Post marketing surveillance (PMS) (also post market surveillance) is the practice of monitoring the safety of Pharmaceuticals or Medical Devices after it has been released on the market. the safety of a drug / Medical Devices after it is used in the general population by large numbers of people who have a wide variety of medical conditions. Post marketing surveillance uses a number of approaches to monitor the safety of licensed drugs and Medical Devices, including spontaneous reporting databases, These data are reviewed to highlight potential safety concerns in a process. Through its premarket review process, assure that risks associated with medical devices have been minimized when those devices first enter the market. However, once Medical Devices are widely used by health care providers and patients, new issues occasionally arise.
The source of Post market surveillance for Medical Devices includes,
Customer feed back
The feedback data include feedback on indication of use, instructions for use and customer satisfaction. A customer feedback format seeking opinion on all above aspects is sent to the customer with a request to return duly filled. When customer does not respond for any reason, the marketing team collects opinion verbally during a meeting or on phone and details entered in the format. Data collected are analyzed through use of any suitable techniques. The results of analysis is shared with others contributing to satisfaction/ dissatisfaction for deciding causes and to initiate corrective actions, wherever necessary.
Customer complaints
Customer complaints/Advisory Notices will be forwarded to the respective department through the sales department. All customer complaints/Advisory Notices will be acknowledged by mail within one working day. Subsequently the pertinent functional heads shall resolve the complaint if required through direct interaction with the customer/customer representative/or by advisory notes (call back).On closure of the complaint, intimation to that effect shall be communicated to the sales department. Reporting shall include the adherence to production schedule, status of development parts and improvement projects identified and their status. Analysis of customer complaints helps to detect the manufacturing problems, Product quality improvements, Knowledge of long term performance or complications etc.
Reports from regulatory authorities
Reports of incidents from regulatory bodies for a similar device manufacturer can be reviewed if available.NC Reports of audits can be used as a feed back for post market experience. Review of these data is considered as an information which can be an early warning for the quality issues of the product and it is communicated immediately to the concerned people if necessary
Literature review
Literature of the similar devices is an important source of post market surveillance. Journals regarding devices are reviewed and information collected and documented.
In house testing
Stability studies carried out on the device proves the long term stability of the device. Sampling and testing of device is carried out as per the standard operating procedure for stability studies
Failure analysis
Failure analysis carried out for the products and CAPA implemented also provides information regarding the post market surveillance
Post market surveillance report
Achievements of PMS system shall include the following
- Detection of manufacturing problems
- Product quality improvement
- Confirmation of risk analysis
- Knowledge of long term performance or complications
- Customer satisfaction
- Performance in different user populations etc.
Based on the post market surveillance through Feed backs, Customer complaints, Regulatory reports ,literature review ,in house testing and Failure analysis an annual report is prepared which is communicated annually through the management review meetings .Based on the report additional points can be included in Risk management process
Malesh M
Regulatory Consultant
+91 8050648432
Health Care Regulatory and QA Consultants 