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Objectives: The aim of this study was to explore the risk assessment tools and criteria used to assess the risk of medical devices in hospitals, and to explore the link between the risk of a medical device and how those risks impact or alter the training of staff.
Methods: Within a broader questionnaire on implementation of a national guideline, we collected quantitative data regarding the types of risk assessment tools used in hospitals and the training of healthcare staff.
Results: The response rate for the questionnaire was 81 percent; a total of sixty-five of eighty Dutch hospitals. All hospitals use a risk assessment tool and the biggest cluster (40 percent) use a tool developed internally. The criteria used to assess risk most often are: the function of the device (92 percent), the severity of adverse events (88 percent) and the frequency of use (77 percent). Forty-seven of fifty-six hospitals (84 percent) base their training on the risk associated with a medical device. For medium- and high-risk devices, the main method is practical training. As risk increases, the amount and type of training and examination increases.
Conclusions: Dutch hospitals use a wide range of tools to assess the risk of medical devices. These tools are often based on the same criteria: the function of the device, the potential severity of adverse events, and the frequency of use. Furthermore, these tools are used to determine the amount and type of training required for staff. If the risk of a device is higher, then the training and examination is more extensive.
It is not clear whether measuring waist circumference in clinical practice is problematic because the measurement error is unclear, as well as what constitutes a clinically relevant change. The present study aimed to summarize what is known from state-of-the-art research.
To identify the magnitude of the measurement error of waist circumference measurements from the literature, a search was conducted in PubMed from 1975 to February 2011.
The measurement error may vary between 0·7 cm and 15 cm. Taking a realistic range of measurable waist circumference into account (60–135 cm), we argue that a short-term clinically relevant change in waist circumference of 5 % may lie between 3·0 and 6·8 cm and a maintained clinically relevant change of 3 % between 1·8 and 4·1 cm.
Based on these results, we conclude it may be difficult to distinguish clinically relevant change from measurement error in individual subjects, due to the large measurement error and unclear definition of clinically relevant change. More research is needed to address these gaps in knowledge. To minimize measurement error, we recommend using a uniform measurement protocol, training and repeated measurements.
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