French medical technology association Snitem has issued a press release noting that the bad behaviour of one company—Pip en l’occurrence—should not be allowed to besmirch the reputation of the medical device sector as a whole. It also cautions against using the breast implant scandal as a pretext for casting doubt on the safety of all medical devices.
“Between 800,000 and 2 million types of medical devices are used to treat patients in France,” notes the press release, and these devices run the gamut from simple bandages and sutures to MRI equipment. Such a diversity of products requires adaptive regulatory controls that are commensurate with the risk level of the device, Snitem adds.
In the press release, the association renews its commitment to participating in the development of Europe’s regulatory framework, especially as concerns high-risk devices. Snitem also stresses that user feedback and the results of investigations into misfunctioning products and potential hazards should inform efforts to improve safeguards.Norbert Sparrow