Temptime and Numedis Collaborate to Bring Proprietary Storage and Transportation Technologies That Advance Corneal Transplant Outcomes
The Numedis Life4°C® product is a biocompatible, advanced corneal preservation system for storing human corneas for keratoplasty for up to 14 days under refrigeration (2-8° C). The Life4°C medium contains more nutrients and preservation components than others on the market, and is used in combination with Numedis proprietary Transend® corneal viewing chamber to provide a state-of-the-art system for corneas shipped domestically and internationally.
All corneas shipped with the Life4°C® system include Temptimes FREEZEmarker® time-temperature monitoring device which triggers when exposed to freezing temperatures, to assure continuous temperature monitoring throughout the cold chain.
"Our mission is to provide the highest quality corneal preservation solutions and corneal viewing chambers for every live cornea, through storage, shipment and transplantation," said Deborah Skelnik, founder and president of Numedis. "We think its critically important to the quality of the corneas – and the impact on surgical outcomes – that all corneas are preserved with state-of-the-art technologies and transported with state-of-the-art freeze indicator devices. Patient safety is our first priority."
FREEZEmarker® is a single-use indicator that continuously monitors temperature during shipping and storage, and is available in various freeze response temperatures.
"FREEZEmarker® provides an easy-to-read, irreversible visual color change to alert when the product is exposed to freezing temperatures," said Ted Prusik, PhD, Senior Vice President, Temptime. "Other electronic indicators take readings at set intervals and may not register brief excursions, but the FREEZEmarker® monitors on an ongoing basis and detects these events," he added.
Freeze Causes Permanent Damage to Corneas
Live human donor corneas must be kept within the 2-8° C temperature window because exposure to freezing temperatures, even for a short period, destroys the tissue. Corneas packed in boxes with wet ice may be at risk for damage because temperatures at various locations in the box may fluctuate out of the 2-8° C range. In addition, extreme temperature variations can occur during shipping.
Corneas that have been frozen appear to be normal but in fact are not; corneas that have been accidently frozen are permanently damaged. Unfortunately, only after surgical transplant, when the cornea fails, does this become evident.
Shawn Wofford, executive director of the Hawaii Lions Eye Bank, based in Honolulu, says freeze events can occur at any time during a shipment, particularly during the initial hours after packaging with wet ice or gel packs.
In his own independent study, Mr. Wofford has observed temperatures vary within a cooler to the point where they can be exposed to freezing temperatures in one section of a cooler and not in another.
"Our eye bank is highly focused on patient safety, which is why we are committed to superior preservation, shipping and transportation systems." said Mr. Wofford. "With Life4°C and FREEZEmarker, I can rest assured that the corneas are well-preserved and well-monitored. And, in the event a cornea is exposed to freezing temperatures, the visual indicator will trigger, and the surgeon can decide not to use the tissue."
About Corneal Transplant
Corneal transplant is a surgical procedure in which a damaged or diseased cornea is replaced by a donated corneal tissue. It is one of the most frequently performed human transplant procedures. According to the Eye Bank Association of America, more than 700,000 corneal transplants have been performed since 1961.
In 2010 alone, more than 42,600 corneal transplants were performed in the US. Not only is corneal transplant a widely-performed surgery; it is a surgery with very high success rates. Over 90% of all corneal transplant operations successfully restore vision to the corneal recipient.
About Numedis, Inc.
Based in Isanti, MN, Numedis, Inc. develops and manufactures products that enhance corneal preservation. Their Life4°C® corneal preservation medium provides excellent endothelial and epithelial preservation with minimal corneal swelling during storage. The TRANSEND corneal viewing chamber has been designed for performance to meet the challenges of extended storage, specular microscopy and shipping. To learn more about Numedis and their products, please visit www.numedis.us.
About FREEZEmarker® and Colloid Technology
Temptime has developed a portfolio of freeze indicator devices, including TransTracker® products, based on advanced colloid technology and manufactured under a quality system consistent with the FDAs Quality System Regulations (QSR) 21 CFR 820 (GMP for medical devices). These indicators, all of which use Temptimes patented FREEZEmarker® technology, provide the greatest value by delivering equivalent to superior accuracy to all other alternatives – both chemical and electronic -- in a cost effective device.
Colloid technology uses an active substance composed of extremely small particles of material that is evenly and stably distributed in liquid. At a precise temperature, the small particles become unstable, removing the forces that keep particles separate and allowing coagulation -- which forms an opaque white color that indicates a freeze event has occurred. Freeze indicator results are irreversible.
About Temptime Corporation
Temptime, the world leader in time-temperature indicators, plays a vital role in the improvement of global health by providing solutions that monitor temperature sensitive medical products, live tissue and devices. Temptime uses its patented technologies to develop and produce devices that provide definitive, irreversible readings while avoiding the environmental hazards associated with battery operated devices. To learn more about Temptime Corporation and its products, please visit www.temptimecorp.com.
Posted by Sean Fenske, Editor-in-Chief, MDT