Groups Urge FDA to Require Barcodes for Medical Devices

A group of big-gun associations and group purchasing organizations (GPOs) called on the FDA to require bar codes on medical devices.

When the FDA began its rule making process in 2002, it solicited comments on the bar coding of medical devices as well. As expected, the comments received spoke largely to the inherent promise of improved risk management through reductions in supply chain and medical errors.

I just don't see the promised benefits of bar coding medical devices. Drugs, blood products and biologicals are used in a high volume that can drive standardization and effectively mandate a specific implementation throughout health care in the US. This rapid inventory turnover also means current hospital inventories can be replaced by bar coded products in days or weeks. Medical devices are purchased once every 7 years or more. If bar codes were mandated today, there will still be a substantial percentage of devices in use without bar codes 10 years from now.

Consumables and implantable devices like catheters, stents and pacemakers might benefit from mandated bar coding. Capturing data through a bar code scan vs. documenting a serial number would result in some increase in data quality, but not the breathless improvements implied by this letter.

However, the FDA decided to only require the bar coding of drugs and biologics in the final rule due to the difficulty of implementing such a far reaching regulation - not because of any perceived error in extending this to medical devices.

Many hospitals already place bar codes on devices for the reasons quoted above. Medical devices (and consumables/implantables) are already required to have serial numbers, so one of the alleged benefits (facilitating recalls) is moot. Advanced supply management solutions like Mobile Aspects, already deliver substantially more benefit than simply bar coding stuff.

Furthermore, bar coding medical devices has vast potential for improved clinical product and service innovation. As the FDA itself has recently noted, a compelling patient safety interest also lies in requiring bar codes for medical devices that could be subject to recalls.

Hmmm, who would not be for “improved clinical product and service innovation?” And all that from bar codes. I sense ulterior motives at work.


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