Scottish campaigners have welcomed proposals which will provide stricter controls on the use of medical devices in EU member states. The changes are designed to provide greater protection for patients and are being implemented in the wake of a number of recent health scandals.
Members of the European Parliament have this week amended draft legislation which includes stricter monitoring and better traceability. Under the new rules tens of thousands of medical devices will now be subject to rigorous scrutiny before they are deemed safe for public consumption. The changes also allow for random testing and factory audits as well as more regular monitoring by authorities.
The calls from health MEPs to tighten the rules on the use of medical devices follow the PIP breast implant scandal which saw thousands of women fitted with implants using non-authorised silicone gel made by French firm, Poly Implant Prothese. Trisha Devine is one of those women and is spokesperson for the PIP Implants Scotland campaign group. She said: “Women like myself all over the world have been subjected to a hugely testing time since we discovered the risk we were at following the PIP scandal. Some have been luckier than others but the whole experience will leave us scarred both mentally and physically.
“Any steps which improve the industry to make it safer are definitely to be welcomed. The steps taken in the Members of the European Parliament are testament that we are being listened to which will give a lot of women great comfort through this difficult and distressing time.” Patrick McGuire is a partner with Thompsons Solicitors which is representing the majority of Scottish Women affected by the PIP scandal as well as a number of people who were fitted with faulty metal on metal hip implants. He said: “This is a significant step forward in ensuring far greater scrutiny of medical devices which are currently on the market. There is a whole raft of changes which are needed to prevent a repeat of the PIP and hip scandals of recent months but we should welcome any commitment to introducing tighter control to protect consumers and patients.”
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