A NOTE FROM THE EDITOR
Risky Business: Devices and the Perception of Safety
How much risk is tolerable in a medical device? The answer may well depend on who you ask, according to Erik Schwanbom, PhD, from the Fachhochschule Lubek in Germany. That was one of the thought-provoking issues raised at a session devoted to Regulation in Reality: The New EU Landscape at the Medical Equipment Design & Technology Exhibition and Conference (MEDTEC) held 7–9 October 1998 in Amsterdam.
Risk analysis is an integral part of the CE marking process. The essential requirements of the Medical Devices Directive (93/42/EEC) state that "devices must be designed and manufactured in such a way that . . . they will not compromise . . . the safety of patients . . . or users." EN 1441, which was adopted by CEN late last year, provides some guidance on identifying possible hazards but it places an interpretive burden on the manufacturer. According to a CEN communiqué issued at the time of the standard's adoption, "Factors influencing the perception of safety include the socioeconomic and educational background of the society concerned and the actual and projected situation of the patient."
The absence of a monolithic model of tolerable risk extends to the various "stakeholders," Schwanbom told MEDTEC attendees. The engineer designing the device, the insurer, and the patient may each have a wildly different understanding of what constitutes tolerable risk. "Engineers may understand the notion of tolerable because they recognize that nothing in life is risk free, but the public often will settle for nothing less than zero risk," said Schwanbom.
Consensus becomes even more elusive under the constraints of language and a sociohistorical context, according to Schwanbom. While the German word for tolerable may approximate its meaning, he said, it doesn't carry quite the same baggage, resulting in a linguistic deficit that is not easily dismissed in such a critical area. Schwanbom also pointed out that in light of German history, tolerable is not a term that should be used casually. "It is, to say the least, a touchy concept," Schwanbom said, one that elevates the debate to a philosophical level. For those reasons, he added, "I have argued against the use of the term tolerable in relation to risk." He suggests that, rather than vainly attempt to translate this and other problem words, a sort of lexicon be established that would provide a definition in the various EU languages. Clarity, if not brevity, would benefit.
While regulatory officials and academics wrestle with these semantic issues, let's not forget that the public always has the last word. In particular, it appears to have little tolerance for risks, minimal or otherwise, associated with a medical device.
"The public will understand that triple bypass surgery carries a 40% chance of death, but it will not accept the failure of a heart valve," noted Gordon Higson, session chair and consulting director of Quintiles Medical Technology Consultants (Staines, Middx, UK). "Medical procedures and devices are perceived differently in the public eye."
Despite the sometimes nebulous guidance available, manufacturers must determine the potential hazards and risks associated with the more-sophisticated devices they make. ISO 10993 and EN 1441 offer some help. More is on the way. A draft document (RM N27) soon to be released by the ISO/IEC joint working group on risk management applied to medical devices reportedly will broaden the scope of EN 1441 by providing a picture of the entire risk management process.
The three-day MEDTEC conference and exhibition touched on numerous other topics of interest to device manufacturers, from the harmonization of vigilance reporting to the status of the packaging directive. A conference summary, along with profiles of some of the innovative products that were launched at the exhibition, will be published in the January/February issue of European Medical Device Manufacturer.
Finally, I would like to extend to all EMDM readers my sincere wishes for a happy, prosperous, and safe New Year. See you in 1999.
