The new article covers the aspects related to recalls of medical devices to be taken by responsible entities to eliminate risks to patients, including the factors to be considered when deciding on the actions to be taken.
The Ethiopian Food and Drug Authority (EFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the way medical devices should be stored and distributed. The document is intended to assist medical device manufacturers, their authorized representatives, importers, distributors, and other parties involved in operations with medical devices related to placing them on the market in interpreting and applying the respective regulatory requirements. The scope of the guidance addresses, inter alia, the aspects related to recalls – special actions to be taken by a responsible party in case it would be identified that the device creates additional risks for users or patients.
Medical Device Recalls: Key Points
According to the guidance, EFDA has the authority to order a recall of any regulated product and cease distributions in cases of contravention of applicable laws and, when the use or exposure to the product will have adverse health consequences. Hence, all the entities involved in storage and distribution are obliged to develop and implement the appropriate documented procedure describing the recall process, which should be in line with corresponding requirements and guidelines. The said procedure should prescribe the efficient measures to be taken to ensure the potentially harmful devices are removed from the market without undue delay.
As further explained by the EFDA, the recall procedure should cover the following aspects:
- The appointment of a responsible person, as well as the scope of responsibility of such a person;
- General matters related to coordination of a recall;
- Contact details for the entity and EFDA;
- Specific requirements to be discussed;
- Notification requirements prescribing the way the authority will be notified about the upcoming recall;
- Risk-based classification for recalls;
- Information about the way traceability will be ensured;
- Details about recipients to be informed;
- Description of the way the products subject to a recall will be handled;
- Measures to be taken to ensure proper separation of recalled medical devices from the original ones;
- Procedure to be followed when returning recalled products to the responsible entity;
- Reporting procedure;
- Information about the actions to be taken in case of the issues identified by healthcare institutions using medical devices.
The authority also mentions that the overall effectiveness of the procedure described herein should be subject to verification regularly – such verification should take place at least annually – to ensure that in case of a recall the products in question would be identified and excluded from public circulation without undue delay. When conducting such an assessment, an interested party should consider the risks associated with the devices and the complexity of operations in general. However, if within the respective period the company has already participated in an actual recall, there is no need to conduct the aforementioned assessment. Should the assessment demonstrate that there are any issues related to the recall process, impacting its overall effectiveness, such issues should be properly addressed, and the appropriate amendments should be implemented to the policy.
The authority additionally emphasizes the importance of implementing an efficient and effective method for identifying customers supplied with a product subject to a recall along with templates of forms and letters for the execution of a recall.
Apart from the general points described hereinabove, the guidance also addresses certain specific matters to be taken into consideration by responsible parties in terms of recalls. In particular, the document describes the approach to be applied concerning medical devices that have been recalled.
As it was mentioned before, recalled products should be stored in a way ensuring they would not be confused and mixed up with new medical devices having no defects. This includes, inter alia, physical separation by storing in another place and/or placing a label “recalled product”. The same approach should be followed when transporting such products.
The authority also states that the general recommendations provided by the manufacturer about storing and transportation should be followed about recalled medical devices as well.
Once a batch of products to be recalled has been identified, the parties who received products from that batch should assess the number of products in stock, as well as the ones that have been already supplied to customers.
According to the applicable notification requirements, the EFDA as a regulatory agency, and also the manufacturer of a medical device in question or its authorized representative should be duly notified about a recall. Based on such notification, the authority is entitled to take the steps to share this information and notify respective national regulating authorities in the sphere of medical devices in other countries where the products subject to a recall are also placed on the market. The applicability of such measures should be determined depending on the risks associated with the medical device in question.
As prescribed by the applicable legislation, all records, including distribution records, should be readily accessible to the designated person(s) responsible for recalls. It is important to ensure such records contain sufficient details about medical devices that have been already supplied to customers. Apart from this, it is also necessary to keep the proper records related to the recall process itself. Upon completion of a recall, a party responsible for a medical device in question should issue a final report covering, inter alia, the details about the numbers of medical devices supplied and recalled.
In summary, the present EFDA guidance provides an overview of the applicable regulatory requirements related to recalls. The document outlines the responsibilities of the parties involved in the distribution of medical devices and specifies the approach they should apply when deciding on the actions to be taken to mitigate the risks associated with medical devices in which the quality defects have been identified.
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