55

APPENDIX A

Sample Policies for a Clinical

Engineering Department
The policies shown below only provide the principles that govern the Clinical Engineering (CE)
Department in a hospital or healthcare system. Details of the processes used for implementing each
policy are described in one or more procedures that may vary somewhat from one part of a system to
another to accommodate different environments, patient demographics, or unique circumstances.

1. Equipment Planning
CE Department shall assist the hospital with the planning and incorporation of new medical
equipment and replacement of existing equipment.

2. Equipment Acquisition
CE Department shall assist the hospital with the procurement of new and replacement medical
equipment.

3. Equipment Installation and Acceptance

The safety and performance of medical equipment shall be verified when it is received and
installed (if applicable), regardless of ownership, before patient use. New equipment shall only
be accepted if the requirements specified in the purchase order (e.g., operating and service
documentation, user and service training) have been satisfied.

4. Equipment Inventory
A current and accurate inventory of medical equipment shall be maintained by the CE De-
partment.

5. User Training
CE Department shall assist the hospital in determining training needs, sources, and methods
for medical-equipment users, and with the coordination of technical utilization training.

6. Equipment Maintenance
Maintenance of medical equipment, regardless of ownership, shall be planned and imple-
mented using appropriate maintenance strategies to keep it safe and performing according to
original functional specifications.
56 A. SAMPLE POLICIES FOR A CLINICAL ENGINEERING DEPARTMENT
7. Equipment Retirement and Disposition
CE Department shall assist the hospital with the retirement and disposition of unwanted
medical equipment.
8. Equipment Modification
Equipment safety and functional specifications shall not be altered by the CE Department or
third parties under its supervision, unless directed by the respective manufacturer or the Food
and Drug Administration (FDA) in a specific recall or upgrade action.
9. Medical Device Recalls
Recalls issued by the manufacturer and/or FDA for equipment managed by the CE Depart-
ment shall be monitored continuously and addressed promptly to reduce risks to patients and
impacts on the delivery of health services.
10. Medical Device Tracking
CE Department shall assist its customers, upon their request, in determining and implement-
ing appropriate processes to track medical devices deemed “trackable” by the FDA.
11. Patient Incident Investigation
CE Department shall assist the hospital in investigating patient incidents involving medical
equipment and follow hospital procedures for reporting such incidents.
12. Control of Documents
Documents shall be controlled in terms of creation, approval, revision, preservation, and dis-
posal to ensure integrity and consistency. All medical equipment management policies and
procedures shall be approved by the appropriate hospital committee or officer before imple-
mentation. The most current, approved version of each document shall be available to the staff,
if relevant to his/her job responsibilities.
13. Control of Records
Records shall be generated when work is performed to provide evidence of work completion.
The records shall be controlled until they can be disposed per hospital record retention policy
or procedure.
14. Management of Test and Calibration Devices
Devices used for inspections, tests, measurements, and calibrations of medical equipment shall
be inventoried, tracked, serviced, and calibrated (if applicable) at appropriate intervals.
15. Vendor Management
Vendors, including manufacturers, and their services (parts and labor) shall be qualified, mon-
itored, and supervised to ensure satisfactory quality and cost effectiveness.
 57
16. Financial Management
The financial performance of the medical equipment management program shall be controlled.

17. Customer Relationship

The requirements and expectations of each user department shall be established at the start
up of operations and reviewed periodically. Close and frequent communication with user
department management shall be maintained by the CE Department management using
mutually agreed upon communication methods. CE Department shall participate in and/or
contribute to hospital committees and task forces related to medical equipment management
and maintenance.

18. Performance Monitoring and Continual Improvement

The performance of the medical equipment management program shall be monitored and eval-
uated periodically using a combination of indicators and audits, with the purpose of finding
opportunities for continual improvement. Continual improvement projects shall be imple-
mented and their results evaluated.

19. Staff Management and Development

CE Department shall provide qualified and competent management and technical staff to
perform management and maintenance of medical equipment. New employees and current
CE Department employees reassigned to new positions shall receive initial job orientation
covering both hospital and CE Department information, policies and procedures, and duties
and responsibilities. Staff competency to perform duties and responsibilities shall be assessed
periodically. Education, training, certification, and other opportunities to advance professional
skills shall be offered to management and technical staff. The performance of management
and technical staff shall be evaluated periodically.
 59

APPENDIX B

Information and Data Sources

on Internet
Listed below are information and data sources available (mostly free) through the Internet. This
list is not exhaustive but contains the main government agencies and non-profit organizations that
produce or provide regulations, standards, and guidance on health technology.

• United States Federal Agencies

– U.S.-Agency for Healthcare Research and Quality (AHRQ):

http://www.ahrq.gov
– U.S.-Centers for Disease Control (CDC):
http://www.cdc.gov
– U.S.-Centers for Medicare and Medicaid Services (CMS):
http://www.cms.gov
∗ Conditions of Participation:
http://www.cms.gov/Regulations-and-Guidance/Legislation/
CFCsAndCoPs/index.html
∗ Clinical Laboratory Improvement Amendments (CLIA):
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
index.html
∗ Clinical Laboratory Accreditation:
http://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/
Accreditation_Organizations_and_Exempt_States.html
– U.S.-Code of Federal Regulations:
www.gpoaccess.gov/cfr/
– U.S.-Department of Health and Human Services (HHS), Office for Civil Rights
∗ Health Information Privacy and Security (HIPAA):
http://www.hhs.gov/ocr/privacy/
– U.S.-Federal Emergency Management Agency:
http://www.fema.gov/
60 B. INFORMATION AND DATA SOURCES ON INTERNET
– U.S.-Food and Drug Administration (FDA):
http://www.fda.gov/default.htm
∗ Biologics (blood and blood products):
http://www.fda.gov/BiologicsBloodVaccines/default.htm
∗ Clinical Laboratory Improvement Amendments (CLIA):
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/
IVDRegulatoryAssistance/ucm124105.htm
∗ Medical devices:
http://www.fda.gov/MedicalDevices/default.htm
∗ Radiation-Emitting Products:
http://www.fda.gov/Radiation-EmittingProducts/default.htm
– U.S.-National Institutes of Health (NIH):
http://www.nih.gov
– U.S.-Occupational Safety and Health Administration (OSHA):
http://www.osha.gov/
∗ Hazardous materials:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=
STANDARDS&p_id=10117
∗ Bloodborne pathogens
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=
STANDARDS&p_id=10051
∗ Ionizing radiation:
http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=
STANDARDS&p_id=10098

• Accreditation, Standards, and Testing Organizations

– American Association of Blood Banks (AABB):

http://www.aabb.org/Pages/Homepage.aspx
– American Osteopathic Association (AOA) HFAP accreditation:
http://www.hfap.org/
– American Society of Histocompatibility and Immunogenetics (ASHI):
http://www.ashi-hla.org/
– COLA (laboratory accreditation):
http://www.cola.org/
– College of American Pathologists (CAP):
http://www.cap.org/apps/cap.portal
 61
– The Joint Commission:
http://www.jointcommission.org
– DNV Healthcare:
http://dnvaccreditation.com/pr/dnv/default.aspx
– ECRI Institute:
http://www.ecri.org
– MD Buyline:
http://www.mdbuyline.com
– National Fire Prevention Agency:
http://www.nfpa.org
– The Advisory Board Company:
http://www.advisory.com
– Underwriters Laboratories:
http://www.ul.com
• Professional and Trade Associations
– Advanced Medical Technology Association (AdvaMed formerly HIMA):
http://www.advamed.org
– American College of Clinical Engineering (ACCE):
http://accenet.org
– American Hospital Association:
http://www.aha.org
– American Institute of Architects:
http://www.aia.org/
– American Institute for Medical and Biomedical Engineering:
http://www.aimbe.org
– American Medical Association:
http://www.ama-assn.org
– American Society for Healthcare Engineering:
http://www.ashe.org
– American Society for Healthcare Risk Management:
http://www.ashrm.org
– American Society for Testing and Materials:
http://www.astm.org
– Association for the Advancement of Medical Instrumentation:
http://www.aami.org
62 B. INFORMATION AND DATA SOURCES ON INTERNET
– Biomaterials Network:
http://www.biomat.net
– Engineering in Medicine and Biology Society of the IEEE:
http://www.embs.org/
– Healthcare Information and Management Systems Society (HIMSS):
http://www.himss.org
– Healthcare Technology Assessment International:
http://www.htai.org
– International Society of Biomechanics:
http://isbweb.org/
– Institute for Healthcare Improvement (IHI):
http://www.ihi.org
– Institute of Electrical and Electronics Engineers (IEEE):
http://www.ieee.org
– International Federation for Medical and Biological Engineering:
http://www.ifmbe.org
– Medical Equipment and Technology Association (META):
http://www.mymeta.org
– National Patient Safety Foundation (NPSF):
http://www.npsf.org
– National Electrical Manufacturers Association (NEMA):
http://www.nema.org
– Radiological Society of North America (RSNA):
http://www.rsna.org
– Regulatory Affairs Professionals Society (RAPS):
http://www.raps.org
– VA National Center for Patient Safety (NCPS):
http://www.patientsafety.gov
• International Organizations
– International Organization for Standardization (ISO):
http://www.iso.org/iso/home.html
– World Health Organization (WHO):
http://www.who.int/en/
– Pan American Health Organization/Organización Panamericana de Salud (PAHO):
http://new.paho.org/index.php
 63
• Medical Information Sources

– Medical Articles (Medscape):

http://www.medscape.com
– Medline/PubMed:
http://www.nlm.nih.gov/bsd/pmresources.html
– WebMD:
http://www.webmd.com/

• Trade Magazines and Publications

– 24x7 magazine:
http://24x7mag.com
– Health Technology Management:
http://www.healthcaretechnologymanagement.com
– Journal of Clinical Engineering:
http://journals.lww.com/jcejournal/pages/default.aspx
– TechNation:
http://1technation.com
– Biomedical Instrumentation and Technology (AAMI):
http://www.aami.org/publications/BIT/
– Medical and Biological Engineering and Computing:
http://www.springer.com/biomed/human+physiology/journal/11517

• Benchmarking Organizations

– Association for the Advancement of Medical Instrumentation—AAMI: AAMI’s Bench-

marking Solution (ABS),
http://www.aami.org/abs/index.html
– ECRI Institute: BiomedicalBenchmarkTM ,
https://www.ecri.org/Products/Pages/BiomedicalBenchmark.aspx
®
– Truven Health Analytics (formerly Thomson Reuters Healthcare): Action O-I
Operational Performance Improvement Solution,
http://thomsonreuters.com/products_services/healthcare/
healthcare_products/a-z/action_oi/
 65

Bibliography
Association for the Advancement of Medical Instrumentation – AAMI, (1999) ANSI/AAMI
EQ56:1999 – Recommended practice for a medical equipment management program, Arlington, VA.
Cited on page(s) 15

Association for the Advancement of Medical Instrumentation – AAMI, (2010a) Infusing Patients
Safely, Priority issues from the AAMI/FDA infusion device summit, Arlington, VA. Cited on page(s)
1, 54

Association for the Advancement of Medical Instrumentation – AAMI, (2010b) ANSI/AAMI/IEC

80001–1:2010 Application of risk management for IT Networks incorporating medical devices—
Part 1: Roles, responsibilities and activities. Cited on page(s) 41

Association for the Advancement of Medical Instrumentation – AAMI, (2011a) A Siren Call to
Action – Priority issues from the medical device alarms summit, Arlington, VA. Cited on page(s) 1,
22

Association for the Advancement of Medical Instrumentation – AAMI, (2011b) Forum Rec-
ommends Unified Name for Field, available at http://www.aami.org/news/2011/050211.
forum.name.html, accessed on 7/22/2012 (AAMI, 2011b). Cited on page(s) 2

American College of Clinical Engineering – ACCE, (2012) Clinical Engineer (Defined), available at
http://www.accenet.org/default.asp?page=aboutandsection=definition, accessed
on 7/22/2012. Cited on page(s) 2

Ackoff, R.L. and Rovin, S. (2005) Beating the System: Using creativity to outsmart bureaucracies,
Maintenance causes failures, pp. 48–49, Berrett-Koehler Publishers, San Francisco. Cited on
page(s) 23

American Society for Hospital Engineering – ASHE, (1982) Part 2: Determining Productivity, in
Medical Equipment Management in Hospitals, ASHE, Chicago IL, pp. 5–7. Cited on page(s)
24, 46

American Society for Hospital Engineering – ASHE, (1996) Medical Equipment Management in
Hospitals, ASHE, Chicago IL. Cited on page(s) 24, 35

Bauld,T.J. (1987) Productivity: Standard terminology and definitions, J Clin Eng 12:139–145. Cited
on page(s) 45, 46
66 BIBLIOGRAPHY
Bureau of Labor Statistics – BLS. BLS Handbook of Methods, Chapter 10 – Productivity Mea-
sures: Business Sector and Major Subsectors, available at http://www.bls.gov/opub/hom/
homch10_e.htm, accessed 2/14/2012. Cited on page(s) 48

Bruley, M.E. (1998) Is there evidence of a problem? Database search results 1977–1998 (April)
ECRI’s Health Devices Alerts (HAD) database and FDA’s MAUDE database. Presentation
made at AAMI/FDA Conference on Medical Device Servicing, Remarketing, and Refurbishing:
Is Regulation Needed, Reston, VA, Sept 17–18. Cited on page(s) 23

Centers for Disease Control and Prevention – CDC, (2012) Hand Hygiene in Healthcare Settings
- Guidelines, available at http://www.cdc.gov/handhygiene/Guidelines.html, accessed
on 8/5/2012. Cited on page(s) 12

Cheng, M. and Dyro, J.F. (2004) Good Management Practice for Medical Equipment, in Handbook
of Clinical Engineering, Dyro J.F. (ed.), Elsevier-CRC Publisher, NY, pp. 108–110. Cited on
page(s) 17

Centers for Medicare & Medicaid Services – CMS, (2011) Office of Clinical Standards
and Quality/Survey and Certification Group, Clarification of Hospital Equipment Mainte-
nance Requirements (Ref: S&C: 12–07-Hospital), dated 12/2/2011. Available at http://
www.cms.gov/Surveycertificationgeninfo/downloads/SCLetter12_07.pdf, accessed
6/13/2012. Cited on page(s) 5, 54

Centers for Medicare & Medicaid Services – CMS, (2012a) National Health Expenditure
Data, available at http://cms.hhs.gov/Research-Statistics-Data-and-Systems/
Statistics-Trends-and-Reports/NationalHealthExpendData/downloads/tables.
pdf, accessed on 7/22/2012. Cited on page(s) 3

Centers for Medicare & Medicaid Services – CMS, (2012b) State Operations Manual, available
at http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Internet-
Only-Manuals-IOMs-Items/CMS1201984.html, accessed on 8/5/2012. Cited on page(s) 13

Cohen, T. (1997) Validating medical equipment repair and maintenance metrics: a progress report.
Biomed Instr Techn 31:23–32. Cited on page(s) 46

Cohen, T. (1998) Validating medical equipment repair and maintenance metrics, Part II: Results of
the 1997 survey. Biomed Instr Techn 32:136–144. Cited on page(s) 46

Cohen, T., Bakuzonics, C., Friedman, S.B., Roa, R.L. (1995) Benchmarking indicators for medical
equipment repair and maintenance. Biomed Inst Techn 29:308–321. Cited on page(s) 46, 50

Corio, M.R. and Costantini, L.P. (1989) Frequency and severity of forced outages immediately
following planned or maintenance outages, Generating Availability Trends Summary Report,
North American Electric Reliability Council, Princeton, NJ. Cited on page(s) 23
 BIBLIOGRAPHY 67
Cram, N. (1998) Computerized Maintenance Management Systems: A Review of Available Prod-
ucts, J Clin Eng 23:169–179. Cited on page(s) 36

David, Y. and Rohe, D. (1986) Clinical engineering program productivity and measurements. J. Clin
Eng 11:435–443. Cited on page(s) 45

Douglas, K.R. (2012) Science on the sidelines. Technation 7:44–49. Cited on page(s) 54

Dyro, J.F. (2004) Accident Investigation, in Handbook of Clinical Engineering, Dyro J.F. (ed.),
Elsevier-CRC Publisher, NY, 269–281. Cited on page(s) 10

Evidence-Based Medicine Working Group – EBMWG, (1992) Evidence-Based Medicine: A new

approach to teaching the practice of medicine, J Am Med Assoc 268(17):2420–2425. Cited on
page(s) 23, 53

ECRI Institute – ECRI, (2012) Inspection and Preventive Maintenance Procedures, Biomedical-
Benchmark™, available at www.ecri.org/biomedicalbenchmark. Cited on page(s) 26, 35

Food and Drug Administration – FDA, (2011) Compliance Program Guidance Manual, Chapter 42
– Blood and Blood Products, Inspection of Source Plasma Establishments, Brokers, Testing
Laboratories, and Contractors - 7342.002, Center for Biologics Evaluation and Research. Cited
on page(s) 8

Fennigkoh, L. and Smith, B. (1989) Clinical equipment management. JCAHO PTSM Series 2:5–14.
Cited on page(s) 24

Fennigkoh, L. (2004) Cost-Effectiveness and Productivity, in Handbook of Clinical Engineering, Dyro

J.F. (ed.), Elsevier Academic Press, Burlington, MA, pp. 199–202. Cited on page(s) 46

Frize, M. (1990a) Results of an international survey of clinical engineering departments. Part 1 –

Role, functional involvement and recognition, Med Biol Eng Comput 28:153–159.
DOI: 10.1007/BF02441771 Cited on page(s) 45

Frize, M. (1990b) Results of an international survey of clinical engineering departments. Part 2 –

Budgets, staffing, resources and financial strategies, Med Biol Eng Comput 28:160–165.
DOI: 10.1007/BF02441772 Cited on page(s) 45

Furst, E. (1986) Productivity and Cost-Effectiveness of clinical engineering, J Clin Eng 11:105–113.
Cited on page(s) 45

Furst, E. (1987) Guest editorial - Special Issue Productivity and Cost Effectiveness, J Clin Eng
12:99–100. Cited on page(s) 45, 50

Gaev, J. (2010) Successful measures: Benchmarking clinical engineering performance. Health Facil-
ities Mgmt 23:27–30. Cited on page(s) 50
68 BIBLIOGRAPHY
Geddes, L.A. (2002) Medical Device Accidents and Illustrative Cases, 2nd ed., Lawyers and Judges
Pub., Tucson, AZ. Cited on page(s) 10

Healthcare Information and Management Systems Society – HIMSS, (2012) Manufacturer Dis-
closure Statement for Medical Device Security, available at http://www.himss.org/ASP/
topics_FocusDynamic.asp?faid=99, accessed on 7/22/2012. Cited on page(s) 7

Hutchins, B. (2006) Suspicion kills national benchmark, Biomed Instr Techn 40:327. Cited on page(s)
50

International Standards Organization – ISO, (1999) ISO/IEC Guide 51:1999, 2nd ed., Safety
aspects– Guidelines for their inclusion in standards. Cited on page(s) 24, 30

International Standards Organization – ISO, (2000) ISO/AAMI/ANSI standard 14971 - Medical

devices – Application of risk management to medical devices. Cited on page(s) 24, 30

International Standards Organization – ISO, (2008) ISO/ANSI/ASQ, Standard 9001:2008 - Qual-

ity management systems – Requirements. Cited on page(s) 33, 39

Johnston, G.I. (1987) Are productivity and cost-effectiveness comparisons between in-house clinical
engineering departments possible or useful? J Clin Eng 12:147–152. Cited on page(s) 45

Kaplan, R.S. and Norton, D.P. (1996) The Balanced Scorecard, Harvard Business School Press, Cam-
bridge, MA. Cited on page(s) 41

Kawohl, W., Temple-Bird, C., Lenel, A. and Kaur, M. (2005) Guide 6 - How to Manage the Fi-
nances of Your Healthcare Technology Management Teams, Ziken International-TALC, St. Albans,
Hertfordshire, UK. Cited on page(s) 46

Maddock, K.E. (2006) (Benchmarking) Glass is half full, Biomed Instr Techn 40:328. Cited on
page(s) 50

Moubray, J. (1997) Reliability-Centred Maintenance, 2nd ed., Industrial Press, Inc., New York, NY.
Cited on page(s) 23

Nader, R. (1971) Ralph Nader’s most shocking expose, Ladies Home J 98:176–179. Cited on page(s)
23

National Conference of State Legislatures – NCSL, (2012) Certificate of Need: State Health
Laws and Programs, available at http://www.ncsl.org/issues-research/health/con-
certificate-of-need-state-laws.aspx, accessed on 8/5/2012. Cited on page(s) 14

National Fire Protection Association – NFPA, (2012) NFPA 99 – Standards for Health Care Facilities,
Quincy, MA. Cited on page(s) 14
 BIBLIOGRAPHY 69
Office of Civil Rights – OCR, (2012) Health Information Privacy FAQ, “Is a physician required
to have business associate contracts with technicians such as plumbers, electricians or photocopy
machine repairmen who provide repair services in a physician’s office?” available at http://
www.hhs.gov/ocr/privacy/hipaa/faq/business_associates/244.html accessed on
7/22/2012. Cited on page(s) 7
Reason, J. (2000) Human error: models and management. Br Med J 320:768–70.
DOI: 10.1136/bmj.320.7237.768 Cited on page(s) 31
Ridgway, M. (2004) The great debate on electrical safety – In retrospect, in Handbook of Clinical
Engineering, Dyro, J.F. (ed.), Elsevier-CRC Publisher, NY, pp. 281–283. Cited on page(s) 5
Ridgway, M.G., Johnston G.I. and McClain J.P. (2004) History of engineering and technology in
health care, in Handbook of Clinical Engineering, Dyro, J.F. (ed.), Elsevier-CRC Publisher, NY,
pp. 7–10. Cited on page(s) 23
Sinek, S. (2009) Start with Why: How Great Leaders Inspire Everyone toTake Action. Portfolio/Penguin,
New York, NY. Cited on page(s) 51
Smith, A.M. and Hinchcliffe, G.R. (2004) RCM–Gateway to World Class Maintenance, 2nd ed.,
Elsevier Butterworth-Heinemann, Burlington, MA. Cited on page(s) 23
Stiefel, R. (2009) Medical Equipment Management Manual, Association for the Advancement of
Medical Instrumentation - AAMI, Arlington, VA, pp. 3–5. Cited on page(s) 5
The Joint Commission – TJC, (2012a) Sentinel Event, available at http://www.
jointcommission.org/sentinel_event.aspx, accessed on 8/5/2012. Cited on page(s) 1,
22, 53, 54
The Joint Commission – TJC, (2012b) Comprehensive Accreditation Manual for Hospitals, Joint Com-
mission Resources, Oakbrook Terrace, IL. Cited on page(s) 5, 26
Wang, B. and Levenson, A. (2000) Equipment inclusion criteria: A new interpretation of JCAHO’s
medical equipment management standard, J Clin Eng 25(1):26–35. Cited on page(s) 24
Wang, B. (2004) Financial Management of Clinical Engineering Services, in Handbook of Clinical
Engineering, Dyro, J.F. (ed.), Elsevier-CRC Publisher, NY, pp. 188–199. Cited on page(s) 40
Wang, B. (2007) Evidence-Based Maintenance? 24x7 magazine 12(4):56. Cited on page(s) 23, 53
Wang, B. (2008) Evidence-based Medical Equipment Maintenance Management, in A Practicum
for Biomedical Engineering and Technology Management Issues, L.R. Atles (ed.), Kendall/Hunt
Publishing, Dubuque IO, pp. 219–254. Cited on page(s) 23, 26, 29, 53
Wang, B. (2009) Strategic Health Technology Incorporation, Morgan and Claypool Publ., Princeton,
NJ. Cited on page(s) 17, 19
70 BIBLIOGRAPHY
Wang, B., Rui T., Balar, S., Alba, T., Hertzler, L.W. and Poplin, B. (2012) Clinical Engineering
Productivity and Staffing Revisited: How should it be measured and how can it be used? J Clin
Eng. DOI: 10.1097/JCE.0b013e31826cc689 Cited on page(s) 1, 26, 44, 46, 48, 54

Wang, B., Rui, T. and Balar, S. An Estimate of Patient Incidents Caused by Medical Equipment
Maintenance Omissions, Biomed Instr Techn, in press. Cited on page(s) 1, 23, 54

Wang, B., Rui, T., Koslosky, J., and Fedele, J., A comparison of scheduled maintenance methods:
OEM-recommended versus hospital-developed. Manuscript in preparation. Cited on page(s) 53

Wang, B., Furst, E., Cohen, T., Keil, O.R., Ridgway, M. and Stiefel, R. (2006a) Medical Equipment
Management Strategies, Biomed Instrum and Techn 40:233–237.
DOI: 10.2345/i0899-8205-40-3-233.1 Cited on page(s) 24, 26, 27

Wang, B., Eliason, R.W. and Vanderzee, S.C. (2006b) Global Failure Rate: A promising medical
equipment management outcome benchmark, J Clin Eng 31:145–151. Cited on page(s) 44

Wang, B., Eliason, R.W., Richards, S., Hertzler, L.W. and Koenigshof, S. (2008) Clinical Engineer-
ing Benchmarking: An Analysis of American Acute Care Hospitals, J Clin Eng 33:24–37. Cited
on page(s) 1, 37, 39, 41, 44, 46, 48, 50

Wang, B., Fedele, J., Pridgen, B., Rui, T., Barnett, L., Granade, C., Helfrich, R., Stephenson, B.,
Lesueur, D., Huffman, T., Wakefield, J.R., Hertzler, L.W. and Poplin, B. (2010a) Evidence-
Based Maintenance: Part I - Measuring maintenance effectiveness with failure codes, J Clin Eng
35:132–144. Cited on page(s) 23, 27, 53

Wang, B., Fedele, J., Pridgen, B., Rui, T., Barnett, L., Granade, C., Helfrich, R., Stephenson, B.,
Lesueur, D., Huffman, T., Wakefield, J.R., Hertzler, L.W. and Poplin, B. (2010b) Evidence-
Based Maintenance: Part II - Comparing maintenance strategies using failure codes, J Clin Eng
35:223–230. Cited on page(s) 23, 27, 53

Wang, B., Fedele, J., Pridgen, B., Rui, T., Barnett, L., Granade, C., Helfrich, R., Stephenson, B.,
Lesueur, D., Huffman, T., Wakefield, J.R., Hertzler, L.W. and Poplin, B. (2011) Evidence-Based
Maintenance: Part III - Enhancing patient safety using failure code analysis, J Clin Eng 36:72–84.
Cited on page(s) 23, 27, 44, 53, 54

Weinstein, R.A. (1998) Nosocomial infection update, Emerg Infect Dis 4:416–420.
DOI: 10.3201/eid0403.980320 Cited on page(s) 12

Zak, J. The Changing World of Maintenance, (2005) Proceedings of the 2005 AAMI Annual Meet-
ing and Conference, Boston MA, Association for the Advancement of Medical Instrumentation,
Arlington, VA. Cited on page(s) 23
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Author’s Biography

BINSENG WANG
Binseng Wang, Sc.D., C.C.E., fAIMBE, fACCE earned Bachelor of Science degrees in both
Physics and Electronics Engineering from the University of São Paulo, a Master of Engineering
degree from the State University of Campinas, and a Doctor of Science degree from Massachusetts
Institute of Technology. He is a Certified Quality Systems (ISO 9001) Auditor and a Certified Clin-
ical Engineer. He started his career in Brazil as a faculty member at the State University of Campinas,
where he created the Center for Biomedical Engineering. He also served as the Special Advisor on
Equipment to the Secretary of Health of São Paulo state. In the U.S., he worked at the National
Institutes of Health and served as Vice President of Quality Assurance and Regulatory Affairs with
MEDIQ/PRN Life Support Services, Inc. Currently he is Vice President of Quality and Regu-
latory Compliance for ARAMARK Healthcare Technologies, where he oversees the nationwide
Medical Equipment Management Program that establishes the operating policies and procedures
for equipment planning, acquisition, maintenance, retirement, replacement, supplier management,
regulatory compliance, risk management, and quality monitoring and improvement. He also ensures
the compliance of ARAMARK teams located at over 700 client sites with medical-equipment laws,
regulations, and standards. He has traveled around the world providing consulting services to several
national governments under the auspices of the Pan-American Health Organization, World Health
Organization, Inter-American Development Bank, World Bank, and numerous non-government
organizations. Dr. Wang is a fellow of the American College of Clinical Engineering (ACCE) and
American Institute of Medical and Biological Engineering (AIMBE), a member of the Health
Technology Technical Advisory Group of the World Health Organization (WHO). He received
the 2010 AAMI Clinical/Biomedical Engineering Achievement Award.