AABB Grants Standards Accreditation to Two SpotSee Products
The HemoTemp II Blood Bag Temperature Indicator, which is an FDA-approved medical device, and the HemoTemp II Activator both were given the “Standards-Compliant” seal.
Communication between the manufacturing plant and retail stores. | Image Credit: © Cagkan - stock.adobe.com
A press release issued on July 24, 2024 announced that SpotSee, a Dallas, Texas-based company that manufactures visual indicators and other types of monitoring devices for a wide range of industries, had received accreditations of “Standards-Compliant” from the Association for the Advancement of Blood & Biotherapies (AABB) for the company's HemoTemp II Blood Bag Temperature Indicator and HemoTemp II Activator (1).
“The AABB is recognized worldwide as a symbol of authority and distinction,” the press release said. “The organization is committed to its core objectives of providing high standards of safety for patients, donors, and facilities. AABB member institutions displaying the AABB accreditation logo are recognized globally for providing quality products and services.”
In the case of the two HemoTemp II products, a thorough review by AABB gave them high marks for quality in equipment and both process and document control, according to SpotSee (1).
“SpotSee sensors are carefully designed with quality in mind,” Tony Fonk, SpotSee president and CEO, said in the press release. “Earning this accreditation and seal of approval communicates to the public that our life science products are trustworthy, reliable, and of the highest quality.”
The blood bag temperature indicator, which is an FDA-approved medical device, is a liquid crystal combination irreversible blood temperature indicator and reversible thermometer for the measurement of blood during transit, and also storage outside the blood bank (1). According to SpotSee, the reversible portion acts like a blood bag thermometer, while the irreversible part warns the user if the blood’s core temperature has exceeded an approximate range of 6 ºC to 10 ºC.
“After activation, the irreversible portion will change color from blue to a non-blue color as the blood temperature increases and as time passes,” SpotSee explains further on the indicator’s product page (2). “Once the indicator has lost its blue color, it will not return to its original color even if the blood unit is re-cooled. This ensures the user of the time and temperature history of the unit.”
A tan color indicates that the temperature is in the lower portion of the desired range, while green signifies it is in the middle (2).
The activator, meanwhile, a block module heater, provides uniform temperature for the purpose of reliably and accurately activating a sensor also bearing the HemoTemp II name (1).
HemoTemp II is the proprietary brand name of SpotSee’s line of blood bag indicators and activators, as seen on a page on the SpotSee website devoted to the company’s offerings of temperature-related products (2). The blood bag temperature indicators are sold in packs of 40, or a larger order consisting of a case of five boxes of 40 indicators each.
SpotSee said that the indicator should not be used as the “sole indication of clinical acceptability of blood for patient infusion,” but rather a tool in the overall kit of a blood temperature monitoring program.
References
1. SpotSee. “SpotSee’s HemoTemp II Receives Standards Accreditation From AABB.” Press Release. July 24, 2024.
2. SpotSee. Blood Bag Indicators and Activators. shop.spotsee.io/temperature_indicators/blood_indicators (accessed July 25, 2024).
