Originally Published May/June 2000
Industry News
- ABHI Conference: Paper Presents Graphic Proof of Hazards Posed by Reused SUDs
- Plastics Supplier Metes Out Microtechnology Materials by the Teaspoon
- Machine Solutions Makes a Bid for Attention
- Software Promotes Implementation of Medical Device Standard
- Conference Notes
- The Year of Living Less Dangerously
- Shows and Conferences
- In Brief
ABHI Conference: Paper Presents Graphic Proof of Hazards Posed by Reused SUDs
Picture this: a cannula protrudes through a tear in its packaging, a pair of curved scissors with cautery is not aligned with the shaft axis, and a catheter hub is coated with a proteinaceous material. Now consider that these devices were found in hospitals and were consequently deemed suitable for use on patients. Reprising a paper on the reuse of single-use devices (SUDs) that he first presented at the recent Global Medical Device Conference in Cancun, Mexico, Peter Schröer of Ethicon Endo-Surgery showed these and similarly disturbing images to attendees of the Association of British Health Care Industries (ABHI) annual conference in London in March.
"This is not a laboratory simulation," stressed Schröer, as he projected magnified images of devices exhibiting an array of defects. "These are images of actual reused devices pulled from hospital shelves." And it was not a pretty picture. For example, of 37 reprocessed devices used in minimally invasive surgical procedures that were examined, 50% exhibited either packaging defects, the presence of contaminants, physical defects, or a combination of imperfections.
In a study on the sterility of reprocessed single-use forceps, researchers Rudolf Reichl and Klaus Roth at Tübingen University (Tübingen, Germany) found that nine out of 10 reprocessed devices were in fact nonsterile. The magnified image shows the wire from an unused device compared with wire from reprocessed forceps.
Contamination and performance issues were illustrated by a reprocessed endoscopic clip applier that was prone to misfiring because of a debris buildup in the clip feed track. The aforementioned curved scissors exhibited not only a 35% misalignment but, upon closer inspection, also revealed a receding protective sheath. Blood and protein contamination, contrast media residuals, and packaging defects were observed among reprocessed catheters taken from German hospitals, reported Schröer. As for 10 single-use biopsy forceps reprocessed by third-party companies and analyzed by staff at Tübingen University, nine of the products were found to be nonsterile.
The results of in vivo thrombogenicity tests conducted on new and reprocessed EP catheter tips by NAMSA were equally damning. A new catheter implanted into a dog's jugular vein for four hours produced minimal thrombosis, while a refurbished model caused slight to moderate thrombosis after only two hours of implantation. "Reprocessed devices that are not adequately cleaned pose a higher risk to patients," added Schröer. "This is in clear conflict with the Medical Devices Directive, which states that medical devices should provide patients, users, and third-parties with a high level of protection and attain the performance levels attributed to them by the manufacturer."
While acknowledging the impact of Schröer's paper, Joseph Putzeys, head of division, directorate general for industrial affairs, European Commission, did raise a caveat during the question-and-answer session following the presentation. "What you're saying is that reprocessing was not done properly in these cases," said Putzeys. "That does not necessarily allow you to conclude that proper reprocessing cannot be done under certain conditions." Putzeys also noted in passing that commercial considerations are not entirely absent from manufacturers' decisions to label some products for single use. Nevertheless, he continued, the European Commission cannot countenance the refurbishment of medical devices without proper controls. "It makes no sense to require manufacturers to submit to rigorous quality controls and not the reprocessors," Putzeys said.
—Norbert Sparrow
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Plastics Supplier Metes Out Microtechnology Materials by the Teaspoon
Custom materials for microcomponents are not only expensive to develop, they are often used in such minuscule quantities that their production is not economically attractive to major materials suppliers. Sensing a market gap, a German group recently formed a new company to develop and supply customized plastics for special applications.
This 50-µm-diam hole was produced by laser machining a new polymer developed by Polymaterials AG. The material features reduced levels of debris during precision machining and is suitable for use in microdiagnostic and analytical equipment.
Operating on the principle that less is more, scientists at Polymaterials AG (Kaufbeuren, Germany) create and produce customized polymers in small amounts for both customer projects and proprietary purposes. The company's services include consulting, feasibility studies, screening, R&D, analysis, laboratory synthesis, and production in quantities up to several tons.
State-of-the-art research and analysis laboratories and a staff of experienced chemists make the company well equipped for such activities. "If a polymer is made, was made, or can be made, then we can get it," says Roland Rehmet, executive board member and principal chemist at Polymaterials. He adds that the company recently constructed a miniplant for custom materials with a production capacity of 10–20 kg. Current projects include the development of a special polymer for the production of lab-on-a-chip products by laser etching, as well as the creation of analyte-specific polymers for microsensors. The company is also working on bespoke materials for microinjection moulding applications.
Rehmet views the company's small staff as a distinct advantage in this field. "Our team is small, but very efficient," he says. "Large-scale industry does not do this type of research—it's not profitable for them, because they have high overhead costs," he adds. Still, Rehmet notes that his firm's strong contacts with major polymer producers will serve it well. "We have partners who can produce large quantities if they are needed," he says, adding that the scientific advisory board of Polymaterials includes several plastics experts from well-known academic and industrial research groups.
According to Rehmet, an increase in the demand for custom materials is a natural evolution in the R&D domain. "Until now, many problems could be solved by engineering," he says. "But now, these engineering solutions are calling for specialized polymers with specific parameters." Rehmet adds that it is possible for a company to perform in-house R&D for as long as two years and still be at a loss for a material.
For more information, contact Polymaterials AG, Sudetenstr. 5, Kaufbeuren D-87600, Germany; phone: +49 8341 916700; fax: +49 8341 916719; e-mail: info@polymaterials.com.
—Benjamin Lichtman
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Machine Solutions Makes a Bid for Attention
Medical technology will meet the Internet this June during the Medical Design & Manufacturing (MD&M) East 2000 Conference and Exposition. Machine Solutions Inc. (Flagstaff, AZ, USA) plans to auction a Torminator stent-crimping machine on the eBay Web site. The auction will coincide with the MD&M trade show in New York City, opening 6 June and closing 8 June.
The Internet auction of a stent-crimping machine will conincide with MD&M East show in New York City.
Machine Solutions specializes in custom machine design for the catheter industry. Daniel Kasprzyk, president of Machine Solutions, came up with the idea of auctioning the Torminator at MD&M West in Anaheim, CA, USA, in January. The company received many requests for the product at the show. As a smaller company, Machine Solutions typically builds units only after orders are received, with manufacturing resulting in a four- to six-week lead time. By building the machine and then auctioning it off, the company can shave weeks off the delivery time, satisfying requests for the Torminator at a faster rate.
The eBay auction also provides another avenue for the company to inform OEMs about the Torminator. "We were looking for creative ways to get the word out on the product," explains Kasprzyk. Between the MD&M shows and the Internet, it looks like Machine Solutions will achieve its goal.
For more information, contact Machine Solutions at 2700 Woodlands Village Blvd., Flagstaff, AZ, 86001, USA; phone: +1 520 5229043; fax: +1 520 5263945; e-mail: machsolns@aol.com.
—Jodi Triplett
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Software Promotes Implementation of Medical Device Standard
A software tool has been released to aid medical device designers in the implementation of a medical information bus standard. The software can be downloaded free of charge from the Institute of Electrical and Electronics Engineers (IEEE; Brussels) or right here on Medical Device Link.
The program is being offered to the medical device industry as a tool to assist in the design, development, and testing of medical device communications software in compliance with the IEEE 1073 Medical Information Bus standard. Adoption of the standard will allow clinicians to link patient-connected bedside medical devices to a bedside patient-monitoring device or a computer network. The standard will permit comprehensive data capture from devices such as infusion pumps, ventilators, and patient monitors, with the goal of improving patient safety and reducing medical errors.
"Our intent is to target intensive-care applications, where clinicians have several devices operating in a critical setting, and plug-and-play capability is absolutely vital," explains Bob Kennelly, executive director of the Medical Device Communications Industry Group (MDCIG), a branch of IEEE. "Clinicians need to be able to capture data across a range of devices," he says.
The most recent version of the software is focussed on infusion pump applications and was designed by Agilent Technologies (Meyrin, Switzerland), one of five sponsor members of the MDCIG. The other members are Alaris Medical Systems (Basingstoke, Hants, UK), Baxter S.A. (Brussels), GE Marquette Medical Systems (Freiburg, Germany), and Siemens Medical Systems (Erlangen, Germany). The MDCIG was created to accelerate, promote, and support the adoption of the IEEE 1073 standard. The group was formed as a programme of the IEEE's Industry Standards and Technology Organization.
For more information, contact IEEE's European Service Centre at 13 Ave. de l'Aquilon, B-1200 Brussels, Belgium; phone: +32 2 7702242; fax: +32 2 7708505; e-mail: b.kennelly@ieee.org.
—Benjamin Lichtman
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CONFERENCE NOTES
New MDA Head Stresses Partnership with Industry
Replacing Alan Kent, who resigned in February as chief executive of the Medical Devices Agency, David Jefferys told attendees at the Association of British Health Care Industries (ABHI) conference that he intends to build on the success of the UK agency by working in concert with manufacturers. Noting that the fast pace of technology will raise myriad new issues in the next five years, Jefferys emphasized that "regulation must encourage innovation, not impede it. We must not generate unnecessary red tape, but at the same time we must promote public confidence," he said. The best way to achieve this set of goals, he added, is in partnership with industry.
"Regulation must encourage innovation, not impede it," stressed David Jefferys, the new head of the UK Medical Devices Agency.
Following a career in clinical and academic medicine, Jefferys joined the medicines division of the UK Department of Health in 1984. With the creation of the Medicines Control Agency in 1989, Jefferys was appointed head of New Drugs European Licensing and was subsequently named director of the licensing division.
Don't Jeopardize Voluntary Nature of Standards, Cautions Putzeys
While applauding the overall success of the New Approach directives, Joseph Putzeys, head of division at the EC directorate general for industrial affairs, sounded the alarm on two fronts that he said "still required attention." In particular, incidents of noncompliance with the basic principles of risk analysis by some certification bodies must be addressed, he noted.
Joseph Putzeys from the European Commission acknowledged that not all notified bodies are equally qualified.
"Nonstandard solutions are an important element for fostering innovation," Putzeys told ABHI conference attendees, "but certification bodies are using standards rather than the essential requirements to certify some critical products." Consequently, voluntary standards are in danger of becoming de facto mandatory standards, he said, thus jeopardizing the intent of the New Approach directives. "Perhaps we need product-specific standards to counter this trend," he mused, quickly adding that he was not personally convinced of the necessity. "Let's discuss it and find an appropriate means to establish new mandates, new harmonized standards," he added, rather than improvising perilous precedents.
Putzeys also weighed in on the competence of notified bodies, recognizing that verification of notification procedures in member states is reaching critical mass, especially in light of the mutual recognition agreement with the United States. It's no secret that there can be considerable differences among notified bodies in terms of qualification, training, and procedures, he noted, adding that this is a "dangerous but unavoidable discussion."
Putzeys announced that discussions are under way involving additional safeguards for a limited number of critical devices. Prefacing his comments by stressing that it is premature to draw any conclusions, Putzeys said that there are a handful of critical products where the issue of proper evaluation has been raised. "In fact, this involves more than the public authorities and really gets into user perceptions and public opinion," he said. "We would not consider calling into question the relationship between the notified body and manufacturer as it is defined today," added Putzeys. "Perhaps the notified body could be asked to submit its report to a review panel," he suggested, adding in strong terms that retesting was not under consideration as part of this process.
Understanding Healthcare Technology Assessments
By now industry should be well aware of the increasingly fundamental role that healthcare technology assessments (HTAs) are destined to play in the commercial viability of medical equipment. Presenting a primer on the modalities and procedures of HTAs, Ann-Marie McIntyre, senior manager at the US-based Lewin Group consultancy, stressed that the aim of an HTA is "not to save money by denying services or to sacrifice individual gains for some public good, but to promote a more rational use of healthcare services." HTAs are a fact of life, she added, and it is essential that the value of a new technology be demonstrated in an appropriate format to the correct audience. Easier said than done, perhaps, but manufacturers may find some useful information on the following Web sites mentioned by McIntyre.
Healthcare technology assessments are something that device manufacturers will have to learn to live with, Ann-Marie McIntyre of the Lewin Group consultancy told ABHI delegates.
The International Network of Agencies for Health Technology Assessment (INAHTA) is a worldwide network of more than 30 agencies and institutions compiling hundreds of comprehensive assessments. A European network is under construction.
The International Society of Technology Assessment in Health Care (ISTAH) adopts an interdisciplinary and international approach to HTA, focussing as much on economic, social, professional, and ethical factors as on technical considerations.
—Norbert Sparrow
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The Year of Living Less Dangerously
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| Christopher Hodges |
the Association of British Healthcare Industries annual conference. "Talk to the media," he urged attendees. "Once the general public is aware of this issue, it will exert pressure for the implementation of regulation," said Hodges. Manufacturers interested in obtaining the tool kit should contact their national trade association or EUCOMED.
Shows and Conferences
Chicago Hosts 23rd NPE Plastics Event
The NPE plastics exposition and conference, a triennial event sponsored by the Society of the Plastics Industry Inc., will take place this year at McCormick Place in Chicago (IL, USA) 19–23 June. More than 2000 exhibitors, 25% of which will be international companies, will occupy more than 1.1 million sq ft. Exhibitors will include suppliers of primary processing and auxiliary equipment; machine and mould components; mould-making services; resins and compounds; and additives, fillers, and reinforcements. The event is expected to attract more than 85,000 visitors from 100 countries. The conference will feature topics such as technology advances in materials, equipment, tool making, processing, and design; development in end-use markets; and equipment purchasing, e-commerce, global competitiveness, and site selection.
For more information, contact the Society for the Plastics Industry Inc., Trade Show Dept., 1801 K St. N.W., Ste. 600K, Washington, DC 20006-1301, USA; phone: +1 202 9745235; fax: +1 202 2967243; e-mail: tradeshows@socplas.org.
Brazil Welcomes Hospitalar 2000
Hospitalar 2000, the seventh international fair for products, equipment, and services for hospitals, health clinics, and laboratories, will be held at the Expo Centre Norte, São Paulo, 27–30 June. At least 550 exhibitors and 50,000 visitors are anticipated to participate in the event. This year's fair will be co-located with Diagnostica, which will showcase products, equipment, and services for clinical tests and pathology. A structural systems and installations exhibit will feature simulations of systems, specialized areas, and processes used in the construction of hospitals, clinics, and laboratories.
For more information, contact Messe Düsseldorf GmbH, Stockumer Kirchstr. 61, D-40001 Düsseldorf, Germany; phone: +49 211 456001; fax: +49 211 456087717; e-mail: nhoekstra@mdna.com.
MD&M East Returns to New York City
The Medical Design and Manufacturing (MD&M) East 2000 Conference and Exposition returns to New York City on 5–8 June. The event, hosted by the Canon Communications family of design and manufacturing publications, will be held at the Jacob K. Javits Conference Center.
MD&M displays will include 260 contract manufacturers; 70 assembly, manufacturing, and CNC equipment exhibitors; 40 QA/QC and testing and inspection exhibitors; 30 sterilization equipment manufacturers and service providers; 30 raw material suppliers; and 25 adhesive manufacturers. Special-feature pavilions will highlight medical electronics, MEDPACK, automation technology, IVD suppliers, and medical equipment networking. The three-day conference will focus on topics such as e-commerce, US FDA and guidance and global approval, process validation, outsourcing, risk analysis, and design control.
MD&M will be co-located with the Atlantic Design Engineering show, sponsored by Desktop Engineering magazine, which will feature CAD/CAM/PDM and contract manufacturing pavilions.
For more information, contact Canon Communications llc, 11444 W. Olympic Blvd., Los Angeles, CA 90064-1549, USA: phone: +1 310 4454200; fax: +1 310 9969499.
—Michelle Stuckey
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In Brief
Nice Move for Nusil
Nusil Technology Inc. (Anglet, France) has announced that it is relocating its European Technical Centre from Arklow, Ireland, to Sophia Antipolis near Nice, France. The 1200-sq-m facility, which features enhanced research and manufacturing capabilities, will serve as a technical solutions centre for customers' application needs, according to general manager Greg Lee. Operating in conjunction with its European headquarters in Anglet, France, which will continue to render administrative, technical sales, marketing, and regulatory support, the Côte d'Azur location will enable the company to rapidly respond to its European clients, Lee added. The facility is expected to be fully operational by the third quarter of this year.
Nusil is a supplier of silicone raw materials to the medical device and other high-technology industries.
For more information, contact Nusil Technology Europe, Atlantic Parc, Les Pyramides No. 5, F-64600 Anglet, France; phone: +33 559 314104; fax: +33 559 314105; e-mail: nusil@europe.wanadoo.fr.
ECRI Publishes Needlestick-Prevention Guide
The Emergency Care Research Institute (ECRI; Plymouth Meeting, PA, USA) has released the "Health Devices Needlestick-Prevention Device Selection Guide," a comprehensive special report on needlestick-prevention device (NPDs) technologies designed to help healthcare facilities comply with recent changes in regulations. The report features comparative evaluations such as brand-name ratings for more than 45 NPDs, which are available in 11 different device categories. Evaluations include supplier and cost information, product descriptions, and results of testing and analyses conducted by ECRI. The report also includes regulatory updates and selection and use guidance. Worksheets and other compliance tools offer users assistance in complying with the U.S. Occupational Safety and Health Administration's (OSHA) recently revised bloodborne pathogens compliance directive, as well as with new legislation in several states, all of which encourage the use of safer medical devices in order to reduce needlesticks.
ECRI is a nonprofit international health services research agency and a collaborating center of the World Trade Organization that provides information and technical assistance to the healthcare community.
For more information, contact ECRI, Weltech Centre, Ridgeway, Welwyn Garden City, Herts AL7 2AA; phone +44 1707 871511; fax: +44 1707 393138; e-mail: info@ecri.org.uk.
Vacuum Insulation Association Formed
The Vacuum Insulation Association (VIA; Arlington, VA, USA) was recently formed to promote communication, research, and education regarding the commercial use of vacuum insulation technology. Members of the new international trade association include component material suppliers as well as fabricators and end-users of vacuum insulation products.
Vacuum insulation systems enclose porous, thermally resistant products in impermeable vacuum containment systems. The technology is particularly suited for applications that require thin, lightweight, high-performance insulation.
For more information, contact VIA, 1600 Wilson Blvd., Ste. 901, Arlington, VA 22209, USA; phone: +1 703 5164506; fax: +1 703 8128743; e-mail: staff@vacuuminsulate.org.
Free Access to NEMA Standards Available On-Line
The Industrial Automation Control Products and Systems section of the National Electrical Manufacturers Association (NEMA) is sponsoring a programme that provides free access to industry standards via the Internet on a one-year trial basis. Users can view or download the automation and control standards through NEMA's Web site. The standards are similar to those of the International Electrotechnical Commission (IEC), but have been specifically developed for US electrical system requirements.
For more information, contact NEMA, 1300 N. 17th St., Ste. 1847, Rosslyn, VA 22209, USA; phone: +1 703 8413200; fax: +1 703 8413300; e-mail: webmaster@nema.org.
—Michelle Stuckey
