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 |