These requirements integrate and specify, for the FPSS, the generic implications currently imposed by the ITER team on the safety systems classified SIC-3.
Accordingly, owing to the differences in the timing of initiation of NIV and the focus on patient safety, we classified these studies into early interventions, late interventions and patient safety assessment categories (Table 1).
Safety barriers were classified and their components were described to evaluate their performance.
Rolling contact fatigue, e.g. head checking, is classified safety critical as these cracks may lead to the derailment of a vehicle.
Safety assessments were classified using the Medical Dictionary for Regulatory Activities.
The safety assessments were classified into five categories: 'definitely'probablybly' or 'possibly' drug-related, and 'possibly' or 'definitely' drug-unrelated.
In addition, we developed a new taxonomy (see Table 3) that classified safety tools, sets of indicators or individual indicators into dimensions of patient safety.
Safety issues were classified as one of four categories: 1) SJW – drug interactions, 2) SJW – contraindications, 3) SJW – therapeutic duplication, and 4) SJW – general.
The highest proportion of safety concerns was classified as miscommunication, while eight 'other' events related to significant delays to inpatient care or problems related to cleanliness and hygiene.
20 Half of all AEs reported by individual case safety reports are classified as "skin and subcutaneous tissue disorders", which are mainly rash and urticaria.
In this study, all excipients for which according to the abovementioned sources there were some safety concerns were classified as "potentially harmful" (Category 2 in Table 1).
