One of the biggest accomplishments in the journey of a drug product is its entry into the market as a commercialized product. But the journey does not end here, now the responsibility comes of tracking the effects of drug product in the patients which gives rise to the term called post marketing surveillance.
Post-Marketing surveillance is a continuous process of observing the effects, safety and efficacy of the drug product after it reaches the patient and reporting and documenting the results observed with a will of product betterment.
What Is Post-Market Surveillance (PMS) For Medical Devices?
Post Marketing Surveillance for medical devices deals with the monitoring of safety and performance of medical devices after they have been released into the market which involves complaints, reporting of adverse effects or beneficial results observed in the patients. PMS is one step in the journey of medical product allowing its improvement and opening the door of new opportunities for the medical device.
Post-Market Surveillance Medical Devices Regulatory Requirements:
In each country there are different regulatory bodies who lay down a set of rules governing the PMS requirements for medical devices. Such as in India the regulations are governed by CDSCO whereas in US BY FDA, in Europe by EU, in Japan by PMDA, in Canada by Health Canada, in China by NMPA, in Australia by TGA, etc.
Let's discuss some of the major global regulatory bodies governing regulations for PMS of medical devices.
US-FDA In US For PMS Regulatory Requirements:
FDA’s 21 CFR part 822 states about the FDA medical device post-market requirements
for PMS.FDA assist PMS by a system called MedWatch form. It is a portal where the users of medical devices can submit the adverse effects, side effects or any other issues regarding the medical device. FDA also conducts its own PMS for medical devices.
There are four criteria where the FDA requires PMS from the medical devices manufacturer, where Class I medical devices are exempted from PMS as they are at low risk. For other classes the criteria are as follows:
For Class II or Class III devices which upon failure may cause serious adverse effects.
For Class II or Class III devices that are widely used in pediatrics.
For Class II or Class III devices are implanted in humans for a long-time duration.
For Class II or Class III devices of lifesaving or life sustaining category.
On FDA demand for PMS of a particular medical device, the manufacturer must initiate it within 15 months and submit according to the requirements of the FDA.
MDR In EU For PMS Regulatory Requirements
EU medical device surveillance is conducted by MDR under EU (2017/745) lays down a set of standards for medical devices. In European countries all the medical devices require to conduct PMS, or if it is not conducted, they need to provide justification for same.
The manufacturer needs to provide PMS specially for novel drug, high risk related devices, pediatric and generic use devices, etc. to confirm their safety and efficacy.
The PMS report must include the following points:
1.PMS plan.
2.PMS procedures.
3.PMS reporting such as safety updates.
CDSCO In India For PMS Requirements:
The CDSCO regulates the rules for PMS of medical devices under medical devices rules 2017, amended in 2022.
The ISO 13485 (Quality Management System) and ISO 14971 (Risk Management for Medical Devices) have set a certain standard for the medical devices to meet which are monitored in PMS.
Reporting is done through Indian Pharmacopoeia Commission (IPC) for PMS. The PMS report should include the following,
The dossier should provide the signature and date of the information.
Certificates of 3 consecutive batches such as, batch release certificates and certificates of analysis.
Corrective and preventive actions specified (CAPA).
How To Create A Post-market Surveillance System?
The above diagram shows the post market surveillance system process. Below is the detailed description of the same.
Planning:
This is the very first step in the PMS system. A good and systematic planning leads to a successful PMS.
This step involves the complete planning the PMS, roles and duties of each person, system to monitor the target patients, etc.
Complaint handling is one important aspect here, which should be managed effectively.
Risk management strategies should be implemented.
Data Collection:
The manufacturers should establish good data collection channels.
The data should be collected using user surveys, product registries, post market clinical follow-up studies, compliant system and social media monitoring.
Data Analysis:
After data collection, the data should be analyzed using different patterns, trends and potential issues.
Data analysis should be made on all the complaints, adverse effects, preventive actions, etc.
This analysis should be done regularly.
Taking Action:
After all the data is collected and analyzed, action should be taken to meet the lacking criteria.
This step may require additional post marketing studies, label modifications, implementing preventive corrective actions, communication with the regulatory bodies, etc.
Training and continuous improvement:
For achieving the PMS, training should be provided on regular basis for the procedures and implementation of PMS.
For continuous improvements regular feedback should be taken from the users and the medical device should be improved according to the new trends.
Thus, all these steps together form the Post marketing surveillance system.
Types Of Post-Market Surveillance Activities:
There are majorly two types of post market surveillance activities such as:
Passive surveillance
Active surveillance
Active Surveillance:
Active surveillance data is collected from the real world to obtain a true picture of device’s real performance, which is achieved by patient feedback, regular complaints, surveys and interviews.
Here it is important to frame précised clinical research questions to bring out the required data, to bring meaning to the surveillance of medical devices.
This kind of study is more expensive than the passive one but provides a deep insight into the medical device performance.
Passive Surveillance:
This type of surveillance involves collection of data from sources such as hospital databases, health insurance claims, medical records.
Passive surveillance gives a broad view of safety and effectiveness of product, although the data in this type of surveillance is constrained as it of medical device users only.
Tips For Effective Post-Market Surveillance:
Create a systematic and effective plan for post-market monitoring.
After collection of data make a detailed analysis of the same.
Conduct frequent customer feedback.
Respond to every complaint and feedback immediately.
Use digital technologies for effective surveillance.
Conduct training of the staff performing surveillance.
Implement preventive and corrective actions as and when required.
Conduct auditing of PMS for medical devices.
Conduct post market clinical follow up.
FAQs:
What is the purpose of Post-Market Surveillance in medical devices?
Post market surveillance confirms the safety, effectiveness and the quality of medical devices after commercialization of medical devices.
What are the key activities involved in Post-Market Surveillance?
Post market surveillance involves activities such as reporting of adverse events, risk assessment, clinical follow up, etc.
What challenges are faced in Post-Market Surveillance?
Reporting adverse events, management of large scale of data, fulfilling all the regulatory requirements for the medical devices are some of the challenges of post marketing surveillance.
What tools are available for Post-Market Surveillance?
Tools such as different software for tracing adverse effects, databases, performance and safety device monitor, etc. are some of the tools in post marketing surveillance.
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