Using Failure Mode, Effect and Criticality Analysis to Improve Safety in the COVID Mass Vaccination Campaign.

Vaccination against SARS-CoV-2 will likely be the most promising way to combat the pandemic. Even if mass vaccination is urgent, it should still always be supported by appropriate patient safety management. The aim of this study, based on failure mode, effects and criticality analysis (FMECA), was to identify possible failures and highlight measures that can be adopted to prevent their occurrence. A team of resident doctors in public health from the University of Padua and specialists in risk analysis in public health examined the mass vaccination process. A diagram was drafted to illustrate the various phases of mass vaccination, analyze the process, and identify all failure modes. Criticalities were ascertained by rating the severity, frequency and likelihood of failure detection on a scale of 1 to 10. We identified a total of 71 possible faults distributed over the various phases of the process, and 34 of them were classified as carrying a high risk. For the potentially high-risk failure modes, we identified 63 recommended actions to contain the cause of their occurrence or improve their detection. For the purpose of detecting potential failures, FMECA can be successfully applied to mass vaccination, which should be considered a high-risk process.

Validation of the visomat comfort eco blood pressure measuring device according to the International Protocol.

The objective of this study was to determine the accuracy of the UEBE visomat comfort eco blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The device evaluation was performed in 33 participants with a mean+/-SD age of 54.3+/-18.7 years (range 30-91 years). Their systolic blood pressure (SBP) was 144.0+/-23.7 mmHg (range 100-180 mmHg), diastolic blood pressure (DBP) was 86.2+/-14.4 mmHg (range 60-110 mmHg), and upper arm circumference was 29.4+/-2.8 cm (range 24.0-34.0 cm). Blood pressure measurements were performed in the sitting position. The visomat comfort eco passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences for the visomat comfort eco (device-observer) were -0.5+/-5.7 mmHg for SBP and -1.4+/-5.3 mmHg for DBP. In conclusion, the present results show that the UEBE visomat comfort eco monitor can be recommended for clinical use in the adult population.

Validation of the SAW-102 wrist home blood pressure monitor according to the protocols of the British Hypertension Society, the Association for the Advancement of Medical Instrumentation, and the European Society of Hypertension.

OBJECTIVE: To determine the accuracy of the SAW-102 wrist oscillometric blood pressure monitor developed by the Sensacare Company according to the protocols of the European Society of Hypertension (ESH), the Association for the Advancement of Medical Instrumentation (AAMI), and the British Hypertension Society (BHS). METHODS: SAW-102 was assessed on 33 participants according to ESH requirements, based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg or more. Then SAW-102 was tested on 85 participants according to AAMI criteria requiring mean device-observers discrepancy within 5+/-8 mmHg. Subsequently, SAW-102 was evaluated on 88 participants according to BHS requirements. Finally, 15 participants with wrist circumference greater than the manufacturer's recommendation (19.5 cm) were studied (large wrist group). Efforts were made to secure a stable position of wrist and arm at the heart level. RESULTS: SAW-102 passed all phases of ESH international protocol for both systolic blood pressure (SBP) and diastolic blood pressure (DBP). SAW-102 passed AAMI criteria with mean differences between SAW-102 and observers of 3.8+/-7.5 and 1.5+/-6.0 mmHg, SBP and DPB, respectively. According to BHS protocol, the device achieved final grading of B/B for SBP and DBP, respectively. Large wrist group did not pass the first phase of ESH protocol. CONCLUSION: This study demonstrated that SAW-102 meets the BHS, ESH, and AAMI standards when measurements are done at the heart level and when the manufacturer's specifications, regarding wrist circumference, are respected. Our data also indicate that exceeding 19.5 cm wrist circumference is accompanied by dramatic decrease of the accuracy of the device.

Validation of the SAA-102 home blood pressure monitor according to the protocols of the European Society of Hypertension, the Association for the Advancement of Medical Instrumentation and the British Society of Hypertension.

OBJECTIVE: To determine the accuracy of a new oscillometric home blood pressure (BP) monitor for arm BP measurement, the SAA-102, developed by the Sensacare Company. DESIGN: Evaluation of the SAA-102 was performed using validation protocols of the European Society of Hypertension (ESH), the Association for the Advancement of Medical Instrumentation (AAMI), and the British Hypertension Society (BHS). METHODS: The SAA-102 monitor was assessed on 33 participants according to ESH requirements, which are based on four zones of accuracy differing from the mercury standard by 5, 10, 15 mmHg or more. Then the oscillometric monitor was tested on 85 participants according to AAMI criteria which require a mean device-observers discrepancy within 5+/-8 mmHg. Finally, the electronic device was evaluated on 93 participants according to BHS requirements, which are based on five phases: before-use calibration, in-use assessment, after-use calibration, static device validation and report of the results. RESULTS: The SAA-102 passed all phases of the ESH international protocol for both systolic and diastolic blood pressure (SBP and DBP). The SAA-102 passed also AAMI criteria for SBP and DBP. The mean discrepancy between the SAA-102 and observers was 0.1+/-4.6 and -2.7+/-5.2 mmHg, for SBP and DBP, respectively. According to BHS protocol, the oscillometric monitor achieved final grading of A/A for SBP and DBP, respectively. CONCLUSION: These data show that the SAA-102 device satisfies ESH, AAMI, and BHS protocols for both SBP and DBP and may be recommended for everyday use for BP monitoring at home and in clinical practice.

Impaired arterial elasticity in young patients with white-coat hypertension.

BACKGROUND: Conflict still exists over whether patients with white-coat hypertension are at increased risk of developing target organ damage compared with normotensive individuals. METHODS: We studied vascular distensibility in 117 young-to-middle age patients with white-coat hypertension, 174 patients with sustained hypertension, and 51 normotensive controls. To obtain a measure of compliance, a model was used that divides the total systemic compliance into large artery (C1) and small artery (C2) compliance. With this aim, radial arterial pulse waves were recorded with a tonometer sensor array by means of an HDI CR2000 device (Eagan, Minnesota, USA). Moreover, pulse wave velocity and the augmentation index were measured using the Specaway DAT system (St Pauls, Sydney, Australia). RESULTS: Patients with sustained hypertension had a greater body mass index than patients with white-coat hypertension (P=0.04) or the normotensive individuals (P=0.01). C1 and C2 were decreased in the two hypertensive groups as compared with those in the normotensive group (P=0.0002 and 0.03, respectively, versus sustained hypertension; P=0.00007 and 0.0004, respectively, versus white-coat hypertension). Pulse wave velocity and aortic augmentation index were increased in the white-coat hypertension patients compared with the normotensive individuals (P=0.02 and 0.004, respectively). Aortic augmentation index (P=0.008) but not pulse wave velocity was increased in the sustained hypertensive patients compared with that in the normotensive individuals. All indexes of arterial distensibility were similar in the two hypertensive groups. CONCLUSIONS: Indexes of arterial distensibility are impaired in the white-coat hypertensive group and similar to those in the sustained hypertensive group, indicating that early changes in the arterial wall can occur in white-coat hypertension. This may account for the higher risk of stroke that has been described in this condition.

Evolution of blood pressure and cholesterol in stage 1 hypertension: role of autonomic nervous system activity.

OBJECTIVE: Controversy remains concerning the pathogenetic mechanisms for the relationship between sympathetic activity, hypertension and lipid abnormalities. We tested the hypothesis that a condition characterized by sympathetic predominance may affect the evolution of blood pressure and lipids in the early stage of hypertension. METHODS: We prospectively studied 163 young stage 1 hypertensive individuals and 28 normotensive control individuals. The hypertensive subjects were divided by cluster analysis into two groups according to low frequency and high frequency components of heart rate variability. Large artery and small artery compliance was assessed at the end of the follow-up. RESULTS: Fifty-nine subjects showed reduced total power and signs of sympathetic predominance in the resting condition, on standing and during mental stress (group 1). At baseline, they had similar blood pressure and metabolic data to the rest of the group (n = 104, group 2) and a greater white-coat effect (P = 0.03). During a 6-year follow-up, 23.7% of group 1 subjects versus 9.6% of group 2 subjects developed sustained hypertension requiring antihypertensive treatment (P = 0.02). In group 1 subjects, there was also a greater increase in total cholesterol (P = 0.01) than in group 2. In addition, at the end of follow-up group 1 subjects had impaired large artery compliance (P < 0.001 versus group 2). CONCLUSIONS: These data indicate that a condition characterized by sympathetic predominance may favour the development of sustained hypertension and hypercholesterolemia early in life, and lead to increased susceptibility to vascular complications. They further indicate that the increased white-coat effect is not an innocent phenomenon.