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fda issues device warning; health canada in monitoring mode
Health Canada and health USAS.
The Food and Drug Administration\'s response to evidence of patient injury caused by some medical devices is almost the opposite. A new B. C.
The study adds more and more evidence about potential complications of plastic
Like the coating on devices such as catheter, guide wire and bracket, it is inserted through blood vessels during minimally invasive medical treatment.
This device is coated so that they can pass through the blood vessels with less friction and damage to the tissue.
However, a study of 110 patients in Vancouver showed that patients died within 90 days after receiving coating equipment, with polymer fragments scattered across different parts of the body.
It was judged that three people were killed by the materials expelled.
Hydrophilic polymer embolism is a term used by experts to describe recently recognized phenomena in which foreign bodies are separated from the surface of the device and transmitted through blood to various organs of the body.
The FDA issued a safety announcement in 2015, saying that there were 500 reports of coating stripping in just two years.
There were 11 equipment recalls and 9 US recalls. S.
Death associated with the stripping or peeling of the guide wire used in cardiac angiography or angiography.
Last year, the FDA followed up with more suggestions.
In contrast, Health Canada has adopted a monitoring position.
Eric morissett, chief media relations officer of the department, said in an email: \"The department reviewed data related to coating layering to ensure that the equipment does not fall off the material.
In addition, the labels of these devices sold in Canada must contain warnings to check if there are any signs of damage to the equipment (
Bending or weakening part of the coating, or layering).
\"Health Canada\'s position is that the benefits of these products continue to outweigh the risks.
This balance of benefits and risks is a key part of the Canadian medical device or drug assessment.
Morrissette said that the Canadian agency was aware of the FDA\'s notice but did not issue its own.
\"If new evidence related to the safety of these devices is exposed, Health Canada will take appropriate action,\" he said . \".
Devices inserted through blood vessels
Called intra-vascular surgery in B. C.
Including products produced by companies such as Bud, Cook, Boston Science, Gore and Canadian hospital specialists.
Postmedia contacted several manufacturers several times to ask them to respond to the latest research.
All declined to comment. Dr.
Dave Wood, a Vancouver interventional cardiologist and director of the heart catheter laboratory at Vancouver General Hospital, said the study \"absolutely\" put forward some \"interesting assumptions\" that need further investigation \".
\"To be honest, it\'s not on my radar. But it is now.
I\'m not trying to belittle the study, but we have clinical trial data on these devices that show that they are generally safe and effective.
Wood said he was not aware of any situation where the coating had fallen off on the equipment he was using.
Patients undergoing intra-vascular surgery after this procedure will be informed that the risk of heart attack and stroke is minimal.
The fact that the coating debris was found to cause the death of three people does not change the general information he gave the patient during the informed consent process, although he admitted that the patient may now be due to news reports. Dr.
John Maguire, a VGH neuropathologist
Arlen Redekop/PNGHe said he is keen to work together on further research and has contacted Dr, head of research.
Neuropathologist John MaguireIn 2017, Dr.
Rashi Mehta and Dr. Rupal Mehta, U. S.
Experts updated doctors on the possible major complications of equipment stratification.
This week, Rupal Mehta said concerns about complications were rare among doctors and medical device industry personnel. Dr.
Ronald Reagan, a professor at the University of California, Los Angeles Medical Center and anatomy pathologist Harry Vettes, collaborated on coating issues, praising researchers in Vancouver.
\"Their research is particularly interesting because it takes advantage of what can be considered as old technology --
Careful tissue analysis of autopsy specimens
Obtain extremely important new information that has a direct impact on the outcome of a specific patient group.
In fact, autopsy is the only way to get this data, Dr.
Maguire and his colleagues congratulated on the care and data analysis of the study.
Vinters said that despite the latest research, the degree of risk cannot be quantified.
\"Autopsy is not a population-
Based on research, they focus on individuals who are highly selected.
When asked whether interventional cardiologists and other experts using this device should provide patients with specific information about this risk in the informed consent process, he said: \"Generally speaking, both the anesthesia and the surgeon agreed-
Includes warnings of possible negative results.
Christopher Thrall, spokesman for the Canadian Institute of patient safety, said research like Vancouver is important, although the agency does not have any statistics on the off-coating of equipment, canadian patients are often prone to adverse events in hospitals due to equipment failure, medication, errors and falls.
For example, every 17 minutes someone dies in a Canadian hospital for treatment complications.
There are about 31,000 people each year.
There are thousands of preventable patient safety incidents every year.
One of the 18 hospital visits caused preventable injuries.
More than complex surgical patients were hurt.
Patients who suffer injuries are four times more likely to die in hospital than patients who do not suffer injuries.
Sal said that the Institute for Safe Medication Practice of the Canadian health standards organization and the Canadian Institute for Patient Safety are working together to support an initiative of Health Canada, the initiative requires healthcare institutions to identify and report serious adverse drug reactions and medical device incidents.