Assessing Scheduled Support of Medical Equipment North Central Biomedical Association Seminar September 5, 2008 Tim Ritter Senior Project Engineer

Assessing Scheduled Support

of Medical Equipment

North Central Biomedical Association Seminar

September 5, 2008Tim Ritter Senior

Project Engineer.

Who is ECRI Institute?

Nonprofit, international health services research agency Seeking to promote the highest standards of safety, quality and

cost effectiveness in healthcare since 1968Resources include

Membership-based access to Web resources, databases, research reports, guides, directories

Consultation services and special projects Information used by

Hospitals, health systems, health plans, and insurers Government agencies, legal and regulatory professionals

©2008 ECRI Institute

Alternative Presentation Titles . . .

To PM or Not to PM . . .How Often is Enough?Recommendations or Requirements?

© 2008 ECRI.©2008 ECRI Institute

© 2008 ECRI.

How safe is “safe”?


In the Beginning . . .

Emergency Care Research Institute – 1968“1,200 US hospital electrocutions/yr” – 1969

5,000/yr according to Ralph Nader by 1971The electrical safety “scare” gives birth to clinical engineeringHealth Devices Volume 1 Number 1 addresses

the isolated power controversyMonthly inspections of defibrillatorsQuarterly inspections of monitors


In the Beginning . . .

Technology was not reliable and possibly dangerousVacuum tubesHigh leakage currentsMetal chassis with minimal fluid protectionAnalog metersHeated stylus recordersLousy batteriesReusable pressure transducers© 2008 ECRI.


© 2008 ECRI.

Over the Past 40 YearsTechnology has become more reliable

Better designed and frequently double insulated

Devices have self diagnostics and error/event logs

Significant failures rarely identified during inspections

The need for preventive maintenance is declining

ECRI Institute has no evidence of injury or death attributable to neglected inspection or preventive maintenance


© 2008 ECRI.

Initial Observations

Many “PM” programs are outdated ─ electrical safety and equipment risk levels are overemphasized

Manufacturer recommendations ─ the same for all units under all operating conditions

Risk managers and regulatory agencies frequently interpret those recommendations to be requirements


© 2008 ECRI.

Initial Observations

Equipment management is essentially risk management.

Nothing can be 100% safe or 100% reliable!

Inspect something today and it can fail tomorrow . . .


What is Scheduled Support?

Inspection – verification of performance and safetyPreventive maintenance – periodic procedures to minimize

risk of failure and to ensure continued proper operation “PM” is frequently used incorrectly to mean inspection

Scheduled support = inspection and/or preventive maintenance

Relatively few devices require true preventive maintenanceThe focus of this presentation: Scheduled Inspections


© 2008 ECRI.

What reasons are given for

performing scheduled support?

To reduce the risk of injury (to patients, staff, visitors)To reduce the risk of significant adverse impact on patient care

(e.g., due to downtime)To comply with codes, standards, and regulations


Initial Questions for Any Technology

Is there value in performing inspections?If so, do what? How often?How to determine, document and update the decision?Are manufacturer recommendations for performance

verifications justified?


What is Risk?

Risk

“ Combination of the probability of occurrence of harm and the severity of that harm.”

ANSI/AAMI/ISO 14971:2000


Assessing Equipment Risk

High-risk devices Medium-risk devices Low-risk devices


© 2008 ECRI.

High-risk devices

Life-support, key resuscitation, critical monitoring and other likely devices whose failure or misuse is reasonably likely to seriously injure patients or staff

Ventilators

Defibrillators

Anesthesia units

Patient lifts


© 2008 ECRI.

Medium-risk devices

Devices, including many diagnostic instruments, whose misuse, failure or absence (e.g. out of service with no replacement available) would have a significant impact on patient care, but would not be likely to cause direct serious injury

Clinical laboratory equipment

Ultrasound scanners

Electrocardiographs


© 2008 ECRI.

Low-risk devices

Devices whose failure or misuse is unlikely to result in serious consequences

Ophthalmoscopes

Electronic thermometers

Cast cutters


© 2008 ECRI.

Defining versus Predicting

Risk level definitions don’t predict probability or nature of device or system failure

High risk devices should be and usually are very reliable

Risk level should be used for prioritizing the completion of scheduled inspections


Case Study: Infusion Pumps

They are usually considered to be high-risk devicesThey have mechanical parts and are used for many yearsA comparatively high number of adverse incidents are

associated with pumps

© 2008 ECRI.


© 2008 ECRI.

Why pumps may not require periodic testing! Flow accuracy does not significantly deteriorate over time (5-10 years)

No reports of insidious or preventable failures

When they do fail, they fail “safe” (stop and alarm rather than over- or under-infusing)

Event logs show primary cause of adverse incidents is

operator error

Survey: some have stopped scheduling inspection or gone to every other year; some inspect a small sample


© 2008 ECRI.

Inspecting Infusion Pumps: How Often Is Enough?

“Many hospitals have a large number of general-purpose infusion pumps in their inventory. Therefore, the frequency at which these facilities schedule routine inspection of these pumps can have a major impact on their workforce utilization and costs. . .ECRI believes that, for most pumps in most facilities, inspection need not be scheduled for more than once a year, and that in many cases even this frequency is unnecessary.” (Health Devices 1998)


© 2008 ECRI.

Low-risk devices

If failure of a device is unlikely to result in serious consequences...

then there is little value in inspecting low risk devices

Some exceptions: ultrasound therapy units and warming cabinets


© 2008 ECRI.

Joint Commission

OK not to schedule IPM – but document decisionOK for different schedules for same device based on

differences in use (hospital versus ambulance defibs)Hospitals may modify manufacturer protocols based on

service experience Support decisions with records that identify issues related

to failure and misuse


© 2008 ECRI.

Is Scheduled Support Required? Acceptance Inspection

Scheduled SupportRequired?

No Yes

Document DecisionChange in Use

Document Decisionand Interval

Identify/DevelopIPM Procedure

Perform IPM(s)

Review AnnualIPM/Repair Data

Review AnnualRepair Data


© 2008 ECRI.

Annual Review of IPM / Repair Data

Review Annual IPM/Repair Data

Any Problems Minimized/Prevented

by IPM?No Yes

Maintain/IncreaseScheduled Support

Decrease/EliminateScheduled Support


Determining and Documenting Scheduled Support Decisions

Need to switch emphasis from equipment “risk level” to failure mode analysis

Need to identify differences in use/environmentNeed to document these issues have been considered

© 2008 ECRI.


Numeric/Formulaic Assessment Tools

These tools tend to emphasize failure effects and ignore failure mode data

Can these tools produce an objective determination?Can they produce consistent results?

© 2008 ECRI.


Hypothetical Scheduled Support Assessment Scheme

Consequence of Failure (1–4)

multiplied by

Likelihood of Failure (1–4) =

“Risk” Score© 2008 ECRI.


Hypothetical Scheduled Support Assessment Scheme

Risk Score ≥8: device is likely to need inspection

How can factoring 2 subjective decisions identifying a worst case failure resultestimating the likelihood of such a failure

produce an objective, definitive determination???© 2008 ECRI.





© 2008 ECRI.

An Interesting Study

Global Failure Rate: A Promising Medical Equipment Management Outcome Benchmark

Journal of Clinical Engineering July/September 2006

Binseng Wang et al. present failure data from three independent service organizations

Data is presented as Failures/Device/Year

Failure = # completed repair work orders


© 2008 ECRI.

What is a Failure?

“The device doesn’t operate”

“Repair or calibration had to be performed”

“Equivalent to a work order”

“Shouldn’t include cosmetic repairs”

“Shouldn’t include work orders for user abuse or error”


© 2008 ECRI.

Failure: Proposed Definition

“The condition of not meeting intended function or safety requirements and or a breach of physical integrity.

A failure is corrected by repair and/or calibration.” A Universal Medical Technology Service Nomenclature

Health Devices - June 2007


© 2008 ECRI.

Definition Challenges

It may be difficult to determine when user abuse or user error is the cause of a failure.

Similarly, environmental conditions (e.g., temperature, electrostatic discharge, line voltage spikes) beyond manufacturer specifications would ideally be excluded but are often not easily identified.


© 2008 ECRI.

Failure Data: Key Questions for Optimizing Scheduled Support Activities

Review findings from inspections and repairs: were any failures not detected by users? were any failures preventable? were any failures due to user abuse?


© 2008 ECRI.

Sources of Information/EvidenceInternal

Maintenance management system – Failure Data!

Use/environment considerations

External

Equipment manufacturers

Official bodies (FDA, Health Canada)

Independent bodies (ECRI Institute)

Other equipment users


Assessing the Need for Inspection

Start with manufacturer recommendations but consider that they were developed:

before reliability data was available for the device in every type of facility, anywhere over its expected life

(i.e., a worst-case use scenario) And, manufacturers sell . . .

service contracts!

© 2008 ECRI.


© 2008 ECRI.


Consider manufacturer recommendations but also equipment service experience and the use environment

Determine appropriate inspection procedure and inspection interval

Eliminate unnecessary inspections particularly on low-risk devices

De-emphasize electrical safety testing


Another Look at Risk

“ Combination of the probability of occurrence of harm and the severity of that harm.”

In terms of scheduled support, the probability of occurrence of harm translates to . . .

quantifying the probability and types of equipment failure


© 2008 ECRI.


Document decisions on a support assessment formPresent conclusions to hospital’s safety/quality committee

for approvalModify inspection intervals based on failure data from

ongoing repairs and changes in device use


© 2008 ECRI.

Failure Data: The Key to Scheduled Support

Failure data is needed to assess the value of scheduled support

Determine and track any failures - that were not/would not have been recognized by clinicians

- that could have been prevented

Step 1: Collect and analyze CMMS data

Step 2: Compare it to data from other service groups


© 2008 ECRI.

Strategies for Change

Process needs to become driven by relevant failure data ─ start by reviewing experience with pumps and monitors

Adopt the proposed definition for failureCollect data for each model to share/compare with other groups ECRI Institute will be facilitating a model-specific failure database When in doubt, perform inspections on a sample


© 2008 ECRI.

Strategies for Change

Lobby manufacturers to be more flexible with maintenance recommendations ( . . .“or in accord with hospital experience”) Request scheduled support requirements in equipment RFPsForward replies of excessive requirements to ECRI InstituteEducate governmental agencies and accreditation groups by demonstrating relevant failure data


What is Benchmarking?

The continuous, systematic search for, and implementation of better practices that lead to improved performance (www.idcon.com)

The process of comparing business practices and performance levels . . . to gain new insights and to identify opportunities for making improvements (Cohen et. al. 1995)

http://www.idcon.com/

Benchmarking and Clinical Engineering

Indicators or metrics – numbers that represent level of performance of significant CE activities Annual service cost/device Average response time Multiple indicators for contrasting cost with service quality

Indicators or metrics – numbers that characterize equipment performance Failure rate Downtime

Evolution of a Product

Health Devices Inspection and Preventive Maintenance System™

becomes BiomedicalBenchmark™

Key new feature: Support Assessment database

BiomedicalBenchmark™ECRI Institute data

BENCHMARK BENEFIT

Acquisition Cost Better budgeting; comparison of Service Cost to Acquisition Cost (a common denominator)

Expected Life Improved planning/budgeting

Service Contract Cost Compare the cost of service options; negotiate better terms

IPM Intervals Estimate workload; suggestions for reducing inspection frequency

BiomedicalBenchmark™User-supplied data

BENCHMARK BENEFITS

CE Department Demographics Compare staffing levels / work space / non-IPM and repair activities

Inspection Intervals External support for your findingsAcquisition Cost Budgeting and negotiating better pricingEquipment Failure Rates Objective basis for scheduled support

decisions; also useful for equipment selectionAverage IPM / Repair Times Estimate / compare work load by modelModel-specific IPM Procedures Reduce time to develop new procedures

© 2008 ECRI.

Questions / Comments?

[email protected] 610-825-6000 x5168 ECRI Institute Web site: www.ecri.org [email protected]


mailto:[email protected]

http://www.ecri.org/




Documents

Assessing Scheduled Support of Medical Equipment North Central Biomedical Association Seminar September 5, 2008 Tim Ritter Senior Project Engineer