The knowledge of TQM can be applied to achieve a better maintenance management system to ensure patient safety, proper equipment functionality and at optimal cost for Dhaka CMH's medical devices. The proposed research will recommend an effective and efficient maintenance management system for the medical equipment of Dhaka CMH using the 5S and quality circle techniques of TQM. ERC is responsible for the maintenance management of Dhaka CMH's biomedical equipment.
The maintenance management system of EME Repair Cell from Dhaka CMH was selected for this study.
Introduction
2 There are about 81 wards and about five thousand medical and non-medical equipments in this hospital. Maintaining such a large number of equipment at optimal cost and ensuring functionality is a daily challenge at Dhaka CMH. Applying TQM (Total Quality Management) in the service sector is not an easy task, as quality in this sector is intangible.
Background of the Study
Objectives
With the help of fishbone analysis, identify all possible causes that contribute to the failure of medical equipment.
Organization of Thesis
Literature Review
Maintenance and Related Definition
- Health technology
- Medical device
- Medical Equipment
- Acceptance Testing
- Calibration
- Clinical Engineer
- Clinical Engineering Department/Group
- Nomenclature of Medical Devices
- Common Descriptive Nomenclature
- Failure
- Inspection
- Performance Inspections
- Repair
- Safety Inspections
The medical device nomenclature is a coding system used to generically identify medical devices and equipment is a coding system used to generically identify medical devices and related healthcare products. Having a nomenclature system in place for medical devices facilitates their management and regulation by standardizing terms that enable communication despite language and other barriers. Several medical device naming systems exist and each is used by a different group of professionals depending on the needs of that group, needs such as maintenance, procurement, accounting, warehousing, regulatory affairs, medical device adverse event reporting and customs operations.
The Global System of Medical Device Nomenclature (GMDN) and Universal Medical Device Nomenclature System (UMDNS) are the two nomenclature systems mainly used for medical devices [5].
Types of Maintenance
- Breakdown Maintenance /Corrective Maintenance /Repair
- Planned (or Scheduled) Preventive Maintenance (PM)
- Maintenance Prevention
7 Line 2: This type of repair is major in nature and can usually be carried out at the ERC. The repair time will be less than 2 hours, and the devices will be returned within 5 working days, depending on the availability of spare parts. Third Line: This type of repair is major in nature and can be performed at the ERC, sent to the supplier/manufacturer, or a service call.
The repair time will usually be less than 4 hours and the equipment will be returned within 5 working days depending on the availability of spare parts/delivery service.
Types of Medical Equipment
It consists of regular inspections, servicing, cleaning, lubrication and replacement of parts to prevent sudden equipment failure. This activity includes a prediction technique to determine the failure rate of certain types of replaceable components (eg, batteries, valves, pumps, seals).
Role of Clinical Engineers
Contracts should be negotiated with external suppliers using well-established terms and conditions, including a documentation system. To optimize the technology management program, clinical engineers must be prepared to take responsibility for the planning and management of technology in all areas. Their methods should be evaluated to provide additional cost savings for life-saving costs, managing and maintaining equipment for high-risk or expensive devices.
The clinical engineers should suggest the best time and method for equipment replacement based on the cost and effectiveness of the equipment, with knowledge of current treatment practices [8].
Repair Management System of Dhaka CMH
- Introduction
- Work Flow
- Instructions for Maintenance Management of EM Equipment
- Repair Procedures of EM equipment
- Types of Repair
All instructions related to the use of the equipment must be kept in separate files and folders. If the equipment is out of service after the warranty period has expired, follow the following procedure:. If the Equipment cannot be repaired by CMH locally, DGMS repairs the equipment through a tender process.
If the charges submitted by the supplier appear exorbitant, a tender will be issued by DGMS requesting a quotation from the supplier/repairer called upon to repair the equipment.
Evolution of Quality
Whenever the repair requires special skills and spares are available, open tender is required through DGMS and a third party is selected to do such repairs. Basically, third-party repairs are performed when repair is not possible by in-house BMETs and equipment suppliers. In the annual maintenance contract, free maintenance and repair service is provided for a fixed fee, the cost of spare parts is covered by the user.
Quality began to be seen as something that encompassed the entire organization, not just the production process. Since all functions were responsible for product quality and everyone shared the cost of poor quality, quality was seen as a concept that affected the entire organization. Before that time, quality was still seen as something that had to be investigated and corrected.
Companies in every industry focus on improving quality to be more competitive. As you will see later in the chapter, the importance of quality is demonstrated by national quality awards and quality certifications sought after by businesses. You can see that the old concept is reactive, designed to fix quality problems after they occur.
The new concept is proactive, designed to build quality into the product and process design [11].
Concept from Quality Gurus
- Walter A. Shewhart
- W. Edwards Deming
- Joseph M. Juran
- Armand V. Feigenbaum
- Phillip B. Crosby
- Kaoru Ishikawa
- Genichi Taguchi
However, Deming has shown that only 15 percent of the quality problem is actually due to worker error. He believed that the managers would remove any fear employees have to identify the quality problem. The principle is fundamentally based on the idea that commitment to quality by senior management and a mechanism to support this commitment should include all employees and suppliers.
34; transformation", Juran on the other hand believes that in order to implement the quality of the enterprise, such a dramatic change is not required and it is required that the quality management is embedded in the organization. 19 the concept of the cost of quality, which is able to measure quality in dollars instead of subjective assessment. The first part of the trilogy, quality planning is needed so that companies overlook their customers, product requirements, and business goals.
The second part of the trilogy, the quality control, emphasizes regular use of the statistical control methods that measure the deviations from the standards. Feigenbaum promoted the concept of a work environment where quality improvements are integrated throughout the organization, where management and employees are fully committed to improving quality and people learn from each other's success. Kaoru Ishikawa is well known for the quality tool called cause and effect diagram, also known as Fishbone or Ishikawa Diagrams.
He said that quality initiatives should be taken at all stages of the organization and all employees should be involved. Ishikawa advocated the implementation of the quality circles, where volunteers solve the quality problems in small groups composed of employees.
TQM in Service Sector
- Cause Effect Diagram or Fishbone analysis (Ishikawa diagram)
- Flowchart
- Quality Circles
The team must agree on a problem statement and then put that question in the "head" of the fishbone. Once the herringbone is done, it's good to understand the root cause of the problem. While some members of the working group may not be willing to participate in the weekly meeting, Circle members will be encouraged to inspire their suggestions and promote their ideas in Circle projects.
Such developments will be a sign of maturity in the circle's activities and will be encouraged as much as possible. Originally, the majority of primary members of the circle were invited and were not forced to attend. They are allowed to leave at any time, even in the middle of training, if they wish.
Since the circle is related to work-related issues and the supervisor is the leader of the team, it follows that the direct supervisors should be the first option to be the circle leader. When the members of the Circle are together in the meeting room, they all vote equally. For example, they can complain about the quality of the products obtained from the previous department.
This aspect of the quality circle activity gives maximum satisfaction to the members. It is important that all members of the circle participate in the presentation as members of the team.
Research Methodology
- Introduction
- Data Collection
- Data from Interview
- Preliminary Survey (Feedback Form)
In-depth interview conducted with clinical engineers (now working and previously working in various positions in Dhaka CMH), BMETs, suppliers and departments.
Findings and Analysis
- Identification of Problems from Collected Data
- Summary of Analysis from Repair Data (DGMS)
- Analysis from Repair Data of ERC (Appendix 1b and Appendix 7)
- Problems Found from Survey (Feedback)
- Problems Found from Interview
- Finding of Root Causes of Problems by Fishbone Diagram
- Fishbone Analysis: Equipment Repair
- Fishbone Analysis: Delay in DGMS
- Fishbone Analysis: Delay in Repair by ERC
- Brief Description of some Identified Problems
- Delay in Repair
- Non Availability of Spares
- Difficulty in Fault Identification
- Identified Major Causes
- Steps to Solution to Problems
Equipment repair, repair delay in DGMS and the causes of repair delay in ERC are analyzed using herringbone in figure 4.3, figure 4.4 and figure 4.5 respectively. There are many causes for which the delay in providing maintenance support by ERC occurs. But most of the time it is difficult to repair the equipment in short time due to many reasons.
Sometimes the cost of the spare or repair quotation submitted by the supplier is so high that DGMS office has to sit several negotiation meetings with the supplier. Sometimes the delay in repair further causes a new part to become faulty, due to long waits for repair. 44 order, he finds a new part of the medical device is faulty, so the whole repair process is further delayed.
The manual system of registration, correspondence, absence of equipment database contributes to the delay in the repair. To reduce the delay in the repair, a maintenance management software should be introduced where the database is made available to ERC, AFMSD, DGMS and user department. In-house certified BMETs should be developed and repair authorization should be obtained from the manufacturing company by providing the BMETs with proper training by the manufacturers.
Some fast-moving parts must be purchased together with the main equipment to reduce delay and repair costs. The concept of preventive maintenance must be understood and followed by both users and BMETs.
Conclusion and Recommendations
Conclusion
Recommendations for Further Research
6] http://www.who.int/gho/health_technologies/medical_devices/nomencalture_system /en/ accessed July 31, 2017. 13] https://www.isixsigma.com/tools-templates/cause-effect/cause -and-effect-aka- fishbone-diagram/ accessed on August 14, 2017. After calling for support from Repair Cell, how long does it take for repair cell technicians to address the problem.
If you are unsatisfied with the support you are receiving from the repair cell, please mention the probable reasons below: (As per priority). What is your suggestion to get a better service in repair and maintenance system for medical equipment/equipment. Based on your experience in EME Repair Cell of Dhaka CMH, nominate major problems you faced in supporting various departments related to repair and maintenance of EM equipment.
![Table 2.2: Summary of contributions of quality Gurus [11]](https://thumb-ap.123doks.com/thumbv2/filepdfnet/10866490.0/34.918.173.821.335.878/table-summary-of-contributions-of-quality-gurus-11.webp)
