Immucor Voices Support for Congressional Hearings on Blood Safety
Monday November 15, 1:58 pm Eastern Time
ATLANTA, Nov. 15 /PRNewswire/ -- Immucor, Inc. (Nasdaq: BLUD - news), the leading provider of blood bank reagents and automated blood bank testing instruments, announced today that Edward L. Gallup, president and chief executive officer, delivered the following letter to Rep. Fred Upton, chairman of the Commerce Oversight and Investigation subcommittee, offering Immucor's support in improving the nation's blood supply.
The text of the letter follows.
Honorable Fred Upton
House of Representatives
Dear Representative Upton:
I would like to offer Immucor's wholehearted support to all initiatives focused on improving the safety of blood products as well as the safety of the administration process. Immucor believes it is incumbent upon each and every industrial partner in this business to continue to investigate ways to develop innovative solutions to the numerous complexities surrounding blood supply and safety issues.
I applaud the diligent efforts of you and the Commerce Oversight and Investigation subcommittee in bringing to light critical issues that threaten our nation's blood supply. While the United States continues to outpace the rest of the world in the delivery of quality health care, human blood remains one of our most important medical resources -- a resource that, as you have reported, is in dangerously short supply.
During the committee meeting for the Oversight Hearing on October 19, 1999, you rallied for a campaign to increase emphasis on blood donor recruitment -- a vital solution to the problem of low blood supplies. We at Immucor believe an equally important strategy is to improve the safety of transfused blood products.
As the nation recruits more blood donors, it is imperative we ensure that patients in the United States never run the risk of receiving the wrong blood.
Blood Safety and Blood Waste
According to the April 1997 edition of the American Journal of Clinical Pathology, more than 6,000 patients around the world died as a result of the improper administration of blood or blood components. In fact, more Americans die each year from receiving the wrong type of blood than contract HIV through blood transfusions.
Other statistics are equally as alarming:
* Dr. David Kessler, former head of the FDA, believes that only one of every 100 fatal transfusion reactions is reported. Research estimates show that in the U.S. alone there are probably more than 2,600 fatal transfusion episodes each year that go undetected or unreported.
* The Serious Hazards of Transfusion (SHOT) -- a report that details serious errors involving transfusions of blood components in the U.K. -- revealed that of 169 cases investigated in 1996-1997, nearly half were episodes where patients had received a blood component intended for another patient. The following year, SHOT reported another 110 new cases of "wrong component transfused to patient."
Since the risk of death is extremely high for a patient who has been given blood incompatible with his or her blood type, statistics like these are a chilling testament to the need for improved tracking procedures.
The waste of blood is also a factor in the depletion of our blood supply. The shelf life of blood products is limited. When blood is issued and leaves the hospital blood bank, it should be transfused within 30 minutes or be discarded. Often, caregivers discover they have the wrong blood components when it is too late to ''save'' the blood from spoiling -- which means precious inventory is wasted.
Solution? -- Technology
At Immucor, we have been working since 1982 with many of our partners in the healthcare industry to improve the safety of blood transfusions. The technologies we have developed, and are developing for hospital and donor facilities around the world, directly address this problem, and provide efficacious, cost-effective solutions.
In 1992, we initiated a long-term project to develop automation for the blood bank serology industry, which is still utilizing systems and processes that date from the 1950s. In contrast, other hospital laboratory departments have been employing automation and advanced electronic interpretation techniques for some time.
Our focus on developing automation for the hospital blood bank also incorporates tracking and verification technologies to ensure that the right blood gets to the right patient at the right time, as detailed below. Based on the industry's enthusiastic response to our progress, we believe this approach should be a focal point of our nation's resources devoted to the safety of blood transfusions.
Blood Automation
As I noted earlier, transfusion errors and misadministration of blood and blood components account for a significant number of deaths in the United States annually.
This was the impetus behind Immucor's development and subsequent FDA clearance of the ABS2000 -- the world's first and only FDA Cleared fully automated blood compatibility system. By utilizing our innovative solid phase assay technology and neural net interpretation techniques, we have improved the reliability of blood testing by eliminating the subjectivity of interpreting results. In other words, Immucor's technology is minimizing the testing errors that can lead to complications from transfusions.
Blood Tracking and Verification
Improving blood analysis and reducing testing errors in the laboratory go a long way towards the elimination of transfusion accidents. But this is only the first part of the equation.
The second part involves blood supply tracking and verification to ensure that blood checked out of the blood bank is administered to the intended patient. Blood that is transfused to the wrong patient can be fatal. Blood that is lost or misplaced must be discarded.
To fight this battle, Immucor enlisted one of our partner companies, Healthcare-ID, Inc. to create a tracking tool called I-TRAC Plus. This device employs sophisticated PalmPilot(TM) technology to address two challenges. First, the system effectively ensures the right label goes on a patient sample prior to submission of the sample to the laboratory. Then, at the patient's bedside, I-TRAC Plus confirms that the unit of blood is matched to the correct patient via a simple scanning of bar codes on the patient's wristband and the unit of blood.
Not only does a system like I-TRAC Plus virtually eliminate the possibility of a patient receiving the wrong blood, it provides an electronic audit trail of the complete transfusion process. This capability will have a positive effect on blood utilization and should minimize the percentage of the blood typically wasted as a result of delays in administration.
In fact, a study completed at Georgetown University Medical Center concluded that...
"I-TRAC insured positive patient sample and blood component identification at all steps of the blood transfusion. Transfusion records in the blood bank and in patient charts were 100% accurate and complete."
We all know that the solution to the problems you raised requires a continued effort to improve public awareness, as well as a focused effort from industry and healthcare providers. Congress' efforts, along with the efforts of a company like Immucor to bring cutting edge technology to this industry, could prove very
instrumental in bringing a much higher level of safety to the transfusion process. I hope we can work together to play a role in this endeavor.
As a first step, I would like to extend an invitation to the subcommittee to tour the blood bank operation at the Georgetown University Medical Center in Washington, D.C. Working with our scientists, Dr. Gerald Sandler, Professor of Medicine and Pathology, has established a state-of-the-art facility using these technologies with the goal of eliminating errors related to the supply and transfusion of blood products. Dr. Sandler invites the subcommittee to visit the facility at Georgetown University and witness what the transfusion service community could be doing to impact blood supply and safety.
I would like to thank you and the Oversight and Investigations subcommittee for your continued effort to carry the banner for those of us in the Transfusion Diagnostics industry. I appreciate your time, and encourage you to expand your strategy to include improving the safety of the transfusion process and reducing the waste that often results during administration. By implementing this strategy in tandem with the campaign already developed for improved donor awareness and recruitment, we can indeed eliminate the blood shortage issue that threatens to become a crisis in the United States and ensure that patients derive the maximum benefit from this vital therapy.
I remain, sincerely yours,
Edward L. Gallup
President and Chief Executive Officer
CC: Gerald Sandler, MD
Immucor, Inc. is the largest blood bank reagent manufacturer in North America, and sells the only fully automated, FDA cleared transfusion diagnostics device on the market. Immucor provides a family of automated systems that address the processing needs of hospital blood banks, reference laboratories and donor centers of all sizes. Extensive information about Immucor, its products and their applications is available at immucor.com .
This press release may contain forward-looking statements as that term is defined in the Private Securities Reform Act of 1995, including, without limitation, statements concerning the Company's expectations, beliefs, intentions or strategies regarding the future. All forward-looking statements included in this document are based on information available to the Company on the date hereof, and the Company assumes no obligation to update any such forward-looking statements. Further risks are detailed in the Company's filings with the Securities and Exchange Commission, including those set forth in the Company's most recent Form 10-K and Quarterly Reports on Form 10-Q.
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