A Roadmap to Medical Tool Pedigree

Chicago 28 September 2006Fast Track Technologies Ltd. has announced a new technical concept for the health care industry: "A Roadmap to Medical Tool Pedigree" at the RFID Applications Conference in Washington D.C. on September 21, 2006. This concept alerts the medical community and provides possible solutions for the causal effect of cross transfer infections and the spread of disease, from medical devices, instrumentation and supplies.

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"There is a definite possibility that health care tools could potentially become the conduit for aggressive mutating viruses, exponentially contaminating and mortally infecting large populations", stated Brad Sokol, CEO of Fast Track Technologies.

Currently, medical instrumentation and supplies have not been included in the National Healthcare Interoperability Model. This is due to the three major competing Universal Medical Device Nomenclature systems (UMDNS, GMDN and UNSPEC).

Mr. Sokol has explored and integrated three theoretical solutions - Tracking medical objects, Sterilization process, and Error-Infection reporting process - to design a closed - micro-hospital - and open loop - macro - improved medical error/infection reporting system - pedigree model for medical devices.

Brad Sokol stated: "Currently, Medical instrumentation and supplies have not been included in the National Healthcare Interoperability Model. This research indicates that there is a possibility for the causal effect of cross transfer infections and the spread of disease, from medical devices, instrumentation and supplies." Additionally, "The primary driver for a universal medical device nomenclature system will be the public's need for safety, accountability and reporting on the progress in addressing the global infection control issue."

His research indicates that medical devices, instrumentation and supplies, directly and indirectly cause up to 26.000 mortalities annually in the United States. Medical device errors are responsible for adding an additional cost of $3,2 - $6,4 billion to the United States health care system a year.

He pointed out that the main vehicle for infection analysis will be an interoperable, universal medical device naming system and near real-time error reporting system. This system will provide the ability to trace back - Pedigree - the source of infection - directly or indirectly - to the specific medical tool(s), procedure and patient. Combined with the recent developments in patient record systems, the medical device pedigree model could be incorporated into the National Healthcare Interoperability Model within ten years.

The benefits to Medical Device Pedigree are:

  1. Reduction of hospital associated infections, reducing mortalities through ensuring sterilization and proper device usage on the correct patient.
  2. Matching patient data records to diagnosis, treatment and device to patient schedule/procedure and infection cause.
  3. Device maintenance and increase regulatory compliance reporting - in cases where infections have been passed from patient to patient due to improper device maintenance.
  4. Reduce theft and counterfeiting of medical devices.
  5. Enable a process to track the reprocessing, recalls, rentals and loaning of medical devices.
  6. Increase supply chain asset visibility resulting in increased productivity, administrative efficiencies and billing accuracy.

Brad Sokol estimates the total cost to develop and implement Medical Device Pedigree throughout the United States health care system at $27 billion; breakeven is expected within 5 years.

The Medical Device Pedigree Model has five major components:

  1. Placing additional variable data fields on an Auto-ID label (RFID tag, 2D Barcodes, etc.).
  2. Nomenclature Sequence Code (NSC): bridges the 11 different medical device naming databases by establishing a relational universal number for each device.
  3. Privacy Preserving Index (PPI): provides confidentiality, data integrity and user authentication.
  4. Nomenclature Sequence Server (NSS). This is a secure relational database that directs queries and retrieves information through a de–registered database environment.
  5. A model for a rules based semi-automated mandatory reporting system of adverse medical device related events.

The key process order events are the 8 L's : last manufacturer, last maintenance, last sterilization, last instrument, last location, last user, last procedure, last patient.

Companies can implement pieces of the model and create new products that could be readied for development within a year and product profitability may be technologically achieved within the next 3 years.

Brad Sokol will donate his work to a non-profit health care organisation for implementation. Mr. Sokol ended by saying: "I intend to donate my work to a non-profit health care organisation for implementation. Due to the informational value and sensitivity of the model's data, this system should be regulated by the federal government." Mr. Sokol's work is currently being reviewed by the CDRH (FDA), NLOM, GS1 and HIMSS.

Fast Track Technologies Ltd. is a research-consulting firm, specializing in the development, assessment and implementation of medical instrumentation, connectivity and infection control systems. Its expertise spans all phases of strategic market, quality systems designs compliant with regulatory strategy processes, resulting in reduced costs and time to market.

You can write Mr. Sokol to get a copy of the Medical Device Pedigree Model at brad@fasttrackrfid.com

More related news is available in the VMW September 2006 article FDA seeking comments on use of identifier system for medical devices.


Leslie Versweyveld

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