The technical relationship between users, medical devices, and biomedical engineering staff in Saudi Arabia has been standardized and considered part of the accreditation requirements for healthcare institutions. These accreditation requirements have been issued under the umbrella of the Saudi Arabia Central Board for Accreditation of Healthcare Institutions (CBAHI),  which also ensures that healthcare institutions comply with their requirements.
Standards for safe operation
Although the CBAHI has certain requirements for the safety of medical devices, these requirements are not considered among the Essential Safety Requirements (ESR).  In contrast to other international regulations, such as in those in the US and Germany, these requirements are obligatory, regardless of the overall weighted scoring criteria. 
One aspect addressed in the CBAHI standard is ensuring that hospitals have policies and procedures that regulate the management of medical devices. Within this requirement, the role and responsibilities assigned to each member of the clinical and technical staff are not well explained. However, the standard necessitates in section HR.7.1.3 that newcomers should attend an orientation program before working independently.  The content of the orientation program should include the safe operation of medical devices and troubleshooting.
Another factor that contributes massively to the safe operation of medical devices is the reporting of adverse medical device events. According to the CBAHI standards, healthcare workers (HCWs) should be aware of the official national requirements and channels for reporting adverse events. Here in Saudi Arabia, the national reporting system for adverse events related to medical devices is a web-based electronic system governed by the Saudi Food and Drug Authority (SFDA). [8–10]
Periodic preventative maintenance (PPM) and procedures related to medical devices
The responsibilities for the different tasks related to medical devices and equipment, such as PPM, sterilization, disposal of non-recyclable items, and ordering supplies, were well recognized and coordinated between the different team members from the ICUs and the biomedical engineering department, as indicated in the respondents’ answers. Of note is that most of the respondents were aware of their roles and that of the biomedical engineering department. Such communication and multidisciplinary team work are important to optimize the management of medical devices in ICUs. 
It would be helpful to create a computer-based inventory system of all ICU devices accessible to all departments involved in the safe handling, processing, and managing of medical devices within healthcare facilities. Such a system would lead the multidisciplinary effort to maintain the safety and traceability of medical devices from all aspects.
The system can include educating users on the utilization and provision of checklists. Additionally, it can help the staff determine when PPM is needed and enhance the technical follow-up of devices, maintenance and repair logs, and the ability to promptly provide users with replacement devices, as well as provide criteria to decide when a device should be discarded.
Existence of super users
The HCWs indicated that when they want to learn more about a medical device within their unit, they tend to contact the device manufacturer first, followed by super users. The majority indicated that their units had no device “super users,” and when they are occasionally present, their specific role as super user is not defined. This finding highlights the need for the official assignment of a super user for each device type or model in every unit. The super user could solve issues faced by the medical staff by leading all aspects related to the use and operation of the device, as well as mentoring and training other users in-house.
The role of the super user, as identified in the German Medical Devices Operation Ordinance Medical Devices Clinical Educator,  is crucial for different aspects related to the safe operation of the medical devices assigned to the super-user. These obligations include attending training sessions on the safe operation of these medical devices that qualify the super user to train other users within the healthcare institution, organizing training on the use of the medical devices for other HCWs, documenting all the activities related to the medical devices, assuring the availability of the IFU of the medical devices, and monitoring PPM compliance.
Other roles for the super user might include organizing discussions to address safety issues regarding the operation of these medical devices with the users, competent authority officers (such as the SFDA), the manufacturer, the biomedical engineering department, and other departments involved in the operation of these medical devices (such infection control). Super users also support the competent authority officer in preparing procedures for reporting adverse events, applying recall procedures for medical devices, and facilitating investigations.
Responsibilities and role of technical staff and troubleshooting
Any technical error encountered during the use of a medical device could have a highly negative impact on the safety of the patient or user. This survey found that 8% of respondents tended to reboot the system immediately once the alarm went off as the first step, 32% considered rebooting the device as a second step, and 22% considered it as the third step.
Ideally, when the alarm on a medical device goes off, the typical action is for users to respond and manage it according to the procedure standards they learned during training for that specific medical device. If they fail to identify and resolve the issue, they should consult the assigned super user. If the issue persists, they should contact the biomedical engineering department and then the manufacturer to manage it properly. It is risky to attempt to reboot and reuse the device when it starts functioning again because rebooting could keep any failure latent, which could result in a serious adverse event if the issue is not identified and managed properly.
Risk information communication
Most of our respondents relied heavily on the manufacturer’s feedback for updates on the risks related to medical devices. A small proportion relied on their colleagues and the medical literature to get updates on the risks related to these devices. Of note is that only six respondents (2%) considered the SFDA to be a source of information about the risk of medical devices. This low percentage could be due to a lack of awareness about the role of the SFDA as a source of medical device risk information and recalls.  The apparent lack of knowledge among the respondents could also be due to a lack of communication between the SFDA and healthcare providers.