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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
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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