Mediware Delivers New Product Ahead of Schedule to Improve Safety of Transplantable Materials BiologiCare™ is the first commercial grade, integrated software product to ensure safe and efficient management of bone, tissue andother cellular products used in healthcare facilities.
LENEXA KS, June 24, 2008 – Mediware Information Systems (NASD: MEDW), https://www.mediware.com/, a provider of ClosedLoop™ clinical systems for blood and medication management, announced the launch of BiologiCare™, a software system designed specifically to track and manage transplantable materials in hospitals, surgery centers, and other healthcare facilities. BiologiCare ensures that donors, tissue vendors and tissue recipients are fully documented and enables these facilities to be fully compliant with current regulations.
“BiologiCare is one of several strategic initiatives that will continue Mediware’s growth and I am pleased that this new product was released ahead of schedule,” said Kelly Mann, Mediware’s president and chief executive officer. “BiologiCare is the first of its kind in a market that is new and rapidly developing.”
The need for BiologiCare stems from the fact that more than 50 percent of U.S. hospitals perform transplantation procedures. These procedures range from using bone chips and tendon tissues in surgery, to organ replacements and the use of marrow and stem cells in advanced therapies. There is not currently an enterprise-wide, automated system to track where these materials were obtained, if they have been stored appropriately, and where they were used. An estimated 10 million transplantation procedures have now been performed.
“New biovigilance programs – which oversee the safe and efficient procurement, use and tracking of these materials – are rapidly developing throughout the world and are a strategic initiative of organizations such as the American Association of Blood Banks (www.aabb.org),” said Mann. “Until now healthcare facilities have not had specific computer systems available to assist them with the complex tracking, storage and reporting requirements of these types of tissues.”
For healthcare facilities, the effective tracking and tracing of transplantable materials has become a serious management problem with few viable solutions. A typical facility will have a wide variety of transplantable tissues from a myriad of suppliers on hand at any given time. Each product type has different storage, processing, matching and use requirements that must be followed to ensure patient safety. BiologiCare assists healthcare facilities address these clinical and operational challenges, including the need to improve efficiencies and maintain strict regulatory compliance.
“This is a commercial grade software system with rich clinical intelligence, full enterprise integration and multi-facility capabilities that enables healthcare organizations to safely and efficiently manage these expensive materials,” said Mann. “With an increasing number of reported adverse events associated with transplanted tissue, it is clear that healthcare needs better technology to address these advanced procedures.”
While the risk of disease is low in transplantation cases, there are recent incidents where tissue suppliers distributed products that improperly acquired and fraudulently documented. In 2005 a scandal unfolded around Biomedical Tissue Services, a New Jersey company accused of using stolen bodies and of shipping nearly 20,000 potentially tainted body parts. In 2006 the FDA shut down Donor Referral Services of Raleigh, N.C. because the FDA said the company had “serious deficiencies” in its processing, donor screening and record-keeping. When potentially tainted body parts are shipped to hospitals the impact is staggering. For every instance the hospital’s staff is required to determine who came into contact with the product and where the product was used. Each person must be notified of the potential risk and whether or not they need to be tested. This discovery requires hospitals to manually search patient records and files, a process that could take staff from days to weeks depending on the number of procedures performed and products used.
“Using BiologiCare, this process can be performed in minutes, reports generated and automatic notifications distributed,” said Mann.
A further safety feature built into BiologiCare is a vendor qualification module. This allows hospitals to define their qualification parameters and manage all vendors to a single standard. This alerts staff receiving products in the event that a vendor’s status is unknown or out of date.
In many hospitals, multiple departments order and store products from multiple vendors and manage these transplantable materials using a paper-based approach. Without centralized controls, monitoring inventories, costs and vendor qualifications is difficult and the risk of waste is high. As the cost of these materials increases, hospitals are becoming more vigilant in their management oversight.
“One customer audited their tissue inventory, which was stored in boxes and refrigerators throughout the hospital, and found that they had $40,000 worth of products that had expired,” said Mann. “This was a tremendous financial loss for this facility.”
While the primary use of these materials is in surgery, many facilities are looking to the hospital blood bank to provide oversight because of the clinical background and experience with rigid controls used to manage similarly regulated products. In the early 1980’s the FDA began regulating the hospital blood supply and strict guidelines for procurement, storage, distribution and use were set in place. Hospital blood banks today must indefinitely keep detailed records of each unit of blood, and where it ended up.
“Regulation and oversight of biologics is definitely on the rise,” continued Mann. “Hospital blood banks are used to managing these types of materials but unfortunately they don’t have the staff or tools to do so efficiently.”
“Using BiologiCare, our customers can know at a glance what they have available, where it came from, where it is stored, and who has had exposure to it. The system also fully documents where it was used in the unlikely event of a recall.”
BiologiCare is available for purchase and Mediware is currently offering introductory web casts to demonstrate the systems features and benefits. Information on the next available web cast, and links to event registration, can be found at https://www.mediware.com.
“Mediware has been designing blood management systems for more than two decades,” said Mann. “We understand the safety, regulatory and reporting requirements for these types of clinical solutions and are pleased to have extended our experience and expertise to this new and exciting field. This will be a growth platform for us in 2010 and beyond and I look forward to announcing our first customers in the coming weeks.”
Mediware delivers blood and medication management software systems that encapsulate information supporting patient therapies, reinforce patient safety practices and improve efficiencies to lower costs. Mediware’s customers include prestigious hospitals, clinics, correctional institutions, blood centers and other public and private health care institutions throughout the world. For more information about Mediware products and services, visit our web site at https://www.mediware.com/.