Advancements in technology aimed toward the healthcare sector have been beneficial to physicians and patients with regards to monitoring one’s health. While these medical devices are proving to be helpful, disturbing news has shed light on how these devices can become harmful to those that use them. Recently, an investigation has revealed that patients are being harmed by unsafe medical devices that are being distributed throughout the global market place.
Questioning the Industry’s Scrutiny of Medical Devices
There is little doubt that medical devices, such as wearables, have benefited users and their doctors in monitoring one’s health. However, a recent article has revealed that these same medical devices can cause more harm than benefits. According to a global investigation, it has discovered that medical devices that have been deemed unsafe are responsible for globally 1.7 million injuries while causing roughly 83,000 fatalities within the last 12 years.
The International Consortium of Investigative Journalists (ICIJ) conducted a year-long investigation of manufacturers of devices, known as The Implant Files, which showed that unsafe medical devices have made their way into global markets because of insufficiently rules regarding testing, poor regulatory systems as well as a lack of transparency. Medical devices known to have resulted in “adverse incidents” include artificial hips, pacemakers, contraceptives and breast implants that were grafted into the bodies of patients.
What is so alarming is that according to the investigation, some of the medical devices hadn’t completed patient trials. One example provided within the report stated how some pacemakers were implanted into patients even though the manufacturers knew of existing issues; meanwhile, other types of devices received approval without utilizing proper regulatory procedures.
ICIJ referenced a case that occurred within the US that involved twenty-seven-year-old Charlissa Dawn Boyce’s family filing a lawsuit. The case stated that Charlissa’s implanted defibrillator, which ended up later being recalled for battery issues by St. Jude Medical, failed to shock her heart into beating again and led to her death. The report discovered that roughly 350,000 defibrillators were used on patients globally before a recall went into effect in 2016.
The Report Proves the Need for Drastic Regulatory Changes
According to Oxford University Clinical Epidemiologist Carl Heneghan, “Products that are harmful can spread across the world very quickly … It’s unacceptable to keep maintaining the system.”
Naturally, questions have been raised as a result of this report on the amount of scrutiny being applied toward these devices before reaching the global industry and then used on patients. There are also questions about whether regulators become aware of defects and act quickly on their findings.
President Professor Derek Alderson of the Royal College of Surgeons commented on the number of incidents regarding these flawed devices by saying it is enough to “underline the need for drastic regulatory changes,” adding the need for introduction of mandatory registries on a national level for implantable devices. He noted that, “in contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence. This is a risk to patient safety and public confidence.”
AdvaMed, the US trade group for medical device manufacturers, suggested the need for a different assessment of medical devices toward pharmaceuticals as implants can be more difficult to randomize throughout clinical trials than drugs. Janet Trunzo, who is AdvaMed Head of Technology and Regulatory Affairs, said that, “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.”
Additionally, Trunzo spoke out against those industry businesses who claimed to have issues achieving patents after a recall occurs. Trunzo said that, “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.”
The US Food and Drug Administration (FDA), responding to questions brought up from the ICIJ, said that patient continues to be a cornerstone of their regulatory commitment, while working towards the birth of a program that will scan clinical information and other data to quickly identify any issues. Also, it recently presented 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 Implant Files that were identified by the ICIJ as the “first-ever global examination of the medical device industry and its overseers.” The investigation was accomplished through ICIJ journalists, along with 250 data specialists and reporters across fifty-eight media organizations within 36 countries that teamed up in running interviews of patients, assess device incident reports and analyzing health records.
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