SFDA Guidance on Safe Use of Medical Devices: Radiation-Related Aspects

Table of Contents

The Saudi Food and Drug Administration (SFDA), the country’s regulatory agency in the sphere of healthcare products, has published a guidance document dedicated to the safe use of medical devices in healthcare institutions. The guidance provides additional clarifications regarding the requirements to be followed by healthcare institutions to ensure medical devices and equipment are used safely and efficiently. 

Safe Use of Radiological and Medical Visualization Equipment 

According to the guidance, when using radiological and medical visualization equipment the healthcare institution should ensure the appropriate requirements are followed, namely:

• There are documented policies and procedures in place, describing the aspects related to radiation protection and safety. The policies are also aligned with the respective regulatory requirements and applicable standards. 
• The aforementioned policies and procedures are strictly followed by the institution and all of its employees. In particular, all doses the employees have been exposed to should be duly recorded. 
• The quality of radiological services should be subject to assessment regularly. Such an assessment should be carried out either by the employees of the same institution having necessary skills and qualifications or by a licensed third-party assessment body, while the results thereof should be duly documented. 
• Should any issue be identified during testing, the authority should be properly notified. In such cases, the correction plan should be provided within 3 business days from the date an issue has been identified. The results of all the actions taken should be also properly documented. 
• The protective screens used for the premises should be subject to regular testing as well to assess their effectiveness. 
• All staff members and patients should be provided with personal protective equipment, which should be available in different sizes and for different purposes. The appropriate protective equipment should be used in any premises where ionizing equipment is used. There also should be a sufficient number of protective glasses, which should be stored in a way preventing them from getting damaged and ensuring their efficiency and functionality (it is also necessary to provide all the patients with the glasses impenetrable for the X-rays). 
• The requirements in the sphere of exposure dose control include, inter alia, the following ones:
  • Provide each employee with two cards for dose measurements;
  • Store individual cards within the whole period of employment;
  • Provide an employee with additional measuring equipment, in case there is a risk of exposure to high doses of radiation. 
  • Conduct a risk assessment based on the expected annual exposure.
  • Provide pregnant employees with additional cards irrespectively of expected exposure level.
  • Placing warning signs on the doors of radiology departments in both English and Arabic, provided they include special signs for pregnant women. 
• All the entrances should be equipped with the signal light to be activated when the radiation is emitted.
• If mobile units are continuously used in specific premises, an additional risk assessment should be duly carried out. Moreover, when using mobile units, movable screens (barriers) should be used as well. 
• All X-Ray premises should be equipped in a way ensuring that healthcare professionals can monitor the state of the patient who is inside all the time. 
• A place for an operator should be safe and properly protected. 

The authority reserves the right to amend and supplement the list provided hereinabove with additional requirements to be followed by healthcare institutions conducting activity with radiation-emitting medical devices. 

Safe Use of Radioactive Materials 

Apart from the requirements related to the use of radiation-emitting medical devices, the guidance also highlights the most important aspects related to the storing and use of radioactive materials. According to the guidance, healthcare institutions are obliged to:

1. Develop and implement documented policies and procedures for the safe use of radioactive materials, keep records on any adverse events and investigations thereof. 
2. Create a special safe place where the radioactive materials will be stored. Access to such places should be restricted and monitored with CCTV. 
3. Ensure the laboratory for preparation of radioactive materials is equipped with communication devices for emergency use, as well as radiation detection and control devices with a sound alert to be placed inside the laboratory. Radioactive medical materials, as well as radiation detection devices, should be subject to periodic calibration. 
4. Ensure the availability of all equipment and infrastructure necessary in case of an emergency, including:
   1. Laundry,
   2. Shower,
   3. Eye spray,
   4. Equipment for identifying radioactive pollution, 
   5. Equipment for removal of radioactive pollution.
5. Develop a safe way for transporting radioactive medical materials to the laboratory. Each time being transported, radioactive materials should be followed by the radiation protection officer, while the transfer should be duly documented and reflected in the internal accounting system. 

In summary, the present SFDA guidance provides a detailed overview of the regulatory requirements healthcare institutions should follow to ensure medical devices are used safely and efficiently. The document pays special attention to the aspects associated with the use of radiation-emitting equipment due to the high risks associated thereto. 

Sources:

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

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.