A patient safety campaigner is hopeful that new government regulations will impact “the wild West” culture that she says previously existed around the use of medical devices.  

Kath Sansom raises awareness of the complications around the use of surgical mesh to treat pelvic organ prolapse, hernia, bladder leaks and in some reconstruction surgeries for women after breast cancer. 

The government now intends to introduce strengthened regulations that prioritise patient safety when it comes to the use of medical devices.  

The draft regulations, known as the Draft Medical Devices Regulation 2024, also propose the devices are closely monitored once they are on the market.  

Last Tuesday (November 26), they were debated at a parliamentary committee which is an early step of the process towards implementation.  

Speaking afterwards, Kath, from March, said: “This is another important step towards improving patient safety in the UK.  

“For years It has been like the wild West for medical devices.  

“New products have been approved on flimsy regulations. With no follow-up to see how patients are doing and no way to pause or suspend a treatment that is causing problems because nobody is checking.  

“We hope the new regulations will go some way to addressing the problems.” 

She added: “Further improvements are needed - for example toughening up how new medical devices are actually approved – however this is a good first step.” 

Other points raised in the debate were that higher risk devices like pelvic mesh will face closer scrutiny; the Medicines and Healthcare products Regulatory Agency (MHRA) will monitor progress; and safety reports will be linked to other international efforts to spot global trends of harm.  

MP Andrew Gwynne, a health minister, also addressed the debate saying the regulations “place patient safety at the forefront”. 

He said: “They will enable not only the MHRA, but the whole health system to better protect patients.”