Industry news
Millennium Bug: Problem May Be Overstated, but Device Manufacturers Should Exercise Vigilance
Janet R. Purdy
Does your medical device conceal a time bomb that is implacably ticking away until 31 December 1999 when it will . . . do what exactly? Continue operating normally? Or will it shut down, possibly endangering the life of a patient? No one is really sure how dramatically the millennium bug, also known as the year 2000 or Y2K bug, will affect the medical device industry. That uncertainty is but one of the troubling aspects of the issue.
The problem results from computer programmers attempting to save precious machine memory by using two spaces instead of four to record a year. Consequently, 2000 is signified by 00, which could create chaos in a program that may presume a wrinkle in time has occurred and that we are now back in 1900. Or, confused by the code, the machine may simply lock up.
Finding a Needle in a Haystack
While experts dispute the estimated global cost of exterminating the bug-- somewhere between US$600 billion and US$1 trillion--few disagree that medical device manufacturers need to deal with it in an expeditious and responsible manner. "We do not believe the year 2000 bug to be a very serious problem for the medical device field," says Bo Höjdefors, principal administration officer of the medical devices section of Sweden's National Board of Health and Welfare in Stockholm. At a hospital with 10,000—12,000 devices, "maybe 50 will need fixing. But first you have to find them. It's like looking for a needle in a haystack," Höjdefors continues. "The sharpest needle (i.e., a critical device) could be dangerous when you hit it. But you must try to find it where it's most critical."
What may be at stake are patients' lives as well as a company's livelihood. Annex I of the Medical Devices Directive requires manufacturers to evaluate and correct problems such as those caused by the millennium bug and holds them responsible for ensuring that devices do not compromise the clinical condition or safety of patients or users during the lifetime of the device. "Manufacturers need to look at the requirements in the directive," says Höjdefors. "Small companies are especially at risk," he adds, because they often lack the resources to deal with such issues.
UK Regulators Recommend Documenting Risk Analyses
Medical device regulators in the UK are advising manufacturers to do a risk analysis of their products and to document this work in accordance with Annex I. "Check that this work meets the letter of the law," says Trevor Lewis, head of Medical Device Consultancy (Cardiff, UK). "Authorities believe the problem affects only a small number of devices. But manufacturers need to check in the mirror and see whether it affects them or not."
In addition to evaluating each device, manufacturers should analyze the design, manufacturing, and testing processes, Höjdefors adds. Companies producing devices that use embedded software need to check this software as well, Lewis advises. "Some products that don't have software may not be affected. But if a product works with dates, the year 2000 may confuse or stop a machine."
Even devices that do not output information with a date or rely on a date to be programmed could be affected. "The medical systems most likely to be affected will be those with results or measurements that are logged against time and date stamps, such as infusion pumps and other monitors or systems with automated calibration timers," says Steve Melton, operations manager of the consultancy ERA Technology Ltd. (Leatherhead, UK). But even systems that seemingly do not use dates may be at risk, Melton continues. For example, "designers may have used generic devices with built-in date functions that are not needed for the specific applications [and which may not be displayed to the user]."
Hans Wenner, an engineer with Eurocat Institute for Certification and Testing, a private medical device consultancy in Rossdorf, Germany, concurs: "Of course, many devices are not using a date to calculate what to do. But the devices are calculating time with the help of real-time clocks," he says. "And what might happen if a syringe pump with an insufficient RTC is used at the millennium change?"
Prioritize Patient-Connected Devices
Instead of panic, experts advise thoroughness. "We have a risk. And the only practical way forward is to look at the criticality of a system based on the consequence of a malfunction," Melton stresses. "If that consequence is deemed to be severe, then carry out an engineering investigation to establish its precise status."
Melton, Wenner, and others believe that patient-connected devices should be given special attention. "If an accounting system breaks down, it is a monetary problem," Höjdefors says. "But if a radiation therapy unit gives a wrong dose, it could be life threatening."
This raises a broader issue, he adds. What if a device is connected to equipment or systems with an untreated millennium bug? For example, consider a patient who is hooked up to an ECG or other type of recorder that collects and digitizes a signal. That signal is transmitted to another piece of equipment, where it is compressed and then sent to a storage system, from where it can be retrieved and examined at a later date. "Your device may look compliant," Höjdefors says. "But it's important to check all links in the chain for the possibility that your device might export the wrong data in two years."
US FDA has also suggested a course of action in a letter from Bruce Burlington, director of the agency's Center for Devices and Radiological Health. The guidelines can be accessed on the Internet at http://www.fda.gov/cdrh/yr2000.html.
Experts advise manufacturers to get started now on their risk assessments, testing, and corrections. In addition, they should develop "contingency plans," Höjdefors says. "What will you do on 1 January 2000 if some of your devices stop working?" It's too late then to analyze all of the equipment, he adds. If you haven't begun yet, identify the most critical systems and devices, and treat them first.
For more information:
Medical Device Consultancy, 6 Bessborough Dr., Cardiff CF1 7NE, UK; phone: +44 1222 221640; fax: +44 1222 221579.
ERA Technology Ltd., Cleeve Rd., Leatherhead, Surrey KT22 7SA, UK; phone: +44 1372 367000; fax +44 1372 367009.
Eurocat Institute for Certification and Testing, Arheilger Weg 17, D-64380 Rossdorf bei Darmstadt, Germany; phone: +49 6154 699330; fax: +49 6154 699350.
Polymer Compounder Constructs
New Facility
Laporte Worldwide Compounding Group, a recent consolidation of Laporte-AlphaGary Ltd. (Syston, Leics, UK), A.W. Compounders (Stoney Creek, ON, Canada), and AlphaGary Corp. (Leominster, MA, USA), is constructing a new plastic compounding plant on a 10-acre site in Melton Mowbray, Leics, UK. The US$20 million facility, which will be located nine miles east of Laporte-AlphaGary Ltd., will serve as a manufacturing facility for the firm's complete product line, including thermoplastic and elastomeric compounds, and promises to nearly double the company's manufacturing capacity.
A key aspect of the new Melton Mowbray facility will be its division by a concrete wall into two plants for the separate production of regulated and nonregulated products, according to Lane Shaw, general business manager for regulated and medical markets. "It is important for us to have a totally isolated site for the development of our medical and food products," says Shaw. "Our customers are getting an FDA-compliant material even to the parts-per-billion range. We don't want to take any chances with cross-contamination between plants."
The Melton Mowbray facility is projected for start-up in the first quarter of next year, and should be fully operational by June, according to the firm. "The Syston plant," says Shaw, "will be closed when the new plant opens for business, and the existing equipment will be transferred."
For more information, contact AlphaGary Corp., 170 Pioneer Dr., Leominster, MA 01453, USA; phone: +1 978 5378071; fax: +1 978 8400856.
Europe's Medical Associations Present Common Front
The boards of directors of EUCOMED, the International Association of Prosthetics Manufacturers (IAPM), and EUROMCONTACT have announced that they are engaging in discussions to explore the possibility of integrating their activities and creating a single European organization. In a joint statement of intent, the associations' management declared that "EUCOMED, IAPM, and EUROMCONTACT are committed to work together to create a single organization capable of representing their sectors of the medical device industry in Europe. Such an organization will ensure effectiveness by focusing on specific technologies guaranteed by an organizational structure with adequate representation of sectoral interests."
The associations have also extended an invitation to other sectoral interests within the industry to participate in the dialogue. Thus far, the European Diagnostics Manufacturers Association reportedly has expressed interest in joining the discussion.
A review of organizational matters is currently being conducted by a working group that is expected to submit a final report and recommendations to the management steering group by the end of the year. The balance of the year, according to the joint statement, will be devoted to confidence building among the associations' members.
For additional information, contact EUCOMED, Rue du Collège Saint-Michel 17, B-1150 Brussels, Belgium; phone: +32 2 7722212; fax: +32 2 7713909.
New Biomedical Innovation Centre Anchors R&D Complex
Sahlgrenska Biomedical Innovation Centre (Göteborg, Sweden), a new biomedical research facility, has opened in proximity to Göteborg University, Chalmers University of Technology, and Sahlgrenska University Hospital, creating Medical Hill, a unique R&D complex in the Göteborg region.
Sahlgrenska Biomedical functions as a cross-disciplinary unit between the universities' R&D and business enterprises. Designed to help establish biomedical firms and next-generation medical products, the centre targets start-up and spin-off companies, satellite research centres, and R&D and service companies such as clinical research organizations.
Biomedical research at the centre will involve age-related diseases, immunology and vaccinology, biomaterials, and cell and molecular biology.
Other facilities on or adjacent to the Medical Hill complex include the Göteborg University campus with a new facility for animal research, and Chalmers University of Technology, which specializes in surface material physics, applied medical electronics and microelectronics, polymer technology, computer engineering, biomechanics, and biochemistry and biotechnology.
For more information, contact the Invest in Sweden Agency, SE-10338 Stockholm, Sweden; phone: +46 8 6768870; fax: +46 8 6768888.
