The amount of data related to Post-Market Surveillance (PMS) has grown extensively in recent years. The primary reason for this change is the detailed regulatory requirements that have been imposed upon the health and regulatory authorities. The purpose of these regulations is to ensure that all the PMS data is exchanged rapidly, efficiently, and reliably.
Performing this PMS is amongst the primary responsibilities of medical device manufacturers. And one of the most effective ways to regulate the PMS process is by implementing blockchain, which has garnered much attention recently. This is because this technology allows the users to manage their data without the help of any centralization authority.
What is Blockchain?
Blockchain is a decentralized distributing ledger meant for recording transactions without any danger of alterations in the blocks. For instance, blockchain can be used in the medical and healthcare sector by offering an efficient and secure exchange of patient data while ensuring data integrity, accessibility, and privacy.
Constitution of a Blockchain
In the blockchain, multiple parties are situated within a network for sharing a single ledger. This ledger is trusted by every party involved in the blockchain.
Levels of Verification in Blockchain Ledgers
There are various levels of verifications of blockchain ledgers. They are:
Public Blockchain
Anyone can view, verify, and add blocks to this type of blockchain.
Private Blockchain
Only particular individuals can verify and add a transaction block to this type of blockchain in this blockchain.
Consortium Blockchain
This type of blockchain is highly restricted. Only a specific group of an organization (for example, banks) can verify and add transactions.
Challenges with the Appropriate PMS
Medical device manufacturers face various challenges when it comes to the implementation of PMS of medical devices. Some of them are
Data Breaches
As the number of technologies for connecting various medical devices is growing, the chances of PMS data getting hacked is also increasing. Therefore, it is a must to have a secure environment for ensuring fast sharing of data. But this timely PMS data exchange across all the different resources and documents is undoubtedly a challenge for the medical device manufacturers.
Adequate and Efficient Traceability
To ensure a solid and well-established PMS system, identifying the leading cause of PMS is necessary. For this purpose, evaluating the sample of the medical device is required for distinguishing the failure mode.
Counterfeit Medical Devices
Counterfeit medical devices are spread across the industry and pose a severe threat to the patient’s safety. Therefore, monitoring PMS efficiently is required in the medical device industry.
Safety-Related Regulatory Actions
Safety-related regulatory actions are required to identify the medical devices present in the market quickly. This process requires a UDI (Unique Device Identifier).
User Error
User error is another significant contributing factor related to adverse events in medical devices.
Lack of Standardization and Harmonization
Lack of standardization is also a significant threat to the PMS data sources. In each PMS data source, the content and the method used for storing data are different. The two primary medical PMS data sources worth mentioning in this regard are:
- Spontaneous Reporting System (SRS)
- Medical Device Registries.
Spontaneous Reporting System
It is a reactive system containing patient harm reports and product problems collected from the healthcare authorities, manufacturers, professionals, and patients. SRS is an organized data resource, and the data collected through it cover large populations. The data processing is centralized in a repository where it can be assessed.
Limitations in SRS
SRS suffers from various limitations such as:
- The lack of harmonized global standard data set for reporting makes data integration from multiple databases difficult
- With SRS, finding the root cause of individual events because of limited information and inaccessibility to the actual device is also challenging
- SRS data is often incomplete and missing, thus impacting the case evaluation
Medical Device Registries
It is an organized system that aims to increase knowledge on medical devices, improve patient care quality, and collect relevant data. Medical device registries contain information such as
- Medical device information
- Medical narratives
- Surgical interventions
- Diagnoses
- Medication.
Advantage of Medical Device Registries
The most significant advantage offered by medical device registries over the SRS is that it provides confirmatory studies and allows performing the active PMS.
Using Blockchain to Address the Challenges Associated with PMS
Implementing blockchain to counter the issues related to PMS can be beneficial in many ways. Some of them are:
Medical Device Traceability
With the global implementation of UDI, blockchain can support recording all production data, ongoing usage, and maintenance. Blockchain technology can also be used after the implementation of EU MDR, which requires a UDI to be placed on every product in human and machine-readable form.
Coordination with Regulatory Actions
With the global adoption of UDI, blockchain adoption can improve all the processes related to regulatory actions. This will lead to the fast and efficient removal of any faulty device from the market. Since blockchain can track and monitor all the supply chain stages, it will ensure data integrity while improving device traceability across the supply chain.
Identification and Mitigation of User Error
Blockchain supports the identification of safety issues for software devices that are related to user error. It rapidly informs the manufacturer about user error and identifies the appropriate training to address that error.
Challenges in Implementing the Blockchain Technology
There are several challenges in implementing blockchain for the PMS process of medical devices. These challenges are:
Security and Data Privacy
Although data is highly secured on the blockchain, its security can get compromised. This happens because blockchain involves a community of users for verifying the architecture of blockchain records. Data privacy is not ensured in a blockchain because all the nodes can view the data.
Data Storage Management
In contrast to traditional web storage systems, blockchain is designed to provide a distributed tool for storing data. But since PMS data is vast in quantity and should be held regularly, the storage capacity of blockchain should be more significant.
Issues Related to PMS Data Exchange
PMS databases are centralized compared to blockchain technology, as most global regulations mandate that a central health authority operate them. Also, there is a need of complying with the data privacy of the PMS data. To overcome these challenges, it is necessary to use private PMS permissioned blockchain with a consensus mechanism known as “proof-of-authority.”
Proof-of-Authority Consensus Mechanism
In this mechanism, only a selected number of participants, i.e. health authorities, reporting facilities, and manufacturers, can validate the transactions for adding them to the PMS ledger.
Challenges Related to Standardization
As blockchain technology is still in its beginning phases, several standardization problems can be related to its implementation. Therefore, health authorities should emphasize developing standardization documents for scrutinizing the data shared on the PMS. Doing so is crucial because the blockchain application will not be resourceful if the existing PMS data is not entirely integrated.
Behavioural and Cultural Challenges
Although the medical device industry is adopting digitalization in its structures, many things still need to be done. For instance, it will be mandatory to ask different healthcare sector stakeholders (doctors, nurses, paramedics, health authorities, manufacturers, etc.) to shift on the computer instead of paperwork, which will be a complicated task.
Financial Costs
Converting all of the existing structure onto the blockchain will be a costly process. For example, many hospitals are not yet computerized and are thus unable to share data with each other. Also, this transitioning from paperwork to technology will require immense support from the health authorities, hospitals, and manufacturers, which will be a timely process.
Alysidia can Help with PMS Blockchain
Alysidia is a Swiss software solution provider currently offering services in IoT, cloud services, customized applications, and supply chain traceability. Our services are specially centred on the healthcare sector. We can help the medical device manufacturers with the efficient deployment of blockchain solutions to ensure the complete PMS integrity of their medical devices while overcoming the challenges in this process. You can contact us through our services by visiting our website alysidia.com.
