Guest blogger Dave Selin, European Sales Manager, Uson, writes:
When William Shakespeare wrote, “The first thing we do, let’s kill all the lawyers,” he probably was not imagining that a weapon of choice would be a tiny RFID tag.
But it is.
The same ISO-standard RFID tags that are used for parts traceability can replace the reams of paper documentation that most devices carry to their grave to help keep litigation at bay. These long paper trails not only eat up time and budgets, but they do not meet the standard of error-free documentation that automated recording of test data affords.
To give lawyers their proper due, we are not making toasters or tea kettles; a medical device can make the difference between life and death, putting it in an entirely different category. Regulations abound and litigation is a fact of life throughout the industry. Litigators are within their rights to ask, “How did you ensure that the device functioned correctly at the time it was used with the patient?”
Traceability of testing and validation of function is not just a concern during manufacture. The cost to automate the recording of test data and build it into the device calibration data that stay with the device during its entire life cycle is negligible. Built-in calibration data is achievable with simple RFID tags that are designed to ISO standards—not only do they replace long paper trails of documentation verifying a device’s function, but they eliminate the potential for human error in validating test results at every phase of the medical device’s life cycle, from initial assembly until it is no longer in use. Again, the cost for writing and reading test data via RFID tags is negligible.
As an example, consider a drug-delivery device for anaesthesia that must mix gases very precisely. With such anaesthesia delivery devices, the entire test history of the part during manufacture can be embedded in a chip; using ISO-standard RFID writers and readers, relevant test data can be attached to a particular serial-numbered device. The hospital using the device can verify the tests, again using ISO-standard RFID readers, and calibration facilities can use the same RFID tags to record validation of the device.
A device that does not meet test requirements is automatically kept from release to market. That’s the initial benefit. Data verifying that the device functions properly stays with the device and cannot be tampered with or altered. If and when a hospital wants to verify device specifications, such as the flow rates of gases into an inhaler system, a simple RFID reader allows them to do so. A calibration facility similarly records proper function before re-releasing the device to the hospital.
The only thing about RFID tagging that puzzles me is why its potential has been largely ignored by device manufacturers, regulators, calibration facilities and litigators alike.
— Dave Selin, Uson