Questioning Some Identification Technology

Recent calls for FDA to require a bar code identifier on all medical devices represent a solution in search of a problem and demonstrate a lack of understanding of the diversity and complexity of medical technology.

Last year, FDA mandated that bar codes be placed on most prescription and certain over-the-counter drugs to help improve patient safety by reducing the number of medication errors in hospitals -- responsible for approximately 7,400 patient deaths per year. While medication errors are a clear and significant problem that can be addressed by bar coding, proponents of the technology can point to no similar health care threat that would be solved by placing bar codes on medical devices. The bottom line is that there is no evidence that extending FDA s bar code requirement to medical devices will result in any demonstrable patient benefit.

Drug Solutions Do Not Apply to Medical Technology Asking FDA to apply to medical devices a remedy specifically intended to address a drug issue reinforces the faulty assumption that drugs are just like medical devices. Bar coding works for drugs because, for the most part, they look alike and have similar packaging. Using bar codes allows for a machine to accurately and quickly read a drug label and thus reduce the potential harm from human misreading.

The diversity and complexity of medical devices, on the other hand, makes the mandatory application of bar codes infeasible and, in some cases, impossible.

• Devices come in all sizes, from vascular stents no bigger than a thumbnail to computed tomography scanners that can take up an entire room.
• Medical devices can be packaged individually or by the hundreds; composed of a wide range of materials requiring various sterilization and storage needs; and designed for single-use or multiple-use, requiring reprocessing.
• Some devices have specially treated surfaces, such as finely polished surgical implants, which could be rendered useless if a bar code were required to be affixed or etched upon them. Mandating the use of bar codes also fails to take into account the rapid evolution of auto-identification technology. Today s cutting edge system could very well be obsolete tomorrow. Under the current voluntary system, medical technology manufacturers and customers agree on appropriate automatic identification standards, packaging levels and devices to meet customers needs. Manufacturers already have auto-identified thousands of devices and will continue to work with customers to decide which other products should be auto-identified. The medical technology industry recognizes the utility of auto-identification systems and has invested substantially in bar coding technology, in particular, where real benefits to patients and users can be realized.
• Infusion pumps, for example, include bar code technology to ensure the safe delivery of drugs. These devices include bar code readers to scan the patient ID bracelets, caregiver ID badges, and the unique identifier on the drug label to ensure the "five rights" of drug delivery: right patient, right drug, right dose, right time, and right route. Having a mandated bar code on the infusion pump itself would add nothing except cost.
• Large volume laboratory analyzers also utilize bar code technology to ensure the right test results are matched with the right patient.

These devices can scan bar codes on patient sample containers and each of the reagents, mixing, and analysis chambers. The analyzer itself does not need a bar code label to ensure patient safety. TMD This article is from AdvaMed, the Advanced Medical Technology Association.