BMT 465: Maintenance Management

1.Management of Medical Technology

Joseph D. Bronzino

2.Clinical Engineering

Yadin David

3.Developing Performance Indicators for Managing Maintenance

Terry Wireman

Definition

Technology management or maintenance management?

Technology Management: An accountable, systematic approach to ensuring that cost-effective, efficacious, safe, and appropriate equipment is available to meet the demands of quality patient care.

During the late 1960s, there was intense publicity surrounding the electrical safety of hospital patients. This safety scare reached its peak when consumer activists, most notably Ralph Nader (1971), claimed that "at the very least, 1200 Americans are electrocuted annually during routine diagnostic and therapeutic procedures in hospitals". This concern has stimulated the initial development of biomedical equipment maintenance programs.

More Definitions

Carer: a patient helper (often unpaid) who look after the patient (e.g. patient spouse or parents).

Professional user / Clinical supervisor: a clinically trained person responsible for the use of medical devices.

End user: A patient who uses a medical device unsupervised at home (e.g. using wheel chair).

More Definitions

Technical supervisor: a person in charge of accepting device tests, installation, repair and maintenance (e.g. biomedical engineer, BM dept. manager).

Prescriber: A person who decides the appropriate device for a given patient (e.g. therapist).

More Definitions

Supplier: The device manufacturer or their agents.

Routine maintenance: Inspection & device care operations carried out by end users and professional users.

Planned preventive maintenance (PPM): Service operation carried out at fixed intervals by technical staff.

The stimulus for effective technology management comes from several areas, including:

Pressure from both the general public and regulatory bodies to improve the quality of patient care.Fear of litigationDesire to provide quality care

The potential for hospitals to save money

Pressure to meet the requirements of the Joint Commission on Accreditation of Health Care (JCAHO)

The Joint Commission on the Accreditation of Healthcare Organizations (JCAHO)

sets standards for healthcare organizations and issues accreditation to organizations that meet those standards.  JCAHO conducts periodic on-site surveys to verify that "an accredited organization substantially complies with Joint Commission standards and continuously makes efforts to improve the care and services it provides."

A comprehensive program in technology management (TM) should include the following elements:

A program to control and monitor equipment performance including:Routine performance testing Initial inspectionPreventive maintenance (PPM)Corrective Maintenance (repair)Calibration and verification of performanceAction on device recalls and hazards

A program that accurately and consistently computes and monitors total equipment maintenance costs, including in-house costs as well as manufacturer and third-party service contracts.

Involvement in all aspects of equipment acquisition and replacement decision.

Development of training programs for professional users and biomedical equipment technicians.

A quality assurance (QA) and risk management (RM) programs relating to healthcare technology.

Initial Inspection/Acceptance Testing:

When a new medical device is received, an initial inspection/acceptance test is conducted in order to do the following:

Verify that all components, accessories, and options listed on the purchase request were received.

Verify the safety and performance features of the device prior to its initial use. Safety and performance should be verified against the manufacturer's specifications.

Record initial performance and safety values to be used for comparison during future inspections.

Satisfy the requiems of the JCAHO by documenting equipment testing prior to initial use.

Maintenance Schedules

Inspections that are too frequent may degrade device longevity and may not be cost effective.

Inspections that are not frequent enough may adversely affect reliability, accuracy, and safety.

A device should be scheduled for periodic inspection, maintenance, or performance verification only if there is a good reason to provide such support. Appropriate reasons include:

Reducing the risk of injury to patient, staff, or visitors.

Minimizing equipment down time.

Avoiding excessive repair costs by providing maintenance at appropriate intervals.

Correcting minor operational problems before they result in major system failures or inaccurate results.

Complying with codes, standards, and regulations.

Medical Devices Risk Levels

High-risk devices are those life-support, therapeutic, and diagnostic devices whose failure or misuse is reasonably likely to cause injury to patient or staff or whose absence or failure could have an immediate or serious impact on patient care.

Medium-risk devices are those devices whose failure, misuse, or absence is not likely to cause serious injury to patient or staff but may have an impact on patient care.

Low-risk devices are those devices whose failure, misuse, or absence is unlikely to result in injury to patient or staff and will have minimal impact on patient care.

Equipment management number (EM)

A simple scoring system can be used to determine whether scheduled maintenance should be performed and at what frequency:

EM= Equipment Function + Physical Risk + Required Maintenance

Only those items with an EM number of 12 or greater are included in the equipment control program and receive regularly scheduled inspections.

Equipment function 10 Life support Therapeutic9 Surgical and Intensive Care

8 Physical Therapy and Treatment

7 Surgical and Intensive Care Monitoring Diagnostic6 Additional Physiological Monitoring and

Diagnostic

5 Analytical Laboratory Analytical4 Laboratory Accessories

3 Computer and Related

2 Patient Related and Other Misc.

Physical Risk

consider what the possible consequences might be to the patient or operator if the equipment fails or malfunctions

5 Patient death

4 Patient or Operator Injury

3 Inappropriate Therapy or Misdiagnostic

2

1 No Significant Risks

Required Maintenance

5 Extensive

4

3 Average

2

1 Minimal

Required Maintenance

Equipment that is predominantly mechanical, pneumatic, or fluidic usually requires the most extensive maintenance. Examples are ventilators, intra-aortic balloon pumps, and hemodialysis machines. These items typically require routine alignment, calibration, or extensive parts replacement.

Devices requiring only performance verification and safety testing are classified as average maintenance level. Example: physiological monitors and infusion pumps.

Devices that require only a visual inspection are assigned a minimal maintenance level. Example: water baths, light sources, and otoscopes.

Scheduled Maintenance Services

Planned Preventive Maintenance: Periodic procedure to minimize the risk of failure and to ensure continued proper operation. (Cleaning, Lubricating, Adjusting and replacing certain parts).

Performance Testing and Calibration: To verify the equipment is fully operational and performing within reasonable, previously specified limits.

Safety Test: Leakage current, ground resistance.

Repair

Repair: Troubleshooting to isolate the cause of device malfunction and then replacement or adjustment of components or subsystems to restore normal function, safety, performance, and reliability.

Comparing different service types

Disadvantages Advantages Organization Fixed overheads;Hard to maintain adequate spare parts stock for all devices;Special tools and test equipment may not be available;Training costs are high (if manufacturers agrees);In-house staff usually not specialists in equipment.

Fast response possible for breakdowns;Technical staff can work closely with professional users;On site repairs can lead to short down times;May generate revenue doing work for other organizations;Often less costly than an outside organization for a given level of service.

In-House

Comparing different service types

Disadvantages Advantages Organization

Negotiate & update contracts with many manufacturers;Staff needed to dispatch & receive devices;Need to monitor quality control of devices;Response time may be long;

Incorporate original standard of device, modifications & updates;Assure access to spare parts;Remote diagnostic via network;No problems with warranty or liability;Availability of training for professionals.

Manufacturer

Comparing different service types

Disadvantages Advantages Organization

May be available for only some devices;Possible liability problems;Manufacturer may be reluctant to train them.

Often cheaper than manufacturer;May have on-site engineer for urgent calls;Fewer external organizations to deal with.

Third party

Indicators

It is an objective, quantitative measurement of an outcome, process, or structure that relates to performance quality.

The event being assessed can be either desirable or undesirable.

Types of indicators

An outcome indicator is a measurement that is a direct function of an outcome.

A process indicator is a measurement of an activity that is part of the process used to bring about an outcome.

A structure indicator is a measurement of the elements within a department or organization that provides the capacity to perform a process.

Characteristics of Good Indicator

Well defined: the data elements of the indicator must be clearly defined without ambiguity or subjectivity so that data collectors over time are not skewed and the same measurement can be obtained by different observers.

Objective: it is factual, without distortion by opinion or personal feelings.

Characteristics of Good Indicator

Measurable: If we cannot measure it, how will we know if change has caused improvement?

Significant: address an issue which is high cost, high priority, high risk, high volume.

Valid: the indictor must have a direct relationship to the structure, process, or outcome that it is measuring.

Indicator Management Process

Define Indicator

The definition of the indicator to be monitored must be carefully developed. This process includes five steps:

The event or outcome to be measured must be described.

Define any specific terms that are used.

Categorize the indicator (process, outcome, structure, desirable or undesirable).

The purpose for this indicator must be defined.

How the indicator is used in specifying and assessing the particular process or outcome must be defined as well.

Establish Threshold

A threshold is a specific data point that identifies the need for the department to respond to the indicator to determine why the threshold was reached.

Monitor Indicator

Once the indicator is defined, the data-acquisition process identifies the data sources and data elements.

As these data are gathered, they must be validated for accuracy and completeness.

The use of a computerized database allows rapid access to the data.

The data must be presented in a format suitable for evaluation.

Evaluate Indicator

The evaluation process analyzes and reports the information. This process includes comparing the information with established thresholds and analyzing for trends.

If an indicator threshold has not been reached, no further action may be necessary.

Identify Quality-Improvment Opportunity

A quality-improvement opportunity may be present itself if an indicator threshold is reached.

The first step in the process is to set up a team to analyze the process identify the problem and find a solution for it.

The solution may include modifying the threshold to more appropriate values.

Implement Action Plan

An action plan is necessary to identify how the quality-improvement solution will be implemented. This includes defining the different tasks to be performed, the order in which they will be addressed, who will perform each task, and how this improvement will be monitored.

Example: Productivity Monitors

Define Indicator:

Monitor the productivity of technical personnel, teams, and the department.

Productivity is defined as the total number of documented service support hours compared with the total number of hours available.

It is a desirable outcome indicator. Provides feedback to technical staff and hospital administration regarding utilization of available time for department support activities.

Establish threshold:

At least 50% of available technician time will be spent providing equipment maintenance support services (resolving equipment problems and scheduled PMs).

At least 25% of available technician time will be spent providing equipment support services (Installations, acceptance testing, inventory management, hazard notification review).

Monitor Indicator:

Data will be gathered every 4 weeks from the equipment work-order history database. These data will consist of hours worked on completed and uncompleted jobs during the past 4-week interval.

Technical staff available hours is calculated for the 4-week interval. The base time available is 160 hours (40 hours/week X 4 weeks) per individual. Add to this any overtime worked during the interval, then subtract any holidays, sick days, and vacation days within the interval.

CJHOURS: Hours worked on completed jobs during the interval.

UJHOURS: Hours worked on uncompleted jobs during the interval. AHOURS: Total available hours during the 4-week interval.

Productivity = (CJHOURS + UJHOURS) / AHOURS

Evaluate Indicator:

The indicator will be compared with the threshold and the information will be provided to the individual. The individual team member data can be summed for team review. The data for multiple teams can be summed and reviewed by the department.

Quality-Improvement Process:

If the threshold is not met or a trend is identified, a quality-improvement opportunity exist. A team could be formed to review the indicator, define the problem, identify ways to solve the problem, and select a solution. An action plan will then be developed to implement this solution.

Homework

Use “Repeat Repairs” as an indicator and develop the indicator management process for it.

Examples for indicators

Adverse incidents per device: % number of times each key device type is involved in a clinical or non-clinical incident. (Operator mistake, equipment fault which maybe a result of maintenance)

Repeat Repairs: number of repairs on a particular device within a specified short period of time.

Downtime: gross amount of time, in hours, that a system or device is down and not available to perform its primary function.

Response Time: time, in hours, from initial call to initial response.

Examples for indicators

Jobs outstanding: not completed jobs in Management information system.

Inventory Accuracy :How many items did the inventory show as

being present in the test location?How many of the items found were listed on

the inventory?Utilisation:

percentage of total number of items present that are in use:

Homework

Provide a clear and comprehensive definition for INDICATOR and suggest two indicators that can be used in the field of medical equipment management.

Cost Analysis for In-House Services

The cost of in-house service program must be known in order to compare it with other service options.

One way to determine costs is to set a price or value on services provided to users.

Cost Analysis for In-House Services

Whether this charge is actually collected by the clinical engineering department or if it is just noted for reference, it provides a management tool to establish the value of services provided.

Hourly Labor Costs

This cost represents the total effective hourly cost of doing business and becomes the hourly labor rate at which the department’s services are billed.

It is easy to compute, understand, and explain to others. It is also the most popular pricing method used by technical service providers.

Hourly Labor Costs (advantages)

1-Permits direct comparisons between the cost of the clinical engineering department and those of equipment manufacturer, or third party service providers.

2-The single best aggregate measure of overall department efficiency by acknowledging all department costs and the effects of staff productivity.

Hourly Labor Costs (advantages)

3-A useful measure of clinical engineering management effectiveness.

4-Serves as the base for all service cost estimates or contracts.

Hourly Labor Costs (calculation)

Hourly Labor Rate ($/Hr.) = (Variable Costs + Fixed Costs)/Chargeable Hrs.

Variable Costs: are the costs that are assumed to vary

(linearly) with production volume or service output.

They can also be viewed as those costs that would not exist if there were no labor force.

Variable Costs include: Salary and wages. Employee benefits. Continuing education expenses. Office supplies and forms. Liability insurance costs. Repai parts and service supplies. All nonfixed telephone charges.

Fixed Costs:

Often referred to as “overhead”, are typically those costs that do not fluctuate with the level of activity.

Fixed Costs include: Effective cost of hospital floor space. Capital depreciation (test equipment) Administrative and clerical labor costs. Fixed telephone charges.

Chargeable hours:

The maximum number of labor hours the department can realistically expect to charge in the fiscal year.

Total chargeable hours (TCH)

=(Number of Employees)x((Available Labor Hrs./Employee)x(Productivity)

Number of Employees, or full time equivalents (FTEs) is the combined number of full and part-time staff whose time will be charged out. This includes all technicians and may or may not include engineering personnel.

Available labor hrs./Employee, includes only regular and overtime hours. It does not include sick time, breaks, vacations, and holidays.

Annual Available Labor Hrs./Employee

= 2080 hrs – vacation hrs. – holiday hrs. – sick hrs.

= 2080 – 80 – 64 – 40 = 1896 Available Hrs.

Productivity, Throughout the service industry, real productivity rarely exceeds 75-80 percent.

Example

Hourly Labor Rate ($/Hr.)

= (Variable Costs + Fixed Costs)/Chargeable Hrs.

= [(Variable Costs – Parts) + (Dept. Fixed Costs) + (Admin. Fixed Costs)] / [(FTEs)x(Available Labor Hrs.)x(Productivity)]

=[($348221 – 115367) + ($55729) + ($52879)] / [(12600 hrs.) (0.70)]

=($341462)/(8820 hrs.)

=$38.71/hr. ≈ $39/hr

$39/hour represents the absolute minimum labor rate the department should use in order to break even.