TY - JOUR
T1 - Exploring Medical Devices
T2 - The Use of Risk Assessment Tools and Their Link with Training in Hospitals
AU - Porte, Petra J.
AU - Verweij, Lisanne M.
AU - De Bruijne, Martine C.
AU - Van Der Vleuten, Cees P.M.
AU - Wagner, Cordula
PY - 2018/1/1
Y1 - 2018/1/1
N2 - 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.
AB - 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.
KW - Classification
KW - Education
KW - Equipment safety
KW - Patient safety
KW - Professional competence
KW - Risk management
UR - http://www.scopus.com/inward/record.url?scp=85045675926&partnerID=8YFLogxK
U2 - https://doi.org/10.1017/S026646231800020X
DO - https://doi.org/10.1017/S026646231800020X
M3 - Article
C2 - 29656730
SN - 0266-4623
VL - 34
SP - 218
EP - 223
JO - International Journal of Technology Assessment in Health Care
JF - International Journal of Technology Assessment in Health Care
IS - 2
ER -