MedReg will allow patients in all countries to rely on the highest safety and data security standards for medical devices
By Dr. Carlos Rizzo
April 21, 2018
Whether you live in or visit the Americas, Europe, Asia, Africa, Australia, New Zealand or the Pacific, you should be able to expect the same level of safety for medical devices at every medical facility because people’s health is equally important in all countries.
Currently, different regulations and quality systems in most countries create an enormous administrative burden and cost on regulators, health authorities and medical device manufacturers. This cost is passed on to hospitals, governments, insurance companies - and ultimately patients.
MedReg wants to achieve the highest possible quality and safety standards while simplifying the regulatory burden and therefore lowering the final cost to hospitals and patients with one global blockchain solution for medical devices.
The MedReg Blockchain is a “one covers all” solution ranging from development to clinical testing, documentation and reporting, all fully automated. MedReg should also reduce animal testing and guarantee the highest level of patient safety at the same time.
Sharing non-competitive data on the MedReg blockchain will lower the regulatory burden for all stakeholders, not only for manufacturers, but also for hospitals and medical centres that need to document each use and maintenance of medical devices. MedReg will also standardise certain processes, such as biocompatibility assessments of commonly used components and many other processes that are currently duplicated by every manufacturer which results in cost that will be unnecessary with the MedReg blockchain.
The standardisation of processes can be performed by any qualified medical research institute and is not limited to only a few select entities. This creates a global competitive research market for the work that needs to be performed and further minimises the cost for each manufacturer - and ultimately the patient.
Supervision by health and data protection authorities is only possible if data is stored on a joint platform outside a medical device. Therefore, MedReg also addresses secure data management for medical devices. A global blockchain is the perfect technical solution because it allows for the creation of one security standard for all data that is created and processed by medical devices. Most importantly, the data received from medical devices cannot be modified after it is recorded on the blockchain. This makes it a perfect tool for inspection, especially since medical devices depend on permanent software updates which may contain bugs that affect their functionality. However, the data stored on the blockchain is immutable and cannot be altered. Even software updates can be tracked on the blockchain so the source and cause of any malfunction can be detected. This way there is no longer a need for device manufacturers to record and report updates because the blockchain allows health authorities with proper authorisation to access and inspect all data in real time.
The MedReg Blockchain considers recommendations from the hospital community and the medical device industry as well as guidelines from the International Medical Device Regulators Forum and requirements from national and regional government organisations, such as the European Commission Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs in the EU, the Food and Drug Administration in the US, the Ministry of Food and Drug Safety in South Korea, the Health Sciences Authority in Russia, the Pharmaceuticals and Medical Devices Agency and the Ministry of Health, Labour and Welfare in Japan, the China Food and Drug Administration, Health Canada, the National Health Surveillance Agency (ANVISA) in Brazil and the Therapeutic Goods Administration in Australia as well as the World Health Organisation and any organisation or country that wants to contribute knowledge and expertise. MedReg is also asking patients and the general public for their comments, questions and concerns (see form below).
The goal of MedReg is not only to fulfill the minimum quality and safety standards for medical devices by law but to create a system that allows manufacturers to receive and process anonymised data from medical facilities around the world in real time which allows them to make improvements to the safety of their devices the moment new information becomes available on the blockchain which brings everyone closer to the goal of ultimate safety and the best possible treatment for patients.
The International Organisation for Medical Device Regulation Compliance, Patient Safety and Blockchain Security (MedReg International or MedReg) works with research institutes, universities and hospitals for clinical investigations of medical devices to create the highest possible standards for patient safety around the world while automating all processes on the blockchain in order to minimise the administrative and regulatory burden for medical device manufacturers and to minimise cost for medical facilities - and ultimately patients.
For Medical Professionals:
MedReg - The blockchain for global regulatory compliance of medical devices and IVD
MedReg's goals are the standardisation of national regulations and the highest possible global safety and security standards for all medical devices.
Submit your comments, questions and concerns