By: Laura Fuentes
Technovigilance means medical devices surveillance (MD) at the commercialization use and stage. It involves the systematic collection and adverse events evaluation, incidents and quality failures related to the medical devices use, allowing to identify, quantify and qualify their severity, frequency and risk factors to establish preventive or corrective measures to strengthen the protection of health and patients, users and citizens safety.
The MDs classification in the National Drug Administration (DNM) is governed by the Medical Device Regulators Forum (IMDRF) criteria: Class A, B, C and D, based on potential risks about use and possible failure, considering different criteria such as duration of contact with the body, degree of invasion, form of invasion, whether it releases a drug or energy, among others, which is why it is important to monitor them because they are an important tool in the treatment and diseases diagnosis, but they carry an inherent risk.
Class A: Low risk, which are not designed to protect or sustain life or prevention of impairment of human health special use and that do not represent a potential unreasonable risk of disease or injury.
Class B: Moderate low risk, submitted to special controls in the manufacturing phase to prove their quality, safety and efficacy.
Class C: Moderate high risk, subject to special controls at the manufacturing stage to demonstrate quality, safety and efficacy.
Class D: High risk, submitted to special controls, destined to protect or maintain life or for a substantial importance use of human health deterioration prevention, or if its use presents a potential risk of disease or injury.
Surveillance of these products requires the both regulatory authorities, manufacturers, distributors and the general public integrated participation.
How do they participate?
Manufacturers:
- Must have implemented an ISO 13485 and ISO 14971 medical device quality management focused on the risk management application.
- Have a post-market surveillance plan.
- Establish responsibilities and workflow among its different economic operators.
- Implement corrective and preventive actions such as (FSCA).
- Notifying regulatory entities about your sanitary surveillance efforts.
Users:
- Observe and document incidents or reactions that are not normal or found on DM labeling.
- Notify the manufacturer and/or regulatory agency of what is identified.
- Follow the measures and instructions issued by the manufacturer and/or regulatory agency.
Regulatory agencies:
- Establish regulation and DM quality policies.
- Perform technovigilance.
Field Safety Corrective Actions (FSCA), what are they?
They are measures issued by the manufacturer with objective to mitigate the risk of death or deterioration of the health patients estatus. FSCAs are communicated to the public by means of Field Safety Notices (FSN).
What can be considered a FSCA?
- DM return
- DM Modification
- DM Replacement
- DM Destruction
- Use recommendations
Where a finding can be notified?
On the DNM website there are 2 forms to make notifications:
- Substandard quality, counterfeit and without sanitary records DM reporting form, which means those products that are found outside of what is specified by the manufacturer.
- Adverse event and incident report form related to the DMs use, which refers to products that misrepresent their identity, composition or origin.
PAHO recommends when we make a medical device use:
- Examine the container/packaging condition for grammatical or spelling mistakes.
- Check expiration date.
- Verify data on the outer packaging versus the inner packaging.
- Check the appearance, it should not have changes in odor o color.
- If you have any questions or need advice, you can contact our team of professionals in the Life Sciences – Regulatory Affairs area through the indicated channels in our platforms.
Text source: Summary of the training given by Milton Salazar, head of the National Center for Technovigilance of the National Directorate of Medicines and RTS 11.03.02:21 Medical Devices. Requirements for Health Regulation.