Medical devices/equipment management policy (incorporating the medical devices management standard)

摘要

An increasing number of medical devices are being used to support the delivery of careudin both Hospital and Primary Care settings. The availability of such devices assistsudgreatly in the ability of healthcare organizations to effectively monitor, treat and supportudthe care of service users in the management of their medical conditions. It also allowsudfor the management of care in a community setting and facilitates self care for patientsudin many instances.udThe World Health Organisation (WHO) has recognized the importance of having in placeudappropriate policies that address all elements related to medical devices which areudsupported by a system of compliance monitoring. The Commission on Patient Safety andudQuality Assurance stressed the importance of adopting standards and guidelines as a keyudelement of effective governance. In the UK it has been identified that 400 people die orudare seriously injured in adverse events involving medical devices each year. Whilstudcomparable figures are not available in Ireland, as part of the HSE’s approach to clinicaludgovernance it is critical to ensure that there are systems in place to confirm that medicaluddevices are managed in a way which complies with the requirements of regulation andudbest practice.udVarious professions within the health services have direct contact with medicaluddevices/equipment, such as the Physiotherapist, Occupational Therapist, MedicaludPhysicists, Lab Scientist, Nurse, Biomedical/Clinical Engineering, Pharmacist, Doctor etc.;udeach having varying degrees of responsibility in the care of medical devices/equipment.udIt is acknowledged that various professions deal directly with the day to day use andudquality assurance of their particular equipment such as Lab scientists performing qualityudassurance for Lab equipment, Occupational Therapists prescribing equipment, MedicaludPhysics performing quality assurance for ionisation equipment, Physiotherapistsudprescribing physiotherapy equipment, nurses and doctors performing user checks etc.udWith respect to the management of medical devices/equipment it is acknowledged thatudthis is the core function of the Biomedical/Clinical Engineering profession.udThis policy has been developed by the HSE to ensure compliance with requirements ofudlegislation and guidance from the European Union (EU), the Health Information andudQuality Authority (HIQA) the Irish Medicines Board, the Health and Safety Authorityud(HSA), the National Standards Authority of Ireland (NSAI) and the Electro-TechnicaludCouncil of Ireland (ETCI), including the Technical Committee 10 (TC10) of ETCI inudmatters related to the management of medical devices / equipment.