Slide1: Prepared By Dr.Eng. Walid Tarawneh Management Program


 The main processes are parts of the infrastructure for successful use of medical devices in diagnoses, treatment and care. These processes are:1. Strategic planning2. Procurement3. Device management and support in clinical use4. Disposal of medical devices5. Knowledge management6. Research and development of medical devices  These processes can ensure safety and cost-effectiveness and can be developed and defined through CED customers stated or un- stated needs.:  The main processes are parts of the infrastructure for successful use of medical devices in diagnoses, treatment and care. These processes are: 1. Strategic planning 2. Procurement 3. Device management and support in clinical use 4. Disposal of medical devices 5. Knowledge management 6. Research and development of medical devices  These processes can ensure safety and cost-effectiveness and can be developed and defined through CED customers stated or un- stated needs. Main processes of the Technology Management System Chart flow of medical technology plan


2. Requirements of a Technology Management Program : 2. Requirements of a Technology Management Program 1. For control & monitor equipment performance For accurately and consistently computes and monitors total equipment maintenance costs, including: For Involvement in equipment acquisition and replacement decisions, development of new services and planning of new construction and major renovations: 4. For Development of training program 5. A quality assurance program relating to technology use Risk management program as it relates to technology


3. Policies & Procedures in the technology management program : 3. Policies & Procedures in the technology management program


4. The needs of establishing a Policy on Medical Equipment Management : 4. The needs of establishing a Policy on Medical Equipment Management This will greatly help to reduce any future problems arising out of: studying the needs for medical equipment Equipment selection Contracts Spare Parts Maintenance of equipment acquired locally, internationally or provided by partner agencies. A medical equipment policy can be implemented nationwide or only in a single health facility. 1.ensure that medical devices meet appropriate standards of safety, quality and performance. 2. provides advice to organization on medical equipment performance and selection, 3. issue a guidance on the management of medical equipment. 5. Responsibility of Medical Technology Management The Medical Equipment Agency (MEA) - The responsible body Primary role


Slide6: 5.2 MEA / MEC RESPONSIBILITY organization and allocation of responsibilities for medical equipment management; inventory management; acquisition and replacement of medical equipment; acceptance and testing; user training; medical equipment servicing and maintenance; accident and medical equipment defect reporting 5.3 MEA /MEC MEMBERS it could be the biomedical engineering dep’t (BED) it could consist of the hospital / organization top management team ( doctors ,nurses ,supply dep’t …etc) It could include both MEA / MEC should cover all involved parties The main requirements to the members of MEC should be knowledgeable impartial and respected by their peers


5.4 MEC –POWER : The MEC must be officially appointed and be given a mandate by the highest authority responsible for organization policies. The MEC will have the power to examine each request to acquire medical equipment, and make decisions according to the conditions specified in the policy. The MEC should also have the mandate to appoint committees to work on and make recommendations on specialist issues. However, the final decision is made by the MEC. 5.6 Enforcing the Policy on Medical Equipment Before the policy is implemented within the organization , it should be broadly discussed and approved When it is approved the top management must enforce it’s implementation The policy will successfully implemented depends on: how strictly it is enforced The skills of the MEC The willingness of the recipient to cooperate with the MEC 5.4 MEC –POWER


6. STRATEGIC PLANNING: 6. STRATEGIC PLANNING 6.1 General hospital owner, hospital management, device users and CED all are involved in STRATEGIC PLANNING dependent on medical technology. long-term perspective on investments ensure that regulations are fulfilled Management arrangements that cover : responsibilities for purchasing, deploying, maintaining and repairing medical devices, including medical equipment Clear leadership 6.2 The information infrastructure for strategic planning need an appropriate information infrastructure to plan and manage medical equipment efficiently and effectively 6.3 Elements of Strategic Planning 1. Investment plan 2. implementation plan 3. safety use plan


7.PROCUREMENT: 7.PROCUREMENT 7.1 objectives 1. To introduce new devices into the health organization 2. The new equipment must meet the safety , medical and technical specifications 3. The new equipment to comply to national /international related standards and regulation 7.2 Elements 1. The Medical needs 2. The Technology Assessment 3. The Specification of Requirements 4. The purchasing conditions 5. The purchasing process 6. The acceptance and the technical control of the equipment 7. The clinical implementation 8. The Warranty conditions and warranty period 9. The Evaluation and Indicators of the procurement process


8. DEVICE MANAGEMENT AND SUPPORT IN CLINICAL USE: 8. DEVICE MANAGEMENT AND SUPPORT IN CLINICAL USE Elements of Equipment management and support services in health care facilities 1 . Training : - user training - technical training 2 . Preventive maintenance - Documented maintenance plan - Evaluation of PPM - User-maintenance program - Documented activities and cost - Safety control and function control - Labeling - Evaluation and Indicators 3 . Planned controls and testing ( inspection ) and quality control 4. Corrective maintenance of medical devices : Documentation , Report of any deviations ,cost , responsibilities , evaluation and control … performance indicators


Slide11: 9. DISPOSAL OF MEDICAL DEVICES - To ensure that only devices providing the intended functions are in clinical use - The disposal of medical devices laws and regulations should be followed, including rules of waste disposals. Any device that has been subjected to: Overloading, Mishandling, Suspect results , Safety deviation, need to be Replaced due to changes in medical procedure, and Expired its date of use, shall be taken out of clinical use . 10. COMPETENCE AND CLINICAL ENGINEERING PERSONNEL - CED should have a maintained ,controlled and reviewed document for QA & QC of all CED activities - education, training, technical knowledge - Communication - description for all functions - records for qualifications, training, skills and experience - training of new employees 11. RESEARCH AND DEVELOPMENT OF MEDICAL DEVICES 12. KNOWLEDGE MANAGEMENT


Slide12: 13. OFFICE AND LABORATORY/WORKSHOP ENVIRONMENT 14. TOOLS AND MEASURING/ TEST EQUIPMENT 15. CALIBRATION AND MEASUREMENT TRACEABILITY 16.SUPPORT PROCESSES FOR CLINICAL ENGINEERING policy for the spare parts supply .storing , purchasing and registration 17. TRANSPORTATION SYSTEM FOR MEDICAL DEVICES 18. SUB-CONTRACTING The CED should ensure that sub-contractors performing activities concerning medical devices are competent and their services according to organization policies for medical devices The CED should inform and advice the organization / clinic of its intention to sub-contract of some CED activities with the reasons related to this attention All activities of sub-contractors should comply to the organization rules ,guides and related standards and comply to the contract conditions CED should monitor , record and evaluate sub-contractors activities in respect medical equipment services . CED should pay attention to user notes regarding services provided by sub- contractor CED should attend, commission, approve sub- contractor services to medical equipment


19. DOCUMENTATION: 19. DOCUMENTATION 1.DOCUMENT AND DATA CONTROL The organization & the CED should have procedures to defined on how to develop, approve, review and adjust documents related to medical equipment technology. 2. MEDICAL DEVICE RECORDS The CED should maintain an information system for registration of medical devices to comply with national / international regulations The medical device registry shall include records on all medical devices inside the organization to facilitate medical device management (investment control, replacement program, maintenance etc.) Criteria for registration shall primarily be based on the safe use of medical devices The records of medical devices should include: Unique identification, The item and group name with referring to accepted nomenclature ,Type, class, serial number, Manufacturer’s name, Purchase data, Date accepted. Current location, Condition of the medical device (e.g. new, used, reconditioned), History of maintenance (control, repair, preventive maintenance) , Maintenance sub-contracts A reference to a preventive maintenance program ,References to the users instructions and the service manual Warranty conditions


20. REPORTING: 20. REPORTING Annual reports should be presented to the hospital management concerning the outcome of CED work, the cost of services including spare parts and logistic expenses Annual reports should be presented to the hospital management, head of clinical departments of CED activities regarding the services provided to medical equipment and training, equipment conditions…etc CED should report to hospital management any recommendation related to improve the use of medical equipment


21. Labeling : 21. Labeling Manufacturer label model ,S/N, Power rating ,address …etc Acceptance label (within the warranty period) local supplier, address, start & end of warranty period , purchasing order No ….etc Quality control label “Valid for use up to: , pass/ not QC , next PPM….etc Precaution label “ out of service, need CAL, transfer to: …etc” Bar code label Sterilizing label Priority and risk level labels