European Industry news
Two European Firms Named Medical Design Excellence Awards Winners
Unipath's fertility monitor and Braun's electronic thermometer are among the 40 products that will be honored at an awards banquet in New York.
Sally Lane
The ClearPlan Easy Fertility Monitor, designed and manufactured in Great Britain, and the Braun ThermoScan, designed, developed, and manufactured in Germany, are among the winners of this year's Medical Design Excellence Awards. The AIRIS II magnetic resonance imaging system, designed and manufactured by Hitachi Systems at facilities in the United States and Japan, was also named a winner.
This year's competition marked the first time the awards were open to competitors worldwide. Of the 175 entries submitted, there were eight international submissions from the United Kingdom, Hungary, and Germany.
In addition to the international winners, there were several award-winning products designed and manufactured in the United States with an international market in mind, such as the Becton Dickinson UniJect injection device and the Intima II catheter.
A panel of eight jurors convened in February to select the winners, judging entries on criteria such as form and function, aesthetics, efficiency, business impact, innovation, ease of use, and cost/benefit ratio. Altogether, 40 winners were selected in 11 categories, including surgical equipment, instruments, and supplies; diagnostic devices; general therapeutic healthcare products and critical care and emergency products; home medical equipment and supplies and self-care products; clinical laboratory equipment and supplies; dental instruments, equipment, and supplies; finished packaging; healthcare furnishings and patient-transfer equipment; implant and tissue-replacement products; other medical and healthcare products; and rehabilitation and assistive-technology products.
The winners are being honored on 26 May at an awards ceremony during the Medical Design & Manufacturing (MD&M) East 99 Exposition and Conference in New York City. The companies will learn at that time whether they have been chosen to receive a gold or a silver award.
Here is a closer look at the winners mentioned above.
The ClearPlan Easy Fertility Monitor
The ClearPlan was designed by Cambridge Consultants Ltd. (Cambridge, UK), Althofen Electronics (Althofen, Austria), and its manufacturer, Unipath Ltd. (Bedford, UK). The ClearPlan, submitted in the home medical equipment and supplies and self-care products category, is a compact, palm-sized, computerized monitor that reads disposable urine test sticks to determine a woman's fertility level. It counts the days of the cycle, identifies which days the user should conduct a test, and provides daily information about the user's fertility level. To use, a woman holds a test stick in her urine stream, then inserts it into the monitor. The monitor optically measures the intensity of the blue lines on the stick to track the hormone levels. The monitor then uses this information to calculate the user's level of fertility. "It does a good job of simplifying a naturally complex, emotional process," noted one juror.
The Braun ThermoScan IRT 3520
The ThermoScan IRT 3520, manufactured in Kronberg, Germany, has been available in Europe for more than a year, and recently received US FDA approval. The device, also submitted in the home medical and self-care products category, provides an accurate, safe, and fast temperature measurement via the ear. It works by measuring the infrared heat generated by the eardrum and surrounding tissue. The thermometer takes eight measurements, or scans, in one second and displays the highest temperature on the readout. The thermometer was designed with safety in mind, in a shape that prevents it from being inserted too far into the ear canal. Jurors were impressed with the device's aesthetics, ease of operation, and speed.
The AIRIS II Magnetic Resonance Imaging (MRI) System
The AIRIS II, an entry in the diagnostic category, was designed by Hitachi Medical Systems America Inc. (Twinsburg, OH, USA), and Hitachi Medical Corp. (Tokyo), and is manufactured by the Tokyo branch. The AIRIS is an open MRI machine with a smaller footprint than conventional equipment. One juror described it as a device that "walks the technology talk." This open MRI system is "friendly to the site planner, friendly to the physician, and friendly to the patients and their families," the juror noted. The AIRIS II features a self-shielded design so that the scan and control room fit in as little as 380 sq ft. A 0.3-Tesla field-strength magnet and phased array coils deliver high image quality without the need for a tunnel-type high-field system, thereby significantly improving patient comfort.
The BD UniJect Prefill Injection Device
Design credits for the UniJect, a packaging entry, belong to the Program for Appropriate Technology in Health (Seattle, WA, USA) and to its manufacturer, Becton Dickinson and Co. (Franklin Lakes, NJ, USA). The BD UniJect was created to solve a major problem associated with administering injections in developing nations: needle reuse and contamination. Costing only 15 to 30 cents per unit, the single-use, prefillable injection device delivers medication when the user presses down on the unit's reservoir. After the dose is expressed, the collapsed reservoir and a one-way valve inhibit refill. Because the drug is premeasured, the accuracy of the dose is assured.
The Intima II Catheter
The Intima II, designed and manufactured by Becton Dickinson Infusion Therapy Systems (Sandy, UT, USA), is an entry in the general therapeutic category. The Intima is similar to the BD UniJect in that it is designed to solve a problem in emerging markets. In many of these markets, a steel needle attached to an extension tube is used to gain access to a vein. These steel-needle sets can only be used for short infusions, which means the veins must be reaccessed for each procedure. The sets are easy to use but painful to the patient and can lead to vein damage and infection. Conventional over-the-needle intravenous catheters use a pliable plastic catheter instead of a steel needle to access the vein and can be left in place for up to 72 hours, eliminating painful repeat needle sticks. Widespread use of this method has been hampered because needle-set users in developing nations do not know the conventional catheter insertion technique. The Intima eliminates this problem by combining familiar needle-set insertion methods with an over-the-needle plastic catheter.
Notified Bodies Are Effective, According to Survey
The results of a survey conducted by the Association of British Health-Care Industries and the Medical Devices Agency (MDA) revealed that device companies were generally satisfied with the overall performance of their notified bodies. That was heartening news for the conformity assessment bodies, which have been under a great deal of fire lately. The survey, which asked UK manufacturers to grade the technical expertise of the notified bodies along with their auditing procedures, revealed that 84% of the companies were satisfied with the overall rigour of the audit, and that 90% of them felt that auditors covered the pertinent areas during their evaluation. The auditors' knowledge of ISO 9000, EN 46000, and the Medical Devices Directive was rated satisfactory to very good by all of the companies answering the survey.
Commenting on specific actions that were undertaken by the notified bodies during audits and Class III design verifications, MDA's John Worrell did express concern regarding some areas that typically received less scrutiny than others during audits. In particular, he noted that auditors were "a little too focussed on quality systems and did not spend sufficient time verifying risk analysis procedures." Echoing a comment made by one of the companies participating in the survey, Worrell noted that an auditor typically has "approximately six hours for routine surveillance, of which two hours are spent filling in forms and typing the report, leaving about four hours to perform the audit. Consequently, the audit tends to be very office and document based rather than process based," said Worrell.
While survey participants rated the notified bodies to be quite effective overall, it should be underlined that they hailed from the UK with the exception of one organization from Germany and another from Ireland. The effectiveness of MDA in monitoring its national conformity assessment bodies is widely acknowledged, and one can't help but wonder how the survey results might differ if it involved notified bodies from other parts of the European community.
"You might say that we have thrown down the gauntlet to other manufacturing associations," said Christopher Jepson, product certification manager at SGS Yarsley ICS Ltd. (Weston-Super-Mare, Somerset, UK), as he challenged Europe's other competent authorities to conduct a survey along similar lines.
The conference on Medical Device Regulation in Europe was organized by IBC UK Conferences Ltd. and the ABHI with the support of MDA.
Glass-to-Metal Sealing Finds Outlet in Implant Market
A company that has supplied glass-to-metal sealing and precision machining services to the military and industrial sectors for several years has been increasingly successful in adapting its technology to active implantable applications. Astro Seal Inc. (Riverside, CA, USA) typically develops a custom package for its OEM customers that consists of a hermetic glass-sealed multilead base and a case ready for the installation of electronic components. The company processes materials such as titanium to fabricate cases and platinum wire for the feed-throughs, and then hermetically seals the connectors by using its proprietary PM-1 glass.
"Biocompatible materials are traditionally difficult to seal," says marketing manager Teri Wortley. "Once the electronics are installed in the device, sealing is difficult because of the potential damage that traditional methods could cause to the electronics. With our process, the biocompatible materials are hermetically sealed and the integrity of the electronic component and the seal are maintained," she adds.
One recent project involved a cochlear implant, a multichannel speech processor that enables people with hearing impairments to recognize sounds. Astro Seal currently is contracting its services to device manufacturers in Austria, Belgium, Denmark, and Australia, as well as other countries. The company cannot comment on these projects, however, because most are still in the design phase and all are subject to confidentiality agreements.
Astro Seal, which has been in operation since 1961, is equipped with state-of-the-art CNC machines and an engineering department that employs the latest CAD/CAM technologies.
For more information, contact Astro Seal Inc., 827-B Palmyrita Ave., Riverside, CA 92507, USA; phone: +1 909 7876670; fax: +1 909 7876677.
US Supplier of SMA Products Gains European Presence
A US-based company that develops, manufactures, and markets products fabricated from shape-memory alloys (SMAs), Memry Corp. (Brookfield, CT) has acquired Advanced Materials and Technologies (AMT; Herk-de-Stad, Belgium). Renamed Memry Europe, the company's expertise resides in copper-based SMAs, nitinol processing, and the development of SMA actuators. Its principal output at the time of the acquisition was the wire used in the fabrication of guidewires and stents along with several nonmedical applications. The acquisition, according to Memry's president and CEO James G. Binch, will enable the company to accelerate its penetration of the European market.
Memry's core business is focused on SMAs, specifically nitinol, whose superelastic characteristics are integral to the design of guidewires, catheters, stents, and related devices. The company has profited from an overall trend among device companies to outsource engineering and manufacturing processes to firms such as Memry with specialized competencies. Writing to shareholders in the company's 1998 annual report, Binch noted that Memry is well positioned to capitalize on this industrywide movement.
"By combining a strong advanced materials technology capability, advanced product and process engineering, and cost-effective and quality manufacturing processes and supply chain relationships, Memry can alleviate these issues for its customers," Binch wrote. He pointed to the company's relationship with US Surgical, for whom it produces components as well as subassemblies, as a model for future partnerships.
In addition to cold drawing lines and annealing equipment, Memry Europe's 15,000-sq-ft facility has sophisticated testing equipment, including a scanning electron microscope, on-site. The company will continue its research into SMA applications and metallurgical issues funded by the EU and the Flanders regional development agency, Binch announced.
For more information, contact Memry Europe, Daelemveld 1113, B-3540 Herk-de-Stad, Belgium; phone: +32 13 553513; fax: +32 13 553514.
EC Proposes Extension of Dual Labelling
The European Commission has tabled a proposal to extend until 2009 the transitional period for the phaseout of dual labelling. This measure would allow companies to continue to list both metric and imperial units of measure on their labels for an additional 10 years. EUCOMED has urged the European Parliament and Council to adopt the proposal without delay.
"The current article 3 of directive 89/617/EEC allows for supplementary indication of units of measurement (in both metric and imperial articulations) until 31 December 1999," says EUCOMED director general Michael Baker. "If the Commission proposal is not approved before this date, then theoretically companies trading in the EU and the United States will need to adhere to the wording of the current directive."
The practical implications for companies affected by this article would include a new cost burden for creating compliant labelling and establishing separate inventory systems and warehousing procedures. The article would severely affect European and US industry, according to EUCOMED, in particular small and medium-sized companies. The pan-European confederation also stresses that units of measurement that are specific to the healthcare sector, the familiarity of medical personnel with these protocols, and the issue of compatibility between devices that were designed based on these units of measurement could pose a safety issue if the directive is slavishly followed.
In a press release issued by EUCOMED following the proposal, the association expressed hope that the extended transitional period would facilitate further talks between EU and US officials and perhaps lead to an agreement on the use of a single worldwide standard for units of measurement.
For additional information, contact EUCOMED, rue du Collège Saint-Michel 17, B-1150 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909; e-mail: eucomed@eucomed.be.
Automation Equipment Supplier Completes Plant Expansion
A maker of integrated automation machinery for device manufacturers has announced the successful completion of a 25,000-sq-ft factory extension. The only company of its kind in the United Kingdom, Arthur G. Russell Ltd. (Arbroath, Tayside) designs and builds automation systems suited for the assembly, testing, and packaging of syringes, blood collection devices, catheters, IV sets, and related components. The expansion, says managing director Lawrence Davie, will enable the firm to "build high-tech products in a safe and clean environment. We can also proudly welcome clients and involve them more in arriving at the best solutions for their businesses," Davie adds.
Automation solutions have the floor as Arthur G. Russell design director Ron Lindsay shows visitors the company's new factory extension.
Using linear and continuous motion formats, automation systems developed by the company attain assembly rates of 700 syringes and 800 cannulae per minute. Device packaging machines achieve rates of 1200 products per minute.
For additional information, contact Arthur G. Russell Ltd., Elliot Ind. Est., Arbroath, Angus, Tayside DD11 2NJ, UK; phone: +44 1241 872961; fax: +44 1241 871723; e-mail: agr@agrussell.co.uk.
Ticona Starts Construction of COC Facility
A supplier of polymers recently began construction of a plant in Oberhausen, Germany, that is ultimately expected to produce 30,000 tn of cycloolefin copolymer (COC). At the groundbreaking ceremony, Ticona GmbH (Frankfurt, Germany) announced that the facility is scheduled for completion by June 2000.
The production process will be the first to use new metallocene catalysts in COCs, a technology that was developed by Ticona and Aventis Research und Technologies GmbH & Co. KG (Frankfurt, Germany). The addition of metallocene catalysts has made the use of COCs cost-effective in the manufacture of products with unique property combinations, according to the company.
Ticona's Topas formulation achieves optical clarity, excellent dielectric properties, biocompatibility, high water vapour resistance, and good temperature stability. According to the firm, the polymer will open up applications in pharmaceutical blister packaging and packaging films as well as optical lenses, syringes, and related medical devices. The USP Class VI material has received a US FDA drug master file number.
For more information, contact Ticona GmbH, Lyonerstr. 38, D-60528 Frankfurt, Germany; phone: +49 69 30582409; fax: +49 69 30536630.
New Rapid Prototyping System Builds Near-Production-Quality Parts
An SLA (stereolithography apparatus) system that achieves a 400% process improvement compared to current high-end systems delivers near-production-quality parts with improved surface finish characteristics. The SLA 7000 Production Solid Imager, introduced by 3D Systems (Valencia, CA, USA), brings the company one step closer to the development of an SLA suited for final production, according to president and chief operating officer Richard Balanson.
"A combination of new solid-imaging materials, a high-power dual-spot laser, and sophisticated software enabled this leap in performance," says Balanson. "The internals have changed a lot, even if the system doesn't look radically different from the 5000 series."
The QuickCast build process, which deposits material in layers as thin as 0.025 mm to create solid objects, allows users to tailor build speed and surface finish to meet a variety of application needs. The fine layer thickness is a critical feature for rapid tooling and other instances where extreme part precision and high surface resolution are desirable. It also reduces the need for hand finishing of parts.
A stereolithography resin developed by Ciba Specialty Chemicals Corp. in conjunction with 3D Systems was formulated specifically for use with the SLA 7000. The material is characterized by its fast photo-speed and mechanical properties.
The system also comes with part-preparation software designed for the Windows NT operating environment and Buildstation 5.0, a companion programme that controls the mechanical functions of the machine. It improves upon the company's traditional UNIX-based software by rendering parts up to six times faster and preparing files twice as fast.
The system has a maximum build area of 508 x 508 x 600 mm, enabling users to produce either a large part or multiple smaller parts simultaneously.
While the SLA 7000 is suited for a cross section of industries, Balanson sees considerable potential for the device in medical imaging. "It is being used in the orthopaedic and prosthetic fields, and there are several applications in the dental industry for modelling dentures and crowns, for example," he says. "We are looking at numerous biomodelling applications," says Balanson, although this is progressing at a faster clip in Europe and Australia than in the United States because of US FDA scrutiny.
The company also heralds the SLA 7000 as a significant milestone on the road to bringing rapid prototyping technology into the production arena. "We have set ourselves a 10-year window to develop an SLA that will take us into final production," says Balanson. To achieve that goal, he says, the company has set its sights on achieving a 10 to 20 x gain in overall system performance.
For more information about the SLA 7000 and 3D Systems's other solid-imaging products and services, contact the company's European office at Rontgenstr. 41, D-64291 Darmstadt, Germany; phone: +49 6151 35040; fax: +49 6151 350444.
New PVC Tubing Outperforms Silicone in Peristaltic Pump Applications
Polyvinyl chloride (PVC) tubing that reportedly rivals the properties of silicone tubing at approximately half the cost is designed for use in peristaltic pumps, volumetric infusion pumps, and related medical devices. The product was developed by Plastron (Industry, CA, USA) and is being extruded and marketed in Europe by its sister company Action Technology Belgium N.V. (Erembodegem, Belgium).
In addition to the material's cost benefits, Plasmed SR-tubing has a "silicone-like feel, good recovery properties, less spellation than other PVC or silicone tubing, and an absence of stress cracking," according to Action Technology's product manager Herman Felix. The USP Class VI material recently underwent testing at the Institute for Biomedical Technology in Ghent, Belgium, and the results exceeded expectations, says Felix. "The test report clearly shows that our Plasmed SR-tubing is, in fact, superior to silicone tubing, which has been recognized until now as the best available material for peristaltic pump applications," he says.
In one test to determine tubing life expectancy, researchers placed Shore 68 PVC tubing, Shore 55 SR-tubing, and Shore 60 silicone tubing in a Cobe roller pump. The pump flow was set at 6 L/min against a back pressure of 500–550 mmHg. According to the results of the test, which was run in duplicate, the PVC tubing ruptured after 46.34 and 71.52 hours of use while the silicone tubing lasted 69.75 and 109.45 hours. The silicone replacement tubing, however, ran for 672 hours without rupturing. "The SR-tubing could have run much longer," says Felix, "but we agreed with the researchers to stop the test after about one month. We could not continue indefinitely."
The researchers concluded that the SR-tubing showed outstanding durability and might have great potential for use in routine and prolonged extracorporeal circulation applications. They also noted that no cracks were observed in the material, suggesting that spellation is minimal.
Action Technology is currently extruding its silicone-replacement PVC in Shore 52 and Shore 60 durometers. The material withstands exposure to gamma sterilization at rates up to 10 Mrd.
For more information, contact Action Technology Belgium N.V., 3e Industriezone, Industrielaan 37, B-9320 Erembodegem, Belgium; phone: +32 53 650711; fax: +32 53 672074.
Alliance to Develop Genomics Technologies
A collaboration to automate membrane filter processing and DNA hybridization, key steps in the mapping of genomes, was recently announced by The Automation Partnership (Cambridge) Ltd. (Royston, Herts, UK) and Lion bioscience AG which is based in Heidelberg, Germany.
"There is no existing automated solution for these processes," explains Ali Ahmadi, genomics program manager at The Automation Partnership. "Our goal is to create a high-throughput system that will improve quality and cost-effectiveness."
The collaboration is concentrating on processes central to gene mapping, including filter control, precision liquid dispensing, and software tracking. Ahmadi notes that several biotechnology, pharmaceutical, and research companies have already expressed interest in the project. "Automation already plays a part in many genomics research facilities, but our approach—applying process engineering to the repetitive parts of research—is new and essential for the success of this vital area," he adds.
The Automation Partnership provides advanced automated solutions for the life science industry, from drug discovery to production and packaging. The company's clients include Bristol-Myers Squibb (Wallingford, CT, USA) and Zeneca Pharmaceuticals (Alderley Park, Cheshire, UK). Lion bioscience AG is a genomics and bioinformatics company that provides integration of a complete collection of proprietary genomics technologies ranging from experimental biology to information technology.
Contact The Automation Partnership (Cambridge) Ltd., Melbourn Science Park, Royston, Herts SG8 6HB, UK; phone: +44 1763 262026; fax: +44 1763 262613.
General Scanning and Lumonics to Merge
General Scanning Inc. (Watertown, MA, USA) has announced an agreement to merge with Lumonics Inc. (Kanata, ON, Canada). The merged company, GSI Lumonics Inc., reportedly would be the world's leading producer of laser-based advanced manufacturing systems. The combined enterprise anticipates annual sales of approximately US$330 million, 15% of which is expected to come from medical device markets.
General Scanning develops and manufactures a line of laser systems for a wide range of applications in the medical, semiconductor, aircraft, and electronics industries. The company also designs and manufactures under ISO 9001 certification a line of thermal printers for medical instrument companies. Lumonics designs, develops, manufactures, and markets laser-based advanced manufacturing systems. Both companies have offices in Germany.
For more information, contact General Scanning GmbH, Lochhamerstr. 11, Maxmilian-Forum, D-82152 Martinsried, Germany; phone: +49 89 89913427; fax: +49 89 89913488.
Plastics Processor Named Certified Supplier
Vitalo Plastics N.V. (Meulebeke, Belgium) has been officially recognized as a certified supplier of medical packaging by its client Medtronic (Minneapolis, MN, USA). The certification comes as Vitalo's packaging division continues to develop its activities in medical blister packaging. The division has production facilities in Meulebeke, Belgium; Manila, The Philippines; and Galway, Ireland. All production sites are equipped with automatic thermoforming machines and Class 10,000 cleanrooms.
For more information, contact Vitalo Plastics N.V., Bruggesteenweg 7, PB 8, B-8760 Meulebeke, Belgium; phone: +32 51 480048; fax: +32 51 487744.
Zevex Extends Partnership with Allergan
Zevex International Inc. (Salt Lake City, UT, USA) announced that the company has extended its strategic partnership with Allergan Inc. (Irvine, CA, USA) for the manufacture of ultrasonic surgical handpieces for all of Allergan's phacoemulsification systems.
Phacoemulsification is a method of cataract extraction that uses ultrasound waves to break the obstructed lens of the eye into small fragments, which are removed through a hollow needle.
For more information, contact Zevex International Inc., 4314 Zevex Park Ln., Salt Lake City, UT 84123, USA; phone: +1 801 2641001; fax: +1 801 2641051.
Ault Acquires LZR Electronics
Ault Inc. (Minneapolis, MN, USA), an independent manufacturer of external power-conversion products, announced that it has acquired LZR Electronics Inc. (Gaithersburg, MD, USA), a provider of external and internal power products.
Ault manufactures external power supplies, battery chargers, switchers, and transformers that are supplied to device OEMs.
For more information, contact Ault Inc., 7300 Boone Ave. N., Minneapolis, MN 55428, USA; phone: +1 612 4931900; fax: +1 612 4931911.
Global Harmonization Goes On-line
To assist international visitors who will be attending the seventh annual meeting of the Global Harmonization Task Force (GHTF) from 27 June to 1 July in Bethesda, MD, USA, a Web site has been established. The GHTF is chaired this year by US FDA's Center for Devices and Radiological Health.
For more information, visit the GHTF Web site or contact the Center for Devices and Radiological Health, 9200 Corporate Blvd., Rockville, MD 20850, USA; phone: +1 301 4432845; fax: +1 301 4438810.
Pharmacia & Upjohn Buyout Announced
Donegal Healthcare Ltd. (Letterkenny, Ireland) has been created as a result of a management buyout of Pharmacia & Upjohn, a full-service contract manufacturer to the healthcare industry. According to director of business development Brian Redmond, Donegal Healthcare is well-positioned to capitalize on the current outsourcing trend in the healthcare industry (see the Special Report in this issue). The one-stop shop, he adds, provides an array of services that include product development, moulding, automated assembly, IV bag manufacturing, packaging, and on-site gamma sterilization. All manufacturing is performed in cleanrooms at the US FDA–registered facility, which is certified to EN 46001 and ISO 9001.
For further information, contact Donegal Healthcare Ltd., High Rd., Letterkenny, Co. Donegal, Ireland; phone: +353 74 22055; fax: +353 74 22915.
Shell Chemicals Combines Product Lines
Shell Chemicals announced the integration of its isoprene rubber (IR) business within the Kraton polymers product range. The creation of Kraton IR elastomers follows a recent Shell Chemicals announcement on the proposed sale of the remaining parts of the general-purpose rubber businesses to Dow Europe (Horgan, Switzerland).
Kraton IR elastomers share many market and application areas with those of the current range of Kraton polymers, including healthcare, skin or food contact, and a variety of adhesive applications where hypoallergenic materials are required. According to company officials, the merger of the two product groups will benefit customers by providing one point of contact for all their needs in these fields.
For more information, contact Shell UK Ltd., Heronbridge House, Chester Business Park, Chester CH4 9QA, UK; phone +44 1244 685000; fax: +44 1244 685010.
Testing Organization Offers Manufacturers Access to Uzbekistan
Intertek Testing Services Ltd. (Cranleigh, Surrey, UK), reportedly the world's largest product and commodities testing organization, has been accredited to test and inspect products for entry into the Republic of Uzbekistan. With this accreditation, the company can provide manufacturers with product safety certification and preshipment inspection. The accreditation was issued by the Uzbek State Center for Standardization, Metrology, and Certification under the Cabinet of Ministers, Republic of Uzbekistan, also called Uzgosstandart, for medical and other product types.
For more information, contact Intertek Testing Services Ltd., Unit 10 Manfield Park, Cranleigh, Surrey GU6 8PY, UK; phone: +44 1483 268800; fax: +44 1483 267579.
EUCOMED Establishes Funding and Reimbursement Group
EUCOMED has formed a new working group on funding and reimbursement. The group, consisting of 14 EUCOMED member representatives, met for the first time on 23 February at the confederation's Brussels offices.
Although actions on individual reimbursement issues will remain the responsibility of national organizations, EUCOMED director-general Michael Baker is hopeful that the new working group will solidify the industry's approach to such issues. "It seems logical to me that we should strive to achieve some form of harmonization, at least on reimbursement procedures within our industry," he says. "The benefits to industry of having just one procedure to be followed rather than a minimum of 15 are obvious," he adds, cautioning that "it may not be possible to harmonize the actual rates of reimbursement."
The immediate short-term objective of the working group is to provide EUCOMED members with overviews on current European reimbursement systems and on existing methods used for the economic evaluation of medical devices. The group will also prepare a series of EUCOMED position papers on issues related to reimbursement.
For more information, contact EUCOMED, Rue du Collège St.-Michel 17 box 8, B-1150 Brussels, Belgium; phone: +32 3 7722212; fax: +32 3 7713909; e-mail: eucomed@eucomed.be.
Where Are the Common Technical Specifications?
Delays continue to plague the publication of common technical specifications (CTSs), which are required for high-risk diagnostic devices under the terms of the In Vitro Diagnostics Directive. "Not all of the government experts have been named to the body that will issue the CTSs, and we still don't know when the first meeting will be held," Maurizio Suppo from MTC Quintiles (Torino, Italy) told ABHI attendees. The analyte-specific performance requirements are quasimandatory for manufacturers of high-risk IVDs. Without them, France and other member states would demand additional national controls for these products, further compromising the principle of market access to devices with a CE marking.
Suppo and Richard Moore, business area director, standardization and environmental affairs, at EUCOMED, also expressed concern that the concept of mandatory performance specifications may spread to other high-risk devices. "If there is dissatisfaction with the quality and timeliness of standards, then this should be addressed, rather than to do away with the new approach principle," said Moore.
MRAs Fail to Live Up to Promise
"If the mutual recognition agreements fail to advance the principle of 'approved once, accepted everywhere,' then they are of little benefit to industry," said Zeger Vercouteren, business area director, commercial affairs, at EUCOMED. Presenting a paper at the ABHI conference, he echoed industry's concern that US FDA has taken an increasingly dominant position within the Global Harmonization Task Force, squeezing out any substantive role for European manufacturers.
Commenting on the progress of global harmonization and mutual recognition agreements, Ian Cutler, director of European regulatory afffairs at Smith & Nephew Europe Ltd. (London), seconded Vercouteren's view. "The potential trading benefits [resulting from the EU and US MRA] are either unclear or dubious," Cutler said.
"The whole concept could be said to be failing," he added, citing as an example the decision of the South American trading bloc MERCOSUR to adopt a regulatory scheme that differs sharply with the EU model.
Legislative Vacuum Hobbles Devices Using Human Tissues
Characterizing the maze of national legislation on the use of human tissues in medical devices as a "dog's breakfast," EUCOMED business area director Richard Moore urged the passage of pan-European legislation to deal with this contentious issue in pace with technological developments. "The technology is moving extremely fast, while industry continues to operate within a legislative vacuum at the European level," he told conference attendees.
EUCOMED and the International Association of Prosthetics Manufacturers soon will issue a draft position paper on this topic, he announced. The paper, he added, will propose that EU legislation cover such areas as donor screening and tissue collection procedures; testing modalities; processing and storage issues; traceability; and labelling, packaging, and distribution matters.
ECRI Offers Telephone Seminars on Y2K
To help healthcare facilities and organizations grapple with the Year 2000 (Y2K) challenge, the Emergency Care Research Institute (ECRI) is hosting a series of Y2K interactive telephone seminars through November 1999. The series will address topics such as contingency planning, noncompliant devices, legal issues, and media relations. All seminars will be held from 13:00 to 14:30 local New York time on the second Wednesday of the month and will include participation by Y2K experts from the medical device industry, hospitals, healthcare systems, and the legal arena.
For more information, contact ECRI, 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA; phone: +1 610 8256000; fax: +1 610 8341275.
MD&M East 99 Returns to New York
The Medical Design and Manufacturing (MD&M) East 99 Conference & Exposition will be held concurrently with the Atlantic Design Engineering show 25–27 May at the Jacob K. Javits Convention Center in New York City.
MD&M will host more than 700 medical OEM suppliers presenting products and services for medical applications. Eight special-feature pavilions will be dedicated to packaging, labelling and bar coding, medical electronics, European markets, CAD/CAM and rapid prototyping, injection moulding, IVD suppliers, and business expansion. A three-day conference will include nearly 50 45-minute sessions, interactive workshops on design and quality assurance, and a full-day track for plastic device manufacturers.
The winners of the 1999 Medical Design Excellence Awards will be announced at a May 26 gala dinner ceremony. Attendees may obtain tickets to the ceremony by contacting Sally Lane at Canon Communications llc, phone: +1 310 4454268; fax: +1 310 4454299; e-mail:
Hosted by Desktop Engineering magazine, the Atlantic Design Engineering show is specifically tailored to meet the needs of engineers, corporate management, and purchasing and marketing departments. Products and services on display will include fastening and joining systems, electrical components, motion control products, fibre optics, and custom assembly systems.
For more information on these events, which are sponsored by Medical Device & Diagnostic Industry magazine, contact Canon Communications llc, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, USA; phone: +1 310 4454200; fax: +1 310 4454299.
ESEM Comes to Barcelona
The European Society for Engineering and Medicine (ESEM) will host its fifth annual conference from 29 May to 2 June at the Hotel Princesa Sofia Intercontinental in Barcelona, Spain. The conference, organized in collaboration with the International Federation for Medical and Biomedical Engineering, will address the theme "Bridging the Two Millenniums." Plenary sessions, roundtable discussions, and presentations are designed to foster interaction among physicians, engineers, and industry representatives.
For more information, contact OTAC S.A., Gran Via Corts Catalanes 454-1r., E-08015 Barcelona, Spain; phone: +34 93 4239408; fax: +34 93 3252708.
