Pharmacovigilance and safety monitoring of medical devices

Pharmacovigilance is a set of activities aimed at detecting and preventing various incidents on the market related to the use of medical devices. Monitoring is carried out by all market participants and actors, including consumers, manufacturers and official structures. The pharmacovigilance system is based on the results or data from consumers and on the basis of post-marketing report with clinical evaluation. More specifically, the implementation of pharmacovigilance is carried out according to the order KR-DSM-320. As the product is monitored during the post-registration period by all participants of the circulation, clear plans and methods of pharmacovigilance are defined. These include incident tracking, quality assessment of each batch, risk-based approach, and submission of clinical reports. In short, pharmacovigilance is carried out to ensure the efficacy and safety of medical products in circulation.

Incidents

Incidents, in most cases, occur in health care facilities and when identified, all information is transferred to the center of expertise. As stated in the rules of pharmacovigilance, the information transmitted must be supported by facts and evidence and described in detail in terms of the potential risk to patients. In case of an incident in individuals, they also have the right to file a complaint. About the incident, the manufacturer or its representative will be informed by the officials and the treatment facility. At this stage, the manufacturer gets in touch with the organization where the incident occurred for further internal investigation, examining the details and identifying the cause and effect relationship. For this purpose, it requests access to the used products against which the complaint was made. And, as provided for in the pharmacovigilance procedure, the organization has an obligation to facilitate such access. There are times when this access is denied, in which case the committee, at the request of the producer, should assist in resolving the problems.

According to pharmacovigilance requirements, the plant or its representative, send to the Center of Expertise two reports according to the annexes of the order, numbers 14 and 15. These are reports on the incident and on actions to improve product safety. It is not uncommon for the incidents described in the notifications to be inconsistent with the descriptions of adverse reactions. In such cases, the manufacturer justifies this fact in the report. NCELS, after receiving all the information, analyzes and informs the manufacturer about the results of the evaluation and the necessary actions. The Center can also stop the investigation, because the tasks of pharmacovigilance are to identify real risks and potential threats. After the end of all investigations, the manufacturer informs citizens about the measures taken and the results achieved, in the format of Annex 16.

Pharmacovigilance of medical devices Exempts producers from reporting in the following cases:

• Expected reactions that are described in the accompanying medical product information
• Cases described in the manufacturer's risk analysis document and included in the registration documents
• Already investigated events for which corrective documents have been sent to the state organization
• Identification of an obvious defect in the device by users, immediately prior to operation
• The design features of the product, which was created to protect against the occurrence of threats, prevented the defective product from being used and it did not result in the patient's deterioration or death
• If such an incident is acceptable and applicable in clinical practice

Clinical report in the post-marketing period

The second objective of pharmacovigilance — is the monitoring of products after they enter the domestic market of Kazakhstan. However, not all products require such monitoring. According to Order No. 320, the manufacturer or its representative sends the results of monitoring only for goods of high risk class 3 and implantable class 2b and then, in the first 3 years after receiving the reg. certificate. It is necessary to report annually by February 1, for incidents of the previous reporting period. Monitoring is carried out according to a prescribed plan, submitted during registration, which consists of regulated tasks and a scheme of actions, with an explanation of the choice of a particular way of obtaining feedback from the market. For the formation of this document, you should use Annex No. 17. After receiving the report, the expert body shall decide within 20 days whether to finalize or continue the monitoring. 

Quality assessment and selection from the market

There are two other procedures in the post-marketing period that are carried out by the health entity. This is the verification of each batch produced or imported into the country. Under this service, applicants confirm the quality of their products through a declaration. The necessary documents are submitted according to the list. Samples do not need to be handed over. Previous versions of the orders obliged laboratory testing. 

The second procedure provides for sampling by the Authorized Body. Such selection is carried out during the year according to the schedule, which is published annually on November 1 on the official website of the regulator. The manufacturer must follow such announcements to avoid violations of the order, because by January 10 of the following year he signs a contract for testing. Then the regulator agrees a detailed selection plan with the manufacturer. If the plan is not agreed by the applicant within 30 days, the authority has the right to decide on appropriate measures.

Products used for the personal protection of patients or medical personnel are subject to selection, but the selection is not limited to this. It depends on the current market situation, needs and risks in general. Only the quantity sufficient for a single examination is selected. The sampling is carried out in accordance with the manufacturer's requirements for temperature and humidity of storage and transportation. The sampling activities must not in any way impair the quality of the product. It is important to know clearly what is not to be sampled - implantable products, IVDs and appliances. 

It should be understood that all of the above are inevitable processes involved in bringing a medical device to the market. All these nuances must be taken into account during the collection of dossiers, before the product is submitted for registration. These are the so-called post-registration risks, which we in the company lcs-kz We pay great attention and emphasize their consideration at the planning stage.