Lecture 01

Part I - HTM Resources

 Content
• Clinical Engineer & Healthcare Technology Management
(H.T.M.)
- AAMI
- ACCE
- ASHE
• Standards & Accreditation
- JCI
- HAS
• Device Approval
- IEC
- ISO
- FDA
- CE
• Health Information System
- IHE
- HL 7
 Content
• Device Specifications & Tender
- ECRI
• Computerized Maintenance Management System (C.M.M.S.)
- HEMS
- TMS
- TMA
- AIMS
• Testing Equipment
- Fluke Biomedical
- BC Group
- Rigel
• Inspection & Preventive Maintenance (IPM) Form
- Fluke Biomedical
- ECRI
 Clinical Engineer &
Healthcare Technology
Management (H.T.M.)
Healthcare Technology Management (HTM)
Key Roles and Responsibilities
Association for the Advancement of
Medical Instrumentation
(AAMI)
www.aami.org
American College of Clinical Engineering (ACCE)
accenet.org
ACCE - Certificate of Membership
 ACCE - Certificate of Membership

Membership Categories
• Individual
• Fellow
• Emeritus
• Honorary
• Associate
• Candidate
• Corporate
• Institutional
Clinical Engineering Domains & Related Roles (ACCE)
Role of Clinical Engineering in the Health
Technology Life Cycle in Vermont USA
 Optimizing Health Care Facilities

American Society for Healthcare Engineering

(ASHE)
www.ashe.org
 Standards &
Accreditation
Local & International
 Joint Commission International
(JCI)
www.jointcommissioninternational.org
Haute Autorité de santé (HAS)
www.has-sante.fr
Device Approval
International Electrotechnical Commission
(IEC)
www.iec.ch
 Structure of the IEC 60601 international standard
International Electrotechnical Commission
(IEC)
 Structure of the IEC 60601 international standard
International Electrotechnical Commission
(IEC)
IEC 60601 International Standard and national standards

International Electrotechnical Commission

(IEC)
 History of ISO 13485:2003
International Organization for Standardization
(ISO)
www.iso.org
 History of EN ISO 13485:2012
International Organization for Standardization
(ISO)
www.iso.org
U.S Food & Drug Administration
(FDA)
fda.gov
 Conformité Européene “European Conformity”
(CE)
ec.europa.eu/growth/single-market/ce-marking/
Health Information
System
Integrating the Healthcare Enterprise
(IHE)
Ihe.net
Health Level Seven International
(HL 7)
hl7.org
 Version 2

Version 3

Fast Health Interoperable Resources (FHIR)

Health Level Seven International

(HL 7)
hl7.org
Picture Archiving & Communication System
(PACS)
Device Specifications
& Tender
Emergency Care Research Institute
(ECRI)
www.ecri.org
 Computerized
Maintenance
Management System
(C.M.M.S.)
C.M.M.S. - Examples
EQ2 - HEMS
Mainspring Health
Four Rivers Software – TMS
TMA Systems – TMA
Phoenix Data Systems – AIMS
Computerized Maintenance
Management System
(C.M.M.S.)
HEMS from EQ2, Inc.
Work Order
Work Order Trends Detail By Quarter
Downtime Means Money – Exam charge data from University of North Carolina Hospitals
Testing Equipment
Fluke Biomedical
BC Group
Rigel
Inspection & Preventive
Maintenance (IPM)
Form
 Inspection &
Preventive Maintenance
(IPM) Form
Fluke Biomedical
 Inspection &
Preventive Maintenance
BiomedicalBenchmark
ECRI
 Inspection &
Preventive Maintenance
BiomedicalBenchmark
ECRI
Clinical Engineering Handbook