The second article addresses certain specific matters related to periodic management reviews, complaints handling, and also the actions to be taken for returned medical devices.
The Ethiopian Food and Drug Authority (EFDA), a country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to good storage and distribution practices for medical devices. The document highlights the most important aspects to be taken into consideration by medical device manufacturers, importers, distributors, and other parties involved in operations with medical devices to ensure the devices are stored and transported properly before they will be delivered to end-users. The abovementioned factors are vitally important since the way such operations are conducted could impact significantly the safety and performance of medical devices when later used for their intended purposes.
According to the guidance, an entity that undertakes operations with medical devices should duly carry out management reviews regularly (annually). As further explained by the authority, such reviews should cover, inter alia, the following aspects:
- The actual implementation of recommendations provided as the result of the previous review;
- Assessment of the situation with the quality policy and objectives, including the analysis of quality metrics and respective KPIs;
- Assessment of the reports provided by both internal and external auditors;
- Notifications on non-compliance;
- Analysis of requests received, including feedback and complaints, as well as corrective actions;
- Evaluation of existing opportunities for further improvement.
The EFDA additionally mentions that the process and results of a management review carried out as described hereinabove should be duly documented.
The authority pays special attention to the approach the entities involved should apply when handling complaints. In particular, the EFDA states that the appropriate documented procedure should be duly developed and implemented. Such a procedure should cover the following aspects:
- The way to distinguish complaints regarding the device itself and distribution;
- The procedure to be followed is to notify all the parties involved, including medical device manufacturer and regulating authority;
- Actions to be taken to investigate the case and identify the root cause;
- The procedure for preparing and undertaking corrective and preventive actions, as well as the way the effectiveness of such actions should be evaluated;
- The way to distinguish complaints regarding the quality and falsified products, including the matters related to information exchange.
It is also important to mention that an entity that carries out operations with medical devices is obliged to keep information about any complaints received.
In certain cases, medical devices could be returned to the entity after being supplied to end-users. According to the guidance, this concept covers such situations as:
- where an establishment supplies a customer with the incorrect medical device which is subsequently returned;
- where a customer returns a medical device to an establishment which they ordered in error;
- where a product is received back to the premises of an establishment having never been received by the customer.
According to the guidance, it is necessary to develop and implement the procedure addressing all the matters related to operations with returned medical devices. In particular, such a procedure should describe the measures to be taken to ensure that returned devices are duly separated from others. As described by the EFDA, returned medical devices should be:
- placed in quarantine upon receipt with a clear status of the goods;
- stored in a manner that prevents access and distribution until a decision has been taken;
- stored as per the manufacturer recommended storage conditions applicable to the specific medical device;
- destroyed unless it is certain that their quality is satisfactory after they have been critically assessed and necessary corrections are made following a written and authorized procedure.
To ensure proper separation from new medical devices, an entity should dedicate a separate area where returned devices would be stored, and all the measures should be taken to prevent mixing both types of products.
Should it be decided to place returned medical devices back on the market, such a decision should be based on a rigorous assessment and risk analysis. Moreover, returned medical devices placed again on the market should have specific identifiers making it easier to distinguish them from other products of the same type. End-users of such products should pay special attention to the way these devices are operating to be able to identify any deviations from the expected performance. Should it be identified that the device does not perform as intended, such a device should be placed on quarantine, and the authority should be notified accordingly.
It is also important to mention that the period from the moment of the device being dispatched to the moment it was returned should be considered as well. In this regard, the authority encourages the entities involved in the distribution of medical devices to set forth specific timelines within which medical devices that were delivered due to the mistake in order or delivery could be returned.
The factors to be considered when determining the future destiny of returned medical devices should include, inter alia, the following ones:
- The device in question, the way it was stored, and the time from the date it was initially supplied;
- The terms and conditions of the agreement between the establishment and customer;
- The results of an assessment of the returned product were subject to;
- Qualification and experience of staff members involved in the assessment of returned medical devices (they should be able to identify falsified medical devices).
As in cases with complaints, it is necessary to keep the records of all cases related to the returned medical devices, including the details of the case and the future destiny of the product in question. Such records should be duly kept at least for two years from the date the decision is taken. The records should be detailed enough to cover all the steps of the assessment. All the devices which were placed back on the market should be included in the respective register which should contain their details, as well as the information about the reason why they were returned. The authority additionally emphasizes that the assessment such devices were subject to should be also documented, while the devices themselves should be placed back on the market only upon formal approval of an authorized person.
In summary, the present guidance provides additional clarifications regarding the applicable requirements for periodic reviews, and complaints handling procedures. The document describes the approach to be applied concerning medical devices that were returned to the same parties.
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