Slide1: Prepared By Dr.Eng. Walid Tarawneh Medical Equipment Life cycle - Management


1.1 Major phases in the life span / cycle of a medical device: 1.1 Major phases in the life span / cycle of a medical device 1. Medical equipment life cycle 7 Phases [1] - (fig1) [1] World Health Organization MEDICAL DEVICE REGULATIONS .global overview and guiding principles. ISBN 92 4 154618 2 Geneva 2003 Fig 1 Manufacturers must point the estimated life span -the manufacturing date , -the life time of the equipment under normal load -the normal load during the operational life cycle -the normal load conditions


Slide3: Assessment of Needs Research Development Testing Manufacture Marketing Transfer Distribution Technology Assessment Evaluation Planning Procurement Installation Commissioning Operation Training Maintenance De-commissioning II . ACQUISITION I . PROVISION III . UTILIZATION 1.2 The Total life cycle of a piece of Medical Equipment Three main stages ( fig 2 )[5] [5] NHS Executive, “The Management of Medical Equipment in NHS Acute Trusts in England”, June 1999 Fig 2


2. Management of Medical Equipment : 2. Management of Medical Equipment 2.1 Medical equipment and patient care Medical equipment represents a substantial asset for the health organization and is central to patient care. Improved clinical outcomes and less time in hospital. medical equipment can involve risks to both patients and staff, medical equipment include all medical devices connected to patients as part of their care in hospital, and medical devices used for diagnostic or laboratory purposes. Medical equipment may also be used to support research and teaching medical equipment, ranging from small, inexpensive items such as stethoscopes and blood pressure gauges each costing less than £100, to complex and costly medical equipment such as magnetic resonance imaging scanners which typically cost £1 million and involve substantial ongoing revenue costs Prescription, treatments, and re-use


2.2 The nature of medical equipment management : 2.2 The nature of medical equipment management The Medical equipment represents a substantial asset that has significant running costs The main aspect of medical equipment management for a typical life cycle are PLANNING (decision to acquire) PROCUREMENT INCOMING INSPECTION INVENTORY AND DOCUMENTATION COMMISSIONING AND ACCEPTANCE TRAINING MONITORING OF USE AND PERFORMANCE MAINTENANCE & UPGRADING EVALUATION DE-COMMISSIONING Management of each phase impacts on the others. Example , in the PLANNING phase we can specify the following conditions that should be met to help the decision process: 1. Demonstrated clinical needs; 2. Available qualified users; 3. Approved and reassured source of recurrent operating budget; 4. Confirmed maintenance services and support; 5. Adequate environment support. These process will impacts the use ,performance &maintenance


Slide6: Chart for main aspects of medical equipment life cycle management* * Walid.S.Tarawneh Aug -2007


2.3 The purpose of Medical Equipment Management : Is suitable for its intended purpose Is understood by users Is in a safe and serviceable condition Meets safety and quality standards and requirements Satisfies the above in a cost-effective manner 2.3 The purpose of Medical Equipment Management Is to ensure that equipment : Justification of need Selection of Equipment Acceptance Training Servicing Disposal and Replacement 2.4 Main Elements of Medical Equipment Management


Slide8: Needs Analysis Strategic Technology Planning Technology Assessment Facility Evaluation Financial Evaluation Equipment Planning Architectural Coordination Engineering Support Specifications Life-cycle cost Templates Terms and conditions Tendering Bid analysis Selection Purchasing Financing 3.Medical Equipment Planning, Procurement, & Management Receiving Staging Architectural, Engineering, and Construction Coordination Installation Quality Assurance Pre-commissioning Inspection Equipment Management Systems and Software Warranty Monitoring Service Contract Monitoring Training Management Risk Management and Quality Assurance Clinical Engineering Department Procedures Quality Documentation (ISO 9000) Planning Procurement Management Determine what you need Decide how to buy Continue to get full value


3.1 Medical Equipment Planning: 3.1 Medical Equipment Planning Needs Analysis : A systematic, qualitative, and quantitative determination of the health care facility needs for technology-based clinical services and related equipment, software, training, and service support. Audit Existing Technology The analyze must contain an auditing process to : Review existing technology in all technology-based services. Assess condition, capabilities & problems with current equipment. Compare utilization with capacity. Review incident reports and repair records and costs. Involve key medical, department, technical, and risk management staff knowledgeable about the technology. 3. Facility Evaluation Development of a clear understanding of the capacity of a healthcare facility and its staff to assimilate a new technology. Architectural (access, space, floor loading, electrical power and medical gas support, heating/cooling, etc.) Staff (size, education, competence, training needs, etc.)


Slide10: 4. Financial Evaluation: Projection of costs and revenues based on the technology’s life-cycle cost or cost-per-use and projected utilization This include the Acquisition options, such as purchase, lease,& sharing with other facilities, are considered to optimize use of resources 5. The Decision Process : which include Identify the relevant criteria/needs & alternatives ,Assessment of the alternatives, Choosing the best alternative and Monitoring the results 3.2 Medical Equipment Procurement Life-Cycle Cost The total cost of ownership–including product, packaging, transportation, related supplies, installation, training of users and support staff, utilities (power, air- conditioning, steam, water, gasses), inspection service, retirement, and the cost of the money itself paid to acquire, use, and support the technology. Methods of procurement I- Traditional : 1)Receiving the requests, 2) Writing the specifications,3) Issuing the request for proposal, 3)Evaluating the proposals and bids ,4) Awarding the bid.


Slide11: II- Modern : 1) Determining the needs,2) Examining the data from testing, user experience, supplier, and life-cycle cost analysis 3) Choosing the best option. 4) Negotiating for the best price. 3. Procurement–Decisions This cover the following: Rent Lease Borrow/share Purchase New versus reconditioned /furbished Purchase method Acquisition time Budget/payment terms Life-cycle cost consideration Maintenance 4. Criteria for Selection This includes : 1. Efficacy 2. Performance 3. Safety 4. Reliability 5.Features 6. Ease of use 7. Cost-effectiveness 8. Service 9. Training 10.Continued user support Formal tendering SELECTTM Other methods


3.3 Medical Equipment Management: 3.3 Medical Equipment Management a) Component Receiving Staging Architectural, Engineering, and Construction Coordination Installation Quality Assurance Pre-commissioning Inspection Equipment Management Systems and Software Warranty Monitoring Service Contract Monitoring Training Management Risk Management and Quality Assurance Clinical Engineering Department Procedures ISO 9000 Quality Documentation b) Management of medical equipment means Intelligent use of resources Making rational decisions based on objective information processes Implementing the decision manpower Equipment Money


SOME CHARTS MODULES FOR MEDICAL EQUIPMENT MANAGEMENT: SOME CHARTS MODULES FOR MEDICAL EQUIPMENT MANAGEMENT ECRI ( Emergency Care research institute ) MODULE HIMSS ( Healthcare Information and Management Systems Society ) MODULE 3. DBE ( Directorate of biomedical engineering – MOH – Jordan ) MODULE


Slide14: 1. ECRI Module


Slide15: 2. HIMSS Module


Slide16: Request for new Equipment Request Evaluation Financing Specification & conditions Tendering Sources for information's Tender Evaluation Purchasing Delivery Installation & Testing Acceptance Training Equipment Under Use Maintenance Inspection, Preventive, Corrective Supplies & Spare part Ordering , Storing Warranty Services Equipment / Company Evaluation Scraping Medical Equipment life cycle module in health care organization 3. DBE Module


3. Some important notes within the different Phases of Medical Equipment Management : 3. Some important notes within the different Phases of Medical Equipment Management 3.1 In The Planning Phase Is the equipment really needed Is it to replace old equipment (new technology /scraped equipment ) Study the reasons behind scraping Is there a budget for it Does it need special environments Does it need training Pay great attention to technical specification and technical conditions for the requested equipment Plan to avoid all mistakes appeared during the use and service of old equipment Plan to avoid mistakes that could appear with the new requested equipment


Slide18: 3.2 In the PROCUREMENT phase Technical specification that comply to clinical needs Specification that comply to quality ,estimated price - more than 2000 manufacturer - different modules within the same manufacturer The conditions included in the purchase request and purchase order must specify that the supplier must supply operating and service manuals, operation and service training, and essential spare parts. The condition must specify the training needed and the duration of training Technical training must be carried by an authorized body preferably the manufacture Trainees should be authorized at the end of the training to operate ,maintain, calibrate and upgrade the equipment on site training


Con’t: Con’t The condition must clearly point that the : Supplier and the Manufacturer can provide spare parts and accessories within the life span of the equipment Supplier and the Manufacturer must point the estimated life span ( manufacturing date ,life time of the equipment under normal load , what is the normal load during the operational life cycle) supplier is authorized by the manufacturer to sale ,distribute, support ,maintain the equipment supplier must give advance that he have a technical supporting teem and technical work shop supplier must supply the purchaser with a priced spare part list for (accessories ,electronic parts, PCB’s, consumables , mechanical parts ,lambs, electrical parts ,optical parts ,tubes, electrodes ,sensors and others The condition must clearly point : The warranty period needed including spare part Penalties for delay of: delivery, installation , PPM services, response to failure requests ,corrective action and maintenance ,consumables /spare parts and accessories delivering Penalties to deviations of specifications and general conditions


3.3 In the Incoming Inspection phase : 3.3 In the Incoming Inspection phase Incoming equipment should be carefully checked for: possible shipment damages compliance with conditions and specifications in the purchase order ( models requested ,QTY’s) delivery of accessories, spare parts ,installation diagrams ,operating and service manuals ,other optional component requested by the purchaser . Manufacturer Test and quality control certificate


4.4 In The Inventory and Documentation Phase : 4.4 In The Inventory and Documentation Phase Complete registration of all basic parameters : equipment type –according to “UMDNS”- Manufacture, Model, S/No, warranty period ,purchasing order no ,location ….etc . Inventory entries should include accessories, spare parts and operating and service manuals. It is advisable to make copies of the manuals for distribution to the users, while the originals of the manuals should be kept at the technical document library for safekeeping. The Generation of the control number as a primary key to each equipment


3.5 In The Commissioning and Acceptance Phase : 3.5 In The Commissioning and Acceptance Phase First step of commissioning must be done by the supplier upon unpacking upon assembling upon installation, calibration, testing upon first time of operation upon training the users The process should be monitored by in house technical staff so that any technical matters can be noted and recorded on the Equipment Service History This give the in house technical staff to gain familiarity with the new equipment Ideally, in-house technical staff should also attend the operator's training session.


3.5.1 Acceptance of new equipment : 3.5.1 Acceptance of new equipment What documentation is needed Equipment Purchasing Order Terms and conditions of purchasing Vender / Supplier Offer Manufacturer test and check list Safety certificate ( FDA /CE ) Registration form Acceptance Check form General check list Technical check list ( depends on the type of the equipment ) Acceptance of certain equipment mean that the purchaser , the in house technical staff , the receiving committee hold 90% of the equipment responsibility. the other 10% is hold by the manufacturer and the supplier within the warranty period


3.6 In Monitoring of Use and Performance Phase : 3.6 In Monitoring of Use and Performance Phase The equipment should be monitored during it’s life cycle not only from technical staff, but also from the users The working life time of the equipment depend on it’s working load , the working environment, the corrective and preventive users and technical actions taken . Studying the performance of the equipment within certain periods of times can give information about Users performance ( monitoring the source of faults) Supplier performance (during the warranty and after warranty ) Technical staff performance( corrective and preventive) Model performance (comparing to others models for the same type of equipment from different manufacturer The technical staff must keep an up to date records for above mentioned subjects and to use all available information regarding these subject from users ,internet ,recalls (from FDA,CE or others) and if possible information from other health organization.


Where and when to use the results of monitoring and performance : Where and when to use the results of monitoring and performance All results form monitoring and studying the use and performance must take into consideration: When preparing specifications ,conditions for new requested equipment When evaluating tenders proposals When planning the preventive maintenance activities When planning training programs for technical and medical staff When determining the stock of spare parts, consumables ,accessories, needed yearly or periodically when evaluating manufacturer ,supplier supports When planning new needs of medical equipment


3.7 In Maintenance Phase : Medical equipment brings benefits AND problems From clinical engineering point of view problems that draws the most attention is Maintenance - Lack of Maintenance - Lack of Spare parts Often cited solutions to the problem - Training of engineers/technicians - Supply of spare parts However, shortcomings( عيوب)at different stages of the equipment life cycle can greatly complicate the Maintenance problem. Example : if maintenance is not considered during the initial stage of making a decision to acquire equipment, maintenance problems can be maximized. 3.7 In Maintenance Phase That cause non-functional of large number of medical equipment


Con’t : Con’t Proper maintenance of medical equipment is essential to obtain sustained benefits and to preserve capital investment Two main types of maintenance > corrective maintenance ( unplanned) > preventive maintenance (planned ): - performed according to certain procedures - preformed during predefined time interval - include: inspection ,operation ,testing, fault finding ,calibration, cleaning, lubricating, parts replacement, safety check and validation of equipment use. All maintenance activities must be recorded time response for the corrective maintenance must be determined for each type of equipment ( priority of servicing )


Determined and Clear Working Maintenance Procedures: Determined and Clear Working Maintenance Procedures Describe the maintenance process Show the sequence of all operation within the process Determine the responsibility of each operation Determine the time period of each cycle within the process Determine the performance measurement tools for the process


3.8 In De-Commissioning Phase: 3.8 In De-Commissioning Phase DISPOSAL OF MEDICAL DEVICES Objective : To ensure that only devices providing the intended functions are in clinical use. CED shall continuously monitor the status of medical devices with respect to disposal. Any device that has been subjected to: Overloading Mishandling Suspect results Safety deviation Replaced due to changes in medical procedure Expired its date of use Has been shown by verification or otherwise to be defective for use shall be taken out of clinical use and degraded for other applications


Many question are raised : Many question are raised Д - is it old ? - is that enough ? - how old ? - Is there a criteria for equipment age ? - Is old put still in use ? Why to scrap it? Д - is it old technology ? - What is the different comparing to the new technology? - automation ?, compact design? ,new features ? - Better performance ? Д - is it defected ? No spare parts available any more ? beyond economic repair ? can not be return to normal working statues ? Д - not safe for use? Д – high running cost? Calculations? Comparison?


When to replace an equipment : When to replace an equipment When looking for new technology with new features and better working performances When safety can not be reach When the maintenance cost reach a predetermined percentage of the equipment value ( old or recent value ) When running cost is high comparing to the income When parts ,consumables ,accessories are no more available When the MTBF , A% ,DT% for more than one year reach certain percentage When Unable to be cleaned effectively prior to disinfection and/or sterilization.


Can replaced equipment be usefully : Can replaced equipment be usefully 1. By using the Equipment history - studying the reasons for replacement - evaluating the maintenance cost - evaluating the model - evaluating the supplier supports - evaluating the working conditions - evaluating the BME /BMT activities - evaluation of technical specifications, purchasing conditions and selection of new equipment 2.Using the working parts as a stock 3. For technical training