Post Marketing Surveillance (PMS) Guide For Medical Devices
Post-marketing surveillance is the process of monitoring the safety of drugs once they arrive at the market, after the accomplishment of the clinical trials.
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What Is Post-Marketing Surveillance?
In Simple words, Post Marketing Surveillance is the fourth phase of clinical trials.
Now you may think what is the clinical trial?
It is a type of research study that examines how well new medical approaches work for humans. These clinical studies test new techniques of screening, prevention, diagnosis, or treatment of a disease.
Post-marketing surveillance is the process of monitoring the safety of drugs once they arrive at the market, after the accomplishment of the clinical trials. The key purpose for accompanying post-marketing surveillance is to recognize the previously unidentified unfortunate effects as well as positive effects.
Methods of Post-Marketing Surveillance
To monitor drug and device safety, post-marketing surveillance employs a variety of methods, including spontaneous reporting databases, prescription event monitoring, electronic health records, patient registries, and record linkage between health databases.
1. Controlled Clinical Trials
Control mentions strict obedience to the protocols. The aim of which is to reduce the irregularity of many factors that might affect the results.
Control features include the double-blind procedure. Where not only the patient but also the investigator is aware of which therapy the patient is getting.
Limitations:
-Reports to the health authority centers directly.
-The most common traditional system in many countries
2. Spontaneous or Voluntary Recording
A communication from an independent (For example consumer, healthcare professional) to an organizational regulatory authority.
Limitations of the Spontaneous or Voluntary Recording.
-By a Communication method, from an individual to a company or a regulatory authority.
-The actual incidents of adverse drug reaction cannot be determined through spontaneous reporting.
-By physician and other health providers & hospitals may alert FDA and pharmaceutical firms to possible adverse effects of drugs
3. Cohort, Studies
Descriptive case studies report unexpected or new events such as the incident of immediate infant death syndrome (SIDS) in numerous household siblings.
4.Case-Control Studies
The data researcher documented the survey and co-relates the circumstances observed with possible reasons.
These are neither sporadic nor cut-and-dried research. They possibly submitted as case study reports whereby specific individual patients with differentiated clinical features are included in the study.
The patient is analysed and assessed for the expected outcome. The results are differentiated with controlled values or are demonstrated as success or failure of the given treatment.
In the case of studies, observations are documented on a regular basis from patients undergo to a specific drug. They may also look for the preceding history of patients with the same result, to find a viable cause-effect relationship.
How do you Conduct Post-Market Surveillance for Medical Devices?
Manufacturers must follow these steps to conduct PMS:
1. Developing a Post Marketing Surveillance plan that includes an evaluation of In case Post-Market Clinical Follow-up (PMCF) is essential.
2. Plan Implementation
3. Create PMS reports on the basis of discovery.
A Post-marketing Surveillance plan details a manufacturer’s blueprints for constantly keep tracking and gathering data and safety details on its device. The PMS plan is a segment of technical documentation of the device and figures out the criteria for the risk/gains estimation of the device and operated for:
4. Data Collection and analysis
-Implement and collected complaints
-By communicating information to controllers and users
-Taking curative actions on devices
-Creating a PMCF plan or thinking about why PMCF is not necessary.
Reporting requirements can be different by region, with the reference below; most reports usually involve data analysis and a description of the curative and precautionary actions taken.
-In the US, Food and Drug Administration requires that manufacturers present a Periodic Adverse Drug Experience Report (PADER/PAER).
-In the EU, manufacturing of low-risk Class I, medical devices must create a post-market surveillance report. Manufacturers of Class IIa, Class IIb, and Class III devices must present a periodic safety update report.
These reports are part of a device’s technical documentation, and the manufacturer needs to update them constantly as per the relevant regulatory bodies’ timelines.
How Spade Health Can Help
The single most important activity that an organization must perform after its device is placed on the market is post-market surveillance. PMS activities such as data collection and analysis from multiple sources, PMCF activities, writing PMS-related reports, and updating inter-dependent regulatory documents based on PMS outcomes can overwhelm even the best teams in an organization!
Spade Health can help you in the following areas of PMS:
-Create the PMS system, including effective PMS and PMCF plans;
-Create and conduct PMCF studies;
-Collect data, analyze trends, and create PMS Reports/Periodic Safety Update Reports.
Our team includes experienced PMS Professionals, Medical Writers, Data Scientists, and Biostatisticians. We have external clinical experts on our panel who will conduct an independent review of the clinical data.
