Keys to the Cold Chain

In January 2008, FDA approved Evicel, a liquid fibrin sealant already approved for use during liver and vascular surgery, for general surgery. The agency reports that Evicel is intended to be sprayed or dripped on small, oozing blood vessels. Once applied, it creates a covering that helps stop bleeding. Manufacturer Omrix Biopharmaceuticals Ltd. (Kiryat Ono, Israel) reports that one clinical study showed that it “achieved hemostasis in less than 10 minutes.”

Evicel requires well-controlled storage. While frozen vials can be held at -18°C or colder (i.e., frozen) for up to two years, unopened vials stored at 2° to 8°C (i.e., refrigerated) can only be held for up to 30 days. It must be discarded after spending 24 hours at room temperature; it cannot be refrigerated once brought up to room temperature; and it cannot be refrozen once it has been thawed.

Even though Evicel has been around for a while in its previous indication (it was marketed as Crosseal for liver surgery use), it is a good example of the latest trend in medicine. Made from human-plasma proteins, Evicel is part of the biotechnology boom giving doctors new tools to improve healthcare. The Washington Institute of Thoracic and Cardiovascular Surgery (Washington, DC) concluded that the use of Evicel “as a sealant for pulmonary and bronchial staple lines results in superior aerostasis . . . Successful aerostasis following pulmonary resection should result in greater patient comfort, lower complications, shorter hospitalization, and lower overall cost.”

Given its storage conditions, however, maintaining Evicel’s efficacy requires vigilance by all its handlers. And it is not alone. Market experts report that more temperature-sensitive products are headed into healthcare. To protect these critical products, new investments will be required up and down the supply chain. Manufacturers will seek sophisticated transportation packaging; third-party logistic providers will need to provide consistently controlled and monitored transport; and hospitals and pharmacies will need to ensure complete control over inventories. The cold chain will need to be tightened. New requirements and solutions are emerging, involving an impressively diverse group of partners along the supply chain.

For instance, RFID-enabled refrigerators ranging from 5 to 56 cu ft are storing temperature-sensitive products at hospitals around the country. Blue Vector Systems (Palo Alto, CA) supplies its Edge Manager appliances to control the RFID readers in the refrigerators, monitoring inventory and door access. Drug inventory is often monitored by distributors. “Hospitals are not inventory experts, and it is expensive,” says John Beans, Blue Vector’s vice president of marketing “Now distributors can handle inventory monitoring, 24 hours a day.”

With such monitoring, hospital costs may also be more manageable. Such smart refrigerators may be installed in hospitals for free. In addition, inventory may be kept leaner in a constantly monitored stock, with little risk to patients. Beans says that any time there are “highcost temperature-sensitive drugs, hospitals do not want to store a lot of them. However, they do not want to run out of them, either. Patients could suffer.” Beans sees RFID-enabled refrigerators eventually moving into point-of-use environments, perhaps close to procedure rooms.

Biotech-enabled drugs and medical devices are not just changing healthcare. They are changing the supply chain, transforming a good portion of it into a cold chain. Partners that make up the links in that chain will need to work together to control and monitor temperature. New packaging and monitoring technology will be key.

Daphne Allen, Editor

daphne.allen@cancom.com

 

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