Dental News - Investigation highlights lack of consistent medical regulation

Dental Tribune International

Wed. 12. December 2018

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LONDON, UK: An investigation headed by the International Consortium of Investigative Journalists (ICIJ) has found that patients worldwide have potentially been fitted with unsafe implantable medical devices. Due to varying international medical regulations, the investigation stated, certain devices have been approved for human use despite previously only having been tested on baboons or pigs.

A total of 250 journalists from 58 news organisations in 36 countries conducted the Implant Files investigation over a period of 12 months. The investigation revealed that, unlike drugs, many medical devices are not required to go through rigorous clinical trials before they become available on the market. Despite medical devices providing obvious benefits to the health and lives of many patients, certain devices could still be available for sale in some countries even after they have been removed from the market in other countries.

The ICIJ found that, over the past decade, medical devices were possibly linked to more than 82,000 deaths and 1.7 million injuries in the US alone, according to data provided by the country’s Food and Drug Administration. In Europe, reported incidents relating to medical devices have continued to increase. In France and the UK, for example, reports of suspected device-associated malfunction and injury have more than doubled over the past nine years to 18,208 and 19,599, respectively.

In April 2017, the European Parliament voted to approve a new set of medical device regulations intended to improve patient safety in the medical and dental industries of the European Union. These regulations are currently in a period of transition that will last until May 2020 and include the establishment of a comprehensive database, the European Database on Medical Devices (EUDAMED), for all medical devices sold in the EU. The EU is currently reviewing how much information will be shared with the public through EUDAMED, although the European Commission informed the ICIJ that device-related injury and malfunction reports were likely to remain confidential.

Prof. Derek Alderson, President of the Royal College of Surgeons (RCS) reassured patients that medical devices are manufactured and used according to very high standards in the UK. “Nevertheless, there have been sufficient number of incidents to underline the need for drastic regulatory changes that the RCS has long called for,” said Alderson.

He continued: “The RCS believes that all new surgical procedures and devices should be registered, with related data collected in the appropriate national audits, before they are routinely offered to patients. All implantable devices should be registered and tracked to monitor their efficacy and patient safety in the long-term.”

“Where feasible, there should be clinical trials, although that can be difficult for some procedures. Surgical trials—many of which the RCS supports—play a critical role in improving patient care, as well as testing the safety and efficacy of new innovations and devices.”

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