This procedure provides the process and defines the practices that must be followed for performing Post Market Surveillance
(Version at end of page)
Signed V16: ML - 15.10.2024
The process covers all processes, activities, products in this SOP.
Approval: Author of the document, Monica Lucas
Changes: National Sales Manager/General Manager
Post market issues may be identified through a variety of sources, including analysis of adverse event reports, a recall or corrective action, reports from other governmental authorities, or the scientific literature. Post Market Surveillance (PMS) activities is the systematic collection of data on the performance of devices during the post marketing phase exist in different countries ISO13485 Clause 5.4.2
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible problems. The specific aims of pharmacovigilance are to:
improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions,
improve public health and safety in relation to the use of medicines and medical devices,
contribute to the assessment of benefit, harm, effectiveness and risk of medicines / medical devices,
encouraging their safe, rational and more effective (including cost-effective) use, and
promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public
The approach is to convene an expert review team to identify the objective, the information that is needed to achieve the objective, appropriate sources and mechanisms for obtaining this information, and facilitate necessary actions
a. Guidance for Industry and FDA Staff - Post Market Surveillance Under Section 522 of the Federal Food, Drug and Cosmetic Act Document issued on: April 27, 2006
b. DG ENTERPRISE AND INDUSTRY Directorate F-Consumer Good Unit F3- Cosmetic and Medical Devices MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 5 April 2007 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
c. PROPOSED DOCUMENT Global Harmonization Task Force Title: Review of Current Requirements on Post Market Surveillance Authoring Group: Study Group 2 Endorsed by: The Global Harmonization Task Force Date: May 2005
QMS - Quality Management System
SOP – Standard Operating Procedure
PMS – Post Market Surveillance
MD – Managing Director
NCCA – Non Conformance Corrective Action
ISO13485 Clause 4.2
PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT
It is intended that Post Market surveillance is performed for any device of the manufacturer which is a class IIb / C or class III/ D device, where the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be-
a. implanted in the human body for more than one year, or
b. a life sustaining or life supporting device used outside a device user facility. ”
c. the company have nominated to also include Sterile products.
The following PMS FORM is to be completed and the PMS RECORD SHEET populated as a record
8.1.1 The PSO role will be fulfilled by the Authorised Representative.
Must have Product Knowledge and Experience.
Must have Practical experience in monitoring and follow-up adverse side effects, clinical studies and clinical pharmacy Reports
8.1.2 The following are guidelines for initiation of pharmacovigilance / Post Market Surveillance evaluation;
New or expanded conditions of use for existing devices
Post Market surveillance may be required to augment premarket data to obtain more experience with change from hospital use to use in the home or other environment or with new patient populations.
Significant changes in device characteristics (technology)
Questions that arise from significant or developmental changes to device technology that can be most appropriately addressed in the post market period. There may be concerns that changes in the technology of a device may affect the duration of the effectiveness of the device, which could be addressed by post market surveillance. In these situations, post market surveillance, through collection of longer-term safety and effectiveness data, may augment premarket data and allow earlier marketing of new technologies without compromising the public health.
Longer term follow-up or evaluation of rare events
Post market surveillance is done to address longer term or less common safety and effectiveness issues of implantable and other devices for which the premarket testing provided only limited information. For example, premarket evaluation of the device may have been based on surrogate markers. Once the device is actually marketed, post market surveillance may be appropriate to assess the effectiveness of the device in detecting or treating the disease or condition, rather than the surrogate. Data collected during post market surveillance may include rates of malfunction or failure of a device intended for long-term use or incidents of latent sequelae resulting from device use.
Public health concern(s) resulting from reported or suspected problems in marketed devices
Post market surveillance may be done to better define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed; if there is a change in the nature of serious adverse events (e. g., severity); or if there is an increase in the frequency of serious adverse events.
8.2.1 The pharmacovigilance / Post Market Surveillance evaluation is done by an expert panel review team established by QA, which includes but is not limited to a representative from marketing, Production, QA, the report is completed by following the PMS FORM. The PSO completes the PMS RECORD SHEET for the approval and recommendation
Information is collated from global marketing and for local markets complaint reports, adverse incident reports, production and marketing material and publications
The PSO will develop any safety alerts, public health notifications and other publications about suspected device problems and distributing them to the public as required – the communication is established (letters, e-mails, notices are developed by the PSO and the MD).
Types of information & feedback may be incorporated into the evaluation:
customer complaints
review of product claims & labelling
post CE-market clinical trials or cohort studies (if conducted)
literature reviews
detection of manufacturing problems & lab / QC test results
knowledge of long-term performance / reliability and / or chronic complications
feedback on training needs for users or user reactions during training
feedback on customer satisfaction / perception
medical device vigilance reporting of the specific device
knowledge of the ways in which the device is misused
experience with similar devices made by BSN medical or competitor products
8.2.2 The PSO will provide a separate Risk Management Plan, when applying for registration or renewal of registration (Electronic copy, CD), for specified medical and pharmaceuticals products as required (THE COMPANY products do not generally fall within these categories);
Innovative medical products or
Medical or pharmaceutical products containing active substances and registered for the first time or
Medical or pharmaceuticals products , with high and medium-risk or
Medical or pharmaceuticals products , for which circulars have been issued by MOH or any other international drug control agencies like FDA,EMEA,MHRA,TGA etc. concerning their safety or adverse side effects
8.3.1 The PSO will prepare a Post Safety Update Report (PSUR), as required, with topics not limited to the following as a guideline,
Executive Summary
Introduction
Worldwide Marketing Authorisation Status
Update on Actions Taken for Safety Reasons
Changes to Reference Safety Information
Inventory and Status of Ongoing and Completed Interventional Clinical Trials
Estimated Patient Exposure in Clinical Trials
Presentation of Safety Data from Clinical Studies
Significant Findings from Interventional Clinical Trials
Observational and Epidemiological Studies
Information from Marketing Experience
Overall Safety Evaluation
Summary of Important Risks
New Actions Recommended
Other Information
Conclusions
8.3.2 Attach any reports - in the Google Drive Folder
In the event of non compliance follow SOP NON CONFORMANCE CORRECTIVE ACTION
The Risk Assessment to is found in SOP PREVENTIVE ACTION RISK ASSESSMENT refer Document
An analytical review is reported monthly to management and this forms part of the input to management review refer Data Analysis
The Trend should pick up any potential and recurring incidents, where corrective action must be reported at the management review to facilitate continual improvement
Corrective actions identified during the evaluation will be documented via the PROCEDURE FOR PREVENTIVE AND CORRECTIVE ACTION AND HANDLING OF NONCONFORMING PRODUCT SOP. Based on the findings of the report, it may be necessary to update the relevant devices risk management modules & technical files
Revision 16; 15.10.2024 - ML - Checked and Confirmed. Digitally signed by ML
Revision 15; 20.11.2023 - ML - Checked and Confirmed. Digitally signed by ML
Revision 14; 25.10.2023 - SCR - Removal of PALIN section 8
Revision 13; 20.10.2022 - ML - Updated PSO role (8.1.1) and Confirmed. Digitally signed by ML
Revision 12; 17.10.2022 - ML - Checked and Confirmed. Digitally signed by ML
Revision 11; 07.10.2021 - ML - Formatting. Digitally signed by ML
Revision 10; 10.05.2021 - ML - Digitally signed by ML
Revision 9, 30.04.2021 - TNA - Approval / Scope / Responsibilities, Risk based approach and Records, and new googlesite format Numbering. Amending links and forms
Revision 8, Digitally signed on03.11.2020 by ML
Revision 1-7, unknown due to googlesite change to new googlesite
Name Retained by/ in Retention period Hard copies Destroyed by
none