EFOMP policy statement 17: The role and competences of medical physicists and medical physics experts in the different stages of a medical device life cycle.

MPPs are trained in the branches of physics associated with the practice of medicine. Possessing a solid scientific background and technical skills, MPPs are well suited to play a leading role within each stage of a medical device life cycle. The various stages of the life cycle of a medical device include establishment of requirements with use-case assessment, investment planning, procurement of medical devices, acceptance testing especially regarding safety and performance, quality management, effective and safe use and maintenance, user training, interfacing with IT systems, and safe decommissioning and removal of the medical devices. Acting as an expert within the clinical staff of a healthcare organisation, the MPP can play an important role to achieve a balanced life cycle management of medical devices. Given that the functioning of medical devices and their clinical application in routine clinical practice and research is heavily physics and engineering based, the MPP is strongly associated with the hard science aspects and advanced clinical applications of medical devices and associated physical agents. Indeed, this is reflected in the mission statement of MPP professionals [1]. PURPOSE: The life cycle management of medical devices is described as well as the procedures involved. These procedures are performed by multi-disciplinary teams within a healthcare environment. The task of this workgroup was focused on clarifying and elaborating the role of the Medical Physicist and Medical Physics Expert - here collectively referred to as the Medical Physics Professional (MPP) - within these multi-disciplinary teams. This policy statement describes the role and competences of MPPs in every stage of a medical device life cycle. If MPPs are an integral part of these multi-disciplinary teams, the effective use, safety, and sustainability of the investment is likely to improve as well as the overall service quality delivered by the medical device during its life cycle. It leads to better health care quality and reduced costs. Furthermore, it gives MPPs a stronger position in health care organisations throughout Europe.

Continuous-flow cryocompression therapy penetrates to bone level in hip fracture patients in a numerical simulation.

BACKGROUND: The aim of this study was to define deep tissue temperature during cryotherapy in postoperative hip fracture patients, by using measured skin temperature as input parameter for a simple numerical model. Second, an association was investigated between pain and tissue temperature distribution, to assess cryotherapy-induced analgesia of soft tissue-derived pain. METHODS: Data from 35 participants in an ongoing trial was used. In three subjects who consented on optional measurements, skin temperature was measured in 3 days during and after cryotherapy. A simple numerical model was developed to calculate tissue temperature distribution during cryotherapy. RESULTS: Inter and intrasubject skin temperature displayed high variation: trochanter 11-27 °C, mid-femur 11-24 °C, distal femur 10-16 °C. Predicted temperatures decreased to 20 °C at 1 cm, 26 °C at 2 cm, and 30 °C at 3 cm tissue depth. Smallest soft tissue layer was measured at the trochanter; 42% had less than 30 mm and 21% had less than 20 mm. Numeric rating scale pain varied (mean = 2.14; SD = 1.92), and no association was found between pain and decrease in temperature (r = 0.064; p = 0.204). CONCLUSIONS: Cryotherapy was predicted to reduce temperature up to 3 cm; in cachectic patients, this reaches the bone, where it might have implications for bone tissue healing when treated for a prolonged period of time. Cryotherapy-induced analgesia is likely to originate from skin analgesia rather than analgesia of muscle or bone-derived pain.

The diastolic flow velocity-pressure gradient relation and dpv50 to assess the hemodynamic significance of coronary stenoses.

To evaluate the hemodynamic impact of coronary stenoses, the fractional (FFR) or coronary flow velocity reserve (CFVR) usually is measured. The combined measurement of instantaneous flow velocity and pressure gradient (v-dp relation) is rarely used in humans. We derived from the v-dp relation a new index, dp(v50) (pressure gradient at flow velocity of 50 cm/s), and compared the diagnostic performance of dp(v50), CFVR, and FFR. Before coronary angiography was performed, patients underwent noninvasive stress testing. In all coronary vessels with an intermediate or severe stenosis, the flow velocity, aortic, and distal coronary pressure were measured simultaneously with a Doppler and pressure guidewire after induction of hyperemia. After regression analysis of all middiastolic flow velocity and pressure gradient data, the dp(v50) was calculated. With the use of the results of noninvasive stress testing, the dp(v50) cutoff value was established at 22.4 mmHg. In 77 patients, 124 coronary vessels with a mean 39% (SD 19) diameter stenosis were analyzed. In 43 stenoses, ischemia was detected. We found a sensitivity, specificity, and accuracy of 56%, 86%, and 76% for CFVR; 77%, 99%, and 91% for FFR; and 95%, 95%, and 95% for dp(v50). To establish that dp(v50) is not dependent on maximal hyperemia, dp(v50) was recalculated after omission of the highest quartile of flow velocity data, showing a difference of 3%. We found that dp(v50) provided the highest sensitivity and accuracy compared with FFR and CFVR in the assessment of coronary stenoses. In contrast to CFVR and FFR, assessment of dp(v50) is not dependent on maximal hyperemia.

Noninvasive mapping of left ventricular electromechanical asynchrony by three-dimensional echocardiography and semi-automatic contour detection.

A system for analyzing left ventricular (LV) electromechanical asynchrony based on transesophageal 3-dimensional echocardiography (3-DE) and semi-automatic endocardial contour detection is described. Eighteen consecutive patients underwent 3-DE. Using TomTec 4DLV software, a 3-dimensional endocardial surface was reconstructed throughout the cardiac cycle. Matlab software generated color-coded polar maps, displaying regional LV displacement and its timing. At the segmental level, Bland-Altmann assessment showed intraobserver variability of LV displacement of 0.1 +/- 3.0 mm and timing of -5.6 +/- 160 ms (bias +/- 2 SD) for all segments and -1.6 +/- 94 ms for the nonapical segments. The combination of 3-DE and semi-automatic contour detection is feasible and provides unique information for assessing regional LV endocardial displacement and electromechanical asynchrony.

Admission blood glucose level as risk indicator of death after myocardial infarction in patients with and without diabetes mellitus.

BACKGROUND: High admission blood glucose levels after acute myocardial infarction (AMI) are common and associated with an increased risk of death in subjects with and without known diabetes. Recent data indicate a high prevalence of abnormal glucose metabolism in patients with unknown diabetes at the time of AMI. We investigated the predictive value of admission blood glucose levels after AMI for long-term prognosis in patients with and without previously diagnosed diabetes mellitus, particularly in those with unknown diabetes but with blood glucose levels in the diabetic range. METHODS: In a retrospective study with prospective follow-up, 846 patients (737 without and 109 with known diabetes) were eligible for follow-up during a median of 50 months (range, 0-93 months). RESULTS: During follow-up, 208 nondiabetic patients (28.2%) and 47 diabetic patients (43.1%) died (P =.002). An increase of 18 mg/dL (1 mmol/L) in glucose level was associated with a 4% increase of mortality risk in nondiabetic patients and 5% in diabetic patients (both P<.05). Of the 737 previously nondiabetic subjects, 101 had admission blood glucose levels of 200 mg/dL (11.1 mmol/L) or more, and mortality in these patients was comparable to that in patients who had established diabetes (42.6% vs 43.1%). CONCLUSIONS: Admission blood glucose level after AMI is an independent predictor of long-term mortality in patients with and without known diabetes. Subjects with unknown diabetes and admission glucose levels of 200 mg/dL (11.1 mmol/L) or more after AMI have mortality rates comparable to those of subjects with established diabetes. Admission blood glucose level may serve to identify subjects at high long-term mortality risk, in particular among those with unknown diabetes.

The diastolic flow-pressure gradient relation in coronary stenoses in humans.

OBJECTIVES: We assessed the feasibility and reproducibility of the instantaneous diastolic coronary flow velocity-pressure gradient relation to characterize different degrees of coronary stenoses. BACKGROUND: Assessment of the hemodynamic significance of coronary stenoses can be difficult. Using sensor-tipped guidewires, various physiologic indexes can be determined in the catheterization laboratory. Each of the current methods, however, has limitations. METHODS: After positioning a Doppler flow wire and a pressure wire distal of a coronary stenosis, the flow velocity signals and the proximal and distal pressure were sampled simultaneously, at baseline and after intracoronary administration of adenosine. The instantaneous diastolic flow velocity and pressure gradient of single cardiac cycles at baseline, at maximal and intermediate hyperemia were plotted. Data were fitted with a regression line using the equation: Delta P = 0 +kv+Sv(2). Measurements were performed in 11 normal coronary arteries, 20 intermediate stenoses and in 7 severe stenoses before and after percutaneous transluminal coronary angioplasty plus stenting. RESULTS: We found significant differences between normal coronary arteries, intermediate and severe stenoses. Percutaneous transluminal coronary angioplasty nearly normalized the highly abnormal flow-pressure gradient relation in the severe stenoses. A high degree of reproducibility was observed. In 3% of the measurements, analysis was not possible due to the occurrence of pressure drift or bad flow velocity signals. CONCLUSIONS: It is feasible to assess the diastolic flow velocity-pressure gradient relation over a wide range of stenoses. It characterizes the hemodynamics of epicardial coronary stenoses and allows discrimination between normal coronary arteries, intermediate and severe stenoses.