With several indicators on the market, it’s increasingly confusing to know what to use – or who to trust.
There’s been a lot of “buzz” lately about measuring core temperature of blood units during temporary storage and transport. Do the adhesive temperature indicators on the market, including Safe-T-Vue, measure core temperature?
The simple answer is NO.
Since all of the available temperature indicators are applied to the blood bag surface, they do not measure core temperature. As most of you know, there is no way to measure core temperature of a blood unit during temporary storage and transport without inserting a temperature probe into the “core” of the bag.
So, if the indicators aren’t sensing core temperature, what are they sensing?
These adhesive temperature indicators are actually measuring the surface temperature of the bag, not core temperature. Safe-T-Vue also measures the surface temperature of the bag. However, through over 20,000 laboratory tests, we have developed direct correlations between blood bag surface temperature and core blood product temperatures. This process allows us to formulate a consistently performing adhesive surface indicator, and assures that Safe-T-Vue indicator response is accurately correlated to actual core temperatures.
How can you trust the performance of a temperature indicator?
1. Published product specifications
Suppliers, like William Labs, publish the temperature accuracy of their products, usually in their product literature and on their websites.
Safe-T-Vue has correlated temperature indication to core blood bag temperature supported by over 20,000 test data results that quantitatively support the consistency, predictability and repeatability of its indicator performance.
2. QA Documentation
Some suppliers take the “proof” of temperature accuracy a step farther, by supplying their customers with QA documents and procedures, documenting the temperature data for that product, for each lot, to prove that testing was performed and the product performs to specification. Safe-T-Vue is shipped with accompanying QA documents, which can also be accessed anytime from our website.
For added confidence and convenience, the validation procedures for Safe-T-Vue are published on the website, for those users who would like to perform their validations and replicate our work in their own labs.
3. FDA 510(k) and Quality Audits
As you know, the purpose of the FDA is to oversee safety. Section 510(k) helps the FDA make sure new medical devices are safe and effective. New medical devices submitted under 510(k) rules must also be “substantially equivalent” to other similar marketed products.
This FDA regulation that applies to medical devices, including temperature indicators, is of critical importance. It assures that the supplier of the product you are trusting to “do its job” is both safe and effective. 510(k) ensures the product is as safe and as effective as other 510(k) devices already on the market.
Just because a product is being sold into the healthcare market, do not assume it has been cleared by FDA 510(k). Ask your supplier – and make them prove it.
Additionally, credible suppliers have a quality plan to support the process and accuracy claims of their products. For example, actual and statistical verification of Safe-T-Vue data supports the product claims. As part of the quality plan, this data is reviewed by the company’s QC staff and annually by external auditors.
We’ve been so stimulated by the recent conversation about core temperature, that we’re making plans now for comparative studies in early 2014, which we will be sharing with you. Our new partnership with Temptime has expanded our time-temperature testing capabilities and laboratory expertise in healthcare, so look forward to these and other test results in the coming year.
As always, if you have any thoughts on core temperature measurement and adhesive temperature indicators, we always appreciate hearing from you. Feel free to post a comment on the VUEPOINT post, or email us.