREGMGR]

Not diminishing cost considerations, I think that UDI is also important for post-market vigilance. It is most relevant for devices that by-nature are separated from their packaging / labeling, and normally wouldn't carry a label.

Yes, agreed. This also applies to devices that are separated from their packaging when first used, and only later are realized to have caused a problem. That includes a large percentage of disposables issues.

 

[Julie O]

Yes, I understand that the healthcare providers were eager to have it due to cost considerations, and their support for it made it easier for FDA to push it through. FDA's own interest is in its potential use for post-market vigilance.

 

[Mark Meer]

I'm still not entirely convinced of the benefits. Devices need to be identifiable, sure (especially, as mentioned, those that are separated from packaging and accompanying docs). ...but is requiring AIDC technology really necessary?

I could easily see the current UDI regs being stripped of the requirement for AIDC, and still be just as effective (implants, and tiny devices notwithstanding).

Ah well, I guess, if nothing else, it's definitely a boon to GS1 and HIBCC!

 

[Julie O]

Mark, I'm so not the expert on this, but...

The benefits to whom?

As for AIDC, I have assumed that it is to save time over manual data entry. Wouldn't all systems that use AIDC work without it? Isn't AIDC implemented as a practical measure, because someone doesn't want to have to do manual entry?

 

[Mark Meer]

My point-of-view is that matters of convenience and practicality should be limited to the realm of marketing and customer-manufacturer agreements, NOT regulations.

If, for example, a hospital has a database that uses GS1 AIDC codes, then they can certainly request from their suppliers to provide GS1 barcodes on their labels.
....or have their own purchasing policies that lean towards purchasing products with these codes.

But for the FDA to mandate AIDC codes, this should really have a better justification than simple convenience.