Medical devices that are substances … for introduction into the body
"A number of devices in question are significant sources of risk, such as spinal implants and devices that administer medicines." Lyn Farley no longer has a pacemaker, after her device gave her a series of electric shocks she was lucky to survive. "I think it's wrong that they can put it off for that long. I wouldn't wish that on anyone to go through what I did," she said.
Danny Vadasz, from the Health Issues Centre, said he had "real concerns about collateral damage to patients" now the tightening of regulations was being delayed. "It's really important that we make sure we follow up with post-market surveillance and monitor how these devices are working in practice and ensure that we're able to contact trace people who've had these implants when things go wrong," she said.'No impact on patient safety'
Source: Healthcare Press (healthcarepress.net)
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