For that very reason, refrigerated vaccine storage is likely to become a much bigger business than ever before.
While the need for and concern about vaccinations is making headlines, health professionals and government health agencies are trying to make sure that any vaccine given is able to deliver its intended protection. The key to that may lie in whether the vaccine has been properly maintained in the “cold chain” that starts at manufacturing and continues until ultimate delivery.
Such concerns have already boosted the demand for thermally protected transport or shipping units, out-of-limits detectors in vaccine packaging, better refrigerator/freezer units in hospitals and healthcare provider offices, and improved temperature monitoring practices and logging devices. Service technicians, whether on hospital staffs or independently employed, may have more and more opportunities to keep vaccine storage units working well.
Energy Storage Technologies Inc., Dayton, Ohio, is experiencing an increased demand for its highly insulated shipping coolers and its refrigerators, which are usually paired with the coolers as a system. Demand for its 110-pound refrigerators, which can run on battery power for up to four days, has brought a near doubling of its production workforce and increased overtime, reports president Lloyd Huff.
Temperature-Critical StuffVaccine makers test for potency only at certain temperatures. The World Health Organization says most live vaccines can survive at room temperature for only short periods of time. Failure to adhere to handling and storage recommendations can reduce or destroy a vaccine’s effectiveness, according to articles in the British Medical Journal and Pediatrics magazine.
In some cases, the outcome of out-of-bound temperatures can’t really be tested … but no one wants to wait and see if a vaccine stored in those conditions has worked, when the disease can cause serious ill health or death. Poor storage discovered last year during a statewide survey in Minnesota resulted in an estimated 5,000-plus patients of two clinics being subjected to revaccination, at the clinics’ expense.
Business BoostersThe vaccination business is getting a huge shot in the arm, as the market is expected to grow. Sales of vaccines are expected to comprise a nearly $10 billion business in 2006, almost double the $5.4 billion in that category last year, according to Merrill Lynch analysts quoted recently by Reuters.
While the fastest growing section of the market over the next few years will be in flu vaccines, according to that report, current popular attention is focused on smallpox vaccinations.
Nearly 1 million U.S. citizens, including up to 500,000 troops and 450,000 healthcare workers, are in line for possible smallpox vaccination early this year. President Bush got his shot in December.
Compliance With CDC RequirementsThe U.S. Centers for Disease Control and Prevention (CDC) issued draft rules for handling smallpox vaccines in late November, covering shipping containers and procedures, secure storage upon delivery, and well-monitored holding temperatures.
With the growth of the vaccine business in general, proper storage may require more or better refrigerators at providers’ offices, and better monitoring of their operation.
Aetna, a major healthcare insurer, recently completed a safe vaccine storage project focusing on improving patient safety at more than 5,300 physicians’ offices nationwide. The project was funded by GlaxoSmithKline, a pharmaceutical manufacturer.
The project sought to improve compliance with CDC vaccine storage guidelines. It included an initial survey of storage procedures, education materials provided by Aetna, tools to support safe vaccine storage, and a follow-up survey.
The following improvements were reported as a result of the project:
The national project followed a pilot program in 2001 that focused on four markets: Detroit, Las Vegas, Phoenix, and Jacksonville, Fla.
Details of the pilot, as well as the significance of the results and interventions, were documented by Julie A. Gazmararian, Ph.D., and seven co-authors in an article in the November, 2002 issue of American Journal of Preventive Medicine.
“Success [of vaccination programs] depends upon two things. You need a lot of people participating, and you need effective vaccines,” according to Natalia Oster, a co-author and investigator with Gazmararian on the project. They are both with the Emory Center on Health Outcomes and Quality in the Rollins School of Public Health at Emory University, Atlanta.
“At GlaxoSmithKline, we were pleased to support this initiative,” said Dr. Stuart Sarshik, medical director of National Accounts.
“It underscores the importance of compliance with the CDC’s vaccines storage guidelines and those required by the FDA. Manufacturing quality vaccines that keep adults and children safe from serious illnesses is our mission. It is important that healthcare providers are able to protect their patients against preventable diseases with a high degree of confidence.”
Dr. Samuel Warburton, who heads Aetna’s quality management programs, said, “We believe in the importance of this Vaccine Safe Storage project as well as other patient safety initiatives. We will continue to support and collaborate with physicians and other healthcare providers in our networks to minimize avoidable medical errors.”
Sidebar: Solar-Powered Vaccine StorageConcerns for safekeeping vaccines and other medicines at proper temperatures and a global need for vaccination have spurred the development of refrigerators that can run on solar or other nonelectric grid sources. These refrigerators can be used in rural and undeveloped areas all over the world.
Some units from Energy Storage Technology, Dayton, Ohio, can operate on solar power with the company’s photovoltaic solar grids.
Kyocera Solar, Inc., Matlacha, Fla.; Sun Frost, Arcata, Calif.; and Schott Applied Power Corp., Rocklin, Calif., are also making solar or nonutility-powered vaccine storage units for use in underdeveloped regions.
SolarChill, which the manufacturer describes as a “solar greenfreeze refrigerator for vaccine and food preservation,” was developed by the Danish Technological Institute and the Danish refrigerator manufacturer Vestfrost.
Its direct current compressor was developed by Danfoss Company of Denmark.
— Jim Norland
Sidebar: Stopping Cancer Cold With CryosurgeryATLANTA — The first-ever research project conducted by the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) in the area of cryogenics is aimed at improving tools used to freeze cancerous tissues. The technique can eliminate invasive surgeries, with an effectiveness comparable to conventional surgery.
Gregory Nellis, Ph.D., principal investigator, and Sanford Klein, Ph.D., co-investigator, both at the University of Wisconsin-Madison, are heading the project, “Data Design for Optimization of Cryosurgical Probes.” The work will include creating a computer program to allow cryosurgical probe design information to be accessed more conveniently.
Cryosurgery is a medical technique for treating cancer in which tumors are frozen in-situ, or in place. Frozen tumors can then either be left alone to be reabsorbed by the body, or surgically removed without worry of spreading the cancer by accidentally puncturing the tumor.
Small-diameter catheters or probes with tips cooled to a very low temperature are used. Until recently, such probes have been relatively large and thus invasive devices cooled by liquid nitrogen, according to investigators. Recent advancements have allowed smaller probes with the same cooling power.
The project will help manufacturers design improved catheters that are optimized for specific requirements of cryosurgical application, Nellis said.
“We hope that this project will result in improvements in refrigeration power and reduction in the size of cryogenic probes. This could increase the number of applications for cryosurgery and improve its effectiveness.”
Publication date: 01/27/2003