The new article addresses the regulatory aspect related to premises used to store medical devices before they will be supplied and describes the approach to be applied when receiving new medical devices and organizing their storage.
Table of Contents
The Ethiopian Food and Drug Authority (EFDA), the country’s regulatory agency in the sphere of healthcare products, has published the guidelines for Good Storage and Distribution practice of medical devices. The document covers the most important aspects to be considered by all the parties involved in operations with medical devices to ensure the products remain safe and efficient throughout all the steps taken before the device is supplied to the end-user. However, the recommendations provided in the guidelines are non-binding, and could be subject to changes, should it be reasonably necessary to reflect the respective changes to the underlying legislation. The scope of the document covers, inter alia, the matters related to premises used to conduct operations with medical devices.
General Requirements
Under the general rule, all the entities involved in operations with medical devices should carry out their activities using a premise that is suitably located, designed, constructed, and maintained, to ensure appropriate operations such as receiving, storage, picking, packing, and dispatch of medical devices. The premises used for storage purposes should have lighting and ventilation to ensure the instructions of medical device manufacturers regarding storage conditions are followed. Access to such premises should be duly controlled. Specific requirements should be also followed in case of radiation-emitting medical devices or other products that are associated with certain hazards. It is also important to ensure that the procedures related to dispatching and receiving medical devices are handled in a way ensuring the products are not exposed to the impact of weather conditions. The authority also mentions that the entity operating the premises is responsible for keeping them clean, and also preventing contamination by cleaning reagents. Moreover, it is important to ensure that the premises are duly protected from the entry of animals or insects. It is also stated that ancillary premises used by the personnel working with medical devices should be fully separated from the premises used to store medical devices. The authority additionally emphasizes that consuming food or smoking in such premises should be strictly forbidden.
As it was mentioned before, an entity conducting operations with medical devices should take the steps necessary to ensure that medical devices are not exposed to the adverse impact of external factors (e.g., weather conditions) when being received by the entity or dispatched. In particular, the authority states that each entity conducting operations with medical devices should duly develop and implement a documented policy describing the procedures to be followed each time receiving new medical devices. Such a policy should include a checklist to be used to verify all incoming delivery to ensure the devices are delivered from the proper entity. The aspects to be covered by a checklist may include, inter alia, the following ones:
- The purchase order,
- Containers,
- Packing list,
- Accessories,
- Label description,
- Batch number,
- Expiry date,
- Quantity.
Receiving of new medical devices should be conducted via the receiving bay upon rigorous inspection and cleaning of the products delivered. In the course of such an inspection, a responsible person should identify any damage caused to the devices or their packaging during transportation. The results of an inspection should be duly documented. To prevent mixup, newly received medical devices should stay in quarantine and, consequently, be kept in separate premises.
In case of collecting samples of medical devices received, it is important to ensure that:
- a representative number of containers in a consignment are sampled and checked,
- sampling is undertaken by appropriately trained and qualified personnel,
- containers from which samples have been taken are labeled,
- all activities are undertaken by a written sampling procedure and sampling plans.
Once the sampling is completed, the products should be placed in quarantine as described hereinabove before the final decision will be taken. During this period, the products should be stored by instructions communicated by the medical device manufacturer. As explained by the EFDA, the procedure to be followed when transferring medical devices from quarantine to stock available for distribution should be described in a respective policy to be developed and implemented by an entity conducting such operations. The authority also reminds us about the importance of ensuring proper separation of products to prevent the products placed in quarantine from being made available for customers together with other products.
Storage Areas
The premises used to store medical devices should meet the respective requirements for ensuring that all the instructions provided by medical device manufacturers are followed. Furthermore, the security measures to be implemented should be sufficient enough to prevent unauthorized access to the premises where medical devices are stored. The products should be stored in a way ensuring they are duly protected against any harmful impact caused by external factors, such as direct sunlight or humidity. All the procedures related to maintaining the premises used to store medical devices should be performed by the respective documented policies to be developed and implemented by the entity operating the premises, while all the records related to the actions taken should be duly kept. In the case of a computerized system used, the evidence demonstrating its efficiency should be in place. Sampling should be conducted in a way preventing contamination or cross-contamination.
As it was mentioned before, any medical devices that are not intended to be made available for the customers (e.g., broken or damaged ones) should be kept separately to prevent mixup. This could include not only a physical separation but also labeling and other measures ensuring that separated medical devices could be easily distinguished from others.
The premises used for storing medical devices should be equipped with fire detection and firefighting equipment. The type of equipment to be used and its configuration should be determined depending on the premises, and also on the medical devices stored therein.
Storage Conditions
To ensure the safety and effectiveness of medical devices, they should be stored strictly by recommendations and instructions provided by their manufacturers. First of all, attention should be paid to such factors as temperature and humidity, which should be duly monitored to ensure they are within the acceptable limits specified by the manufacturer for this type of medical device.
In summary, the present EFDA guidance highlights the most important aspects related to the premises used to store medical devices. The document describes the procedures to be followed when receiving new medical devices, as well as the requirements the premises should meet.
Sources:
http://www.fmhaca.gov.et/wp-content/uploads/2022/01/Guidelines-for-Medical-Device-GDP-and-GSP.pdf
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