This “Trend Reporting” shall be procedured and planned immediately for transitional substances covered by the MDR. In addition, in order to prepare this report, it is necessary to take a statistical training.
Manufacturers shall report any statistically noteworthy augment in the frequency or intension of incidents.
Let’s say you have a reusable active device. Your product is designed which has some unpleasant malfunctions after using some time. It has the potential to deteriorate at the end of the first year. Cause you didn’t make a durable product because of its costs.
You know that during second year your device is going to be malfunctioned at least third time. Your risk management has treated this problem. Your clinical evaluation affirmed it and then your risk-benefit determination accepted it.
We understand that after all these acceptances, your device turns out to be safe and effective.
The number of occurrence need to be kept under 1 year of use. You should begin to monitor these occurrences. If your device is malfunctioned 4th time in second year, it’s automatically non-compliant. Your device is approved for third case after one year. If you have a 4 case in second year, you should investigate and do something as the manufacturer. You need to inform the regulator that there is a problem with your device.
1
Manufacturers shall report, by means of the electronic system referred to in Article 92, any statistically significant increase in the frequency or severity of incidents that are not serious incidents or that are expected undesirable sideeffects that could have a significant impact on the benefit-risk analysis referred to in Sections 1 and 5 of Annex I and which have led or may lead to risks to the health or safety of patients, users or other persons that are unacceptable when weighed against the intended benefits. The significant increase shall be established in comparison to the foreseeable frequency or severity of such incidents in respect of the device, or category or group of devices, in question during a specific period as specified in the technical documentation and product information.
The manufacturer shall specify how to manage the incidents referred to in the first subparagraph and the methodology used for determining any statistically significant increase in the frequency or severity of such incidents, as well as the observation period, in the post-market surveillance plan referred to in Article 84.
2
The competent authorities may conduct their own assessments on the trend reports referred to in paragraph 1 and require the manufacturer to adopt appropriate measures in accordance with this Regulation in order to ensure the protection of public health and patient safety. Each competent authority shall inform the Commission, the other competent authorities and the notified body that issued the certificate, of the results of such assessment and of the adoption of such measures.
You upload your trending report to EUDAMED. Your competent authority analysis these reports. If needed, your authority can make an official announcement of your high risk trends or warn your NB to take necessary actions.
According to the document “Manufacturer’s Trend Reporting of Adverse Events” of Global Harmonization Task Force, statistically, trend tracking is done as follows:
You have to gather these data below:
One data-point (i) = n/d is calculated for each time interval, and for the purposes of this document is defined as the observed incidence expressed as a percentage. Patient exposure over time will need to be measured or estimated for the denominator ( d) place of the used product volume, for devices such as medical implants that are continually in use. However, where data about exposure to use are not known to a manufacturer, the number of products in the field may have to be used as the denominator (d).
If relevant, ( e.g., for implants) trending might also be initiated for clinical findings or other variables such as age, weight and gender of patients, age of the device) and others.
IMPORTANT NOTE:
Only market areas (this means EU) where adverse event reporting is established should be included in the trending. Otherwise the frequency of known events may not match the used volume, leading to wrong results.
In order to create a good baseline these two way can be followed:
Time interval needs to be short enough (e.g. 1 month) to facilitate timely corrective action especially for high risk devices
A significant increase means:
(a) a rapid and continuous increase in (i) over a limited number of time intervals for high volume products ( eg over 1 – 3 months)
(b) a slow and continuous increase in (i) over a larger number of time intervals for low volume products ( eg over 3 – 6 months),
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