The Swiss healthcare group Roche signed an agreement on April 11 to acquire the medical instruments division of Austria-based AVL. Financial terms were not disclosed, and the acquisition is subject to regulatory approval.
The privately held AVL Medical Instruments is a leading supplier of blood gas and electrolyte analyzers for point-of-care testing. AVL has offices around the world and manufacturing facilities in Grav, Austria, and Roswell, Ga.
“The acquisition will complement Roche’s position in the diagnostic’s market and enhance the company’s presence at the most critical points of healthcare delivery — in emergency rooms, intensive care units and operating rooms,” said Roche Diagnostics head Heino von Prondzynski.
AVL is one of Austria’s largest high-tech companies. It was a leading contributor to the development of the internal combustion engine and a supplier of sensors and engine testing systems to car manufacturers worldwide. For 30 years, AVL has applied this sensor technology in the medical field. In 1999, the 750 employees of AVL Medical generated sales of about $386 million.
Roche is in a position to fully realize the potential of the AVL product line and technology portfolio, according to Helmut List, AVL chairman and CEO.
In 1998, Roche and AVL joined forces to develop a system that combined AVL’s point-of-care Opti system with Roche’s glucose meter and co-ag and cardiac diagnostics. The system is still under development.
20,000-plus to attend 52nd AACC Annual Meeting & Clinical Lab Exposition
The American Association for Clinical Chemistry, Inc. (AACC), will hold its 52nd Annual Meeting & Clinical Laboratory Exposition from July 23 to 27, 2000, at the Moscone Center in San Francisco. The meeting will be held concurrently with the Annual Meeting of the American Society for Clinical Laboratory Science (ASCLS).
AACC’s exposition is an annual opportunity to keep up with the latest developments in the field of laboratory science and to see the most recent products available for clinical laboratories. In 1999, the meeting attracted close to 15,000 participants and more than 500 exhibiting companies. In 2000, the education program features 183 sessions of interest to clinical laboratory medicine professionals.
DiaSys’ new partnership with a Chinese medical equipment distributor results in 100 urinalysis workstation orders
The urinalysis and fecal concentrate workstations made by DiaSys Corp. of Waterbury, Conn., have been approved by the Health Ministry of China, the equivalent of the U.S. FDA. The certification, which is effective for a four-year period, approves DiaSys workstations for use by all 60,000 medical laboratories in China.
The company also entered into a multi-year partnership with Hua Sin Science Co., Ltd, in Guangzhou, China. Hua Sin, DiaSys’ distributor in China for the past year, is the exclusive distributor of urine chemistry analyzers for Bayer Corp. Under the new sales and distribution plan, which include all DiaSys’ current and future products, the two companies will work with the Chinese government to standardize urinalysis in China on instruments from Bayer and DiaSys. DiaSys has received orders for 107 "R/S" urine sediment workstations from Hua Sin, 65 of which have or are in the process of being delivered.
DiaSys previously announced that it has entered into a strategic cooperation agreement with the U.S. Diagnostic Division of Bayer Corp. and with the Canadian Health Care Division of Bayer Inc.
Signing the China distribution agreement (from left to right): Professor Xu Jianbang, Diasys President and CEO Todd M. DeMatteo, Hua Sin Science Co. President Luo Yong Qiang
Red Cross suspends blood system due to adverse reactions
HemaSure Inc. of Marlborough, Mass., developer and supplier of blood filtration technologies, was notified April 11 by the American Red Cross that it was suspending the use of its r/LS System. The suspension is pending the outcome of an investigation of non-critical adverse reactions in a small number patients who have received blood filtered with the r/LS.
Jack McGuire, HemaSure’s president and chief executive officer, said the company is working diligently with the Red Cross to gather information to resolve the issue as soon as possible.
Bad blood spreads disease to millions in developing countries
Unreliable blood supplies expose millions in developing countries to deadly diseases, according to the World Health Organization, which made blood safety the focus of this year’s World Health Day on April 7.
The primary reasons for the exposure are lack of commitment and support on the part of many governments, said Gro Harlem Brundtland, WHO Director-General. The result is chronic shortages of safe blood donors in developing countries and an absence of quality control and testing.
HIV, Hepatitis B and C, syphilis and malaria can be spread via the blood supply. WHO and the United Nations AIDS Agency estimate that 5.6 million new HIV infections occur annually. Between 5 and 10 percent of HIV infections worldwide are transmitted through the transfusion of infected blood and blood products, and the problem is critical in developing countries.
Dr. Uton Muchtar Rafei, WHO regional director for South-East Asia, said 80 percent of the global population, which lives in developing countries, has access to 20 percent of the global supply of safe blood.
Medical giants team up to streamline Web purchasing
Five healthcare heavy hitters recently unveiled a plan to establish a new Internet-based company to streamline the purchasing of supplies and equipment to hospitals and healthcare providers.
The Global Healthcare Exchange will include five manufacturers: Johnson & Johnson of New Brunswick, N.J.; GE Medical Systems of Waukesha, Wis.; Baxter International Inc. of Deerfield, Ill.; Abbott Laboratories of Abbott Park, Ill.; and Medtronic Inc. of Minneapolis.
The network will handle purchasing transactions for these companies. While the contracts are hammered out between manufacturer and customer, healthcare providers and institutions may select products from the catalogs of all five participants and make transactions through Global Healthcare Exchange.
“Our customers have told us they want one global single source to streamline transactions combined with important clinical information,” said James Lenehan, chairman of medical devices, diagnostics and the health systems group at Johnson & Johnson.
One issue the Exchange addresses is healthcare customers’ distaste for using the numerous proprietary ordering systems required by manufacturers. Abbott Chairman and CEO Miles White explained that this situation complicates the procurement process.
“The exchange will not only let customers enter and track the orders, but allow them to access correct contract pricing direct from the manufacturer,” he added. “Today, these processes require a great deal of follow-up in faxes and phone calls.”
The new organization also plans to work with major group purchasing organizations rather than compete with them to streamline the purchasing process.
The Exchange is trying to create enough flexibility so that if individual hospitals or GPOs want to participate, they could be accommodated.
In March, GPO Premier Inc., of San Diego, bought Medibuy.com and merged it with its Premier Health Exchange. The goal, according to a Premier press release, “to bring greater efficiency to the nation’s healthcare supply marketplace,” is similar to the one voiced by the new Global Healthcare Exchange.
Despite the potential for competition from its suppliers and business partners, Premier CEO Rick Norling expressed little concern about the launch of the Exchange. “The companies have shared these latest plans with us, and we look forward to seeing what further opportunities for synergy will be created as their work and ours proceeds,” he said.
Helena Laboratories purchases Array Medical including point-of-care product lines
Helena Laboratories of Beaumont, Texas, has purchased the products and technology of Array Medical of Somerset, N.J. Terms of the deal were not disclosed.
The Array Medical technology includes platelet aggregation and anticoagulant monitoring equipment. According to a Helena spokesperson, these product lines will complement its hemostasis product business by allowing expansion into the growing point-of-care segment. This new division will be called Helena Point of Care.
Helena products and services focused primarily on laboratory electrophoresis, chromatography and coagulation. Array Medical develops and markets products for point-of-care monitoring and management of thrombotic conditions in critical care environments such as stroke, heart attack, pulmonary embolism and deep vein thrombosis. To date, Array products are represented in more than 50 countries through a local dealer network. Products include the Actalyke Activated Clotting Time Test System, Ichor self-contained point-of-care hematology instrument, Nicky neonatal heel incision device for blood sampling and Triplett bleeding time test device.
In December 1999, Array received FDA clearance to market Plateletworks, a bedside platelet aggregation test technology for cardiovascular disease.
June 30 is Nikon Small World photo competition deadline
The deadline for entering the 26th Annual Nikon International Small World Competition is June 30, 2000. The annual photo competition, run by Nikon Inc. of Melville, N.Y., honors excellence in microscope photography.
Prizes include a $5,000 vacation trip or an array of Nikon products. Each participant may submit up to three 35mm transparencies taken using a light microscope. Digital images duplicated in 35mm-slide format are encouraged. Entries will be judged on their originality, informational content, technical proficiency and visual impact. All varieties of specimens, magnifications and optical techniques are permitted, and the use of Nikon equipment is not required.
|Last year’s contest winners: (left) first prize, newt lung cell in mitosis; (right) second prize, Viagra dissolved in ammonia.|
Winners will be announced in November in New York City, where the first place winner will be flown as Nikon’s guest. Winning photos will be displayed in a traveling U.S. exhibition during 2001 and will be featured in a Nikon calendar.
For more information on the competition, write to Nikon’s Small World Competition, Nikon, Inc., 1300 Walt Whitman Road, Melville, N.Y. 11747 or phone (631) 547-8569. Entry forms may be downloaded from the Nikon Web site.
Automatic blood screening system impacts quality in transfusion industry
An automated approach to the process control of viral screening for blood and plasma samples can enable blood centers to more efficiently comply with aggressive blood safety standards and stringent government mandates.
The Ortho Summit System, which includes Ortho Assay Software and the Ortho Summit Processor, both from Ortho-Clinical Diagnostics of Raritan, N.J., automates critical steps in the viral-marker blood screening and tracking process, decreasing the likelihood of human error.
Traditionally, quality assurance practices have depended primarily on technologists. Today, blood centers also must comply with mandates ranging from compliance standards for assay performance, to operation management. Meeting these requirements usually involves changes to a center’s operational procedures. One solution has been automating test processes. Automation allows a blood center to quickly acquire the capabilities to satisfy FDA requirements relating to donor screening, starting with minimizing human error.
The Summit System supports regulatory compliance through its assay performance and menu, control of testing processes and automation of procedures. The system automates ELISA tests for the six viral markers (HCV Ab, HBcAb, HBsAg, HTLV-I/II Ab, HIV-1/HIV-2 Ab, and HIV-1 p24Ag) the FDA requires blood centers to perform.
HIMA Board elects Beckman-Coulter’s Wareham chairman
The Health Industry Manufacturers Association’s (Washington, D.C.) Board of Directors elected John P. Wareham as chairman for a one-year term beginning in March 2000. Wareham, who is currently chairman, president and chief executive officer of Beckman Coulter, Inc. of Fullerton, Calif., succeeds Ronald Dollens of Guidant Corp.
Wareham has served as a HIMA board member since 1995 and has chaired the Board’s Technology and Regulatory Affairs Policy Committee and In Vitro Diagnostics Sector Advisory Committee, which focuses on domestic and international regulatory and payment issues for this industry sector.
Wareham, who has been chief executive officer of Beckman Coulter since September 1998, was named chairman of the company in February 1999. He was named president of the company in 1993. Prior to these appointments, Wareham was chief operating officer for Beckman. He began his career as vice president of the Diagnostic Systems Group.
|Sunquest Information Systems Inc., Tucson, Ariz., has signed an agreement with wireless communication technology company Data Critical Corp., Bothell, Wash. to have it market and distribute Sunquest’s Clinical Event Manager. CEM, a wireless, Web-enabled alert system, automatically sends vital clinical data to clinicians via e-mail or pager. Data Critical will market CEM in addition to its own wireless StatView Alarm Notification system. StatView transmits patient information and ECG waveforms to caregivers from patient monitors.
Sunquest also has signed on LAB-InterLink Inc., Omaha, Neb., in a value added reseller (VAR) agreement which allows Sunquest to market LAB-InterLink’s LAB-Frame Select Laboratory Automation System services along with it FlexiLab LIS. The Sunquest solution combines LAB-InterLink’s patented LAB-Trax specimen transport device, including specimen carrier, LAB-Master processing modules, and LAB-Manager software which automates and integrates analyzers from multiple disciplines and transports numerous specimen collection containers. LAB-InterLink, a developer of specimen transport and robotics software, has acquired Labotix Automation, Inc., a Canadian manufacturer of the RRUSH hardware family of laboratory processing modules. Financial terms were not disclosed. The merged company will be headquartered in Omaha, and the Labotix automation division will continue to operate from Canada.
Madison, Wis. based Third Wave Technologies, Inc. announced that Massachusetts General Hospital in Boston is the 20th clinical center to adopt its proprietary Invader technology for use in routine clinical applications. Third Wave has launched three sets of Invader technology-based, analyte-specific reagents and assay controls for clinical use. Reagents specific for mutations in the factor V (Leiden), factor II (prothrombin), and methylene tetrahydrofolate reductase (MTHFR) genes are available.
Michael Laposata, M.D., Ph.D., chief of the division of laboratory medicine at Massachusetts General, said the lab will use Invader as part of its hypercoagulation testing.
Lab equipment manufacturer Jouan SA, St. Herblain, France, has acquired Heto-Holten, a Danish manufacturer of laminar flow biosafety cabinets, refrigerated baths and circulators, freeze dryers and deep freezers. Heto-Holten also manufactures clean rooms.
LabCorp, Burlington, N.C., has been selected by Foundation Health Federal Services as a preferred lab provider for Tricare beneficiaries in nine states — Arkansas, California, Idaho, Louisiana, Oklahoma, Oregon, Texas, Washington, and Arizona. Tricare is the Department of Defense program that provides healthcare services to eligible military personnel and their families. Foundation Health Federal administers managed-care programs for 1.5 million eligible military dependents.
LabCorp has completed the acquisition of certain clinical testing assets of Bio-Diagnostics Laboratories of Torrance, Calif. BDL provides clinical laboratory testing services in the South Bay area of Los Angeles County. Its 1999 clinical revenues were about $12 million.
This is the company’s second acquisition in Southern California this year. LabCorp is a national clinical laboratory with annual revenues of $1.7 billion in 1999.
LabCorp also has entered into a definitive agreement with San Diego-based Pathology Medical Laboratories to acquire its laboratory testing business.
Specialized Health Products International, Inc., Bountiful, Utah, has received an initial $1.5 million payment from Kendall Healthcare Products Co. for 11 Specialized safety needle products that Kendall will distribute. The agreement includes Specialized’s patented FlexLoc and ReLoc technologies for each of the 11 products named. Development of the safety syringe product is progressing.
Dade Behring, Deerfield, Ill., has signed a three-year, sole-source agreement to provide MicroScan instruments and reagents for microbiology testing to Irving, Texas-based Novation, the supply company of VHA and UHC.
The new agreement extends to organizations that purchase supplies through HealthCare Purchasing Partners International LLC, a company that markets Novation agreements to 4,600 organizations outside the VHA and UHC alliances.
In compliance with a preliminary injunction issued by the U.S. District Court for the District of Maryland, Roche Diagnostics has agreed to transfer to Igen International, Inc., Gaithersburg, Md., its physician office laboratory (POL) customers in the United States. The transfer will involve 60 diagnostic systems. In addition, Igen said it believes an estimated 225 systems outside the United States fall within the scope of the preliminary injunction. Igen will pursue the disposition of those additional systems during the course of litigation with Roche. Igen expects to start shipping test kits to the U.S. POL customers by the end of June.
The preliminary injunction arose from a lawsuit filed by Igen against Roche claiming multiple breaches of a license agreement between the companies. Under the agreement, Igen granted Roche the rights to develop and commercialize diagnostic systems, based on Igen’s Origen technology, for use in centralized hospital laboratories, clinical reference labs and blood banks. According to Igen, it retained the rights to commercialize its technology in all other markets, including POLs. The suit charges that Roche underreported royalties owed to Igen and sold systems outside the licensed field. Issued in 1998, the preliminary injunction enjoined Roche from marketing systems based on Origen technology to physician’s offices. The injunction also required Roche to transfer its physician office customers to Igen and escrow all physician office revenues pending the final outcome of the litigation. Roche asked the U.S. Court of Appeals for the Fourth Circuit to overturn the injunction, however in December 1999, the Court of Appeals upheld the District Court’s ruling.
TriPath Imaging, Inc., Burlington, N.C., received an FDA warning letter in April alleging that the company had improperly distributed certain promotional materials. The FDA did not have any concerns with the safety and effectiveness or performance of the AutoCyte Prep product, according to TriPath. The company will continue to market and sell the product while working with the FDA to resolve its concerns. TriPath develops products to improve cancer screening. Its AutoCyte Prep System is FDA-cleared as a replacement for the Pap smear.
Hemagen Diagnostics, Inc., Waltham, Mass., has received FDA clearance to market nine of its clinical chemistry reagents for use on the Roche Diagnostics Cobas Mira chemistry analyzer. In March Hemagen announced the first four clearances related to the agreement. In conjunction with that agreement, Hemagen agreed to seek FDA clearances for all of its products to be specifically marketed for use on Roche instruments. The first four clearances were total protein, albumin, calcium, and GGT. The nine new product clearances are total bilirubin, magnesium, creatinine, phosphorus, triglycerides – (GPO, AST) uric acid, direct bilirubin and ALT. Prior to this agreement, Hemagen sold six products to Roche, and during the last three years, sales to Roche were approximately $900,000.
Triple G Systems Group of Toronto, a software provider that automates and integrates medical lab processes, has announced that it will offer its Ultra software on a Web-enabled application services provider (ASP) basis to complement direct license sales. With the ASP offering, Triple G customers can rent the company’s software and related services on a fee-per-transaction basis, instead of licensing, installing and maintaining it themselves. Triple G’s Ultra product is designed specifically for large, complex, multi-site environments, processing in excess of 30,000 specimens per day. In addition to front-office test ordering and the delivery of test results, the software manages the back-end processing of specimen management, testing, validation, interpretive reporting, billing, accounts receivable, network and database administration.
Immucor, Inc., Norcross, Ga., manufacturer of blood bank reagents and related products, said that Quest Diagnostics plans to place Immucor’s automated blood banking systems in select facilities. Immunocor’s systems are designed to make blood transfusions safer. Quest, which has 40 U.S. diagnostic sites, has already taken delivery of its first system.
Independent lab calls for competition in Ohio’s newborn screening program
The founder of one of the country’s largest independent testing laboratories for newborn babies has called on legislators and public health officials to allow private laboratories to offer newborn health screening in Ohio.
If private laboratories are allowed to compete, Ohio newborns will be screened for six times as many deadly but treatable disorders as they are under the current state monopoly, said Dr. Edwin Naylor, founder and president of Neo Gen Screening Inc. of Pittsburgh.
At issue is a state law requiring that blood samples be collected from Ohio newborns and sent to the Ohio Department of Health’s Laboratory for the analysis of rare but treatable inherited metabolic disorders. Although current technology allows newborns to be tested for more than 30 such disorders, the state-operated laboratory screens for five and is considering adding three others.
Naylor said the disorders are treatable, but that they must be identified as early as possible after birth to prevent premature death or irreversible health damage. Testing blood samples is the best way to discover the disorders in babies that at first seem to be completely healthy, Naylor said.
Naylor’s objective is to encourage legislative change that will allow the medical community to establish newborn screening requirements and allow hospitals to choose among qualified competing providers of screening programs.
Sunquest ranked top LIS vendor in recent study
Healthcare information systems provider Sunquest Information Systems Inc. of Tucson, Ariz., was ranked as the number one LIS vendor and number two specialty clinical software vendor in a recent KLAS Enterprises Healthcare IT (information technology) Performance Report.
The survey ranks the top 20 healthcare information system vendors, contains data gathered from close to 2,000 healthcare facilities, and includes product evaluations and CIO interviews. Other clinical information vendors ranked in the study were: ADT, Cerner, 3M, ADAC, SCC, HCS and Mediware.
Sunquest was ranked as one of the top three vendors in 11 of 18 performance categories, receiving first or second ranking in quality implementation, proactive service, meeting expectation, promises kept, providing customers with their money’s worth and repeat purchase confidence.
ThermoGenesis places third system with N.Y. Blood Center
ThermoGenesis Corp. of Rancho Cordova, Calif., has sold its third BioArchive System to the New York Blood Center (NYBC). Each BioArchive System, comprised of sterile bags and a robotic nitrogen storage device, is used by NYBC to process, cryopreserve, and archive up to 3,626-placental/cord blood (PCB) units. The Class II exempt device is for the preservation of blood components and blood products.
Additional BioArchive Systems are likely to be acquired since NYBC has recently had success in treating patients with Acute Lymphoblastic Leukemia and sickle cell anemia. It also plans to expand its inventory to 50,000 PCB units by 2003. Its NYBC Placental Blood Program has collected more than 12,000 PCB donations. It has provided units for approximately 1,000 transplants since 1993.
Started in a garage, Labconco celebrates 75 years in business
Scientific equipment manufacturer Labconco Corp. of Kansas City Mo., is celebrating 75 years in business. Originally named Laboratory Construction Co., it was founded in 1925 by Ralph Callaway and Philip Goldfisch.
The original location was a small garage, and the company’s first product was a Kjedahl Nitrogen Determination Apparatus. Labconco now manufactures hundreds of products including ventilation products, glassware washers, multiple sample evaporators and electrophoresis equipment and desiccators.
Health Hero secures $21 million financing round led by OpenTV
Health Hero Network Inc. of Mountain View, Calif., an Internet company that connects healthcare providers with their home-based patients through a secure network, announced that it has received $21 million in funding from OpenTV, a digital interactive television software provider and InvestCare Partners.
Steve Brown, Health Hero CEO, said the company is solving one of the most persistent problems in e-health; making the Internet work for those who provide care every day. The company’s solution extends care, through appliances and interactive television, to the people who need it the most, according to Brown.
The Health Hero platform includes a secure, private web site for sending queries and viewing patient responses, and the Health Buddy patient appliance, which enables caregivers to remotely collect data about a patient’s symptoms, behavior, knowledge and data from home medical devices such as blood glucose meters and blood pressure cuffs.
Health Hero allows caregivers to rapidly identify changes in a patient’s condition, focusing attention on those in need of intervention, a factor that can have an impact on reducing healthcare spending while improving the quality of care.
Hycor puts allergy, auto-immune testing on one device
Hycor Biomedical Inc. of Garden Grove, Calif., began shipment of its HY-TEC 288 automated testing system in April. The hardware and software package uses a single blood sample to test for up to eight autoimmune conditions or more than 900 specific allergies in a single run.
The allergy and autoimmunity disease testing segments of the in vitro diagnostics market are currently not being served by a single major company, according to J. David Tholen, president and CEO of Hycor. The lab can run more fully automated allergy and autoimmune testing on the HY-TEC 288 than any other instrument, he said.
|CLMA, AACC and CLAS hold Northeast regional conference
The 2000 Northeast Region Conference and Exhibition, sponsored by the Clinical Laboratory Managers Association, the Clinical Ligand Assay Society and the American Association for Clinical Chemistry, was held April 25 and 26 in Boxborough, Mass.
It featured 71 booths and more than 50 vendors including Clinical Diagnostic Solutions, Dade Behring, Diagnostics Stago, Medical Automation Systems, Ortho-Clinical Diagnostics, and Sarstedt. The two-day conference hosted 247 attendees and offered educational sessions on point-of-care testing, laboratory trends, new technologies and the occupational environmental.
Infectious Diseases of Concern to Laboratorians, an educational session presented by Alice Skolnik, R.N., MPH, an infection control practitioner in the Boston VA Health Care Systems, focused on lab-acquired infections and their prevention and control. Skolnik said there is a lack of good case control studies on this topic and that infections among lab associates are underreported.
"If you are working with any known pathogens, and you are exposed, look at the whole picture," Skolnik said. "I always say use the most caution and pretend you’ve been infected with the worst pathogen and go from there."
Skolnik said laboratorians need to be aware of the various routes of transmission for infection, such as direct contact, indirect contact, droplet transmission, airborne transmission, and common vehicle transmission, which is contact with contaminated food and water.
One of the biggest hazards in the lab is being exposed to infection through respiratory contact including fungi. Skolnik said when working with an unknown or something that looks like a yeast, it is important to take precautions. "One of the most important things is for laboratorians to make sure they have good skin integrity, and make sure skin integrity is intact when working with anything that could be hazardous," Skolnik said. Healthcare workers should know what agents they are working with and be vaccinated. For example, Skolnik recommends a Hepatitis B vaccine if you are working in a lab where you could be exposed to the virus. Hepatitis B still poses the greatest threat to laboratory workers.
Skolnik recommended that lab workers consider double-gloving when handling anything that might rip or tear gloves and that hand washing is the greatest preventative measure against infections. To ensure safety, supervisors need to ensure regulatory adherence. In some labs, Skolnik said baselines should be done for employees working with viruses like HIV. Risk assessments should also be done when new procedures, equipment, reagents and employees are introduced or a procedure is changed.
"People who work in the lab know best what they need," Skolnik said.
April brings a shower of state needlestick prevention laws
The Med-Design Corp. of Ventura, Calif., which designs and develops safety needle products for medical use, reported that in April that West Virginia Governor Cecil H. Underwood and Minnesota Governor Jesse Ventura signed into law legislation mandating the use of safety needle products in their states.
The West Virginia law requires the director of the Division of Health to propose rules that mandate the use of devices that minimize the risk of needlestick and sharps injuries to healthcare workers. The law also requires that the Director prepare and maintain a list of systems that either do not use needles or use needles and sharps with engineered safety.
The Minnesota law requires employers to write an exposure control plan that includes procedures for identifying and selecting existing sharps injury protection. Employers must use the best safety devices available regardless of whether such devices are available for purchase through any group purchasing organization with which the employer may have a contract.
In both laws, employers must establish an evaluation system to determine which devices provide adequate needlestick protection, patient safety, and do not interfere with medical procedures. Both laws require worker training and needlestick monitoring.
In November 1999, the Occupational Health and Safety Administration (OSHA) issued new Compliance Directives to enforce the use of available, approved and effective safety-engineered needles in virtually every healthcare facility in the United States. Safety Needle legislation, such as that enacted by Minnesota and West Virginia, expand the OSHA mandate to include state and municipal healthcare employers not governed by OSHA and further strengthen enforcement.
Michael Simpson, chief operating officer of Med-Design, said the additional laws will save the lives of many healthcare workers annually and hasten the conversion of the medical sharps market to safety-engineered needle products. Med-Design is well positioned to capitalize on the transformation. The company has previously licensed Safety IV Catheters, Safety Blood Collection devices and Safety Injection Syringes. It has another 10 safety needle products in development. Among the new products are often-overlooked needle-based devices, such as prefilled vials, dental syringes and A/V fistula needles.
Also in April, Maine Governor Angus S. King, Jr., and Georgia Governor Roy E. Barnes, signed into law legislation mandating the use of safety needle products. Meanwhile, Iowa’s Governor Thomas Vilsack, on April 25, signed into law a bill that directs the state’s Department of Public Health and Labor Commissioner to study state and federal laws and regulations relating to needlestick injury protection.
Med-Design, which currently has more than 22 safety needle products, holds numerous U.S. and international patents on safety needle devices that enable medical workers to perform medical procedures at reduced risk of exposure to accidental needlesticks.