What should be done immediately after the incident?
Answer
• Do not move the medical device or its accessories unless it poses a danger to the patient or medical staff.
• Do not change the control settings for any medical device.
• Do not disconnect or dispose of any disposable or disposable accessories or parts such as wires, catheters, electrodes, tubes belonging to the medical device ... etc., as their presence is important in understanding the event.
• Adequate capture of photos.
• Document: who was there, who worked, what happened, etc.
• Report the event to SFDA.
Question
complaints
Answer
written, electronic or oral communication that alleges deficiencies
related to the identity, quality, durability, reliability, usability, safety or
performance of a medical device that has been released from the
organization’s control or related to a service that affects the performance
of such medical devices
Question
"Medical devices adverse event"
Answer
means any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat
Question
Incident
Answer
means any malfunction or deterioration in the characteristics or
performance of a device made available on the market, including use-error
due to ergonomic features, as well as any inadequacy in the information
supplied by the manufacturer and any undesirable side-effect
Question
Who can report?
Answer
Everyone can report: users, health practitioners, manufacturers, authorized representatives, suppliers or distributors.
Question
"How to report medical devices adverse events, incidents and complaints?"
Answer
Through one of the following channels:
• National Centre for Medical Device Reporting (NCMDR) website
https://ncmdr.sfda.gov.sa/default.aspx
• Saudi Vigilance
https://ade.sfda.gov.sa/
• Call center 19999
• Tameni App
Question
How to update the responsible person information in the radiation emitting medical devices assessment report?
Answer
Contact the radiological health executive administration via this e-mail: rh.md@sfda.gov.sa
Question
What are the requirements of evaluating the safe use of radiation emitting medical devices in healthcare facilities?
Answer
"You can find the requirements and guidance through this link
https://www.sfda.gov.sa/sites/default/files/2021-03/RequirementRadiationProtectionSafetyE.pdf
Question
"What are the importation and clearance requirements for medical imaging products? "
Answer
The importation and clearance requirement is being updated and it will be published soon.
Question
What are Medical Imaging products?
Answer
They are non-radioactive pharmaceutical products or products used in radioscopy, and SFDA approval is required for importing
