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

Hdl Handle:
http://hdl.handle.net/10147/109308
Title:
Medical devices/equipment management policy (incorporating the medical devices management standard)
Authors:
Health Service Executive (HSE) Office of Quality and Risk
Publisher:
Health Service Executive (HSE)
Issue Date:
11-Mar-2010
URI:
http://hdl.handle.net/10147/109308
Item Type:
Technical Report
Language:
en
Description:
An increasing number of medical devices are being used to support the delivery of care in both Hospital and Primary Care settings. The availability of such devices assists greatly in the ability of healthcare organizations to effectively monitor, treat and support the care of service users in the management of their medical conditions. It also allows for the management of care in a community setting and facilitates self care for patients in many instances. The World Health Organisation (WHO) has recognized the importance of having in place appropriate policies that address all elements related to medical devices which are supported by a system of compliance monitoring. The Commission on Patient Safety and Quality Assurance stressed the importance of adopting standards and guidelines as a key element of effective governance. In the UK it has been identified that 400 people die or are seriously injured in adverse events involving medical devices each year. Whilst comparable figures are not available in Ireland, as part of the HSE’s approach to clinical governance it is critical to ensure that there are systems in place to confirm that medical devices are managed in a way which complies with the requirements of regulation and best practice. Various professions within the health services have direct contact with medical devices/equipment, such as the Physiotherapist, Occupational Therapist, Medical Physicists, Lab Scientist, Nurse, Biomedical/Clinical Engineering, Pharmacist, Doctor etc.; each having varying degrees of responsibility in the care of medical devices/equipment. It is acknowledged that various professions deal directly with the day to day use and quality assurance of their particular equipment such as Lab scientists performing quality assurance for Lab equipment, Occupational Therapists prescribing equipment, Medical Physics performing quality assurance for ionisation equipment, Physiotherapists prescribing physiotherapy equipment, nurses and doctors performing user checks etc. With respect to the management of medical devices/equipment it is acknowledged that this is the core function of the Biomedical/Clinical Engineering profession. This policy has been developed by the HSE to ensure compliance with requirements of legislation and guidance from the European Union (EU), the Health Information and Quality Authority (HIQA) the Irish Medicines Board, the Health and Safety Authority (HSA), the National Standards Authority of Ireland (NSAI) and the Electro-Technical Council of Ireland (ETCI), including the Technical Committee 10 (TC10) of ETCI in matters related to the management of medical devices / equipment.
Keywords:
MEDICAL EQUIPMENT; MEDICAL DEVICES; QUALITY; QUALITY STANDARD

Full metadata record

DC FieldValue Language
dc.contributor.authorHealth Service Executive (HSE) Office of Quality and Risken
dc.date.accessioned2010-08-09T15:52:29Z-
dc.date.available2010-08-09T15:52:29Z-
dc.date.issued2010-03-11-
dc.identifier.urihttp://hdl.handle.net/10147/109308-
dc.descriptionAn increasing number of medical devices are being used to support the delivery of care in both Hospital and Primary Care settings. The availability of such devices assists greatly in the ability of healthcare organizations to effectively monitor, treat and support the care of service users in the management of their medical conditions. It also allows for the management of care in a community setting and facilitates self care for patients in many instances. The World Health Organisation (WHO) has recognized the importance of having in place appropriate policies that address all elements related to medical devices which are supported by a system of compliance monitoring. The Commission on Patient Safety and Quality Assurance stressed the importance of adopting standards and guidelines as a key element of effective governance. In the UK it has been identified that 400 people die or are seriously injured in adverse events involving medical devices each year. Whilst comparable figures are not available in Ireland, as part of the HSE’s approach to clinical governance it is critical to ensure that there are systems in place to confirm that medical devices are managed in a way which complies with the requirements of regulation and best practice. Various professions within the health services have direct contact with medical devices/equipment, such as the Physiotherapist, Occupational Therapist, Medical Physicists, Lab Scientist, Nurse, Biomedical/Clinical Engineering, Pharmacist, Doctor etc.; each having varying degrees of responsibility in the care of medical devices/equipment. It is acknowledged that various professions deal directly with the day to day use and quality assurance of their particular equipment such as Lab scientists performing quality assurance for Lab equipment, Occupational Therapists prescribing equipment, Medical Physics performing quality assurance for ionisation equipment, Physiotherapists prescribing physiotherapy equipment, nurses and doctors performing user checks etc. With respect to the management of medical devices/equipment it is acknowledged that this is the core function of the Biomedical/Clinical Engineering profession. This policy has been developed by the HSE to ensure compliance with requirements of legislation and guidance from the European Union (EU), the Health Information and Quality Authority (HIQA) the Irish Medicines Board, the Health and Safety Authority (HSA), the National Standards Authority of Ireland (NSAI) and the Electro-Technical Council of Ireland (ETCI), including the Technical Committee 10 (TC10) of ETCI in matters related to the management of medical devices / equipment.en
dc.language.isoenen
dc.publisherHealth Service Executive (HSE)en
dc.subjectMEDICAL EQUIPMENTen
dc.subjectMEDICAL DEVICESen
dc.subjectQUALITYen
dc.subjectQUALITY STANDARDen
dc.titleMedical devices/equipment management policy (incorporating the medical devices management standard)en
dc.typeTechnical Reporten
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