On or about July 10, 2012, the Federal Register will publish the following item …

DEPARTMENT OF HEALTH AND HUMAN SERVICES: Food and Drug Administration

Unique Device Identification System; Proposed Rule

The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.

FDA expects the UDI system will provide additional benefits. For example, UDIs could be used to enhance management of the Strategic National Stockpile, inventory management, and the provision of high-quality medical services.

UDIs will facilitate the development of more useful electronic patient records by allowing providers to electronically capture and record important information concerning the use (including implantation) of a device on a patient. UDIs could help identify similar devices in the event of a shortage, and could help detect counterfeit devices.

The FDA database would not include patient information.

For example, we expect UDIs could be used by other Federal agencies, such as the Centers for Medicare and Medicaid Services, the National Institutes of Health, the Centers for Disease Control and Prevention, the Department of Defense, the Department of Homeland Security, and the Department of Veterans Affairs, for a wide variety of purposes, ranging from management of the Strategic National Stockpile, inventory management, and the provision of high-quality medical services. Other benefits include facilitating the development of more useful electronic patient records by allowing providers to electronically capture and record important information concerning the use of a device on a patient. UDIs could help identify similar devices in the event of a shortage, and could reduce the potential for injury from counterfeit devices by offering a better way to detect a counterfeit product and remove it from the market.

Through our work with the Global Harmonization Task Force (GHTF) and foreign regulatory partners, we envision that the UDI system would support global public health initiatives with which FDA is concerned, including more efficient and effective cross-border identification of devices, adverse event reporting and postmarket surveillance, and would improve our ability to communicate and respond to issues and concerns about devices used not only in the United States, but in other nations as well.  <Source>

This is the beginning of the uniform labeling, tracking and control of medical devices by federal agencies. It is anticipated that the first devices will be those Class 1 devices which require a doctor’s prescription. However, given the stated benefits listed in this 165-page document, it appears that other federal agencies (as well as the international community and United Nations) may use the information in unintended ways without a patient’s knowledge or consent. Over time, detailed medical records, especially those linked to federal payments such as Medicare and Medicaid, will most certainly become subject to real-time monitoring and belong to the federal government. Thus giving rise to “Big Brother” with or without Obamacare. Obamacare simply speeds up the process.

Bottom line …

It should be noted that device numbers will be “unique” and not just a category identifier. Thus allowing for the tracking of both devices and individuals. I only wish that our government was smart enough to re-do the social security numbering system (I provided a schema for doing this at http://www.onecitizenspeaking.com/2010/08/fire-the-head-of-the-social-security-administration-for-incompetence.html.) which has been thoroughly compromised by illegal aliens using forged or stolen social security numbers. And who says illegal aliens do not cause harm to our nation?

It should be noted that one of the uses of the UDI specifies identifying devices in the event of a shortage. One wonders if the shortage will be caused by the waste, fraud, abuse and mismanagement that is sure to come with the Obamacare program.

Any way, here it is! For your consideration, the beginning of a program that could result in the loss of your medically-related privacy as the government institutes tracking systems for individual devices. If you wish to do anything, I strongly suggest that you join the Electronic Frontier Foundation (eff.org) and advocate for privacy laws that would send any government worker to jail with a mandatory term should patient information be compromised or used for commercial or political purposes.

-- steve

Social Security Re-design formula. …

0000-0-0-000-00-0000-0 (AAAA-D-C-SSS-SS-SSSS-K)

I suggest that, keeping with a sixteen digit structure to allow existing infra-structure (computers, terminals, etc.) to be used for authentication and verification (two different processes), that the new number incorporate the old number (SSS-SS-SSSS) in some manner, that a check digit (K) be placed at the end of the number string; and that the remaining six digits be used to indicate the reauthorization/verification agency (four digits, AAAA), type of confirming documents presented (one digit, D) and citizenship status (visa, legal alien, citizen, etc., C)