The patient becomes a mouse? A number of medical devices in Europe have been exposed to problems
(original title: patients become mice? This life-threatening cardiac pacemaker has been exposed to safety risks)
according to the BBC report, the BBC, together with the international investigation alliance, and a number of media around the world, including the guardian and the British medical journal, have found that the European medical device industry has made use of loopholes in the regulatory system, resulting in a variety of unsafe Medical devices that have not been tested enough have been implanted into patients
products that have been tested on baboons or pigs and corpses have failed, and have entered the market and human body. These medical devices implanted into the human body include cardiac pacemakers, spinal orthotics, artificial knees and artificial buttocks
the survey also found that even doctors may be kept in the dark about the risks of the treatment devices they recommend to patients
a leadless pacemaker has problems
because of irregular heartbeat, 82 year old Maureen mcreeve became the first person in Britain to install a nanostim pacemaker. Cardiac pacemaker is a life-saving implantable device that emits electrical pulses to keep the heart beating regularly. Traditional pacemakers send pulses through electrode wires, but the wires are easy to break. Nanostim is the first leadless pacemaker
when he became the first person to implant a leadless pacemaker, Maureen was very excited, and he felt like a "white mouse" by adding the weighed powder into the mixing chamber of the high-speed mixer. "I'm really grateful to be selected. It sounds too good to be true."
▲ according to the BBC, three years later, the battery in Maureen's pacemaker failed, but the doctor couldn't take it out. Now, she uses a traditional pacemaker to maintain her life, and the broken pacemaker is still in her heart. "I don't like having a piece of metal in my heart. It doesn't work there. Just put it there."
Maureen is not the only one who has this experience. The batteries of leadless pacemakers in some patients also failed or parts were scattered, which has caused at least two deaths and more than 90 serious injuries. Finally, the pacemaker was withdrawn from the market for safety reasons
because the evidence proving its safety does not predict that the total industrial output value will reach 10trillion yuan by 2025; By 2035, the nanostim leadless pacemaker had long been rejected by German security agencies. However, the company transferred to the UK and was approved according to British standards, resulting in casualties of the above patients
a number of medical devices have been exposed to have problems
in Europe, the CE mark obtained by medical devices from authorized institutions is the same as the mark obtained by spit drivers and kettles. There are 58 such institutions in Europe. As long as any one of them approves a product, the product can be used in the whole European economic area. However, if one institution refuses to approve, the company has 57 other institutions that can continue to try to apply
this media survey found that the problematic devices include: those implants that have failed in the baboon test have split in the patient's back; Implantable contraceptive device causes internal injury and internal bleeding; Implantable defibrillator does not work; Shape implants for urinary incontinence cause internal painBBC found that the performance of an implant for the treatment of severe scoliosis in children was compared with that of a microcomputer controlled electronic universal experimental machine. The implant was only tested on pigs and cadavers and then entered the market. Anthony, a 14-year-old boy, implanted this product five years ago
as a result, the implant broke in his body only one year later. After replacing the new implant, the new implant broke again one year later. Anthony is not satisfied with the current rapidly changing market and has to permanently remove this product. However, its manufacturer, nuvasive, claims that there are always risks in the treatment of scoliosis
▲ according to the Anthony diagram of correcting the spine, the problem of some medical devices is a mystery for both patients and doctors due to the lack of data and transparency
device companies always need to prove the safety of their products, but in fact, they need much less "evidence" than patients think. Even doctors who do device implantation may not see the evidence of the safety and effectiveness of a device
the British Bureau of standards said that the evidence of the safety of nanostim pacemakers could not be discussed because of "confidentiality requirements". The media survey found that nanostim only did a clinical study before it was approved to enter the market. The study was conducted on 33 patients for only 90 days
"we are talking about permanently implanted pacemakers, so I think that clinical research is too perfunctory." Professor Rita riedberg of the University of California, a world-renowned cardiologist, said, "these implants will take ten or twenty years. After 90 days of observation, we can't understand the clinical effect of the pacemaker."
▲ Professor Rita riedberg, the world's famous cardiologist, according to the BBC
Royal College of surgeons call for a complete regulatory change
"thanks to medical devices, countless people are now living healthier, more quality, and less dependent on others." MedTech Europe, an organization representing the medical device industry, said, "without those thousands of medical devices, people's lives are unimaginable." The organization also called the certification body a "professional, impartial, transparent and independent person"Abbott, a manufacturer of nanostim pacemakers, said that many patients have received the help of their leadless pacemakers, and more people will benefit in the future. Abbott also said, "after obtaining the CE certification, nanostim has further conducted after-sales clinical follow-up research in Europe."
in this regard, the Royal College of surgeons called for "radical regulatory changes". Professor Derek Alderson, President of the society, said, "all implanted devices should be registered and their effectiveness and safety should be monitored for a long time."
source of this article: Red Star: Wang Lishan_ nbjs7182
Copyright © 2011 JIN SHI