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Risk assessment and management in biomedical equipment maintenance.,…
Risk assessment and management in biomedical equipment maintenance.
patient safety
It is a serious public health problem worldwide.
: :
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educe the number of deaths as a result of errors in the provision of health services
barriers to risk control of patients and biomedical equipment
entities that prioritize patient safety
protect the integrity of the patient and clinical staff in the event of adverse events
due to human failure or technical problems associated with the use of medical devices
INVIMA
regulations related to medical devices and patient safety
Decreto 4725 de 2005. marketing and surveillance permits for medical devices
Resolucion 4816 de 2008
classifies events and incidents and how to report them
risk analysis
intended use, purpose of biomedical equipment
risk identification
risk calculation
Risk assessment
risk acceptability decisions
risk control
options analysis
implementation
residual risk assessment
general risk acceptance
post control information
, risk management experience and review
classification of biomedical equipment
life support- very high risk
mechanical fan example
diagnosis- detection or treatmen
therapeutic- dedicated to restoring functions, relief from illness, injury
so these are classified into
class I low risk - surgical instruments, gauze
Class IIA moderate risk - suction equipment
Class IIB high risk - pulmonary ventilator
Class III very high risk - heart valves, pacemakers
Ministry of social protection