Post-market Clinical Follow-up(PMCF)study Plan
and Post-market Surveillance（PMS）
1 Objective
The objective of this document is to establish Post-market Clinical Follow-up (PMCF) study plan and post-market surveillance (PMS).
The Post-market Clinical Follow-up (PMCF) Study Plan was establish to evaluate long-term performance and safety of the Lubricating jelly produced by Nantong Health&beyond Inc. and to confirm the acceptability of identified risks and to detect emerging risks on the basis of factual evidence.
The proposed device is subjected to Post-market Surveillance (PMS). which includes market . information feedback. physician consulting. vigilance system as well as communication with authorized representatives and safety of the device.
2 PMCF Study Plan
The Post-market Clinical Follow-up(PMCF) Study Plan is to be conducted after putting the devices on the market. The objective of the study is to demonstrate safety and effectiveness of the proposed device through post-market clinical follow-up.
2.1 Intended Use and Research Questions
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Intended use is described as follows.
Lubricating jelly intends to use for intestinal tract, intubation, vaginal examination before applying to the medical devices, which can increase smoothness, reduce stimulation.
The PMCF Study is conducted to address the following questions;
-whether identified risks in risk management acceptable in practice;
-long-term performance and safety of the device;
-whether there is emerging risks in practice;
2.2 Study Method
2.2.1 Population
The study population will be selected based on criteria equal to that of the premarket clinical investigation. The selection criteria are described as.
a) Criteria for Enrollment
Patients qualified for this inverstigationn should meet the following requirements;
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vaginal examination;
intestinal tract examination;
urinary catheterization;
Age above 18 and below 75(include) and no requirement for gender;
Patients who agree with follow-up evaluation according to the plan;
Patients or their legal representative should sign the informed consent.
b) Criteria for Exclusion
Patients should not be enrolled for the investigation if any one of the following conditions exists;
Patients do not fit the above criteria;
skin allergy;
dermato pathicpatients;
The Operation and postoperative nursing of patients with inappropriate;.
c) Mumber of cases
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Cover each cases(vaginal examination, intestinal tract examination, intestinal tract examination);
Total 25 people of each case.
2.2.2 Sites, schedule and Investigators
The Post-market Surveillance Study (PMCF) will be conducted in big hospitals and clinical centres at home(Three big hospitals and five clinical centres) next two years(Jul-2014 ~ Jul-2016). And HB clinical engineer will choose the investigators who will be well-trained Inspection doctors. .
2.2.3 Statistical analysis
The Post-market Surveillance Study (PMCF) is intended to enroll more than 75 patients based on the selection criteria mentioned above. A 90-day follow-up is considered to be long enough according to clinical experience and general practice. Statistical methodology will be adopted to analyse data collected through the study. The statistical method used in pre-market clinical investigation also applied to this study.
2.2.4 Conclusion
Data collected through the PMCF study will be analysed by people with appropriate expertise. Statistical methods will be adopted in the process of
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analysis to ensure the data gives scientific results and conclusions. And appropriate conclusions will be drawn from the analysis. A final report with conclusions will be issued according to collected data and results of analysis.
3 Post-market Surveillance
The Lubricating jelly is also to be subjected to Post-market Surveillance, which includes the following processes;
a) Vigilance System
The vigilance system was establish in accordance with MEDDEV 2.12/1 rev 8 Guidelines on a Medical Devices Vigilance System and is conducted in according to 《Vigilance System Control Procedure》(QSP821-01)。
b) Collection of feedbacks from end-users and distributors
Consultations with orthopaedics physicians as well as other end-users and distributors well be done to collect as much as fast-hand feedbacks and
information on safety and effectiveness of the device. The communication channel will be established and maintained to ensure flow of information in a timely manner. Collection of feedbacks is conducted in accordance with 《Feedback Control Procedure》(QSP850-02).
C) Review of Clinical Study and Research Literatures
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Literatures of recent clinical study and research will be searched to keep up with recent study on the device, especially those involving safety and effectiveness of the device.
c) Risk Management Update
Risk management will be updated based on inputs such as information from vigilance system, feedbacks as well as literature review to demonstrate current status of the device and the technology. Identified new risks will be subjected to risk management process and measures will be taken to reduce the risks to acceptable level.
4 Summing up of Post-market Clinical Follow-up study and Post-market Surveillance
HB clinical engineer is in charge for summing up of PMCF and PMS, the final conclusion should address the following questions:
-whether identified risks in risk management acceptable in practice;
-long-term performance and safety of the device;
-whether there is emerging risks in practice;
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