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 Iterate Safety standard consideration Literature search Yes Definition of the medical requirements Information Gathering Process Assessment of environmental conditions

Survey of available equipment

Buy off-the-shelf? No Preparation of system specification

Decision Process

Solicitation of proposals Proposal and equipment evaluation Vendor selection Issue contract or purchase order Equipment acceptance

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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

Decisionmaking 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. 2. 3. 4. 5. 6. 7. 8. 9.

Space Power Weight Temperature range Vibration and shock Electric and magnetic field Explosive and flammable environment Humidity and moisture 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 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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Electric and magnetic fields

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 Dont 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. 2. 3.

Scope Applicable Documents

Precedence Specification Changes

Requirements
Design Objectives General System Requirements Specific System Requirements

4.

System Testing and Acceptance

Vendor Test Requirements System Acceptance Testing Acceptance Criteria

5.

General
Documentation Requirements Training Warranty Maintenance
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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 vendors 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 equipments 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 vendorspecific 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 exist between human users and the computer systems they use in the performance of their various tasks
182 Faulkner, C., 1998

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

Context

Tasks

To design system that is: Transparent Easy to use Easily understood Meet task requirement

Faulkner, C., 1998

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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 A.I
Help facilities Equipment Design

Sociology
Modeling Understanding The user The user Groupware Aesthetic Appeal User Interface Layout

Ergonomics

Art

Anthropology

Users body shape Physical Capabilities

Design

Physiology

Creating consistency

Faster Machines, system Means of building better UI Language For Commands

Engineering

Philosophy Linguistics

Computer Science
Faulkner, C., 1998
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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, 1998
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Important Concepts
Affordances Visibility Feedback Constraints restricting the kind of user interaction that can take place at a given moment 5. Mapping layout 6. Consistency
1. 2. 3. 4.

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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, 2002 HCI in the new millennium

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User experience goals

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

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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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Measures of Usability

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?

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

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.

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

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

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

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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