Asset Mgmt = Inventory Mgmt + Maintenance Mgmtcedglobal.org/wp-content/uploads/2018/08/7.part_2.pdf · 07/08/2018 · 2) Evidence-based scheduled maintenance 3) Evidence-based corrective

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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


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


Initial Investment- Equipment price- Accessories- Shipping,

insurance & customs

- Installation

< 20% of TCO

Invisible Costs- Operations- Maintenance- Administrative- User learning

> 80% of TCO



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


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


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.


Technology Acquisition

Technology Planning

ProductSelection

Procurement

Alternatives to Purchasing

Technology Audit

Technology Evaluation

Evaluation Consolidation

Technology Plan

InstallationAcceptance

Technology Management


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


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)


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

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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


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









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]


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


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!


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


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)


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


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


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


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


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


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?









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.


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!


Latent Conditions

Active Failure

J. Reason’s Swiss cheese model

Adapted from Reason J. Managing the Risks of Organizational Accidents, Ashgate, 1997


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


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


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


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


Please contact us if you have any questions, comments or suggestions Binseng Wang [email protected]

mailto:[email protected]

Documents

Asset Mgmt = Inventory Mgmt + Maintenance Mgmtcedglobal.org/wp-content/uploads/2018/08/7.part_2.pdf · 07/08/2018 · 2) Evidence-based scheduled maintenance 3) Evidence-based corrective