Medical Devices under scrutiny
There are currently around half a million Medical Devices on the market, ranging from corrective glasses and contact lenses, to X-ray machines, pacemakers and in vitro diagnosis devices. But are they really safe?
Thinking about breast augmentation with silicone implants? Many consumers would now think twice after the fraud case that struck public opinion about a couple of years ago involving a French manufacturer, PIP, accused of putting into the global market faulty breast implants made of sub-standard industrial silicone with abnormally high rupture rates. In France, the implants had to be recalled and PIP was forced into liquidation with huge losses. Nevertheless, the case damaged the confidence of patients and of consumers at large to an extent hard to restore.
This case was pinpointed in September last by the European Commission when commenting on the opportunity for its then just launched proposals for a new regulation on medical devices – MD (which will replace Directive 90/385/EEC regarding active implantable medical devices and Directive 93/42/EEC regarding medical devices) and for a new regulation on in vitro diagnostic medical devices – IVDMD (to replace Directive 98/79/EC regarding in vitro diagnostic medical devices).
Extending and clarifying the scope of legislation and other major innovations
There are currently around half a million MD and IVDMD on the market, comprising products ranging, respectively, from corrective glasses and contact lenses to highly sophisticated life-support machines; and from tests of cholesterol level to reagents to detect HIV. The Commission’s proposals firstly aim at extending and clarify the scope of these two EU legal instruments. Implants for aesthetic purposes are now included. Tests which provide information about predisposition to a medical condition or a disease (e. g. genetic tests) or tests providing information to predict treatment response or reactions (e.g. companion diagnosis), two major tools for personalised medicine, are now clearly considered to be IVDMD.
Other important innovations include strengthening of tools for assessing and controlling the safety and performance of devices: stricter requirements for clinical evidence were introduced and stronger supervision of independent assessment bodies is foreseen. Better rules for traceability of devices and a clearer definition of suppliers’ (manufacturers, importers and distributors) responsibilities were introduced as well. These responsibilities are not waived in the case of internet sales. On the other hand, an extended database on devices will provide patients and healthcare professionals with transparent, thorough and updated information which will enable better informed decisions. Suppliers will also benefit from confidence reassurance, clearer rules, easier trading within the internal market and facilitated international trade, as the proposals are intentionally aligned with international guidelines.
A number of important ethical issues
These proposals will now be submitted to the analysis of COMECE’s Reflection Group on Bioethics which will meet at the end of February. The focus will certainly be put on the assessment of diverse ethical issues which in one way or another can arise, mainly within the ambit of the IVDMD. The Group has already issued two Opinions addressing genetic testing in general: Comments on Opinion No. 18 of the European Group on Ethics (EGE) concerning "Ethical aspects of genetic testing in the workplace" (10.10.2003) and Ethical and cultural aspects of genetic testing (27.02.2004). One of the major concerns was the possible use of such tests – either for health-related purposes or not (insurance, employment, scientific or criminal investigation purposes) – as means of social or economic discrimination. More specific issues referring to, for example, direct-to-consumer genetic testing (DCGT), namely by means of online selling, will now be assessed. Complex questions of informed decisions, the trust relationship between medical doctor and patient, medical and genetic counselling and the advertising of DCGT are likely to be tackled. Also: patients’ rights, genetic data protection and the responsibility of device suppliers; or even the pre-market evaluation of devices based on clinical evidence of their safety and performance, and risk-benefit analysis. All these issues are particularly acute with respect to self-tests for the determination of pregnancy or for detection of trisomy 21 or of HIV.
Hopefully, after the Commission’s proposals have been passed and have come into force in the European Union, you will need to think only once next time you look in the mirror and feel uncomfortable with your breast size.