The National Center for Medical Device Reporting (NCMDR), the medical device sector of the Saudi Food and Drug Authority (SFDA) that is in charge of managing a database of information on safety and performance related aspects of medical devices, has so far issued 750 recalls of defective medical devices this year. The recalled medical devices were mostly foreign manufactured and imported and sold by locally authorized distributors, according to data of the NCMDR. The recalled devices were approved by competent authorities in their country of origin, including the US Food and Drug Administration (USFDA) and Medicines and Healthcare products Regulatory Agency (MHRA) of UK. Since the establishment of the NCMDR in February 2007, it has so far recalled 3,740 medical devices from 2007 to 2010. Medical devices are recalled when they are defective, pose risk to health, or when they are both defective and a risk to health. Conditions like these of the medical devices violate the law established by SFDA. However, SFDA said that a recall of a medical device does not always mean that its use must be stopped. Recalls sometimes imply that the medical device needs to be checked, adjusted or fixed. The action of recall is necessary in order to protect the interest of patients and the public who will be using the medical devices, considering the rapid growth of the Kingdom's public healthcare programs and health services, which, at present, have over 333 hospitals with 46,000 beds, 1,848 health centers, and approximately100 medical centers. These government facilities exclude private medical institutions, which are also benefited by the SFDA's recall orders of defective medical devices. SFDA also makes it certain that medical devices introduced for use are safe and conforms to internationally recognized standards, and that their performance ensures the safety of the patients and medical devices operators. Another reason why SFDA issues recalls is the increasing number of medical devices being used privately and personally by patients. Medical devices, such as blood glucose meter for diabetic patients, blood pressure gadgets, and other electronic and electromagnetic medical devices, which are openly marketed, should be subjected to regulatory requirements. In order to protect patients and the health professionals using medical devices, SFDA has set up an online medical devices reporting system, implemented through the NCMDR. The system identifies events in which patients and medical staffs suffered harm as a result of failure or misuse of a medical device, or when the medical devices fail and harm the environment. The recall of a defective and harmful medical device may be done by healthcare providers and practitioners, such doctors and nurses, the manufacturers of the products or its authorized representatives and distributors, and the general public affected by the defective medical device. __
