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Table 1 Dimension of proposed medical equipment maintenance management assessment checklist

From: Assessment of medical equipment maintenance management: proposed checklist using Iranian experience

Sub-categories

Standards

Data collection method

Data collection source

Scores

0

1

2

Resources

Physical resources

Providing appropriate physical space

Observation

Head of Medical Engineering Unit

Lack of space with adequate access

Enough space but inappropriate

Existence of a place with adequate and sufficient access

Providing a special place for repairing devices in hospitals

Observation

Head of Medical Engineering Unit

There is no specific place

 

There is specific place

Allocation of maintenance unit in medical engineering unit

Observation

Head of Medical Engineering Unit

The maintenance unit is not assigned to the medical engineering unit

 

The maintenance unit is assigned to the medical engineering unit

Providing a safe and healthy work environment

Observation

Head of Medical Engineering Unit

The work environment is not safe and healthy

 

The work environment is safe and healthy

Requirement of computer and necessary facilities in medical engineering unit

Observation

Head of Medical Engineering Unit

Lack of minimum necessary facilities (telephone line, fax and internet)

The necessary facilities (telephone line, fax and internet) are not enough

Equipped with telephone line, fax and internet, with the necessary administrative facilities

Providing localized medical equipment maintenance software

Observation

Head of Medical Engineering Unit

The maintenance software available in the world is not used according to the native conditions of the country

 

The maintenance software available in the world is used according to the native conditions of the country

The establishment of a maintenance computer system

Observation–documentation review

Head of Medical Engineering Unit

There are not enough conditions to set up a computer maintenance system (CMMS)

 

There are enough conditions to set up a computer maintenance system (CMMS)

Provision of some technical checklists (test and repairs checklists)

Observation

Head of Medical Engineering Unit

Lack of checklists needed for safety testing and repairs

Incomplete availability of safety and repair test checklists

Existence of complete checklists required for safety test and repairs

Existence of a specific system for recording failures

Observation–interview

Head of Medical Engineering Unit

There is no specific system for recording failures

 

There is specific system for recording failures

Access to up-to-date software in the field of maintenance

Interview

Head of Medical Engineering Unit

It is not possible to access up-to-date software in the maintenance area

 

It is possible to access up-to-date software in the maintenance area

Human resources

Providing a stable and trained force for the medical engineering unit

Observation–interview

Head of Medical Engineering Unit—medical engineers and technicians

The available manpower has not been fixed and they have not received the necessary training

The available manpower has been fixed but has not received the necessary training

OR

The available manpower has received the necessary training but is not fixed

The available manpower has been fixed but has received the necessary training

Allocation of medical engineering force based on need

Observation–interview

Head of Medical Engineering Unit

There are not enough skilled manpower (for every 100 hospital beds, at least one engineer and one technical technician)

There is skilled manpower, but not enough. (For every 100 hospital beds, at least one engineer and one technical technician)

There is enough skilled manpower. (For every 100 hospital beds, at least one engineer and one technical technician)

Financial resources

Allocation funds to medical equipment maintenance

Interview–documentation review

Head of Medical Engineering Unit

The required budget or credit is not estimated and provided each year in accordance with the Medical Equipment Maintenance Regulations

 

The required budget or credit is estimated and provided each year in accordance with the Medical Equipment Maintenance Regulations

Assigning a revolving fund to the medical engineering unit

Interview–documentation review

Head of Medical Engineering Unit

The revolving fund is not allocated for the medical engineering unit

 

The revolving fund is allocated for the medical engineering unit

Econometrics and cost–benefit calculation of equipment maintenance

Interview–documentation review

Head of Medical Engineering Unit

Documents are not available

Documents are incomplete

Documents are complete

Dimension

Standards

Data collection method

Data collection source

Scores

0

1

2

Quality control tests

Safety test

Perform safety tests

Observation–interview

Head of Medical Engineering Unit

None of the safety tests (electrical, physical–mechanical, radiation, chemical, user, etc.) are performed according to the regulations for the maintenance of medical equipment

Some safety tests (electrical, physical–mechanical, radiation, chemical, user, etc.) are performed according to the regulations for the maintenance of medical equipment

All safety tests (electrical, physical–mechanical, radiation, chemical, user, etc.) are performed according to the regulations for maintaining medical equipment

Calibration

Ensuring quality controls performed by companies

Interview–documentation review

Head of Medical Engineering Unit

Quality controls performed by companies are not guaranteed (no specific obligations)

 

Quality controls performed by companies are guaranteed (have certain obligations)

Planning and conducting quality control tests

Interview–documentation review

Head of Medical Engineering Unit

There are no specific program quality control tests

 

Quality control tests have a specific program

Labeling of calibrated equipment

Observation–documentation review

Head of Medical Engineering Unit

Calibrated equipment is not regularly labeled

Calibrated equipment is labeled but not regularly

Calibrated equipment is regularly labeled

Performance test

Perform technical tests

Observation–documentation review

Head of Medical Engineering Unit

Technical tests are not performed by allowed agencies or service providers

 

Technical tests are not performed by allowed agencies or service providers

Perform practical tests

Observation–documentation review

Head of Medical Engineering Unit

The relevant test is not performed by the trained user and is not according to the checklist provided by the manufacturer or legal representative and under the supervision of the Medical Engineering Unit

 

The relevant test is performed by the trained user and is according to the checklist provided by the manufacturer or legal representative and under the supervision of the Medical Engineering Unit

Perform laboratory tests

Observation–documentation review

Head of Medical Engineering Unit

The relevant test is not performed by the trained user and is not according to the checklist provided by the manufacturer or legal representative and under the supervision of the Medical Engineering Unit

 

The relevant test is performed by the trained user and is according to the checklist provided by the manufacturer or legal representative and under the supervision of the Medical Engineering Unit

Perform clinical tests

Observation–documentation review

Head of Medical Engineering Unit

The relevant test is not performed by the trained user and is not according to the checklist provided by the manufacturer or legal representative and under the supervision of the Medical Engineering Unit

 

The relevant test is performed by the trained user and is according to the checklist provided by the manufacturer or legal representative and under the supervision of the Medical Engineering Unit

Inspection and preventive maintenance (IPM)

Management processes to extend the life of the device

Perform timely and regular preventive maintenance

Observation–documentation review

Head of Medical Engineering Unit

A preventive maintenance program is not developed and implemented

A preventive maintenance program is developed but it runs incompletely

A preventive maintenance program is developed and implemented

Insufficient knowledge in the field of preventive maintenance

Interview

Head of Medical Engineering Unit—medical engineers and technicians

None of the employees of the Medical Engineering Unit have sufficient knowledge and awareness in the field of preventive maintenance

Some employees of the Medical Engineering Unit have sufficient knowledge and information in the field of preventive maintenance

All employees of the Medical Engineering Unit have sufficient knowledge and information in the field of preventive maintenance

Preventive maintenance priority over quality control and repair

Interview

Head of Medical Engineering Unit

Preventive maintenance is not a priority in the medical engineering unit's action plan

 

Preventive maintenance is a priority in the medical engineering unit's action plan

Periodic, internal, case, practical inspection

Existence of some sub-rules

Interview

Head of Medical Engineering Unit

The existing rules and regulations regarding maintenance are not necessary and appropriate

The existing rules and regulations regarding maintenance are necessary but not appropriate

The existing rules and regulations regarding maintenance are necessary and appropriate

Using accreditation measures to assess the maintenance of medical equipment

Interview

Head of Medical Engineering Unit

From accreditation measures are not used to assess maintenance activities and processes

 

From accreditation measures are not used to assess maintenance activities and processes

Examination of medical equipment through human senses and specialized checklists

Interview

Head of the University Medical Equipment Office or

Experts introduced by him and the head of the medical engineering unit

Lack of investigate and supervision of all operations (review and monitoring of quality control tests of medical equipment, review of facilities and ancillary facilities related to equipment, review of the environment around medical equipment, assessment of device usage by user and assessment of the performance of technical personnel)

(By checklist)

Investigate and supervision of some operations (investigate and monitoring of quality control tests of medical equipment, investigate of facilities and ancillary facilities related to equipment, investigate of the environment around medical equipment, assessment of device usage by user and assessment of the performance of technical personnel)

(By checklist)

Investigate and supervision of all operations (investigate and monitoring of quality control tests of medical equipment, investigate of facilities and ancillary facilities related to equipment, investigate of the environment around medical equipment, assessment of device usage by user and assessment of the performance of technical personnel)

(By checklist)

Determining the time period of periodic visits

Interview–documentation review

Head of Medical Engineering Unit

Not according to the action plan

 

According to the action plan

Developing plan for periodic visits

Documentation review

Head of Medical Engineering Unit

An action plan has not been developed

 

An action plan has been developed

Existence of an external observer

Interview

Head of Medical Engineering Unit and Hospital Manager

The external supervisor has not been appointed to inspect and oversee the affairs of the medical engineering unit

 

The external supervisor has been appointed to inspect and oversee the affairs of the medical engineering unit

Developing standards in maintenance contracts

Documentation review

Head of Medical Engineering Unit

The service, maintenance and repair contract have not a specific framework. (According to regulations)

 

The service, maintenance and repair contract have a specific framework. (According to regulations)

Preparing a list of essential equipment

Documentation review

Head of Medical Engineering Unit

The list of essential equipment has not been prepared and is not available to the departments

A list of essential equipment has been prepared but is not available to the departments

The list of essential equipment has been prepared and is available to the departments

Ensuring the existence of safe electricity (every six months, the hospital's electricity is controlled by an electrician and the available documents)

Observation

Head of Medical Engineering Unit

The items mentioned in the regulations regarding electrical safety are not observed and performed

The items mentioned in the regulations related to electrical safety are incompletely observed and performed

The items mentioned in the regulations regarding electrical safety are completely observed and performed

Periodic review of the correct operation of the device by the user

Interview–documentation review

Head of Medical Engineering Unit

The correct operation of the device is not checked periodically by the user

 

The correct operation of the device is checked periodically by the user

Lack of uniformity of assessment checklists

Documentation review

Head of Medical Engineering Unit

The medical engineering unit does not have a specific checklist to assess the maintenance status of medical equipment

 

The medical engineering unit has a specific checklist to assess the maintenance status of medical equipment

More visiting to defective devices

Interview–documentation review

Head of Medical Engineering Unit

Defective devices are not checked regularly by a medical engineer (existence of action plan)

 

Defective devices are checked regularly by a medical engineer (existence of action plan)

Clarification of regulations and notification instructions

Interview–documentation review

Head of Medical Engineering Unit—medical engineers and technicians

None of the medical engineering staff are aware of the regulations and instructions issued by the Department of Medical Equipment/not all employees know the rules clearly

Some of the medical engineering staff are aware of the regulations and instructions issued by the Department of Medical Equipment/some of employees know the rules clearly

All of the medical engineering staff are aware of the regulations and instructions issued by the Department of Medical Equipment/all employees know the rules clearly

Requirement to follow orders from high levels

Interview

Head of Medical Engineering Unit

Orders issued by the Department of Medical Equipment are not properly complied

 

Orders issued by the Department of Medical Equipment are properly complied

Access to the booklet of the set of maintenance rules and regulations

Interview–documentation review

Head of Medical Engineering Unit

None of the staff members have access to the booklet

Some of the staff members have access to the booklet

All of the staff members have access to the booklet

Completion and observance of accreditation measures

Interview

Head of Medical Engineering Unit

The unit does not meet any of the criteria on a regular basis

The unit meets some of the criteria on a regular basis

The unit meets any of the criteria on a regular basis

Implementation of maintenance rules and regulations

Interview

Head of Medical Engineering Unit

The rules announced by the Office of Medical Equipment do not run regularly

 

The rules announced by the Office of Medical Equipment run regularly

Existence of written and comprehensive instructions

Documentation review

Head of Medical Engineering Unit

There are no comprehensive guidelines for maintaining medical equipment

There are written guidelines for maintenance medical equipment, but they are not comprehensive

There are comprehensive guidelines for maintaining medical equipment

Information bank

Providing medical devices ID (identification)

Electronic, comprehensive and intelligent electronic medical ID

Observation–documentation review

Head of Medical Engineering Unit

Medical ID are not regularly prepared and updated

Medical equipment ID has been prepared but not up to date

Medical ID are regularly prepared and updated

Easy access to ID information

Interview–documentation review

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians/Department Employees

Employees do not have access to ID information

 

Employees have access to ID information

Use of indigenous and global evidence

Communicate with standard scientific references

Interview–documentation review

Head of Medical Engineering Unit

The head of the medical engineering unit does not have access to scientific standard references (scientific articles, scientific sites, international standards, etc.)

 

The head of the medical engineering unit does not have access to scientific standard references (scientific articles, scientific sites, international standards, etc.)

Utilizing the information of the manufacturer in the assessment

Interview

Head of Medical Engineering Unit

There is no access to the manufacturer’s information and it is not operated accordingly

There is access to the manufacturer’s information, but it is not operated accordingly

There is access to the manufacturer’s information and it is operated accordingly

Conducting studies and research in the field of medical equipment maintenance

Documentation review

Head of Medical Engineering Unit

The medical engineering unit does not conduct research on the maintenance of medical equipment

 

The medical engineering unit conducts research on the maintenance of medical equipment

User guide

Preparing and installing quick user labels

Observation–documentation review

Head of Medical Engineering Unit

Quick user tags are not provided and installed on all devices

 

Quick user tags are provided and installed on all devices

Preparation of manuals in both Persian and English for each device

Observation–documentation review

Head of Medical Engineering Unit

The manual of each device has not been prepared and has not been provided to the user of the device

The manual of each device has been prepared but has not been provided to the user of the device

The manual of each device has been prepared and provided to the user of the device

Documentation

Archive of executive processes (repair, quality control and PM documentation)

Observation–documentation review

Head of Medical Engineering Unit

Maintenance procedures are not fully documented and archived

Some of maintenance procedures are fully documented and archived

Maintenance procedures are fully documented and archived

Use of HIS system in maintenance

Observation

Head of Medical Engineering Unit

The medical engineering unit is not equipped with the HIS system

 

The medical engineering unit is equipped with the HIS system

Educating

User and technical education

Educational supervisor participation in user training

Interview–documentation review

Head of Medical Engineering Unit/Educational supervisor

Educational supervisors do not cooperate with medical engineers in educating users

 

Educational supervisors cooperate with medical engineers in educating users

Targeted training courses

Interview

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians/Department Employees

Training courses are not purposeful or useful

 

Training courses are purposeful or useful

Acquaintance of the officials of the medical engineering unit with the management

Interview

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians

None of the medical engineering officers are familiar with medical equipment maintenance management

Some of the medical engineering officers are familiar with medical equipment maintenance management

All of the medical engineering officers are familiar with medical equipment maintenance management

The effectiveness of training courses

Interview

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians/Department Employees

The trainings are not effective

 

The trainings are effective

Providing the possibility for all medical engineers to participate in training workshops

Interview

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians

It is not possible for all engineers and technicians to participate in training workshops

 

It is possible for all engineers and technicians to participate in training workshops

Nurse’ level of education in the field of general equipment

Interview

Users

Medical equipment users have not been trained in general equipment

 

Medical equipment users have not been trained in general equipment

User retraining about essential equipment

Interview

Users

Users are not retrained about essential equipment

 

Users are retrained about essential equipment

Invitation of expert professors to teach

Interview

Head of Medical Engineering Unit

Expert professors are not invited to teach

 

Expert professors are invited to teach

Visiting the production lines of medical equipment and supplies companies

Observation

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians

Medical engineers and technicians do not visit manufacturing companies

 

Medical engineers and technicians visit manufacturing companies

Participate in in-service training for official and contract forces

Interview–documentation review

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians

Medical engineers and technicians do not participate in in-service training

 

Medical engineers and technicians participate in in-service training

Conducting classes and training courses for managers, engineers and users

Interview–documentation review

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians/Users

Classes and training courses are not scheduled

 

Classes and training courses are held as scheduled

Developing a training program based on the training needs of users and engineers

Interview–documentation review

Head of Medical Engineering Unit

The training program is not developed based on educational needs

 

The training program is developed based on educational needs

Service

Repair (corrective maintenance)

Repair of medical equipment according to the regulations and supervision of device repair

Interview

Head of Medical Engineering Unit

The repair of medical equipment is not in accordance with the regulations and the medical engineer does not observe their repair by companies

Medical equipment is repaired according to the regulations, but the medical engineer does not observe their repair by companies

The repair of medical equipment is in accordance with the regulations and the medical engineer does observe their repair by companies

Necessity of warranty and after-sales service in repair

Documentation review

Head of Medical Engineering Unit

Medical equipment has no warranty or after-sales service

Some medical devices have a warranty and after-sales service

Medical equipment has warranty or after-sales service

Repair of vital and capital equipment by allowed agencies

Interview–documentation review

Head of Medical Engineering Unit

Capital equipment is not repaired by allowed agencies

Some of the capital equipment is repaired by allowed agencies

Capital equipment is repaired by allowed agencies

Make it possible to repair the device inside the hospital

Interview

Head of Medical Engineering Unit

It is not possible to repair some medical equipment inside the hospital

 

It is possible to repair some medical equipment inside the hospital

Decommissioning

Observing the decommissioning process in maintenance management

Observation–documentation review–interview

Head of Medical Engineering Unit

The decommissioning process is not followed according to the instructions and notification rules

 

The decommissioning process is followed according to the instructions and notification rules

Outsourcing

Communication with reputable companies

Interview–documentation review

Head of Medical Engineering Unit

Medical engineering unit is not associated with reputable companies

 

Medical engineering unit is associated with reputable companies

investigate the performance of private companies

Interview

Head of Medical Engineering Unit

The performance of private companies is not monitored by the Department of Medical Equipment

 

The performance of private companies is monitored by the Department of Medical Equipment

The role of third parties in quality control

Interview

Head of Medical Engineering Unit

Quality control is not done by private companies

 

Quality control is done by private companies

Buy maintenance software from private companies

Observation–documentation review

Head of Medical Engineering Unit

Maintenance software is not purchased from private companies

 

Maintenance software is purchased from private companies

Cooperation and coordination of ministries and universities with private companies

Interview

Ministry and university officials

The Ministry and the University do not cooperate with private companies

 

The Ministry and the University cooperate with private companies

Outsourcing of service, maintenance and repair

Documentation review

Head of Medical Engineering Unit

Outsourcing does not have a general framework according to the regulations

 

Outsourcing does not have a general framework according to the regulations

Designing and implementation

Process management

Formation of joint committees by the Department of Medical Equipment

Documentation review

Head of Medical Engineering Unit

The committee’s minutes are not available

The minutes of the committee are available, but not complete

The minutes of the committee are complete

Define the level of user access to medical equipment

Interview

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians/Users

The user access level policy is not defined

 

The user access level is defined according to the relevant policy

Inter-sectorial communication in hospitals

Interview–observation

Head of Medical Engineering Unit, Medical Engineers and Technical Technicians/Users

The Medical Engineering Unit does not have a specific protocol for communicating with other departments and units

 

The Medical Engineering Unit has a specific protocol for communicating with other departments and units

Planning for maintenance in the office of medical equipment

Interview–documentation review

Head of Medical Equipment Department

The Medical Engineering Unit has no plans for any medical equipment maintenance activities

The Medical Engineering Unit has plans for some medical equipment maintenance activities

The Medical Engineering Unit has plans for all medical equipment maintenance activities

Develop and define internal policies

Documentation review

Head of Medical Engineering Unit

No policy has been developed for the maintenance of medical equipment

 

A policy has been developed to maintenance medical equipment

Develop an action plan for the medical engineering unit

Documentation review

Head of Medical Engineering Unit

An action plan for maintaining medical equipment has not been developed

 

An action plan for maintaining medical equipment has been developed

Management infrastructure in the medical equipment department

Interview

Head of Medical Equipment Department/Head of Medical Engineering Unit

The Department of Medical Equipment does not have a strong infrastructure

 

The Department of Medical Equipment have a strong infrastructure

Existence of a specific assessment structure for maintaining medical equipment

Interview–observation

Head of Medical Equipment Department/Head of Medical Engineering Unit

Medical equipment maintenance does not have a clear structure for assessing this process

 

Medical equipment maintenance does not have a clear structure for assessing this process

Prolonged administrative processes

Interview

Head of Medical Equipment Department/Head of Medical Engineering Unit

The administrative process is long and cumbersome

 

The administrative process is not long and cumbersome

Creating unity of procedure in the medical engineering unit

Interview–observation

Head of Medical Engineering Unit

The Medical Engineering Unit does not have the unity of procedure in the implementation of affairs

 

The Medical Engineering Unit has the unity of procedure in the implementation of affairs

Knowledge and attitude

Medical professional dominance in hospitals

Interview

Head of Medical Equipment Department/Head of Medical Engineering Unit

There is Medical professional dominance in hospitals to buy and choose medical equipment

 

There is not Medical professional dominance in hospitals to buy and choose medical equipment

Involvement of non-experts in the medical equipment department

Interview

Head of Medical Equipment Department/Head of Medical Engineering Unit

Non-experts are involved in decision-making and policy-making in the field of medical equipment

 

Experts are involved in decision-making and policy making in the field of medical equipment

The correct understanding of management and users hospital about maintenance management

Interview

Hospital management and users

Hospital management and users are not familiar with maintenance management

 

Hospital management and users are familiar with maintenance management

Change the view of the officials to the medical engineering unit

Interview

Head of Medical Equipment Department/Head of Medical Engineering Unit

The medical engineering unit in the hospital does not have a specific and established position

 

The medical engineering unit in the hospital has a specific and established position

Purchasing management

Buy the device from the website of reputable companies

Documentation review

Head of Medical Equipment Department/Head of Medical Engineering Unit

Medical equipment is not purchased from reputable companies

 

Medical equipment is purchased from reputable companies

To buy equipment based on need

Documentation review

Head of Medical Equipment Department/Head of Medical Engineering Unit

Medical equipment is not purchased based on the needs of the area and the target

 

Medical equipment is purchased based on the needs of the area and the target