2006N-0292

Unique Device Identification

FDA Comment Number :

EC7

Submitter :

Mr. Adrian Blakey

Date & Time:

08/21/2006 10:08:05

Organization :

Mr. Adrian Blakey

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

Yes. The should not be mandatory and should be left to the discreation of the manufacturer. If for example a specific device can be assembled, modified or repaired by the inclusion or exclusion of specific instances or sub-assemblies or parts, then presumably these parts will already have idenitities in the vendor's system and should be individually identified.

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

N/A but take a look at http://signup.mylid.net/signup/ as an example of using the light weight identity system (form of OpenId) to identify people.

How should a unique device identification system be developed?

Adopting a URL as a device identifier will bypass the need for a lengthy process for developing an identifier.

For example: device manufacturer XX could decide that its ids were of the form: http://xx.com/id/nnnnnnnn-nn where nnnnnnnn-nn was the manufactuer's existing serial numbering scheme. These identifers could be printed on the device, or exposed electronically.

Should unique device identifiers be considered for all devices?

Yes. Each device has an ontological notion of "identity" - it exists - therefore it should have a way of being digitally identified electronically in order to be able to participate in eCommerce transactions - such as "return data from", "update characteristics" etc.

What are the barriers for establishing unique device

None if you do what I say - just use URLs. They are in common usage, can be read by browsers, encapsulate existing numbering schemes, can support pseudonyms. If there are any barriers it is the requirement that a server exisits somewhere (in the device?) that will return an html page (by default) when the device URL is entered into a browser attached to the Internet.

What are the incentives for establishing a uniform, standardized

Purchasers will prefer to buy produts that can easily be integrated into "whole product" solutions at lower cost.

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

The FDA should just say "use URLs as unique electronic identifers for your devices" and them suggest use of the OpenId specification

(http://openid.net/) for sharing and trust. The beauty of the OpenId spec is its extensibility, so if the schems already proposed do not work, then the vendor is welcome to create another.

What solutions have you developed or could be developed for

Specification for URL based identity management http://openid.net

GENERAL

Adopting a URL as the standard electronic health care device identifier will enable all the requirements to be met.

Implementing Unique Device Identifiers

How should the UDI and its associated minimum data set be

This is irrelevant if a "meta" protocol is chosen. For example if the device's electronic identifier was a URL and the URL supported a "meta" query the requester could say somethnig like: http://xx.com/id/123456-00?meta - the URL might respond with list of available attributes that could be look-ed up.

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

No. http is a technology independent protocol that is implemented on a wide variety of hardware - there are many open source http implementations. If a bar code is chosen - then either the code should represent a URL, or should be easily converted into a URL say by cnovention e.g. if the bar code is XX-YY-ZZ then it should be possible to construct a URL to a "bar code directory" service that will redirect to the specific device's URL say http://universaldeviceidlookup.net/XX-YY-ZZ -> http 303 -> http://companyxx.com/yy/zz

Should the UDI be both human readable and encoded in an

Yes - a URL can do this. Either print it on the outside of the device. Or suggest that the device manufacturer publish the convention by which a serial number printed on the outside of the device can be converted into the URL identifier e.g. device made by manufactuer ABC, can be found by prefixining the serial number with http://ABC.com/id/ If the device itself supports an electronic network connection, (IrDa, Bluetooth, ethernet ...) then the device could "squarke" on port 80 and respond directly to http requests.

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

Device URL; Name of device String; Vendor name String; device manufacture date; device serial number - no more informaion that would ordinarily be written on the outside of the device and accessible by anyone, or an anonymously identfied consumer of the information. Just having the device URL would obviate having any additional information on the device. Same informaiton for every device. The device URL would be the entry point for obtaining a more, extensive set of device information. The URL would by convention be expected to return an HTML page with as much information as the device manufactuer was willing to disclose to an anonymous user. The same URL might aslo disclose the same information in a more machine readable (XML/RSS) format by adopting a suitable URL based protocol - such as LID. Further, the LID protocol accepts an incoming identity URL to identify the source of the http request, which can be applied (by suitable software) to determine what additional information should be returned to the requester.

UDI Benefits and Costs

For hospitals and other device user facilities considering

After EHR, before all other issues. As high as priority as "universal interoperability."

From your perspective, what are the obstacles to implementing

None.

From your perspective, what are the setup costs measured in

Costs to build a web page and associate it to an existing database. If the information is readily available and the company has a web presence this could take as little as 2 weeks, to say 6 months for a less agile company and cost say $1m.

From your perspective, what is the expected rate of technology

If you use a URL the uptake can be very fast - people already use a browser and the Web.

From your perspective, what public health and patient safety

In the "continuum" the movement, staging, disbersment, and recovery of durable medical equipment, such as oxygen cylinders, beds etc. is a huge cost. For a $17bn institution the potential saving in being able to efficiently track DEM is estimated to be $100m oper annum.

If you have already implemented a form of unique identification on your medical device labeling, what investments in equipment, training, and other human and physical resources were necessary to implement the use of UDIs?

N/A

Referring specifically to completing medical device recalls in

100%

What infrastructure or technological advancements are needed

Adopting a URL will incur, low, no needs for more infrastructure.