Unsafe medical devices allowed into global markets harm patients, investigation reveals

Global examination raises questions over how much scrutiny medical devices actually undergo in the industry.
07:42 AM
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A global investigation has found that unsafe medical devices have caused 1.7 million injuries globally and almost 83,000 deaths in the last 12 years.

According to The Implant Files, a year-long investigation of the manufacturers of devices by the International Consortium of Investigative Journalists (ICIJ), unsafe medical devices have been allowed into global markets as a result of poor regulatory systems, a lack of transparency and insufficiently strict rules on testing.  

Some of these medical devices that have caused “adverse incidents” include pacemakers, contraceptives, artificial hips and breast implants grafted into patients’ bodies. 

The investigation found some devices did not complete patient trials. The report stated that some pacemakers, for example, were implanted even though their manufacturers knew of problems; other devices were approved without proper regulatory procedures. 

In the report, ICIJ referenced a case in the US, where 27-year-old Charlissa Dawn Boyce’s family filed a lawsuit after an an implantable defibrillator, which was later recalled by St. Jude Medical for battery problems, didn’t shock her heart back into beating and resulted in her death. It found that nearly 350,000 of the defibrillators were used on patients globally before the recall occurred in 2016.

Another example of a faulty medical device is in India, where 44-year-old Vijay Vojhala suffers from difficulty walking, vision problems and irregular heart rhythms, which he claimed was a result of his Johnson & Johnson replacement hip. More than half a million patients globally got these replacement hips before they were taken off the market.

Findings "underline the need for drastic regulatory changes"

Oxford University Clinical Epidemiologist Carl Heneghan told the Australian Financial Review it was unacceptable to keep maintaining this system.

The findings have raised questions over how much scrutiny devices actually undergo in the global industry before being used on patients and if regulators pick up and act on findings fast.

According to The Guardian, the Royal College of Surgeons President Professor Derek Alderson said the number of incidents involving flawed devices is enough to “underline the need for drastic regulatory changes”, in addition to the introduction of mandatory national registries for implantable devices.

“In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence,” he said. “This is a risk to patient safety and public confidence.”

According to the Australian Financial Review, US trade group for medical device manufacturers AdvaMed recommended that medical devices should be assessed differently to pharmaceuticals as implants are harder to randomise during clinical trials than drugs. 

"To suggest that human trial mandates would end future harm misleads both the patient and the public into falsely thinking that all adverse events can be erased through such trials," AdvaMed Head of Technology and Regulatory Affairs Janet Trunzo said.  

Trunzo also spoke against industry businesses that claimed to have problems reaching patients after recalls.

"High-risk medical devices, especially life-sustaining implants, have specific tracking procedures in place to ensure companies can quickly notify patients and providers of any significant issues," Trunzo added.

Responding to questions from the ICIJ, the US Food and Drug Administration (FDA) mentioned that patient remains a cornerstone of its regulatory commitment and that it is working towards the creation of a program that scans clinical information and other data to identify problems quickly.

It also recently introduced a new goal to be "consistently first among the world's regulatory agencies to identify and act upon safety signals related to medical devices".

The ICIJ identified The Implant Files as the “first-ever global examination of the medical device industry and its overseers.” To run the investigation, ICIJ journalists, along with 250 reporters and data specialists across 58 media organisations in 36 countries teamed up to assess device incident reports, analyse health records, and run patient interviews. 

Originally published on Healthcare IT News Australia.