The new article addresses the matters related to ancillary activities conducted by the entities involved in operations with medical devices including but not limited to dispatching medical devices to end-users, and also the activities that could be outsourced.
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of medical devices, has published a guidance document dedicated to good storage and distribution practices for medical devices. The document is intended to provide additional recommendations regarding the way the activities with medical devices should be carried out before they will be supplied to customers to ensure safety and effectiveness. The guidance also provides additional clarifications regarding the applicable regulatory requirements and describes the approach to be followed by medical device manufacturers, distributors, and other parties involved to achieve and sustain compliance thereto.
The scope of the guidelines covers, inter alia, the matters related to dispatching medical devices. In this regard, the authority states that all the procedures should be based on the respective written policies to be developed and implemented by the parties involved. The products should be supplied only to the ones who are entitled to receive them. Moreover, it is important to ensure the distribution records are duly maintained, as they can be used in case of withdrawals or other corrective actions. The authority additionally emphasizes that the parties conducting the distribution of medical devices should retain copies of proof of authorization or permits provided by the parties to whom the products are distributed. Medical devices should be supplied exclusively based on an order provided by the recipient.
According to the guidance, distribution records should include the following details:
- Date of dispatch;
- Complete business name and address (no acronyms), type of entity responsible for the transportation, telephone number, names of contact persons, the status of the addressee (e.g. retail pharmacy, public hospital or community clinic, private health institution);
- A description of the products;
- Quantity of the products, i.e. number of containers and quantity per container (if applicable);
- Applicable transport and storage conditions;
- A unique number to allow identification of the delivery order; and
- Assigned batch number and expiry date (as appropriate).
Thus, the records kept by distributors should be sufficient to ensure traceability of medical devices supplied, including potential recalls or combating counterfeit products. For this purpose, distribution records should contain details about the batch numbers and expiration dates.
As explained by the EFDA, the loading procedures should be based on a last-in/first-out (LIFO) approach to mitigate the risks. Fragile medical devices should be treated with additional care. In case medical devices are based on outdated technology, or the supply date is close to the date of expiration, such devices should not be supplied. During all operations, medical devices should be prevented from unauthorized access, especially during transportation. About the latter, the EFDA emphasizes the importance of following the appropriate procedures to ensure that:
- The identity of the devices is not lost;
- The devices do not contaminate and are not contaminated by other products;
- Adequate precautions are taken against spillage, breakage, misappropriation, and theft; and
- Appropriate environmental conditions are maintained, for example, using a cold chain for thermolabile reagents.
The authority also mentions that an entity conducting operations with medical devices should duly develop and implement the documented procedure describing the way of actions in case of any issues related to storage and transportation. Any person who has identified an issue during transportation should notify the responsible person without undue delay. In case of any deviations identified, such information should be communicated to respective parties as well, and all records related to such communication should be duly kept. If the transported medical devices contain hazardous materials, the appropriate safety requirements should be duly followed.
Any issues identified during transportation and storage should be investigated, and the results of such investigation should be recorded.
The guidance also provides additional clarifications regarding the activities that could be outsourced. In particular, the authority states that the companies should have documented procedures describing the way some of the activities could be outsourced based on the respective agreement to be concluded between the parties involved. The scope of the said agreement should cover, inter alia, the following aspects:
- compliance with this guideline and the principles of GSP and GDP;
- the responsibilities of all entities for measures to avoid the entry of substandard and falsified medical devices into the distribution chain;
- training of personnel;
- conditions of subcontracting subject to the written approval of the contract giver; and
- periodic audits.
Moreover, before entering the agreement, a party intended to outsource some of its activities to the provider should conduct a rigorous assessment of the latter by the virtue of on-site audits or by requesting documentation necessary to demonstrate compliance with the respective requirements and standards. A party that is going to conduct activities with medical devices should have necessary resources depending on the type and nature of activities, e.g., premises, personnel, etc. Additionally, the authority states that the provider should not conduct any actions that could potentially impact adversely the devices in question.
Substandard and Falsified Medical Devices
Apart from the matters described hereinabove, the scope of the guidelines published by the EFDA also covers the approach to be applied to mitigate the risks associated with substandard and/or falsified products. In particular, the authority states that an entity conducting operations with medical devices should duly develop and implement the appropriate procedures prescribing the way such devices should be identified and handled. Should such devices be identified, all the parties involved should be notified accordingly without undue delay. The products in question should be separated from other devices to prevent mix-up with the ones of the proper quality and to prevent them from being placed on the market and/or supplied to the customers.
When operating with medical devices that were recalled or returned for other reasons, an entity conducting such operations should ensure these devices would not re-enter the supply chain. Special attention should be paid to the products containing radiation-emitting elements – all activities related to these devices should be performed strictly by the applicable regulatory requirements and standards to ensure the safety of people.
In summary, the present EFDA guidance provides important clarifications and recommendations regarding the way the activities related to transportation and storing medical devices should be handled. The document highlights the key aspects to be considered by importers, distributors, and other parties involved.
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