Lifesaving medical devices being sold in Australia despite breaching US quality guildelines
A COMMONLY used lifesaving stent that prises open blocked arteries of heart attack victims is being sold in Australia even though its manufacturer breached US quality guidelines.
Our own medical regulator the Therapeutic Goods Administration (TGA) also identified problems at the US factory during an inspection but is still allowing the device to be sold here.
The stent is used in 135 Australian hospitals and in nine out of ten patients who receive a balloon expandable covered stent (Atrium Advanta v12 stent) during cardiac procedures.
Two chest drains (Oasis and Express) also produced by the company are used in 268 Australian hospitals on eight out of ten patients, usually trauma victims, who need such devices.
Medical device manufacturer Atrium insists the medical devices are safe but is asking Australian hospitals to sign a “certificate of medical necessity form” acknowledging the risks of using the product.
A US District Court banned the manufacture and distribution of 22 medical devices produced by Maquet and its subsidiary Atrium in February.
The ruling came after US medical watchdog the Food and Drug Administration found the company had been involved in major violations of quality regulations at three of its plants.
Ten inspections of the company’s factories between 2009 and 2013 found significant problems and the company was issued with two warning letters from the FDA.
The FDA was concerned about the time it was taking the company to report and investigate adverse events associated with its medical devices among other issues.
“There has been no indication that any of the products are unsafe. The consent decree does not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market,” a spokesman for the company said.
It took the company a month to notify Australian hospitals of the FDA action.
The FDA reported Maquet companies had recalled another 45 of its devices from sale in the US between 2009 and 2014, five of these devices were classified as Class 1 representing the most significant risk to patients.
The TGA reports that another 17 Maquet devices were recalled for product correction or recalled between October 2012 and December 2013.
A spokeswoman for the TGA said it had conducted an inspection of the quality management system in place at the Maquet manufacturing facility in Hudson, New Hampshire USA and identified some issues.
“Evidence was provided to the TGA to show that the manufacturer took appropriate and acceptable steps to address issues identified during the inspection,” it says.
A follow-up inspection by the TGA will take place to confirm the ongoing acceptability of the manufacturer’s quality management system.
The TGA says while regulators have similar safety standards they have different compliance mechanisms and Australia’s approach aligns with the European Commission.
“The TGA ensures that appropriate actions are taken by medical device manufacturers, while ensuring that Australians continue to have access to the quality products they need,” the spokeswoman said.
“The TGA’s record of adverse events does not currently indicate a safety concern in relation to the medical devices cited in the consent decree,” she said.
Maquet says the TGA inspected the Atrium site in 2013, several months after the FDA and after Atrium had made improvements. The TGA recertified the quality management system for another 5 years.
“The NSW Ministry of Health is working with the state’s peak clinical safety body, the Clinical Excellence Commission to examine advice from the TGA and FDA, which will help to inform our decision on whether the devices will continue to be used in NSW public hospitals,” the spokeswoman said.
The US District Court in New Hampshire said Maquet could only sell seven of its banned products overseas if hospitals signed a “certificate of medical necessity form”.
News Corp has obtained a copy of this form being sent by the company to Australian hospitals.
News Corp understands that one private hospital chain Healthscope is refusing to sign the certificate of necessity.
Maquet says the form “is not intended to shift legal liability to customers” but instead is “intended to make certain that customers are adequately informed on the situation prior to purchasing.
The company says in the last five years the complaint rate for Atrium Advanta v12 product lines in Australia is 0.3 per cent and for the drains 0.00086 per cent.
Source:News
