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Is the equipment performing according to specifications submitted by the manufacturer and approved by the FDA?
Is the equipment safe (for both users and patients)? Is the equipment reliable? Does and when the equipment needs to be serviced? Where is the equipment if it needs to be serviced (routine or
subject to a recall)? Is there enough quantity and variety of equipment for adequate
patient care?
Asset Mgmt = Inventory Mgmt + Maintenance Mgmt
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feedback
Health Policy(Mission & Vision)
StrategicPlanning
Acquisition
Maintenance &Management
Installation/Acceptance
Clinical Use
Retirement
Quality Improvement& Risk Management
Utilization Standards
Technology AssessmentRegulations & StandardsMarket Competition
Financial ConstraintsEpidemiological Data
Service Suppliers
Manufacturers& Distributors
Facilities Management
Information Technology
Material Management
Architects
Inventory/Asset Management
33Copyright © 2016 by Binseng Wang – All Rights Reserved
Initial Investment- Equipment price- Accessories- Shipping,
insurance & customs
- Installation
< 20% of TCO
Invisible Costs- Operations- Maintenance- Administrative- User learning
> 80% of TCO
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Clinical leaders have requested equipment that well exceed available budget (US$30 M)
Your group was asked to evaluate the requests and recommend the final list to hospital executives.
Requested equipment Combination PET/MRI: $10M Gamma knife: $8 M Full integration of equipment with electronic health records
(EHR): $7 M Fully automated clinical lab system: $5 M Fully integrated, robotic surgical system: $4 M Wireless telemetry system for ICUs: $3 M Replacement of all infusion pumps: $2 M Miscellaneous equipment replacement: $5 M
36Copyright © 2017 by Binseng Wang – All Rights Reserved
Start with a presentation of the basic principles of quality, risk and asset management for Clinical Engineering (~60 min)
Audience divided into groups of 5-10 persons for exercises Each group will perform three exercises of application of the
basic principles presented):1) Strategic technology incorporation2) Evidence-based scheduled maintenance3) Evidence-based corrective maintenance
Each group will spend 20 minutes on each exercise and report on its conclusions in 3 minutes
Afterwards, I will spend 10 minutes discussing the exercise. So each exercise will take ~50 min
Will take a break from 10 to 10:30 AM, after the first exercise
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PET+MRI Gamma knife EHR Clinical Lab None of above
There is no right (or wrong) answer! It all depends on other variables not specified in the exercise, i.e., • Institution’s mission & vision• Needs versus desires• Resources availableThe only right answer is having a good PROCESS for technology incorporation.
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Technology Acquisition
Technology Planning
ProductSelection
Procurement
Alternatives to Purchasing
Technology Audit
Technology Evaluation
Evaluation Consolidation
Technology Plan
InstallationAcceptance
Technology Management
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Facilities Mgmt
Information Technology
Material Mgmt
Organization Board or CEO
Chief Medical Officer
Chief Nursing Officer
Chief Operations
Officer
Technology Incorporation
Committee
Chief Finance Officer Task
Force 1Task
Force 2Task
Force 3
ClinicalEngineering
Other Suppliers
Manufacturers
Architects
Technology AssessmentRegulations & StandardsMarket Competition
Financial ConstraintsEpidemiological Data
Health Policy(mission, vision, strategies, etc.
Admin Support
Technical Support
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Many contributors, each with a different role, taking turns serving the process
A good team Enlists all key stakeholders Uncovers the real issues Gathers the right information Identifies all the options Puts everything on the table
Reminder: Joint Commission International (JCI) has requirements for the selection and acquisition of laboratory and radiology equipment (but not for biomedical)
41Copyright © 2017 by Binseng Wang – All Rights Reserved
After evaluating all the requests, the TIC can rank the request by the “total score” and the costs associated
ITEM EQUIPMENT BEING EVALUATED
QTY REQUESTED
NEED EVALUATION
BENEFITS EVALUATION
IMPACT EVALUATION
COSTS EVAUATION
TOTAL
SCORE
UNIT COST (US$)
EXTENDED COST
(US$)
CUMULATIVE COST
(US$)R
egul
ator
y or
Car
e St
anda
rd
Epid
emio
logy
Mar
ket
Com
petit
iven
ess
Clin
ical
Fina
ncia
l
Indi
rect
Infr
astr
uctu
re
Use
rs
Mai
nten
ance
Inve
stm
ent
Rec
urre
nt
Use
rs
1 Ebola-virus detector 5 0.0 5.0 3.0 5.0 2.0 3.0 -5.0 3.0 2.0 2.0 4.0 2.0 2.4 $20,000 $100,000 $100,000
2 Wound aspirators 12 3.0 3.0 1.0 4.0 -2.0 -1.0 1.0 2.0 -2.0 -3.0 -4.0 2.0 0.3 $65,000 $780,000 $880,0003 LED surgical lights 8 -2.0 -3.0 0.0 3.0 1.0 0.0 -1.0 1.0 2.0 -2.0 0.0 0.0 0.2 $50,000 $400,000 $1,280,0004 Ultra-fast CT (256
slice) 1 1.0 2.0 4.0 4.0 2.0 3.0 -4.0 -3.0 -4.0 -5.0 -3.5 -3.0 0.2 $800,000 $800,000 $2,080,0005 Surgical robot 1 0.0 1.0 4.0 2.0 -1.0 1.0 -4.0 -4.0 -5.0 -5.0 -4.0 -3.0 -1.1 $1,500,000 $1,500,000 $3,580,000
42Copyright © 2017 by Binseng Wang – All Rights Reserved
If manufacturers’ recommended scheduled maintenance were followed rigorously, you would never have enough staff and other resources to comply.
Develop an Evidence-Based SM method to keep equipment safe and reliable considering True preventive maintenance (PM) Safety & performance inspection (SPI)
Show how you will evaluate your SM method for safety and effectiveness?
Equipment Categories Diagnostic imaging equipment Radio-therapy equipment Surgical equipment Monitoring equipment Laboratory equipment
43Copyright © 2017 by Binseng Wang – All Rights Reserved
Start with a presentation of the basic principles of quality, risk and asset management for Clinical Engineering (~60 min)
Audience divided into groups of 5-10 persons for exercises Each group will perform three exercises of application of the
basic principles presented):1) Strategic technology incorporation2) Evidence-based scheduled maintenance3) Evidence-based corrective maintenance
Each group will spend 20 minutes on each exercise and report on its conclusions in 3 minutes
Afterwards, I will spend 10 minutes discussing the exercise. So each exercise will take ~50 min
Will take a break from 10 to 10:30 AM, after the first exercise
44Copyright © 2017 by Binseng Wang – All Rights Reserved
Also known as Planned maintenance Preventive or preventative maintenance Pro-active maintenance Inspection and preventive maintenance (IPM)
Goal Enhance reliability of equipment => increase availability of
equipment (“reliability”) => improve patient safety & care Objectives Reduce preventable failures => Preventive maintenance (PM) Detect failures in progress => Inspection (for potential failures) Detect hidden failures => Inspection (for hidden failures)
SM = PM + SPI [true preventive maintenance and safety and performance inspection]
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Plan: Design scheduled maintenance strategies. Do: Test the strategies in small-scale if possible. Check: Evaluate the results (safety & effectiveness) Act: Keep the strategies if they improved safety or
effectiveness. Otherwise, revise them. If you have new ideas, start the cycle again.
Reproduced from ASQ.org
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I used the Fennigkoh & Smith (aka risk-based criteria) to plan SM, so why do I have to evaluate SM?
Pres. Dwight D. Eisenhower said:In preparing for battle I have always found that plans are useless, but planning is indispensable.
Good planning does notguarantee good outcomes!
Just like school attendance does not ensure learning!
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A very, very old method; firstproposed by someone who said“Eppur si muove (and yet it doesmove)
The “scientific method” Galileo Galilei (1564-1642) Francis Bacon (1561-1626) René Descartes (1596-1650) Some claim it actually goes
back to Hippocrates (460-370 bce) Carl Sagan said it is actually within
our genes
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Source: Donabedian A: Evaluating the quality of medical care. Milbank Quart., 44:186-203,1966.
Patients OutcomesCare Process
STRUCTURE CARE PROCESS OUTCOME• Material Resources
(building, equipment, etc.)
• Human Resources (personnel # & qualification)
• Organizational Structure
• Patients & care takers: seeking or carrying out care
• Providers:• Diagnosis• Therapy• Other services
• Improvement in patient’s knowledge and behavior
• Patient satisfaction with care
Structure
(equipment)
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PROPOSED DEFINITION
A continual improvement process that analyzes the effectiveness of maintenance resources deployed in comparison to outcomes achieved previously or elsewhere, and makes necessary adjustments to maintenance planning and implementation.
Fishing = Process Catching = OutcomeTackle = Structure
An analogy based on Dr. Donabedian’s model
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Primary goals of equipment maintenance (including SM) Safety: equipment is safe for patients and clinical users Reliability: equipment is available for use whenever needed
Therefore: Safety Evaluation: determine if the maintenance strategy is enhancing
the safety of patients and clinical users (i.e., reduce equipment malfunctions that negatively affect patients and clinical users)
Reliability Evaluation: determine if the maintenance strategy is enhancing the reliability of equipment and, thus, the care of patients (i.e., making equipment more available for use when needed)
Safety Effectiveness =Reliability
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Code Failure Cause Description SM/CM
NPF No problem found (or the reported problem was not duplicated). both
UPF Unpreventable failure, typically caused by normal wear and tear but is unpredictable. CM
ACC Accessory failure, excluding batteries, typically caused by normal wear and tear. both
BATT Battery failure, i.e., battery(ies) failed before the scheduled replacement time. Does not include scheduled replacement of batteries.
both
NET Failure in or caused by network, while the equipment itself is working without problems. Applicable only to networked equipment.
both
USE Failures induced by use, e.g., abuse, abnormal wear & tear, accident, or environment issues. CM
EF Evident failure, i.e., a problem that can be detected, but was not reported by the user, without running any special tests or using specialized tester.
SM
SIF Service-induced failure, i.e., caused by CM or SM that was not properly completed or a part that was replaced and failed prematurely (“infant mortality”).
CM
HF Hidden failure, i.e., a problem that could not be detected by the user under normal circumstances, unless running a special test or using specialized tester.
SM
PF Potential failure, i.e., failure is either about to occur or in the process of occurring but has not yet caused equipment to stop working or problems to patients or users.
SM
PPF Preventable and predictable failure, typically caused by wear and tear that can be predicted or detected.
CM
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YEAR Decade Total
%Data Type 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013# incidents reports received 31 28 47 46 48 49 62 88 58 61 518 NA# incidents investigated 28 26 39 36 41 48 61 84 53 60 476 91.9%# investigated incidents with harm, including deaths (to patient or user) 12 11 16 21 11 21 23 38 17 27 197 41.4%# investigated incidents with deaths 6 5 4 8 7 9 9 12 7 7 74 15.5%# investigated incidents with deaths but no equipment or accessory failures 5 4 2 4 4 7 9 8 3 5 51 10.7%# investigated incidents traced to equipment or accessory failures 14 8 14 19 19 24 22 31 21 30 202 42.4%# investigated incidents potentially related to maintenance omission 1 0 0 1 0 2 0 0 1 1 6 1.3%# equipment managed 694,14
8 827,503 944,449 942,006 920,109 895,064 905,747 1,195,054 1,176,401 1,182,936 9,683,417# SM performed 555,31
8 662,002 755,559 753,605 744,209 726,933 768,669 935,020 885,629 905,955 7,692,900# repairs performed 277,65
9 331,001 377,780 376,802 358,546 359,177 364,629 455,046 474,211 473,016 3,847,868
Reproduced from data collected and presented by Aramark Healthcare Technologies at MD-Expo Oct. 2014
53Copyright © 2017 by Binseng Wang – All Rights Reserved
Data Analyzed (3-Hosp System) 3 years: 2012-2014 Inventory: ~7,900 units
FCC Analysis Few SIF, HF, PF and PPF However, one equipment group had several HF (9 out of 65
units) => further review needed• Most due to premature component wear out not subject to
OEM-recommended SM Conclusion: Failures were NOT
caused by not following OEMbut the strategy needs to be revised, i.e., following OEM doesnot guarantee effectiveness.
totalper year
CM/PM rate
CMs 5381 1794 23%PMs 11012 3671 46%
Code #WO Equip GroupsSIF 6 6HF 16 7PF 4 4PPF 7 5
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Develop an Evidence-Based CM method to keep equipment safe and reliable for Diagnostic imaging equipment Radio-therapy equipment Surgical equipment Monitoring equipment Laboratory equipment
How to prioritize repairs by equipment category? When to drop SM in favor of CM and vice-versa? How to ensure the repairs are correctly performed? How to evaluate the safety and effectiveness of your
CM strategy?
55Copyright © 2017 by Binseng Wang – All Rights Reserved
Start with a presentation of the basic principles of quality, risk and asset management for Clinical Engineering (~60 min)
Audience divided into groups of 5-10 persons for exercises Each group will perform three exercises of application of the
basic principles presented):1) Strategic technology incorporation2) Evidence-based scheduled maintenance3) Evidence-based corrective maintenance
Each group will spend 20 minutes on each exercise and report on its conclusions in 3 minutes
Afterwards, I will spend 10 minutes discussing the exercise. So each exercise will take ~50 min
Will take a break from 10 to 10:30 AM, after the first exercise
56Copyright © 2017 by Binseng Wang – All Rights Reserved
Also known as Unscheduled maintenance Repairs Reactive maintenance
Goal Restore equipment safety and/or functionality as soon as possible
=> increase availability of equipment (“reliability”) Objectives Reduce “down time” Detect failure causes and determine future possible preventive
actions => Preventive maintenance (PM) enhancement Detect failures in progress => Inspection (for potential failures) Detect hidden failures => Inspection (for hidden failures)
Thus a full scale inspection (SPI not PM) is required after each (functional) repair to ensure that equipment is safe and performing according to its original specifications.
57Copyright © 2017 by Binseng Wang – All Rights Reserved
Mission Criticality (MC) Defined as the equipment’s role or importance within the
organization’s mission Examples Low MC: a particular defibrillator. While critical for the survival
of a particular patient who is having a cardiac arrest, it may not be necessary to give this unit the highest priority in repairs (or SM) when a sufficient number of working defibrillators is currently available within the organization
High MC: the sole lab automated chemistry analyzer system. While not high-severity, it quickly becomes a bottleneck for the hospital as many patients will be left without proper diagnosis and, consequently, proper care
CM Priority = mission criticality, i.e., fix the equipment with the highest MC first!
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Latent Conditions
Active Failure
J. Reason’s Swiss cheese model
Adapted from Reason J. Managing the Risks of Organizational Accidents, Ashgate, 1997
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SPI = safety & performance inspection: a combination of visual inspections, tests, and measurements performed to verify device safety and performance according to specifications.
Case: Ventilator PCB replacement requires disconnecting battery leads
Probability #Pt Potentially HarmedSingle Servicer Organization
#Ventilator PCB repairs/year 100 1000SPI NOT required after service
Forgot BATT 1% 1 10SPI required after service (ideal)
Forgot BATT 1%SPI missed BATT 1%Combined 0.01% 0.01 0.1
SPI required after service (realistic)Forgot BATT 1%Forgot SPI 10%SPI missed BATT 1%Combined 0.109% 0.109 1.09
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Record all patient incidents (and “close calls”), including those involving lasers, imaging/radiologic, and laboratory equipment
Investigate all incidents and perform (simplified) root-cause analysis (RCA)
Classify RCA conclusion with a “failure cause code” (FCC) For incidents assigned with codes SIF, HF, PF or PPF (potential
maintenance omissions), determine the underlying cause “unsafe acts” (aka “active failures”) committed by individual staff
(employed by hospital, OEM, or third party), e.g., lapses or slips “latent conditions” created by the organization due to oversight or
deliberate violation of regulations, codes or standards. SIF includes “repeated repairs” or “incomplete repairs”
CodeNPFUPFACCBATT
NET
USEEF
SIF
HF
PF
PPF
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Assign a “failure cause code” (FCC) for all scheduled maintenance (SM) and repair workorders
Determine the amount of SIF, HF, PF and PPF found Determine within each of these 4 FCCs the number of equipment
groups (i.e., same brand and model, and similar ages, utilization location and intensity, and users)
Look for the equipment groups with “unusually” high #FCCs per group, especially PPFs
For these groups, determine the underlying cause “unsafe acts” (aka “active failures”) committed by individual staff (employed
by hospital, OEM, or third party), e.g., lapses or slips “latent conditions” created by the organization due to oversight or
deliberate violation of regulations, codes or standards. If >50% of the FCCs analyzed is due to “latent conditions,” then
determine whether it is caused by the adoption of AEM strategy, i.e., a maintenance frequency and/or procedure different than those recommended by the respective manufacturer. If so, revise it.
CodeNPF
UPF
ACC
BATT
NET
USE
EF
SIF
HF
PF
PPF
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Wang B. Strategic Health Technology Incorporation, Morgan & Claypool Publ., Princeton NJ, 2009
Wang B. Medical Equipment Maintenance: Management and Oversight, Morgan and Claypool Publ., Princeton NJ, 2012
Atles LR (ed.). A Practicum for Biomedical Engineering and Technology Management Issues, Kendall/Hunt Publishing, Dubuque IO, 2008
Dyro JF (ed.). Handbook of Clinical Engineering, Elsevier-CRC Publisher, NY, 2004
62
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Please contact us if you have any questions, comments or suggestions Binseng Wang [email protected]