International Vigilance System Is Globally on Track
A pilot project may speed the advent of a harmonized adverse-event reporting system, US FDA's Larry Kessler announced at MEDTEC.
Norbert Sparrow
Within the next three to five years, manufacturers around the world will be able to submit one adverse-event report to the worldwide community, according to Larry Kessler, director of the Office of Surveillance and Biometrics at US FDA's Center for Devices and Radiological Health. "Harmonization is just around the corner," Kessler told attendees at MEDTEC, an exhibition and conference devoted to Europe's medical device manufacturing industry that was held recently in Amsterdam.
Since 1995, the development of a harmonized vigilance and postmarket surveillance system has been the mandate of Study Group 2 (SG2), which Kessler chairs, of the Global Harmonization Task Force. Its efforts will be put to the test when an international vigilance pilot is launched, possibly as early as January 1, 1999. Kessler summarized the progress made by SG2 and touched on some of the remaining issues during a keynote address transmitted live via satellite to the RAI International Exhibition and Congress Centre from his office in the United States.
During the session, Kessler cited some SG2 milestones that made the pilot feasible. In particular, he lauded the study group's development of standardized reporting rules and an 11-step decision tree that enables manufacturers to ascertain whether an event is reportable worldwide by answering a series of yes-or-no questions. SG2 has also established a minimum data set that outlines the requisite elements of an adverse-event report along with a form, modeled after EU vigilance reports, that is designed to streamline communication between competent authorities. The sum of these parts, according to Kessler, represents a promising structure for a coherent global reporting system.
Once the pilot gets under way, manufacturers should not be surprised to start receiving calls from competent authorities in third countries, he stressed. "A French manufacturer, for example, may well be contacted by a German competent authority regarding an adverse event associated with his equipment," said Kessler.
National Differences Stymie Harmonized Reporting
At various sessions throughout the three-day conference, however, members of industry and regulators raised questions about some of the finer points that harmonized procedures must resolve if the endeavour is to succeed. The types of adverse events that rise to the level of a vigilance report, the status of user error, and the circumstances under which vigilance reports may be made public were among the provocative issues that fueled lively discussions during the three-day conference.
Jaap Laufer, president of European Medical Device Consultants (Eerbeek, Netherlands), voiced concerns regarding the selective reporting of complaints at a session he chaired on worldwide adverse-event reporting. Laufer stressed that industry currently relies on a patchwork of documents that often provide contradictory guidance for the reporting of events. In particular, "national differences in reporting criteria currently make adverse-event reporting about as harmonious as the former Yugoslavia," he wryly noted. Of foremost concern, according to Laufer, are interpretive differences at the regulatory and company levels, overreporting by less experienced companies, and the actual versus perceived risk of certain devices such as breast implants and engineered heart valves. "The system is doomed to function inefficiently until a framework is established that is embraced by everyone," Laufer added.
The extent to which user error should motivate an adverse-event report initially pitted US authorities against their EU counterparts within SG2. "There was a significant difference of opinion," acknowledged Kessler. "The United States held the view that any information about user error would be welcome but not relevant to reporting decisions, whereas the European Union took the position that the event was not reportable if the manufacturer could document user error as the cause of the adverse event." SG2's current position maintains that pure negligence is not reportable, but that other user errors that have resulted or could result in death or serious injury should be reported. "We are discussing now where to draw the line in this complex area," Kessler added.
How Much Does the Public Need to Know?
Presenting the device manufacturers' point of view at a session devoted to risk analysis and postmarket surveillance, director of European regulatory affairs for Guidant Europe N.V./S.A. (Zaventem, Belgium) Philippe Auclair stressed the importance of carefully evaluating information before it is disseminated. "The exchange of information among competent authorities has been inaccurate and misleading in some instances," said Auclair, "and this can be extremely damaging to a company if it is made public." Auclair argued that manufacturers should be given the opportunity to review information relating to adverse events before it is distributed to the public. He also stressed that only information relevant to the user should be released. Misinformation, he added, is of particular concern when innovative devices are targeted. "These products may present greater risks, but they also provide greater benefits," said Auclair, who cautioned authorities against inadvertently compromising technological progress by establishing ill-conceived vigilance procedures.
That point was echoed by Jacob Norden, special advisor on medical devices to the Norwegian Board of Health. The premature release of information "could irrevocably harm the manufacturer," he said at a session on adverse-event reporting. "And we should not forget that 80% of adverse incidents are the result of user errors," he added.
These and related issues will be addressed within the framework of the international vigilance pilot, according to Kessler. In particular, pilot participants will meet to evaluate the system's strengths and weaknesses—and tweak the process accordingly—after the pilot has been running for several months, Kessler added. All of the countries represented in SG2—the United States, Canada, Japan, Australia, Germany, the United Kingdom, France, Belgium, Switzerland, Norway, and the Czech Republic—are eligible to take part in the pilot. Thus far, the participation of the United States, Japan, Australia, the United Kingdom, Germany, and Norway is still awaiting approval.
MEDTEC will return to the RAI International Exhibition and Congress Centre in Amsterdam on 21–23 September. The show is organized by Canon Communications llc and sponsored by European Medical Device Manufacturer. For more information, contact MEDTEC, P.O. Box 12997, London NW5 2WX, UK; phone: +44 171 4854343; fax: +44 171 2672788.
DuPont Establishes Medical Packaging Subsidiary
DuPont (Wilmington, DE, USA) has signed a letter of intent to purchase Kenpak Inc. (Commerce, CA, USA), a manufacturer of sterile packaging. Kenpak will become part of a newly created, wholly owned subsidiary called DuPont Medical Packaging Systems Inc., also headquartered in Wilmington.
The subsidiary will focus on meeting the primary packaging needs of device manufacturers by offering finished products such as pouches, header bags, and rollstock for form-fill-seal operations. DuPont will continue to provide rollstock of Tyvek spunbonded olefin to sterile packaging manufacturers.
The acquisition of Kenpak and creation of DuPont Medical Packaging Systems, according to DuPont Tyvek global business director Mike F. Donnelly, will enable the company to broaden its capabilities. Through this buyout, DuPont gains access to Kenpak's proprietary and patented package designs, its technology for uncoated sterile packaging, and the company's proprietary high-speed machinery for the manufacture of sterile packaging products.
For more information, contact DuPont Medical Packaging Systems Inc., Chestnut Run Plaza, Laurel Run Building #705, P.O. Box 80705, Wilmington, DE 19880-0705, USA; phone: +1 800 4489835; fax: + 1 302 9993788.
European Device Database Pilot Launched
A comprehensive CD-ROM database that compiles information on suppliers of medical devices, market studies, hazard reports, and test results is currently being piloted in Germany, the UK, Italy, Portugal, Greece, and Cyprus. The project, which was launched in early December, is modelled after MedPro, a CD-ROM that is distributed quarterly by TNO Prevention and Health (Leiden, Netherlands) to Dutch healthcare institutions.
MedPro provides its subscribers with detailed information on available medical equipment as well as test results indicating the quality, usefulness, and safety of the devices. Archived hazard reports are included; subscribers also receive a weekly update via the Internet comprising recently issued reports and information on upcoming conferences and exhibitions. According to TNO engineer Chris van Nimwegen, approximately half of all Dutch hospitals receive the CD-ROM.
A demo CD-ROM of the proposed European database, called Euro-MedPro, is available from the company. The demo, which is currently limited to defibrillators, includes data from various European countries and features full database functionality. User-interface language on the demo is optional. English, German, Italian, Dutch, and Greek languages are available now, and others will be offered.
The prototype database for Europe is a product of the EC-sanctioned Biomedical Equipment Assessment and Management (BEAM) project, of which TNO is a member.
To receive a demo copy of Euro-MedPro or for more information about the pilot project, contact Chris van Nimwegen, TNO Prevention and Health, Technology in Health Care Div., P.O. Box 2215, NL-2301 CE Leiden, Netherlands; phone: +31 71 5181266; fax: +31 71 5181902; e-mail: chr.vanNimwegen@pg.tno.nl.
Packaging Sessions Focus on Environmental Issues
Device companies will need to consider the design requirements of the Packaging and Packaging Waste Directive (PPWD) for medical devices that are now in development, said Jean-Louis Evans of Viridis Medical Strategies (London). Evans outlined the key issues involved in complying with the PPWD during MEDTEC sessions devoted to packaging.
"Whereas in the past, environmental factors were one of many parts of the marketing mix that had to be assimilated in product and packaging design, the directive has now provided a legal basis for these requirements," Evans said.
Of primary concern to device manufacturers is the directive's mandate to limit packaging volume and weight along with an emphasis on design and production methods that facilitate reuse or recovery and that minimize the presence of noxious or other hazardous substances that may be released during incineration or landfill.
The directive is being transposed by member states in a piecemeal fashion. Because there is no notified body system for the PPWD, device companies will need to demonstrate compliance in each country. In addition, each authority may adopt a different interpretation of what packaging is, how strictly the law will be applied, and how much evidence is needed to demonstrate compliance.
One of the significant challenges presented by the directive is the logistics of collecting and organizing data to demonstrate compliance. Because many people are involved in making decisions related to packaging—design engineers, packaging engineers, purchasing managers, and transport managers—much of the information is decentralized, Evans said. Often, the people who have information about the packaging material's weight and ability to be recycled or recovered are not the same individuals who have to demonstrate compliance to authorities. Device manufacturers will need to set up an information management system to collect the data and make it available to regulatory or environmental managers in Europe, Evans said. Ideally, he added, the responsibility should be decentralized and integrated into existing management systems.—Amy Allen
Display Specified for Robotic Surgery System
A high-resolution 14-in. colour medical display has been selected for a minimally invasive surgical system that uses proprietary electronics, robotics, and visualization to execute complex surgical procedures. The display manufactured by Barco N.V. (Kortrijk, Belgium) was chosen for its image quality, stability, and reliability, according to Intuitive Surgical Inc. (Mountain View, CA, USA), which produces the surgical device. Barco's high-resolution medical displays feature a unique circuitry design and calibration system that enables the reception of high-quality images necessary in colour-critical medical applications.
The Intuitive system comprises a viewing and control console, which houses dual Barco displays that produce a stereoscopic 3-D image of the surgical field, and a surgical arm unit that positions and manoeuvres the surgical instruments. Seated behind the console, the surgeon handles instruments with the same flexibility as those attached to the robotic arm; by means of highly specialized technology, the surgeon's hand movements are replicated by the surgical arm at the operation site.
The unit has been used to successfully perform computer-enhanced open-heart operations in France and Germany, as well as general surgical procedures in Belgium. It is currently awaiting FDA clearance in the United States.
For additional information on the medical displays, contact Barco N.V., Display Systems, Kortrijk, Belgium; phone: +32 56 233579; fax: +32 56 233460; e-mail: ann.galland@barco.com. To learn more about the surgical system, contact Intuitive Surgical Inc., 1340 W. Middlefield Rd., Mountain View, CA 94043, USA; phone: +1 650 2377000; fax: +1 650 5262060.
Supplier of Machining, Coating Services Launches Expansion Effort
AUS-based company specializing in ultraprecision machining of miniature and subminiature components and surface treatment services has announced that it is expanding its marketing efforts in Europe. Norman Noble Inc. (Highland Heights, OH, USA), which currently does business with medical device manufacturers in Germany and the Netherlands, has appointed Med-Net GmbH (Münster, Germany) as its European representative.
Equipped with lasers, Swiss-type automatic lathes, and high-speed small-hole EDM, CNC, and conventional machines, Norman Noble collaborates with engineers and medical professionals on projects that range from prototyping to high-volume production. The company also offers in-house programming, heat treatment, finishing, and laser marking services.
Surface treatments available for medical devices include superhard USP Class VI coatings for stainless steel and aluminium and an electropolishing process that brightens, deburs, and passivates stainless steel, titanium, and nitinol.
With expertise in the production of components ranging from 1-mm-diam stainless-steel medical washers to bone saw guides, Norman Noble's stated goal is to establish itself as a single-source supplier for the machining, coating, finishing, and laser marking of devices throughout Europe.
For more information, contact Norman Noble Inc., 5507 Avion Park Dr., Highland Heights, OH 44224, USA; phone: +1 216 7615387; fax: +1 216 7610455.
High-Impact Acrylic Alloy Is Just What Doctor Ordered
Athermoplastic alloy supplied by CYRO Industries (Rockaway, NJ, USA) has been specified for a portable binocular headlight developed by an Australian otolaryngologist and Welch Allyn Inc. (Skaneateles Falls, NY, USA). The diagnostic device, which offers three-dimensional viewing into small cavities for general ear, nose, and throat examinations and related procedures, is designed to be worn on the head or mounted on a pair of glasses. Consequently, specifications for the LumiView called for a lightweight, comfortable, and durable material, says Neil Hoselton, commodity manager of plastics for Welch Allyn.
Welch Allyn investigated ABS, polycarbonate, and PC/ABS blends before settling on the CYREX 200-418 black alloy. "Polycarbonate is susceptible to flow lines," says Hoselton, and the product needed to be free of cosmetic defects. In addition, the material also gave Welch Allyn a colour option that "provided a high-gloss surface, easily achievable with mould temperatures between 150° and 200°F."
Because the device is prone to much handling and dropping, impact resistance was also a consideration. That also worked in the material's favour, notes Hoselton, because its notched Izod impact strength is almost double that of polycarbonate. "High impact properties, as well as excellent resistance to alcohol and lipids, were major factors in our choice," says Hoselton.
Other features of the material include low processing temperatures, a lower specific gravity than polycarbonate, high heat-deflection temperature under load, low shrinkage, and easy conversion from polycarbonate, ABS, and PC/ABS moulds.
For more information about CYREX alloys, contact CYRO Industries, 100 Enterprise Dr., Rockaway, NJ 07866-5055, USA; phone: +1 800 6315384; fax: +1 973 4426117.
