Nowadays, health systems in general, and emergency systems in particular, are undergoing major changes. They are seeking to improve the quality of their services and the efficiency of their activities. They must adapt to a rapidly changing context of increasing health care expenditure, scientific and technological progress and changes in user behaviour [1-3].

As a result, the management of medical emergencies is a priority in health system policy. It requires the cooperation of all the actors involved both upstream (pre-hospital emergency medicine) and downstream (hospital emergency medicine) of emergency services [1, 2].

In this context, the Emergency Medical Service (EMS) has a mission of primary importance, namely the regulation of emergency medical assistance from patients’ orientation according to their situation to their-transport destination. The management of medical transport adapted to emergency situations is provided by the EMS’ mobile intensive care units [4, 5].

Thus, factoring in the regulations on the maintenance and quality control of medical devices [6, 7] can lead quite naturally to the implementation of quality procedures. This happens through the establishment of a quality management policy in the exercise of biomedical activity according to standards [8]. For this reason, the main inspiration sources are the professional standards drawn up by biomedical professionals in the form of guides [9-11], as well as or international and European standards [12-14], which are mainly concerned with the management of medical devices [15].

Indeed, ensuring the quality and safety of care is one of the major challenges for any health care institution. In this perspective, the proper management of medical devices is a key element. Promoting quality within one's establishment guarantees a service of good quality [16].

The quality approach fits perfectly in the increasingly normative and regulated world our health care institutions are confronted with. Among other things, it enables them to meet patients' expectations, promote the principle of continuous improvement and strengthen their leadership. Numerous guidelines offer a complete overview of the important elements to be mastered [7, 9, 12, 17, 18].

To date, few authors have focused on the biomedical activity related to the main tool of the EMS missions, namely the mobile intensive care units, or medicalised ambulance [19, 20]. It must be considered as a medical resuscitation device whose reliability and availability are a necessary to guarantee the safety and quality of pre-hospital care [21].

In this paper, we intend to carry out a self-assessment of the biomedical activity related to medical devices on board a fleet of 46 EMS medical ambulances in the Moroccan context. That process was done in two phases: in March 2021 and after 6 months in October 2021. This follows the government's policy to strengthen the regulatory framework for medical devices [22] and health transport.

The present study is performed in the EMS and focuses on the biomedical section activities, more specifically, the medical devices embedded in a fleet of 46 EMS medical ambulances.

The methodology adopted for this purpose is based on an analysis allowing the evaluation and observation of practices related to biomedical activity in these ambulances.

A synergy between the High Authority of Health referential (Criterion 8k) [7] and the Guide of Best Practices in Biomedical Engineering referential [6] was made, and a self-diagnosis based on these two standards was performed.

2.2. Criterion 8k of the High Authority of Health Standard

This tool consists of five processes comprising 29 clear iterations. Each of these iterations corresponds to a High Authority of Health assessment level of “E1”, “E2” and “E3” as shown in Fig. (2) [23].

Fig. (1). Self-assessment process.

Fig. (2). Biomedical equipment management of High Authority of Health criterion 8k.

The evaluation grid for criterion 8k of the High Authority of Health reference framework is used to generate the evaluation results by mapping the various items to be evaluated. The evaluation of this criteria is done according to 6 levels of veracity as indicated in Table 1 [7].

Table 1. The 6 levels with legend and percentage of veracity.

Legends	Scales used in the calculations
	Item	Rating	% of Veracity
No one in the service has any doubts	False Unanimous	0	0%
At least one person considers that the statement is not really false	False	0.2	20%
There is nothing to identify the achievement of the action	Somewhat False	0.4	40%
The action is carried out randomly	Somewhat True	0.6	60%
The action is carried out systematically	True	0.8	80%
It is possible to prove to an external peer that the action was carried out	True Proven	1	100%

Each iteration was assigned a level of veracity expressed as a percentage. This made it possible to give a step-by-step assessment to be able to capitalise on the experience at the end of the procedure. The result was generated in mapping on the High Authority of Health levels and processes.

The self-assessment by the Guide of Best Practice of Biomedical Engineering was made on the good practices of realization since it constitutes the core business of the biomedical activity. Thus, the self-diagnosis concerned the two processes, namely: the Support Activity Process and the Medical Device Management Process, as shown in Fig. (8). A summary of the evaluation grid is presented in Appendix 2.

Fig. (9) summarises the results of this self-assessment in the form of a radar graph.

These graphs give a clear picture of the evolution of the different axes after six months following the first evaluation performed in March 2021. There has been a considerable improvement in the scores of some axes, even reaching the 100% threshold. However, a 14% decrease was noted for the axis entitled: Ensuring the reception of Medical Devices (Fig. 10).

The self-assessment technique is a natural part of a continuous improvement cycle. Thus, the two self-assessment tools, which are intended to be complementary, have made it possible to highlight the main areas on which the institution must concentrate its efforts. The aim is not only to improve biomedical activities but also to promote the professionalism of the biomedical section.

Indeed, the implementation of corrective actions, following deviations from the set recommendations, will follow the Deming PDCA cycle (Fig. 11).

Fig. (11). Flow chart.

The results obtained following the self-assessment by the HAS (March 2021: 44% / October 2021: 63%) and by the G.B.P.B.E (March 2021: 67.54% / October 2021: 80.96%), show a real determination by the institution to improve the quality of pre-hospital care. It should also be noted that these results remain acceptable given the number of services provided to patients according to the standards in use. Thus, the increase in the scores recorded after six months shows the institution's willingness to keep up with technological developments and to adapt to changes in emergency systems.

Indeed, the effectiveness of the two self-diagnosis tools was reflected in the recommendations on which the improvement efforts were focused over a period of six months. Thus, a synergy between the biomedical department and the contracted company, which provided the necessary resources, allowed for reactivity in working on the recommendations generated. This led to an improvement in the scores for the majority of the axes of the two self-diagnosis tools. A decrease was noted for one of the G.B.P.B.E. axes (Ensuring the reception of medical devices), which is essentially due to the decrease in the purchase of medical devices during this period, which was essentially devoted to the preparation of annual investment plans. It should also be noted that the change in the establishment's strategy led to a change in investments relating to new medical devices, which decreased compared to previous years.

Thus, the framework followed by the biomedical service constituted a real dashboard by centralising and making accessible the data relating to the activity of maintenance, control and management of the biomedical equipment of medical ambulances using the following recommendations:

• Identification of critical medical devices internally with an appropriate method (FMECA) [25, 26];
• Management of risks related to medical devices through the creation of emergency procedures to meet the needs of health care teams;
• Implementation of a dedicated digital platform specifically for the inventory and management of biomedical equipment;
• Provide a schedule for preventive maintenance (forecast or systematic) and control of medical devices embedded in medical ambulances. The periodicity will be fixed according to the type of device and the frequency of use;
• Implementation of the Safety, Quality and Maintenance Register (SQMR) in paper format to encourage the involvement of all persons likely to fill it in and to ensure that it is updated in the digital platform;
• Corrective actions should be subject to consultation of the SQMR to determine whether medical devices have recurring failures;
• Provide for Control, Measurement and Test Equipment (CMTE) for calibration or repair of medical devices;
• Implementation of a dashboard on the maintenance and availability of medical devices embedded in medical ambulances;
• Provide for standardised procedures for quality control and maintenance of medical devices;
• Establish peer-to-peer self-assessment schedules in the future;
• Involve the top level in the results of self-assessments;
• Provide access to documentation relating to biomedical activity in numeric format by the digital platform to ensure speed and guarantee access to other users;
• Updating of documentation related to the biomedical activity and removal of outdated versions;
• Informing users of faults that occur and training them in good usage practices.

In this work, we have attempted to emphasise the important and necessary place of maintenance and control of embedded medical devices in EMS ambulances.

This strategy has allowed the identification of actions to be carried out and tools to be used, through the implementation of relevant procedures and working tools that will subsequently contribute to the quality assurance process.

On this basis, it would be interesting to set up a maintenance and quality control strategy as a first step and then to start a global quality approach integrating the managerial aspects of the different institution departments.

Indeed, the two self-assessment tools are complementary and effective solutions available to the biomedical community. They allow continuous improvement and are therefore a prerequisite for any successful maintenance and quality control strategy .

Nevertheless, and in the light of the above, it should be noted that the culture of biomedical activity remains a marginalised concept with a vague outline in Moroccan legislation. In this context, it would be judicious to concentrate efforts in order to regulate biomedical practices, which are the cornerstone of the reliability and safety of biomedical equipment, with the aim of ensuring the quality of patient care. Thus, the development of a Moroccan Accreditation Reference System (MARS) could constitute a real instrument of continuous improvement for our health establishments in their quest for efficiency.