lecture 4: equipment procurement and vendor management 147

Lecture 4: Equipment Procurement and

Vendor Management

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Outline Equipment Acquisition Process

Definition of Clinical Requirements Environmental Survey Survey of Available Equipments Specifications and Interface control Solicitation of Proposals Equipment Evaluation Vendor Selection Contracts Purchase Requisitions and Purchase Orders Equipment Acceptance

Control of the Acquisition Process

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Equipment Acquisition Process Physician initiation

Definition of the medical requirements

Assessment of environmental conditions

Survey of available equipment

Buy “off-the-shelf”?

Preparation of system specification

Solicitation of proposals

Proposal and equipment evaluation

Vendor selection

Issue contract or purchase order

Equipment acceptance

Iterate

Safety standard consideration

Literature search

Yes

No

Information Gathering Process

Decision Process

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Info Gathering Process: Equipment Acquisition Process The first three steps is information gathering

to assure that clinical engineering department has: Acquired the proper clinical requirements from the

medical and nursing staff Assessed the safety, user interfaces,

environmental impact and conditions under which the equipment must operate

Conducted an appropriate survey of the state of the technology and the commercially available equipment

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Info Gathering Process: Equipment Acquisition Process Decision–making phase begin after the

completion of data gathering and the needs of medical staffs have been converted to detailed and quantitative engineering requirements

If the decision is to purchase equipment, purchase order is issued

Device is listed in equipment inventory and maintained in accordance

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Info Gathering Process: Definition of Medical Requirements Team

Medical, nursing and clinical engineering representation Medical staff – pertains to the physicians and surgeons. They

are somewhat less interested in the operation of the machine system. They are strongly interested in the machine or system output.

Nursing – intimately involved with the knobs and dials used to obtain the result the doctor requires

Clinical engineer – technical representative of the team and technical liaison to the officer, which assures that the system is safe to use. They are the ones who will train the user to use the system and system effectiveness is also assured.

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Info Gathering Process: Definition of Medical Requirements Each member of the team must

Define the general clinical goals Write statements of the clinical objectives related to the problem

at hand that will serve as a basis for choosing evaluating and accepting the equipment

Clear and precise, comprehensible to all parties (Make it Specific Measurable Accurate Realistic Time-framed)

Be careful not to make it a wish list

Specify the physiological variables measured or controlled Physiological to be measured by the equipment must be defined

to achieve the goals Variables should be directly measurable

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Info Gathering Process: Definition of Medical Requirements Characterize the likely range of these

variables To determine the type of transducer to be employed, its

dynamic range, and type of signal conditioning that will be required

If its research in nature, more flexible, adaptable and expensive equipment to assure experimental success

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Info Gathering Process: Definition of Medical Requirements Determine the restrictions of a medical

nature Serious attention must be paid to the restrictions

imposed “is the patient at risk from infection such that invasive

measures cannot be employed?” “are there certain output data which are not

acceptable?” “how rapidly should a change in a monitored variable be

made known to the medical staff?”

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Info Gathering Process: Environmental Survey “Gathering the information concerning the

environment in which the equipment will operate”1. Space

2. Power

3. Weight

4. Temperature range

5. Vibration and shock

6. Electric and magnetic field

7. Explosive and flammable environment

8. Humidity and moisture

9. Applicable standards

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Info Gathering Process: Environmental Survey Space

Generally considered a restriction applying only to large systems

Is a concern essential in institutions where negotiations for additional space may take months and involve highest level of the organization

For large equipment, dimensions of the access route to the proposed location for the equipment and its transporters should be determined.

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Info Gathering Process: Environmental Survey Power

A survey of the local or power system should be made

Includes voltage, number of phases, available current per phase and the presence and type of emergency power

The availability of compressed air, a form of power sometimes required in patient-care

Existing access to central oxygen, anesthesia, suction, water and waste disposal services should be noted as well

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Info Gathering Process: Environmental Survey Weight

Assess the strength and stability of individual instruments or small systems on existing wall or floor-mounted support structures

For large systems, maximum safe floor loading of the area to be employed, and of the access route for equipment being transported to that area, should be checked.

Temperature range Temperature must be controlled for staff and patients If operation is not 24 hours, environmental controls may be

disabled at night and on weekends. If large systems or instruments that purposely generate

heat as part of their operating cycle are visualized, the existing air-conditioning capacity in the space the equipment will occupy should also be determined

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Info Gathering Process: Environmental Survey Vibration and shock

Characteristics of any unusual mechanical environment to which the equipment will be subjected should be determined

Electric and magnetic fields Be particularly careful to note the presence or

proximity of diathermy and electrocautery devices, radio paging antennas and large electric motors

Special shielding or relocation of equipment may be required to cure severe interference problems

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Info Gathering Process: Environmental Survey Explosive and flammable environments

Use of special equipment designed and powered to eliminate the danger of explosion is advised.

If the equipment will be used in an oxygen-enriched environment, it should be noted to address safety issues

Humidity and moisture If an apparatus or component must operate in especially high or

low relative humidity, this should be noted. Most equipment are operated in humidity controlled environment where a humidity meter is used.

Occasionally some equipment may need to operate in an environment containing water droplets or standing water, such a requirement should be noted. This leads to the use of a sprinkler system – which can have a deleterious effect on some expensive electronic equipment. The presence of workable floor drain should be available to prevent flooding in the use of sprinkler system.

The sprinkler can be replaced by non-aqueous substance.

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Info Gathering Process: Environmental Survey Applicable standards

Codes, standards and regulations should be reviewed.

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Info Gathering Process: Survey of Available Equipment Literature search Vendor contacts Get a running cost estimate Iteration Decision Combination State of the art development

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Info Gathering Process: Survey of Available Equipment Literature Search

Begin among the advertisements carried by various publications relating to the intersection of the medical or biological fields and engineering or current industrial periodicals

Look into newsletters and information services Main objective: determine who is carrying out

development work in the particular area of medical interest, and what instrumentation are used in this effort

Medical libraries and public library systems

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Survey of Available Equipment Vendor Contacts

List potential vendors of the equipment you wish to acquire Get the contact of the local sales representatives of each

manufacturers Request specific equipment specification sheets

Running Cost Estimate It is a cost estimate which is accumulated and modified as

one gathers technical information about the equipment to be acquired.

Useful to establish some idea of the cost of the components, or system of the components to be acquired

Don’t forget to include the installation cost which is an important component of the total cost

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Survey of Available Equipment Iteration

Findings should be available in brief but understandable form to the users: manufacturing data, various governmental standards

Formal presentation to the users with the important points Objective: develop discussion and interaction among

committee members Moment of truth: examining tradeoff between user needs

and cost Process of maximizing the system “cost effectiveness” be

carried out at the user level, and that out of the process comes a rationale to support acquisition of the system

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Survey of Available Equipment Decision

Four major directions for acquisition Direct purchase

If user needs can be met by commercially available instruments or systems

Evaluation of the equipment of competing vendors, and selection of a vendor from those qualified should precede the actual generation of the purchase order

Contract purchase In large systems, user needs are usually met only by

assembling a number of commercially available components, properly interfacing these components, and designing in the appropriate system control features

“Customized”

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Survey of Available Equipment

Combination An alternative to procurement, the clinical engineering

need to carry out the component interfacing itself. Commercial system components are purchased directly Acquisition of equipments from single vendor and the

clinical engineering department will carry out the interfacing Can result to finger-pointing if problems occur

State-of-the-art development Required if the commercially available components or

systems cannot meet the users needs Clinical engineers would develop the machine and

interface which can be funded by government or private sector

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Specification of Interface Control Specification Format

1. Scope2. Applicable Documents

PrecedenceSpecification Changes

3. RequirementsDesign ObjectivesGeneral System RequirementsSpecific System Requirements

4. System Testing and AcceptanceVendor Test RequirementsSystem Acceptance TestingAcceptance Criteria

5. GeneralDocumentation RequirementsTrainingWarrantyMaintenance

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Specification of Interface Control Scope

Brief description of the areas that the specification will cover

Applicable documents Documents that could assist vendors who respond to the

solicitation of proposals Address the problem precedence of documents referenced

in the specification Defines the route to be followed for the incorporation of

changes in the specification following the initial issuance Drawing of the equipment with specification changes

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Specification of Interface Control Requirements

The core of the technical portion of the specification First part: system motivation, description of the system

design objectives, Second part: general requirements that the system to be

proposed

System Testing and Acceptance Notifies vendors how the system is proposed to be tested Describes the criteria to be used to determine acceptability

General Cover details that do not fit other sections

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Sample requirements: cancer monitoring system

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Sample requirements: cancer monitoring system

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Equipment Evaluation Quantitative comparison of each vendor’s proposal

and/or equipment with regards to the following factors:

System Performance Physical Construction Reliability Maintainability Safety Human Factors Cost Accuracy Interchangeability

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System Performance Quantitative electrical and environmental

parameters from each supplier or vendor or equipment will be compared = comparison matrix

Judge the vendor based on the data in the matrix comparing it with the user needs as well

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Physical Construction

Each vendor should be responsive to any restrictions your specification placed on the equipment

Module, subassembly, system size and weight should be evaluated

Comparison matrix can be constructed

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Reliability

Equates to the “Mean Time Between Failure” or MTBF of the equipment

You can measure it by doing test and gathering data to perform statistical test

Qualitative feel of the equipment’s reliability through examination of the component quality, evidence of sound manufacturing processes and evidence of mechanical resistance to shock, impact and vibration

Check the judicious sealing of circuitry against dust, dirt and moisture

Can do consultation with other clinical engineers of hospital regarding the performance of the equipment

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Decision Process: Solicitation of Proposals Request for proposal should list the

enclosures and contain a very brief discussion of the reason for the request

The final section of the request for proposal should indicate the approach that will be used to evaluate the proposal and includes disclaimer

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Maintainability Refer to the “Mean Time To Repair” of

equipment It requires attention to the availability of

quality maintenance documentation, spacing and ease of removal of components when they fail, rapid availability of any vendor-specific components, availability of a local vendor supported maintenance facility and availability of specialized training for the technicians from the vendor

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Safety Each vendor adheres to some accepted

specification of safety Safety in AC power system ground and

patient lead leakage system

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Human Factors

Usability issues in the interface of the equipment

HCI and User Interface Design

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What is HCI?

Human Computer Interaction

Computer Human Interaction (used in the US)

Replaced Man Machine Interaction (MMI)

Human Machine Interaction (HMI)- might be a better choice

The study of the relationships which The study of the relationships which exist between human users and the exist between human users and the computer systems they use in the computer systems they use in the performance of their various tasksperformance of their various tasks

Faulkner, C., 1998Faulkner, C., 1998182

Definition of HCI

Human-computer interaction is a discipline concerned with the design, evaluation and implementation of interactive computer systems for human use and with the study of major phenomena surrounding them.

Association of Computing Machinery (ACM)

Special Interest Group in Computer-Human Interaction (SIGCHI),

1992.

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What is HCI?

Understand how user interact with computers to design easier and more satisfying systems.

User

TasksContext To design system that is:

• Transparent• Easy to use

• Easily understood• Meet task requirement

Faulkner, C., 1998Faulkner, C., 1998 184

Interaction Design

Designing INTERACTIVE PRODUCTS to SUPPORT people in their everyday and working lives.

Make GOOD DESIGN and not POOR DESIGN.

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A multi-disciplinary design perspective

Psychology

Sociology

Art

Design

Engineering

Computer Science

Linguistics

Philosophy

Physiology

Anthropology

Ergonomics

A.I

UnderstandingThe user

ModelingThe user

Helpfacilities

Equipment Design

Groupware

Aesthetic Appeal

User InterfaceLayout

Faster Machines, systemMeans of building better UI

Language For Commands

Physical Capabilities

Creating consistency

Users body shape

Faulkner, C., 1998Faulkner, C., 1998186

Goals of HCI To develop or improve the:

SAFETY Safe to use; does not cause injury or harm

UTILITY functionality - things that the system can do

EFFECTIVENESS can do what it purports to do accurately and completely

EFFICIENCY can do what it purports to do easily, without too much resources or

overheads

USABILITY EASY TO USE and EASY TO LEARN, and gives satisfaction

of systems.

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Goals of HCI

The aim of HCI is, therefore, to produce systems that are both natural and transparent to use.

Above all, the aim of HCI should be to develop systems that do not involve the user in significant amount of learning time or in significant amount of learning effort.

The systems should be effective, fun and safe to use.

Faulkner, 1998188

Important Concepts

1. Affordances

2. Visibility

3. Feedback

4. Constraints – restricting the kind of user interaction that can take place at a given moment

5. Mapping – layout

6. Consistency

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Visual Affordance

Perceived and actual fundamental properties of an object that determine how it could be used Chair is for sitting Ball is for throwing Button is for pushing

Refer to an attribute of an object that allows people to know how to use it

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Usability

Usability is the KEY CONCEPT in HCI

Human Computer Interaction (HCI) is the study and the practice of usability. It is about understanding and creating software and other technology that people will want to use, will be able to use, and will find effective when used.

John Carroll, 2002HCI in the new millennium

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Satisfying - rewarding Fun - support creativity Enjoyable - emotionally fulfilling Entertaining …and more Helpful Motivating Aesthetically pleasing Motivating

User experience goals

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Measures of Usability

Time to learn: How long does it take for typical members of the user

community to learn how to use the commands relevant to a set of tasks?

Speed of performance: How long does it take to carry out the benchmark tasks?

Rate of errors by users? How many and what kinds of errors do people make in

carrying out the benchmark tasks?

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Retention over time? How well do users maintain their knowledge after an hour,

a day, a week? Retention linked to time to learn and frequency of use

Subjective satisfaction How much did users like the different aspects of the

system?

Measures of Usability

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Difference between UI and HCI User Interface:

Medium through which user communicate with computer.

Human Computer Interaction: Discipline concerned with the design, evaluation, implementation

of interaction computing systems for human use, and with the study of major phenomena surrounding them

ACM SIGCHI 1992

Concern with ALL aspects that relate to the interaction between user and computer

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Example of Bad Design

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Accuracy

Measure of the device’s ability to provide measured values within an acceptable range of some known standard

Accuracy should be evaluated and tolerance established

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Equipment Evaluation

Clinical Evaluation Involves hands-on use of the submitted

equipment by the medical staff. With respect with the following factors:

Quality of in-service training Clinical Performance Human factors evaluation

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Vendor Selection

a memorandum of justification of the reasons for vendor recommendation should be prepared, which consists of: Engineering evaluation and ranking Clinical evaluation and ranking Cost evaluation Additional information Recommended vendor

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Contracts Prepare contracts for the chosen vendor,

which consists of: Cover/signature sheet Schedule of work

A brief description of the following A list of applicable documents Statement of work Terms of delivery and acceptance Work schedule Cost and terms of payments Warranty and service

Set of general provisions Covers the legal rights of both parties

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Purchase Requisitions and Purchase Orders If equipment survey results a decision to buy “off-

the-shelf”

Purchase requisitions A multi-copy form containing the information to be prepared

by the purchasing department for a purchase order

Purchase Order Contains information transferred directly from the purchase

requisitions

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Purchase Requisition Form

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Purchase Contract

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Equipment Acceptance

Subsystem and system tests should be made to assure that all system components and the overall system complies with the specification

Three sources of information, useful for preparing the required test procedure The specification Vendor data sheets on off-the-shelf components Vendor-supplied test procedures, a deliverable

contract item

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Equipment Acceptance

Test at the subsystem level first, and the system level, in order to assure that the overall system to be tested is made up of properly performing subassemblies

Information contained in test procedures and data sheets will form the basis for equipment acceptance as well as equipment control program

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Test Procedure

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Test Procedure: Data Sheet

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Control of the Acquisition Process Coordination Responsibility and Payment

Clinical engineers must be able to effectively communicate with clinical users, the purchasing department, contract office, accounting department, and the vendor

Clinical engineers must assure the hospital, through equipment quality assurance program that the equipment received meet its technical specification and that vendor payment is therefore in order

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Control of the Acquisition Process Establish policy agreements between clinical

engineering and both the purchasing and accounting department to provide the control required for an effective equipment acquisition system

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Mini-Case

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List the steps involved in the equipment acquisition process and break down into two phase

Phase 1: Information gathering process Phase 2: Decision making process

Analyze the phase 1 and phase 2 by identifying the problems and weakness and make recommendations as well.

Mini-Case: select a hospital and do the following:

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For Phase 2: How do they get vendor contacts and ask them to bid in procuring medical equipment?

For Phase 2: Get a sample purchase contract and describe the major items in the contract. Analyze and compare the concepts learned in vendor contract


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In the equipment acquisition process, what considerations are most important to the physician? To the nurse? To the clinical engineer? To the administrator?

In the equipment acquisition process, what HCI concerns do the users have? Identify these concerns. If the concerns are not met by the equipment, what do the hospital management do?


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Get the steps carried out in an environmental survey regarding medical equipment procurement.

How do the hospital get the “running cost estimate,” during equipment acquisition?

Identify the hospital process as well in system testing and acceptance testing. Get a sample of test data sheet – analyze the information: are all information relevant and needed? What changes can be done to be more efficient?


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Reference

Bronzino, J.D. (Ed.). (1992). Management of medical technology: a primer for clinical engineers. Boston: Butterworth-Heinemann

Webster, J.G. & Cook, A.M. (Ed.). (1979). Clinical engineering: principles and practices. Englewood Cliffs, N.J..: Prentice-Hall, Inc.

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