2014 Mec1

Download as docx, pdf, or txt
Download as docx, pdf, or txt
You are on page 1of 21

TERMS OF REFERENCE(TOR)

FOR
MEDICAL EQUIPMENT MANAGE-
MENT COMMITTEE
W/U/N/E/M/M/C/S/HOSPITAL, HOSSANA

1st edition October 2007E.C


2nd edition September 2008E.C
3rd edition December 2009E.C
4th edition February 2010E.C
4th edition February 2011E.C
5th edition February 2012E.C
6th edition August 2014E.C

Prepared By: - MEC Committee


Date: - Hamle 30, 2014
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

1 Contents
1 Contents....................................................................................................................................1
2 Abbreviations...........................................................................................................................3
3 Background..............................................................................................................................4
3.1 EHSTG..............................................................................................................................4
3.2 Health Care Technology Management.............................................................................5
4 Goal..........................................................................................................................................6
5 MEC organization....................................................................................................................6
5.1 Members list......................................................................................................................6
5.2 Working procedures..........................................................................................................6
5.3 Duties and responsibilities................................................................................................7
6 Medical equipment management strategies.............................................................................8
6.1 Introduction.......................................................................................................................8
6.2 Medical equipment inventory establishment and management........................................8
6.3 Inclusion and exclusion criteria for ME to be included in the MEMP.............................8
6.4 Medical equipment maintenance......................................................................................9
6.5 Medical equipment procurement and disposal................................................................10
6.5.1 When to procure......................................................................................................10
6.5.2 Who is responsible for procuring?...........................................................................10
6.5.3 Why to procure........................................................................................................10
6.5.4 What to procure.......................................................................................................10
6.5.5 How to procure........................................................................................................11
6.5.6 Preparing for equipment delivery and commissioning............................................12
6.5.7 Medical equipment disposal committee..................................................................12
6.6 Planning and budgeting for medical equipment management........................................13
6.7 Medical Equipment Training..........................................................................................13
6.8 Functions of the Medical Equipment Maintenance Department....................................13
7 Amendment of the TOR.........................................................................................................13
8 Frequency of meeting.............................................................................................................14
Appendix L Sample Work Order Form.........................................................................................21

2
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

2 Abbreviations

MEC Medical Equipment Committee


SMT Senior Management Team
MEMP Medical Equipment Management Program
MEMU Medical Equipment Management Unit
RCBD Regional Capacity Building Directorate
HTM Health Technology Management
ME Medical Equipment
EHRIG Ethiopian Hospital Reform Implementation Guidelines
EHSTG Ethiopian Hospital Services Transformation Guidelines
MEMIS Medical Equipment Information System

3
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

3 Background
3.1 EHSTG
In Ethiopia, the lack of proper management of medical equipment has limited the capacity of
health institutions to deliver adequate health care. To minimize this gap the federal ministry of
health (FMOH) developed the EHRIG guidelines. In 2009 the EHRIG guidelines were replaced
by the EHSTG guidelines. Chapter 15 of the EHSTG is about medical equipment management
and contains 11 standards. One of these standards says that there should be a functional medical
equipment committee (MEC):

EHSTG, chapter 15, standard no. 3:

“The Hospital has a Medical Equipment Management Advisory Committee from multi-disci-
plinary team to updated the hospital’s core Medical equipment list and make direction on dis-
posal of Medical equipment as well as to share ownership“

Chapter 15 of EHSTG also describes the responsibilities of the MEC:

4
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

EHSTG, chapter 15, paragraph 3.2:

The MEC is chaired by the medical director of the hospital and the head of medical equipment
management unit should be the secretary. Depending on the equipment being discussed by the
MEC, specialists from the associated department/case team may also participate. The MEC
should be composed of the hospital medical director and representative of nurses, pharmacists,
laboratory, administrative personnel and biomedical personnel basis. The selection of mem-
bers of the MEC should be a clear and transparent process. The Committee should establish
Terms of Reference (TOR) that clearly outline the roles and responsibilities of the committee
members and should meet on a regular basis as defined in the TOR and as-needed in emer-
gency situations.

The MEC is responsible to:

I. Oversee establishment of a medical equipment inventory


II. Develop a model medical equipment list
III. Monitor the implementation of policies, standards and guidelines for:
 Planning and procurement of medical equipment
 Donation of medical equipment
 Disposal of medical equipment
 Review incident reports related to medical equipment

3.2 Health Care Technology Management


Healthcare Technology Management (HTM) is the organization and coordination of a number of
activities that ensure the successful management of equipment related to the care of patients in a
healthcare facility. The process begins with planning and assessment of needs and includes pro-
curement, training, operation, maintenance, decommissioning and disposal of the item. This is
known as the healthcare technology management cycle and is graphically represented in (Figure
1)

5
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Figure 1 (Source: Bird, Caroline, et al. ‘How to Manage’ Series for Healthcare Technology,
Guide 1: How to Organize a System of Healthcare Technology Management. Hertfordshire, UK:
TALC, 2005.)

6
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

4 Goal

The goal MEC is to improve the management of medical equipment in the hospital which will
contribute to improved quality and capacity of healthcare services.

5 MEC organization
5.1 Members list
The medical equipment committee consists of the following members: -

1. Chief clinical director (CCD) (Chairman)


2. Head of biomedical engineering department (secretary)
3. Biomedical engineer
4. Biomedical technician
5. Head of OB/Gyn department
6. Head of surgical department
7. Head of pediatric department
8. Head of medical department
9. Head of radiology department
10. Head of ophthalmology department
11. Head of operating rooms
12. Head of Intensive Care Unit
13. Head of emergency department
14. Head of laboratory
15. Head of Pharmacy department
16. Head of finance department
17. Nursing director
18. Environmental health specialist
19. Quality manager

According to EHSTG guidelines, the medical director of the hospital is the chairperson of the
committee and the head of the biomedical engineering department is the secretary.

5.2 Working procedures

 All members will be informed about the meeting at least one week in advance.
 All relevant documents should be distributed to all members at least 3 days before the
meeting.
 Committee communications will be via the chairperson.
 Decision making:

7
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

o Effort should be made to reach consensus whenever possible.


o Ordinary decisions will be taken by a simple majority
o The chair may use a casting vote in the event of a tied decision

5.3 Duties and responsibilities

The chairperson of the MEC:


 Shall be member of the hospitals Fixed Asset Management Unit (FAMU)
 Represents the MEC in the hospitals senior management team (SMT) and may
participate on governing board meetings when it is relevant to share medical equipment
issues and concerns to governing board members.
 Invites all members and other concerned persons to the committee meetings and shares
the agenda to all members at least three days before the meeting date.
 Follows through delivery of action points.
 Ensures appropriate documentation, interpretation and dissemination of reports.
 May establish sub committees of the MEC to undertake some of the functions.
For example: disposal committee, procurement committee, ME inventory management
committee and budgeting committee. All sub committees are led by chairperson of MEC.
 Receives relevant reports from all case teams and biomedical engineering department on
medical equipment management activities and submits performance and other reports to
the SMT.

Members of the MEC:


 Develop and monitor implementation of the medical equipment strategy
 Oversee establishment of a medical equipment inventory
 Develop a model medical equipment list
 Establish and monitor the implementation of policies for:
o Procurement of medical equipment
o Donation of medical equipment
o Acceptance testing and installation of medical equipment
o Maintenance of medical equipment, including a list of external suppliers of main-
tenance services
o Disposal of medical equipment
o Training of hospital staff for the use of medical equipment
 Determine the annual budget for implementation of the medical equipment strategy
 Review incident reports related to medical equipment

8
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

6 Medical equipment management strategies


6.1 Introduction
The strategies of managing medical equipment will be mainly based on EHSTH Chapter 15
which gives very good guidance on how to manage medical equipment. The strategies described
in the following chapter will include:

 Medical Equipment Inventory Establishment and Management


 Inclusion And Exclusion Criteria For ‘Medical Equipment’ To Be Included in The Medi-
cal Equipment Management Program
 Medical Equipment Maintenance
 Medical Equipment Procurement and Disposal
 Planning and Budgeting for Medical Equipment Management
 Medical Equipment Training
 Functions of the Medical Equipment Maintenance Department

6.2 Medical equipment inventory establishment and management


 Ensuring which item should & should not be included in inventory and medical
equipment management program.
 Subcommittee of MEC Ensure if inventory is done once semiannually.
 Make sure one or more department representative should participate on inventory of
their respective department.
 Inventory team is responsible to visit every department and record every item of ME
according to data collection form.
 State equipment which is obsolete and need to remove and transferred to a storage
area during inventory.
 The inventory MEC should use ‘speaking number ‘inventory system. This system in-
dicates the location, the type of equipment and the individual number of the equip-
ment as needed in medical equipment management information system (MEMIS).
 Establish an inventory database to record and manage all items of equipment. This
can be paper based or computerized, with paper back.
 prepare a water proof PVC sticker to label with its inventory number
 Managing spare part inventory using stock and bin card system.

6.3 Inclusion and exclusion criteria for ME to be included in the MEMP

Whether equipment is included in or excluded from the Medical Equipment Management


Program (MEMP) depends on the following aspects:
 Equipment function

9
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

 The physical risks associated with the equipment during both normal use and reasonably
anticipated abnormal use
 The maintenance requirements of the equipment.
 The incident history of the equipment

The MEC should decide whether equipment shall be included in the MEMP. When necessary,
standard criteria from chapter 15 of EHSTG can be used.
For example, the MEC may decide to exclude smaller, less expensive and easily replaceable
items from the medical equipment inventory and program (for example sphygmomanometers,
stethoscopes, glucometer IV stand patient screen, trolly and etc.).

6.4 Medical equipment maintenance

The MEC shall oversee the proper maintenance of all medical equipment in the MEMP. This can
be done according to the standards listed in chapter 15 of the EHSTG guidelines. A detailed
checklist is also available.
The hospital management has a functioning supportive supervision team which visits the Bio-
medical engineering department every quarter. This team checks whether the BME departments
is functioning according the EHSTG standards. As long as the supportive supervision team is ac-
tive, their reports can be used by the MEC to get insight in the current maintenance status.

 Check that all medical equipment should undergo regular planned preventative mainte-
nance (PPM)
 Preparing SOPs for each item of equipment including instructions on simple PPM and
troubleshooting that can be performed by users of the item.
 Check that if equipment maintenance department develop schedule for each item of
equipment.
 Follow that Instrument operators can follow SOPs to perform simple corrective mainte-
nance.
 Follow if Corrective Maintenance Report should be completed and stored in the Equip-
ment History File. A sample Corrective Maintenance Report is presented in Appendix K.
 Done an assessment if a large piece of equipment requires major rehabilitation to deter-
mine whether it is worthwhile repairing the item or whether it would be better to pur-
chase a new one.
 Whenever an item of equipment is faulty this should be reported immediately to the med-
ical equipment maintenance department using a Service Request/Work Order Form
 Three copies of the Work Order Form should be prepared (using carbon copy paper):
 The first copy should be kept by the user department and filed in a ‘Maintenance
Pending File’

10
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

 The second two copies of the Work Order Form should be submitted to the
Equipment Maintenance Department together with the broken item
 In the event that several items required repair at the same time then ‘High prior-
ity’ equipment should be repaired before ‘Medium’ or ‘Low Priority’ equip-
ment.

6.5 Medical equipment procurement and disposal


6.5.1 When to procure
NEMMH established MEC to oversee procurement policy which is developed on EHRIG.
 The MEC should decide to go through the official procurement process semiannually,
and establish a procurement team responsible for identifying the needs of the hospital.
6.5.2 Who is responsible for procuring?
A professional with medical equipment maintenance, or an assigned procurement sub MEC, will
be responsible for:
 Reviewing departments’ equipment requests
 Assessing equipment need
 Choosing “appropriate” vendors for medical equipment purchases (when applicable)
 Researching different models and vendors
 Reviewing Tender Committee recommendations for purchase approval

6.5.3 Why to procure


Based on EHSTG the procurement team has the responsibility to identify where the greatest
needs of the hospital lie and as such should consider the main reasons for procuring equipment
and related items as listed here:
 Equipment requires replacement
 Additional equipment is needed to provide a basic level of care
 Additional equipment is needed to exceed a basic level of care
 Additional equipment is required outside the Institute’s plans
 Equipment-related items are needed

6.5.4 What to procure


The procurement team is responsible to identify the appropriate product to purchase based on a
number of factors. The equipment:
 be appropriate to the hospital setting
 Be of good quality and safety
 Be affordable and cost-effective
 Be easily used and maintained and
 consult any existing Institute policies, plans, guidelines, and other re-
sources,

11
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

6.5.5 How to procure


MEC use two ways to obtain equipment for NEMMCS hospital which is purchase and donation.
6. 5.5.1 Requesting Items for Procurement
 Department heads/managers are responsible for submitting a medical equipment request
to the MEC
 The MEC conducts a needs assessment for the requested equipment and verifies and up-
dates the request details with the department head/manager .appendix L
 The MEC considers all costs related to the equipment purchase, including staff training,
auxiliary supplies and identifies special needs such as physical space, infrastructure up-
grades, water, electricity, warranty coverage, after sales service, and safety measures.

6.5.5.1.1 Preparing the Purchase Document

 The MEC submits good, thorough technical request documents to the Purchasing Depart-
ment to be included in the purchasing documents that will be given to interested suppli-
ers.
 MEC should prepare Equipment specification and quantities required
 MEC should also include Technical and environmental data that describe the conditions
in the hospital. See Appendix O for guidance
 Summary price schedule for the offer
 Order information for bidders
 Evaluating the Bids MEC plays a significant role in this process. The MEC should make
recommendations to the hospitals Tender Committee, who is usually responsible for the
final decision.
 After the Tender Committee makes its recommendations, it is useful to consult with
maintenance department. This may include the MEC, department heads, equipment
users, biomedical Engineer/technicians or other Health Care Technology Management
(HTM) staff.
 After the final decision is made, the pharmacist within Purchasing Department will begin
the award and purchasing procedure.

6. 5.5.2 Requesting Items for Donation

The hospital MEMU should strictly follow National Medical Equipment Donation Directive for
the receipt of donated medical equipment. The directive describes the conditions under which
donated medical equipment will be accepted by the hospital. For example:
 Donated equipment must be in good working order

12
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

 Equipment will only be accepted if the item is needed by the hospital and is described in
the Model Equipment List and associated annual Equipment management Plan
 Instruction manuals, in English, should be supplied with the donation
 Supplies, consumables and spare parts for the equipment should be readily available in
Ethiopia. If that is not possible, at least 1 to 2 years of needed consumables and spare
parts should be supplied by the donor
 with the donated equipment
 Expertise for the maintenance and repair of the equipment should be available in Ethiopia
 The equipment must be compatible with other medical equipment system in the hospital.
 The equipment must not require any special storage or operating conditions that the hos-
pital cannot provide (for example air conditioning, humidity control etc.)
 The donor should provide training in the regular use and preventive maintenance of the
equipment, if relevant, and
 The donor should provide follow up support regarding use of the equipment, where ne-
cessary.
 When items are donated the hospital and donor must agree who is responsible for cus-
toms clearance, including approval of the item by the regulatory authority if necessary.
 The MEMU should establish a list of desired equipment that is based on the Model
Equipment List and associated Equipment annual Plan.
 The list of desired items and donation policy should be given to all individuals/ organiza-
tions that are willing to make a donation to the hospital. All equipment donations should
be reviewed by MEMU and approved by the hospital management before acceptance
6.5.6 Preparing for equipment delivery and commissioning
 Site preparation is often required (Appendix F)
 Organizing Lifting Equipment
 Organizing Warehouse Space
 Installation and Commissioning Details
 Training Details

6.5.7 Medical equipment disposal committee


 The MEC should establish a sub–Disposal Committee to oversee the disposal of all medi-
cal equipment no longer required by hospital (see Appendix B)
 Check that if the disposed of medical equipment is removed from the institute’s inventory
and a record should be entered into the Equipment History File.
 Check if the Equipment History File is moved to a separate storage location for ‘inactive’
equipment items.

6.6 Planning and budgeting for medical equipment management


 The MEC is must work on Budget Development
 MEC is responsible to identify the costs associated with each component of the program
from procurement to maintenance and spare parts to disposal.
 The MEC has prepared a preliminary budget; it should be brought forth to hospital man-
agement for approval.
13
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

 If the budget exceeds what has been allocated for equipment management, internal dis-
cussions should occur to determine if money from another department can be shifted
 The equipment management budget that is prepared by the MEC should be submitted to
the Federal Capacity Building Directorate (FCBD) for inclusion in the hospitals an-
nual budget plan.

6.7 Medical Equipment Training


 The MEC is responsible for overseeing all user training for medical devices, whether in-
service or conducted by suppliers/external parties.
 Training should be conducted at various times throughout a staff member’s career:
 Training at the commissioning of equipment
 Refresher training
 The MEC should establish an Equipment Training Plan that describes the training needs
of hospital’s staff for the use of medical equipment.

6.8 Functions of the Medical Equipment Maintenance Department


MEC checks that if the established medical equipment maintenance departments is accountable
for their responsibilities:
 Establish and maintain the medical equipment inventory
 Develop and maintain Equipment History Files for all equipment
 Establish SOPs for equipment use, safety, PPM and troubleshooting procedures
 Establish PPM schedules
 Conduct repair of equipment or outsource to an appropriate body when necessary
 Conduct acceptance testing and installation of new equipment
 Provide staff in-service training on the correct and safe use of equipment and basic trou-
bleshooting and preventive maintenance measures
 Track equipment inventory, service history, and work order

7 Amendment of the TOR


The TOR will be reviewed every time to be agreed by all members of the Equipment Committee
with agreement of hospital senior management team and the approval of the governing board.

8 Frequency of meeting
The team will meet every 2 months after the committee is organized and may conduct on
urgent meeting when needed

14
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

15
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Appendix B Typical Equipment Lifespan

The following is a list of typical equipment lifetimes developed by the American Hospital
Association. The list reflects how equipment lasts within the United States healthcare
system, whether it was manufactured in the U.S. or abroad. While this may not be
directly applicable to the Ethiopian context, it is useful to have and use as a reference.
Diagnostic and Treatment Departments. See EHSTG Chapter 15 appendix B

16
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Appendix F Common Site Preparation Steps for Installation of


Medical Equipment

Step Activity
 Study the manufacturer’s site preparation instructions
Review technical needs  Use experience and common sense

 Cut supply connections and remove the existing item


Remove existing equipment  Cannibalize the existing item for parts

 Build any special construction required, such as a transformer


housing, lead screening, room extension
 Make any special modifications necessary, such as enlarging the
Construct or alter building
doorway, or building a worktop
 Remove any scrap or other items from the room

 Undertake the work required to provide (as necessary):


 A new transformer
 A new or upgraded generator
 A single phase or three-phase supply at the site of installation
Provide electrical requirements
 A special circuit breaker
 A special socket outlet
 An electrical circuit with sufficient capacity

Ensure the electricity installation is Undertake:


safe • An exercise to ensure that all relevant electrical installations are
properly grounded and tested
• Any remedial works as required

Provide water and drainage Undertake the work required to provide (as necessary):
requirements • Adequate water pressure
• Water treatment
• Increased pipeline diameter
• Proper drainage
• Appropriate connection points

17
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Provide steam sup-ply Undertake the work required to provide (as necessary):
requirements • A steam supply at the proposed site
• Increased pipeline diameter
• A boiler which can accommodation the increased load
• Appropriate connection points

Undertake the work required to provide (as necessary):


Provide gas supply • Relevant gas supplies at the proposed site
requirements • Appropriate connection points

Provide extra specific Depending on specific guidelines for certain types of equipment (as
requirements for installing detailed by the equipment supplier), provide:
the equipment • Bolts in the ceiling for attaching operating lights in the-atres
• Trenches for supply lines to dental suites
• Trenches for waste water for washing machines, etc.

Provide any additional Provide any associated items as necessary for the equipment or
equipment needs installation, such as:
• An uninterruptible power supply (UPS)
• A water pumps

For damage
• systematically open one crate at a time
• check the boxes/packages inside each crate for possible damage
• systematically open one package at a time and note what you
find on the relevant documents (see Appendix H)
• Keep all packaging, supports, labels and booklets, as you may
have to re-pack the equipment to return it for re-pairs.
• unpack the equipment carefully
• ensure that the equipment and its associated supplies do not
appear to be damaged
• if anything appears damaged, take a photograph if possible, and
notify the supplier

• check that the delivery matches the packing list(s)


Against documentation • check that the contents comply with the specifications in the
purchase order – in other words, check the type and model of all
equipment and supplies
 check that the quantities are according to the purchase order

18
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Technical requirements
• ensure that the voltage shown on the packing list (or on the
packing case) for electrical equipment is compatible with your power
supply
• check that the equipment data plate matches your order and the
packing case/list and, for electrical equipment, that the voltage stated is
correct
• for electrical equipment, ensure the mains lead and battery
charger, where applicable, is included

 check that all the necessary consumables, accessories and spare


parts have arrived as per the purchase con-tract
The ‘package’  keep these equipment-related supplies together in a dry, cool and
safe place until you can issue some and register the rest into the
Stores system
 check that the operating manual, service manual (including a
wiring/circuit diagram), and any assembly and installation
instructions have arrived as per the purchase contract
 keep the manuals together in a dry, cool and safe place until you
can make copies and issue/store them
 notify the supplier if any documentation is missing or seems
unacceptable (e.g., in another language than re-

19
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Appendix K Sample Corrective Maintenance Report

Work order number:


Equipment type Inventory Number

Model Serial No.

Description of equipment failure

Cause of equipment failure (if known)

Part of machine / equipment to be maintained

Corrective action

Time required
Spare parts replaced

1. 2. 3.

Engineer 1 Signature 1 Date

Engineer 2 Signature 2 Date

User comments

Name Signature Date

20
TERMS OF REFERENCE FOR MEDICAL EQUIPMENT MANAGEMENT COMMITTEE

Appendix L Sample Work Order Form


SECTIONA: To be completed by user

Equipment type: Inventory Number:

Item location:

Name of user making request: Date:

Description of problem:

SECTION B: To be completed by head of equipment maintenance

Date request received: Work order number:

Priority of task(high/medium or low) Task allocated to:

SECTION C: To be completed by maintenance engineer /technician

Problem detected:

Was item repaired? Yes NO

If yes, complete maintenance report form. If No,state reason work not completed and
reture work order form to head of equipment
Return item to user. maintenance for follow up and completion of
Equipment returned work order (by assining to another technician
to:_________________________ or out sourcing)

Date of
returned:______________________________

Name of maintenance Engineer / technician:______________ signa-


ture:____________

21

You might also like