SFDA Guidance on Safety for Use of Medical Devices: Overview

Table of Contents

The Saudi Food and Drug Administration (SFDA), Saudi Arabia’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to the requirements for the safe use of medical devices and raw materials in healthcare institutions. The present document constitutes the initial version of the guidance. The scope of the guidance covers such aspects as:

• Storing and transpiration of medical devices and raw materials; and 
• Determining the optimal temperature values and storing conditions for medical devices and raw materials. 

The document is intended to provide additional clarifications for the regulatory requirements to be followed to ensure medical devices are used safely and efficiently, while all the risks associated thereto are duly mitigated to the lowest extent possible. The recommendations provided in the guidance are addressed to any healthcare providers operating in the country. 

General Requirements 

First of all, the document outlines the general requirements healthcare facilities should follow. According to these requirements, healthcare providers are obliged to:

1. Strictly follow any requirements related to safety and effectiveness when using medical devices.
2. Ensure all the devices and raw materials used are duly registered and permitted for use in the country. 
3. Should the registration certificate expire and cannot be renewed, consider the following aspects:
   1. It should be an official letter issued by the medical device manufacturer by the device of which the latter commits to supply original replacement parts and components, as well as to perform maintenance of the medical software. 
   2. All reports on regular maintenance and quality control should be in place.
   3. All other applicable requirements should be followed. 
4. Appoint an authorized person to be in charge of communications with the authorities for incidents and adverse events associated with medical devices used by a healthcare facility. 
5. Duly develop and implement the appropriate documented policy on adverse events, associated with medical devices and raw materials, prescribing the procedures for post-market surveillance. 
6. Comply with the respective regulatory requirements related to radiological safety. 

Apart from the above, healthcare providers should:

• Use medical devices strictly following their intended purpose and do not use them for any other purposes;
• Make sure the radioactive medical materials are allowed for use and have all necessary permissions;
• Comply with the requirements in the sphere of radiology (ionizing and non-ionizing emission);
• Ensure the implantation card is in place and contains the following details:
  • Name of the patient and doctor,
  • Name of the healthcare facility,
  • Date of implantation;
• Ensure that the medical device is supplied with all the necessary components and documentation as described by its manufacturer;
• Duly notify the authority about any non-compliant or counterfeit medical devices;
• Provide all information about medical devices that are non-compliant in the context of the applicable regulatory requirements;
• Notify the authority promptly about the reparable incidents and adverse events associated with medical devices following the appropriate procedures and policies; 
• Comply with post-marketing requirements;
• In case of a safety warning received – follow the recommendations contained therein;
• Cease using a medical device, should this be prescribed under the corrective actions announced until further notice;
• Apart from following the general incident notification requirements, duly inform the authority about any incidents associated with radioactive materials as prescribed by the appropriate procedure;
• Ensure the clinical trials undertaken in the authority are conducted in line with the applicable regulatory requirements to ensure the safety of patients; 
• Duly document the clinical trials and results thereof;
• Ensure that the advertising materials are approved by the authority;
• Conduct maintenance of medical devices used by engaging third-party contractors having necessary certification;
• Carry out maintenance of radiation-emitting devices in a specific place. 

The document also describes the functions of the department responsible for medical devices. According to the guidance, such a department should fulfill the following obligations:

• Ensure the necessary documented policies and procedures are in place;
• Conduct maintenance and calibration of medical devices regularly as prescribed by the manufacturer in the technical documentation accompanying the devices;
• Recycle medical devices following the respective requirements;
• Take the actions prescribed by safety warnings and implement corrective actions announced;
• Ensure that the requirements prescribed by the medical device manufacturer in technical documentation are followed;
• Conduct initial acceptance of implantable devices to ensure they meet the requirements outlined in specifications and could be used;
• Receive implantation reports confirming that the device has been duly implanted, while the patient has been instructed on the way the device should be used; and also to ensure the device operates as intended; 
• Receive all the reports related to cleaning and decontamination;
• Ensure the appropriate training for the personnel involved in operations with medical devices; 
• Ensure that all necessary examinations are duly performed before using the device;
• Compile and follow the periodic maintenance schedule;
• Ensure the device is duly calibrated; 
• Follow recommendations provided by the medical device manufacturer for maintenance and calibration of the device. 

Special Requirements for Radiological Equipment 

The guidance also provides an overview of specific requirements to be followed for radiation-emitting products used in healthcare facilities for medical image capturing, diagnosing, and other purposes. First of all, an institution using such devices should duly develop and implement respective policies specifying the details of operations with these products in a safe manner. These policies should be strictly followed and also reviewed from time to time to ensure they are up-to-date and reflect the recent changes to the applicable regulatory requirements in the sphere of radiological safety. For instance, healthcare institutions are obliged to conduct measurements of emission doses and keep the appropriate records confirming that these doses are in line with the respective limits. Radiation-emitting devices should be subject to periodic testing to be conducted by qualified staff having the necessary skills and knowledge. The results of testing should be duly documented and kept as well. Should an issue be identified, a correction plan should be prepared within 3 business days. Furthermore, healthcare providers are responsible for ensuring the proper operations of the protecting screen preventing exposure to emission, while all the specialists working with the radiation-emitting devices should be provided with the personal protective equipment.

In summary, the present SFDA guidance provides additional clarifications for regulatory requirements healthcare institutions should follow when using medical devices. The document provides general requirements to be followed irrespectively of the device type, as well as device-specific requirements. 

Sources:

https://beta.sfda.gov.sa/sites/default/files/2022-01/MDS-REQ3.pdf

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