According to data from the Belgian National Institute for Health and Disability Insurance (RIZIV / INAMI), in the beginning of 2016, Belgium had 2441 active anesthesia specialists (certified specialists and trainees) [6]. This sets this survey´s cross-sectional percentage at 14.2% of the total active Belgian anesthesiologists, 13.2% of the certified Belgian anesthesiologists, and 17.5% of the Belgian anesthesiogy trainees. Concerning the accredited specialists (diploma-holding), it is however not known if all them are dedicated in exclusivity to anesthesia-related fields such as Intensive care, Emergency department or Pain clinic. It is thus possible that the representability percentage of this survey is different than calculated, although practically very difficult to confirm.
In general, these survey results agree with the findings of Green et al on the American anesthesiologists population: Apps enjoy a significant degree of confidence and believed to have a potential use on all phases of perioperative care [3]. Peripherals also enjoy a high confidence on potential use, rating 57.0% [95%CI: 50.1 - 63.9%] of the responders their confidence as 80% or higher that these can be useful in Anesthesia care. Nine and a half percent [95%CI: 0 - 19,5%] of the surveyees rated Apps’ usefulness in anesthesia as 1 or bellow (on a 0 to 5 scale), and 14.6% [95%CI: 4.9 - 24.3%] gave the same rating when asked about Peripherals. Thus, although there is a comparable optimism for Apps and Peripherals, the latter enjoy a proportionally greater degree of disbelief. The reasons for this discrepancy were not evaluated by this questionnaire, but one can speculate that the underdeveloped regulated market of smartphone peripherals for diagnostic aid is still not firmly established within today´s anesthesia practice. Although the major players have already created a dedicated peripherals market line (for example, Philips LumifyⓇ portable echography series), convincing of practitioners on their usefulness is still needed. Curiously, when asked on which peripherals they wanted to see developed, 61.7% of the anesthesiologists answered “Echography”. This area is one of the more exploited in terms of smartphone peripherals, and has been explored both by the major players in the medical device industry, as well as by less known competitors. Although not being able to put forward significance numbers, some of the answers on our questionnaire suggested that some of the practitioners did know of the existence of such products but found them economically inaccessible. Other, however, suggested they had no knowledge of such devices. Another possible reason that might contribute to the greater disbelief might relate to the medical use of an originally partially non-medical device. Although it seems logical that controlled CE-labelling (Conformité Européenne) of smartphone peripherals for medical use might help overcome this, the subjective factor cannot be underestimated. Just like heavy, well designed and good fitting over-head headphones feel subconsciously better than in-ear equivalents, traditional anesthesia monitors might still convey more confidence [7].
Another curious pattern observed on the surveyees’ answers was the fact that although 57.0% [95%CI: 50.1 - 63.9%] considered Apps useful in anesthesia (classification of 4 or 5 out of 5), only 45.3% [95%CI: 37.3 - 52.9%] reported actually using them in their daily practice. This gap was even bigger when analyzing smartphone peripherals (47.9% [95%CI: 40.3 - 55.5%], and 3.2% [95%CI: 0 - 13.6%], respectively), although easier to justify considering the underdeveloped smartphone peripherals market.
In line with the study of Green et al, dosage apps (static and dynamic) were chosen by the majority as the most useful [3]. Digital books and perioperative apps followed.
As opposed to the study of Green et al, our group found significant differences between anesthesia trainees and specialists. Although there was a major positivity towards mobile apps in both groups, training anesthesiologists displayed a significantly higher confidence on mobile apps than consultants (72.1% vs 51.6%, respectively). This positivity trend held for smartphone peripherals, although with overlapping 95% confidence intervals. The reasons for this differences can only be speculated on.
These definitely promising technologies are increasingly being introduced in our daily practice and play an important facilitating role. However, one must not forget that these freely available tools are not always subject to formal approval procedures that scientifically validate their clinical use. Most of these are part of the off-label/”use at own risk” category (commonly referred to as “Grey Area Apps”) - applications freely available without formal evaluation of their function for their stated (medical) use [8]. Taking this into mind, the European Union has created between 2016 and 2017 a workgroup for the development of mHealth assessment guidelines [8]. However, the group was not able to endorse concrete guidelines by failure to reach a minimal intra-group consensus [9]. As of this moment, Grey Area Apps remain unregulated. There is, however, a non-binding “privacy code of conduct on mobile health apps” that outlines the core values that should guide mobile health application development [10]. It provides a theoretical competitive advantage against non-conform Applications and speeds up an eventual CE-label request. As for applications aiming for a formal regulated national market entry, compliance with the EU regulation 2017/745 (from 5 April 2017) is mandatory. Together with the EU norm 2017/746, they regulate the European market of medical devices since May 2017. European Union state members fall, thus, under these norms.
It is thus obvious that mobile Applications and Peripherals are quickly permeating all phases of Healthcare, with the right steps are being taken for their scientifically validated integration. Peripherals still lag behind mobile applications although they constitute an economically and clinically important area. Care must still be taken owing the majority of available Apps fall within the unregulated category of “Grey Area Apps”. Last, but not least, care must also be taken to avoid over-reliability/dependency on Apps, with the consequent side-tracking of basic clinical skills.
Conclusions
Belgian Anesthesia practitioners show a significant positive attitude towards smartphone Apps and Peripherals, mirroring international reported trends within other medical sectors. There is evidence of an international recognition of the potential of these technologies within the healthcare domain, with consequently rising regulatory efforts from medical societies and national legislative bodies.