FDA the Gold Standard for Medical Device Safety
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A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago...
![FDA the Gold Standard for Medical Device
Safety
By: Nikita Angane, MS
A year-long investigation titled “Implant Files”, which was initiated by the ICIJ
(International Consortium of Investigative Journalists) and involved 250 journalists from 36
countries, was released a few weeks ago. The investigation pointed out “dysfunctionalities” at
the regulatory agencies responsible for regulating medical devices worldwide. Moreover, the
investigation showcases some cases where the implanted medical devices failed to deliver the
promised results.
There is a big gap that exists between the needs of the patient and what the currently
available medical devices can offer. The various manufacturers and the US-FDA are in constant
collaboration in an effort to innovate, develop, and commercialize safe and effective medical
devices. While no regulatory authority canbe considered ideal, US-FDA is still considered to be
the most robust in providing regulatory oversight of all the agencies in the world.
The investigation cited a fact that the US-FDA holds the largest database of adverse
events reported by the users for each device. The FDA requires manufacturers and user facilities
under 21CFR 803 to report any adverse events encountered while using the medical device,
including any minor harms [whether or not if the medical device directly contributed to its
occurrence]. However, it is worth noting that FDA’s adverse event reporting platform
[MedWatch], is the largest publicly available database on device safety.2 MedWatch is also able
to send out information about recalls and clinical safety. On the other hand, in the EU and
Mexico, though the incident reports are collected, they are not available to be shared with the
public.1
FDA also requires that the manufacturer provides a Unique Device Identifier (UDI) for
each of its devices to include the medical device’s information in the Global Unique Device
Identification Database (GUDID). This database not only helps the FDA to track the device
through its distribution and use, but it also helps the public gain information about a device
from this open resource. The UDI requirement is part of the 21 CFR 801 regulatory requirement.
On the contrary, the European regulations did not have any requirements on placing UDI on
medical devices prior to the release of the new EU-MDR in 2017.
FDA’s 510(k) clearance program has been criticized the most in the investigation;
however, if it weren’t for this program, we would have never been able to see the rapid
development the medical device industry has been making. Manufacturers would refrain from
investing in research and development if they knew a big share of the financials will have to be
invested in human trials and rigorous testing. Industry groups argue that the 510(k) route is
necessary because devices are constantly being improved incrementally. From a practical
standpoint, human testing doesn’t make sense in such cases, according to the industry.](https://image.slidesharecdn.com/icijinvestigationblog-200421192232/85/fda-the-gold-standard-for-medical-device-safety-1-320.jpg)
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FDA the Gold Standard for Medical Device Safety
- 1. FDA the Gold Standard for Medical Device Safety By: Nikita Angane, MS A year-long investigation titled “Implant Files”, which was initiated by the ICIJ (International Consortium of Investigative Journalists) and involved 250 journalists from 36 countries, was released a few weeks ago. The investigation pointed out “dysfunctionalities” at the regulatory agencies responsible for regulating medical devices worldwide. Moreover, the investigation showcases some cases where the implanted medical devices failed to deliver the promised results. There is a big gap that exists between the needs of the patient and what the currently available medical devices can offer. The various manufacturers and the US-FDA are in constant collaboration in an effort to innovate, develop, and commercialize safe and effective medical devices. While no regulatory authority canbe considered ideal, US-FDA is still considered to be the most robust in providing regulatory oversight of all the agencies in the world. The investigation cited a fact that the US-FDA holds the largest database of adverse events reported by the users for each device. The FDA requires manufacturers and user facilities under 21CFR 803 to report any adverse events encountered while using the medical device, including any minor harms [whether or not if the medical device directly contributed to its occurrence]. However, it is worth noting that FDA’s adverse event reporting platform [MedWatch], is the largest publicly available database on device safety.2 MedWatch is also able to send out information about recalls and clinical safety. On the other hand, in the EU and Mexico, though the incident reports are collected, they are not available to be shared with the public.1 FDA also requires that the manufacturer provides a Unique Device Identifier (UDI) for each of its devices to include the medical device’s information in the Global Unique Device Identification Database (GUDID). This database not only helps the FDA to track the device through its distribution and use, but it also helps the public gain information about a device from this open resource. The UDI requirement is part of the 21 CFR 801 regulatory requirement. On the contrary, the European regulations did not have any requirements on placing UDI on medical devices prior to the release of the new EU-MDR in 2017. FDA’s 510(k) clearance program has been criticized the most in the investigation; however, if it weren’t for this program, we would have never been able to see the rapid development the medical device industry has been making. Manufacturers would refrain from investing in research and development if they knew a big share of the financials will have to be invested in human trials and rigorous testing. Industry groups argue that the 510(k) route is necessary because devices are constantly being improved incrementally. From a practical standpoint, human testing doesn’t make sense in such cases, according to the industry.
- 2. Page 2 of 2 The decline in the number of warning letters’ issuance and device recalls is also cited as loose regulatory oversight by the FDA throughout the investigation. FDA stated in its response that the agency has taken up a new approach where it conducts more inspections to oversee the compliance of the companies, rather than issuing warning letters. As far as the low number of recalls being considered as lenient regulatory enforcement by the FDA, Larry Kessler, a University of Washington Professor rightly said “The U.S FDA is set up to get things on the market and not to get things off the market”.4 Lastly, it is imperative to note that Governments in Asia, Africa, Middle East and many other countries do not even have established regulations for medical devices.1 They actually look to the FDA to regulate medical devices. While no agency can be deemed perfect to regulate matters of human health, the FDA has continuously kept its commitment to protect and promote public health and continues to do so. For all your compliance and regulatory needs please call E.M.M.A International at (248) 987-4497 or send an email to info@emmainternational.com. 1 ICIJ(Nov 2018) Medical Devices Harm Patients WorldwideAs Governments Fail On Safety retrieved on 12-05- 2018 from https://www.icij.org/investigations/implant-files/medical-devices-harm-patients-worldwide-as- governments-fail-on-safety/ 1 ICIJ(Nov 2018) Everything You Need to Know About the ImplantFiles retrieved on 12-05-2018 from https://www.icij.org/investigations/implant-files/what-you-need-to-know-about-the-implant-files/ 1 ICIJ(Nov 2018) US plans ‘significantmodernization’for medical device approval retrieved on 12-05-2018 from https://www.icij.org/blog/2018/11/us-plans-significant-modernization-for-medical-device-approval/ 1 AP news (Nov 2018) At FDA, a new goal,then a push for speedy device reviews retrieved on 12-05-2018 from https://www.apnews.com/9f8ea03a4d324d1ba5585680d280804b