The new article describes the aspects related to various operations with medical devices and the way they should be undertaken by all the parties involved.
Table of Contents
The Ethiopian Food and Drug Authority (EFDA), the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the good storage and distribution practice of medical devices. The document is intended to provide additional clarifications regarding the applicable regulatory requirements, as well as recommendations to be considered to ensure compliance thereto by all the parties involved in operations with medical devices. In particular, provisions of the guidance address the matters to be taken into consideration when storing and transporting medical devices to ensure their continued safety and effectiveness. At the same time, provisions of the guidance are not binding and could be subject to changes reasonably necessary to reflect respective changes to the applicable legislation. The scope of the document covers, inter alia, the aspects related to:
- Stock control and rotation;
- Qualification and validation;
- Activities and operations, including receipt, storage, repacking and relabelling; distribution, and transport.
The guidance describes best practices to be followed when storing and transporting medical devices before they will be supplied to end-users.
Stock Control and Rotation
According to the guidance, an entity conducting operations with medical devices should duly develop and implement written procedures describing the approach to be applied about stock control and rotation. Moreover, an entity should also keep records of all the stock changes. As further explained by the EFDA, these records should include:
- Periodic stock reconciliation (performed at defined intervals);
- The root cause for stock discrepancies (if any);
- CAPAs was taken to prevent recurrence of discrepancies;
- Damaged containers received (if any) and actions taken;
- List of Items identified as close to their retest or expiry date and or removed from useable stock (due to expiry).
Qualification and Validation
Apart from the stock control procedure described hereinabove, an entity should develop and implement the appropriate policy addressing the matters related to qualification and validation, including their scope and extent. The said policy should be developed taking into consideration the particular premises and equipment used, as well as other policies and procedures implemented. The authority also emphasizes the importance of the investigation of deviations (if any).
The document also provides clarifications regarding the applicable requirements related to the personnel the entities operating in the sphere of medical devices should have. In this regard, the EFDA states the following:
- An entity should employ a sufficient number of specialists necessary to support its operations, having appropriate qualification and experience;
- It is required to appoint a responsible person who will take responsibility for the implementation and proper maintenance of a quality management system (the guidance also states that such a person should be independent of operating activity of the company);
- The staff of an entity should have all resources reasonably needed to perform their functions about quality system, and also to be able to identify any issues in the way the procedures are implemented;
- It is important to ensure the key persons, as well as other staff of an entity, are not exposed to external impact of any kind in a way that could impact adversely the quality of the services provided or the products themselves;
- The policies to be developed and implemented should address the matters related to environmental protection and integrity of medical devices;
- All the staff should be properly trained to ensure all the members are aware of the appropriate requirements;
- Moreover, the particular specialists operating with specific medical devices (for instance, radiation-emitting products), should perform respective training as well;
- It is important to ensure all the employees involved in operations with medical devices are equipped with all they need to perform their activity safely and efficiently;
- The firm should develop and implement codes of practice and procedures to prevent and address situations where persons involved in the storage and distribution of medical devices are suspected of, or found to be implicated in, any activities relating to the misappropriation, tampering, diversion, or falsification of any product, it is also stated that an entry should duly notify the respective authorities in case such situations occur.
Activities and Operations with Medical Devices
Apart from the aspects described hereinabove, the guidance addresses the matters related to other operations that could be conducted. In this regard, the authority explicitly states that all the activities should be performed strictly by the applicable legislation, as well as recommendations and guidelines published by the authority, and also the appropriate written procedure to be developed and implemented by an entity conducting such activities. The document further provides additional recommendations related to such activities as:
- Receipt. All items an entity deals with should be received from authorized suppliers. Once an item (a medical device) is received, it should be subject to rigorous examination to identify any issues that may take place. This includes both technical issues with the device itself, as well as the ones related to the documentation accompanying the device. The items that do not meet acceptance criteria should be separated from other items and marked accordingly. At a later stage, they should be subject to a rigorous investigation.
- Storage. When storing medical devices, an entity should ensure the appropriate instructions of the manufacturer are duly followed. Apart from this, it is important to take the steps to ensure that the devices would not be subject to contamination and/or mix-ups.
- Repackaging and Relabelling. First of all, the authority states that it does not encourage repackaging and relabelling of medical devices, while where repackaging and relabelling must occur, these activities should only be performed by entities appropriately authorized to do so and in compliance with the authority’s relevant directive(s) for repacking and by cGMP requirements.
- Distribution and transport. As in the case with storing, transportation of medical devices should be undertaken in strict accordance with the instructions communicated by their manufacturer. It is also important to take all the steps that are necessary to prevent the adverse impact that could be caused to the medical device about its safety and effectiveness. Concerning distribution, the authority emphasizes the importance of keeping the appropriate records, that could be used in case of recalls to ensure traceability of the devices supplied to end-users.
In summary, the present EFDA guidance covers the most important aspects related to specific operations with medical devices and also provides additional clarifications regarding the applicable regulatory requirements in terms of personnel involved in such activities.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.