CODE OF PRACTICE FOR GOOD ENGINEERING MAINTENANCE MANAGEMENT OF ACTIVE MEDICAL DEVICES (FIRST REVISION) ICS: 11.040.01 Descriptors: medical electrical equipment, code of practice, Biomedical Engineering, maintenance,
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Page Figures A1 Competency level………………………………………………………………………. 30 B1 Asset label number…………………………………………………………………….. 48 B2 Maintenance status………………………………………………….…………………. 48 B3 Equipment under warranty…………………………………………………………….. 49 B4 Proposed for disposal/exemption…………………………………………………….. 49 B5 Danger tag ……………………………………………………………………………… 50 B6 Equipment under observation…………………..…………………..………………… 50 J1 Example layout for a maximum of two personnel…………….…………………….. 65 J2 Example layout for a maximum of six personnel……………………………….…… 66 Annexes A Biomedical Engineering competency and career development guidelines ………………………………………………………………………………. 28 B Examples of equipment tags …………………………………………………………. 48 C Example of PPM checklist based on manufacturer’s service manual……………. 51 D Example of work order form……………………………………………..……………. 54 E Recommended uptime target for equipment……………………..…………………. 55 F Calculation of uptime …………………………..…………………………………….... 58 G MMIS for Biomedical Engineering Services ………………………………………… 59 H Key performance indicator (KPI) …………………………………………………….. 63 J Example of workshop setup…………………………………………………………… 65
Committee representation The Industry Standards Committee on Medical Devices and Facilities for Healthcare (ISC R) under whose authority this Malaysian Standard was developed, comprises representatives from the following organisations: Association of Malaysian Medical Industries Association of Private Hospitals of Malaysia Atomic Energy Licensing Board Biomedical Engineering Association Malaysia Department of Standards Malaysia Federation of Malaysian Manufacturers Institute for Medical Research Malaysia Medical Device Association Malaysian Association of Standards Users Malaysian Medical Association Malaysian Nuclear Agency Malaysian Organization of Pharmaceutical Industry Malaysian Rubber Board Malaysian Rubber Export Promotion Council Medical Device Bureau Ministry of Health Malaysia Pharmaceutical Association of Malaysia Radiation Physics, Biophysics and Medical Physics Sub-Group of Institute of Physics Malaysia SIRIM QAS International Sdn Bhd Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences) Universiti Teknologi Malaysia (Faculty of Science) The Technical Committee on Code of Practice of Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare Facilities which developed this Malaysian Standard consists of representatives from the following organisations: Association of Private Hospitals of Malaysia Biomedical Engineering Association Malaysia Faber Medi-Serve Sdn Bhd/Healthtronics Malaysia Sdn Bhd Healthcare Technical Services Sdn Bhd (KPJ) Hospital Universiti Kebangsaan Malaysia Independent Expert Malaysian Medical Association Ministry of Health Malaysia (Medical Device Bureau) Ministry of Health Malaysia (Engineering Services Division) Pantai Medivest Sdn Bhd Radicare (M) Sdn Bhd SIRIM Berhad (Secretariat) Sistem Hospital Awasan Taraf Sdn Bhd Universiti Kebangsaan Malaysia (Faculty of Allied Health Sciences) Universiti Malaya (Department of Biomedical Engineering) Universiti Sains Malaysia (Medical Campus) Universiti Teknologi Malaysia (Faculty of Electrical Engineering) University Malaya Medical Centre
FOREWORD This Malaysian Standard was developed by the Technical Committee on Code of Practice of Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare Facilities under the authority of the Industry Standards Committee on Medical Devices and Facilities for Healthcare. This Malaysian Standard is the first revision of MS 2058, Code of Practice for Good Engineering Maintenance Management of Active Medical Devices. Major modifications in this revision are as follows: a) Incorporation of new definition on “active medical device”; b) the definition for “breakdown maintenance” was modified; c) amendment to the definition of “emergency maintenance”; d) incorporation of new definition on “healthcare facility”; e) incorporation of new definition on “medical device”; f) sub-clause 5.2 p) regular monitoring of hazards and alerts relating to medical devices,
was added; g) amendment to sub-clause 6.6.1 a); h) amendment to first paragraph of 6.7.1.2; i) amendment to sub-clause 21.5 g); j) amendment to first paragraph of 22.1; k) incorporation of sub-clause 22.1 g); l) amendment to sub-clause 23.1 f); m) amendment to sub-clause 23.3; n) incorporation of new Figure A1; o) amendment to examples of equipment tags in Annex B; p) amendment to PPM checklist examples in Annex C; and q) incorporation of new Figure J2, to give an example workshop setup for a maximum of
six personnel. This Malaysian Standard cancels and replaces MS 2058:2008. Compliance with a Malaysian Standard does not of itself confer immunity from legal obligations.
CODE OF PRACTICE FOR GOOD ENGINEERING MAINTENANCE MANAGEMENT OF ACTIVE MEDICAL DEVICES
1. Scope This Malaysian Standard applies to all active medical device placed for use in any healthcare facility or any other facility which requires maintenance. This standard is not applicable for medical equipment placed and used in any facility not intended to be used on human. 2. Normative references The following normative references are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the normative reference (including any amendments) applies. MS IEC 60601-1, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance MS IEC 60364-7-710, Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations MS IEC 61010-1, Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements MS IEC 62353, Medical electrical equipment - Recurrent test and test after repair of medical electrical equipment MS 838, Code of practice for radiation protection (Medical X-ray diagnosis) Atomic Energy Licensing Act 304 GHTF Document N15:2006, Principles of Medical Devices Classification Registration of Engineers Act 1967 Revision 2002 3. Definitions For the purposes of this standard, the following definitions apply. 3.1 Acceptance testing Acceptance testing is qualitative and quantitative tests carried out on the medical device upon completion of installation and prior to use for clinical service, to ensure its safety and performance is in accordance with manufacturer’s specifications, purchase agreement, and statutory requirements.
3.2 Active medical device Any medical device, operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices (Source: GHTF Document N15 dated June 27 2005). 3.3 Authorised agency Any agency approved by the Ministry of Health Malaysia. 3.4 Biomedical Engineering Services Any in-house or third party personnel or organisation recognised by an authorised agency responsible to carry out, implement and/or manage Biomedical Engineering activities. 3.5 Breakdown maintenance The actions taken to restore the defect in the operation or the usage of equipment usually detected by the user who takes the equipment out of clinical use. 3.6 Corrective maintenance The actions performed to restore an item to a specified condition when it fails to function as per manufacturer’s specification. Corrective maintenance includes routine corrective maintenance, breakdown maintenance and emergency maintenance. 3.7 Competence Competence is a standardised requirement for an individual to properly perform a specific job. It encompasses a combination of knowledge, skills and behaviour utilised to improve performance. More generally, competence is the state or quality of being adequately or well qualified, having the ability to perform a specific job/role. 3.8 Downtime (for a particular piece of equipment) The percentage of time during which a particular medical equipment is not available from a minimum number of "common functional units" in a ward, a department or a specific area. Downtime does not include upgrading time or the time when the medical equipment is not required to be available. 3.9 Emergency maintenance Emergency maintenance is performed as necessary, such as when no other medical device substitutes are available and action taken in the quickest and most efficient manner to ensure restoration of affected services.
3.10 Equipment user/user 3.10.1 Home user An individual who owns and uses medical equipment for personal care. 3.10.2 Operator of medical equipment An individual who handles or operates medical equipment in a healthcare facility, such as doctors, nurses, medical assistants, radiologists, etc. 3.11 Established organisation Recognised local or international body in Biomedical Engineering. 3.12 Healthcare facility Any premises in which one or more members of the public receive healthcare services, which includes: a) medical, dental, nursing, midwifery, allied health, pharmacy, and ambulance services
and any other service provided by a healthcare professional; b) accommodation for the purpose of any service provided; c) any service for the screening, diagnosis, or treatment of persons suffering from, or
believed to be suffering from, any disease, injury or disability of mind or body; d) any service for preventive or promotion of health purposes; e) any service provided by any healthcare para-professional; f) any service for curing or alleviating abnormal condition of the human body by the
application of any apparatus, equipment, instrument or device or any other medical technology; or
g) any health-related services. 3.13 Healthcare facility authority The management of healthcare organisation. 3.14 In service Medical equipment placed at user location and functioning to manufacturer’s specification. 3.15 Key performance indicator (KPI) Measurable indicator used in the development of a quality assurance program.
3.16 Medical device Medical device is defined as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of;
a) diagnosis, prevention, monitoring, treatment or alleviation of diseases;
b diagnosis, monitoring, treatment, alleviation of or compensation for injury;
c) investigation, replacement, modification, or support of the anatomy or of a physiological process;
d) supporting or sustaining life;
e) control of conception;
f) disinfection of medical devices;
g) providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body;
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. 3.17 Preventive maintenance A planned maintenance program which specifies frequency, tasks and activities to be done in order to ensure that all equipment is operating as per manufacturer’s specifications and is in safe working condition. 3.18 Scheduled Maintenance Scheduled maintenance is planned maintenance program to ensure an optimum performance, safe operation, minimum downtime, and maximum useful life from each equipment system. 3.19 Self-inspection Self-inspection is an organised method of internal review that allows a manager to view critical areas and available resources. The self-inspection focuses on the mission, resources, training, and personnel within the department. 3.20 Service uptime The percentage of time during which a particular Biomedical Engineering Service is available from a minimum number of "common functional units" in a ward, a department or a specific area. Uptime includes upgrading time and the time when the biomedical equipment is not required to be available. 3.21 Unscheduled maintenance Unscheduled maintenance involves those actions necessary to restore normal function, safety, performance, and reliability to malfunctioning equipment.
3.22 Uptime (for a particular piece of equipment) The percentage of time during which a particular piece of medical equipment is performing or is available to perform its intended function. Uptime includes upgrading time and the time when the medical equipment is not required to be available. 3.23 Uptime target The list of uptime percentage predetermined based on healthcare facility authority agreed benchmark for medical equipment to achieve, to reflect effectiveness of maintenance and medical equipment reliability. 3.24 Warranty Scope of services and liability coverage by the supplier of medical equipment within a contractual/defined period. 4. General 4.1 Maintenance consists of scheduled maintenance and unscheduled maintenance. The former includes servicing undertaken by the user in the sequence and intervals indicated in the instructions for use, a periodic maintenance performed by the Biomedical Engineering Services, by an outside maintenance firm preferably approved by the manufacturer, or by the manufacturer himself or his agent. 4.2 The equipment maintenance program ensures equipment is serviceable, safe, and properly configured. The maintenance of equipment shall include: a) technical assistance in evaluating and selecting equipment before it is purchased, and
to ensure the equipment has optimum performance and fulfils safety criteria; b) initial inspections, scheduled preventive maintenance, safety evaluations, and
calibration of equipment and supporting utilities; c) a responsive repair service that minimises equipment downtime; d) a quality assurance program for continuous improvement; e) assistance in training medical personnel on how to operate equipment safely and
effectively; and f) upkeep of documentation that meets both regulatory and accreditation requirements
and the needs of the overall equipment management program. 4.3 The reason for servicing equipment is to maintain its usability in such a way that: a) the equipment functions in the intended manner; b) the equipment is safe for the patient and for the user; and c) the interruptions of use are minimised.
5. Responsibilities These responsibilities are furnished as minimum requirements and are not intended to limit management functions to the areas. 5.1 The healthcare facility authority shall ensure the healthcare facility comply with international/national electrical safety standards (e.g. MS IEC 60364-7-710). Healthcare facilities shall ensure that the active medical devices to be purchased conform to MS IEC 60601-1. 5.2 The Biomedical Engineering Services shall: a) implement and manage the organisation’s equipment maintenance program; b) obtain required facilities and equipment for the organisation’s maintenance program; c) ensure equipment is maintained in a serviceable condition at all times; d) plan for equipment support in the conceptual phase of each new equipment system; e) develop an equipment management plan; f) develop and publish local policies and operating instructions (OI) as required; g) develop references from the maintenance management report to evaluate the
effectiveness of the maintenance programs; h) establish a work control and priority system to ensure uninterrupted service to
supported activities; i) establish a periodic maintenance and inspection schedule and ensures maintenance
personnel perform scheduled maintenance; j) manage the appropriate use and supply of spare parts; k) outsource maintenance service of those systems when there are no adequate training,
tools, test equipment, and staff; l) ensure that all ionising radiation emitting equipment maintenance comply with the
Atomic Energy Licensing Act 304 and MS 838; m) develop a self-inspection checklist and perform at least an annual self-inspection to
ensure that required functions are properly managed; n) perform a customer survey at least annually to determine the adequacy, quality, and
effectiveness of maintenance support and the degree of compliance; o) assist in investigation of equipment adverse events and near incidents when requested;
and
p) regular monitoring for hazards and alerts relating to medical devices.
a) comply with competency requirements as stipulated in Annex A; b) register with the Board of Engineers as per specified in the Registration of Engineers
Act 1967 Revision 2002 as appropriate; c) attend relevant trainings and/or continuing professional development (CPD) trainings
with recognised and authorised professional bodies; and d) manage and administer Biomedical Engineering Services as per 5.2. 5.4 Equipment users shall:
a) ensure only equipment authorised by the Biomedical Engineering Services is used. For an example of the equipment authorisation certificate/sticker/report, refer Annex B;
b) ensure equipment is used only for its intended purpose; c) operate equipment in accordance with user’s manuals; d) care for and upkeep the equipment to ensure it is always operating properly and in
serviceable condition; e) immediately report equipment malfunctions or damage to the biomedical maintenance
services; f) ensure appropriate user maintenance is performed; g) not attempt repairs beyond the operating techniques described in the user’s manual; h) ensure equipment requiring user calibration is calibrated before use; i) replace user maintenance consumables as and when required; j) routinely clean and dust equipment; k) be aware of conditions that may injure the patient or damage the equipment; l) report to the Biomedical Engineer/Technician of any anomalies such as erratic meter
responses, electrical flashing or arcing, or unusual sounds that may indicate malfunction;
m) initiate a request for maintenance; n) immediately impound any equipment and consumables involved in an incident and
notify the relevant department; o) clean equipment in compliance with local infection control policies; p) properly place the equipment during use, store and protect the equipment; and q) report equipment adverse events and near incidents to appropriate parties.
5.5 Home users shall ensure that only competent individual/organisation carry out maintenance on their equipment, in accordance with this standard. In the event that the home user brings the equipment to the healthcare facility, it will/will not be subjected to maintenance by the Biomedical Engineering services depending on the policy of the healthcare facility, where applicable. 6. Scheduled maintenance 6.1 The scheduled maintenance program consists of a series of planned maintenance requirements and inspections. The program is designed to ensure that medical equipment is maintained in the highest possible state of operational throughout its life cycle. The program has the following purposes: a) simplify complex maintenance tasks; b) provide a readily manageable maintenance program; c) facilitate scheduling and controlling maintenance actions; d) provide a means for detecting impending equipment failures; and e) forecast and plan manpower and material requirements. 6.2 Scheduled maintenance can be divided into three categories. 6.2.1 Planned Preventive Maintenance (PPM) PPM is planned maintenance of equipment that is designed to improve equipment life and avoid any unplanned maintenance activity. PPM includes lubrication, cleaning, adjusting, and PPM Kit replacement (if applicable) to extend the life of equipment and facilities. 6.2.2 Calibration Calibration is the measurement and adjustment of various device parameters to ensure its accuracy within prescribed standards. 6.2.3 User maintenance Responsibility of the equipment user department to carry out the basic maintenance on routine basis such as daily, weekly or monthly activities to ensure condition and functionality of the equipment are maintained as recommended by the manufacturer. 6.3 The minimum scheduled maintenance frequencies shall be developed based on the following guidelines. 6.3.1 The manufacturer’s recommended frequencies as established in equipment servicing or operation manual. 6.3.2 Established industry norms such as frequencies recommended by any established organisation in Biomedical Engineering recognised authorised agencies. 6.3.3 Area of use, equipment user experience and patient risk assessment subject to user recommendation and approval by the Ministry of Health Malaysia.
6.3.4 Biomedical Engineering Services personnel shall perform the scheduled maintenance at these minimum frequencies and may increase scheduled frequencies when appropriate. 6.3.5 Scheduled maintenance frequencies shall not be reduced without written approval of the healthcare facility authority. The schedule changes shall not adversely affect patient care or user and patient safety. 6.4 The individual equipment scheduled maintenance activity checklist shall be established from the following sources: a) scheduled maintenance checklist as recommended by the manufacturer as stated in
user, service or operation manual; or b) generic scheduled maintenance checklist as recommended by established organisation
in Biomedical Engineering recognised by authorised agencies for equipment without manufacturer recommendation; and
c) additional checklist developed by healthcare facility authority based on standard
operating procedures for any user maintenance. 6.5 The scheduled maintenance workload shall be programmed and distributed evenly throughout the year, taking into consideration the following constraints: a) peak workloads and periods when personnel may be absent due to training, leaves,
holidays, deployments, exercises, etc; b) availability of test equipment and special tools, taking into consideration the test
equipment calibration requirement; c) user department constraints; and d) whenever possible, the scheduled PPM and calibration execution date shall be
concurrently programmed in order to increase efficiency. 6.6 Plan preventive maintenance (PPM) 6.6.1 PPM is a comprehensive program of planned and scheduled maintenance on all relevant equipment in healthcare institutions, provided with the following objectives:
a) fewer machine breakdowns, resulting in reduced equipment downtime; b) better conservation of assets and increased life expectancy of assets, thereby eliminating
premature replacement of system and equipment; c) reduced overtime costs and more economical use of maintenance workers due to working
on a scheduled basis instead of an ad hoc basis to repair breakdowns; d) timely, corrective maintenance repairs circumvent fewer large-scale repairs; e) reduced cost of repairs by reducing secondary failures. When parts fail in service, they
usually damage other parts; f) identification of equipment with excessive maintenance costs; indicating the need for
corrective maintenance, user training, or replacement of obsolete equipment; and
g) improved safety and quality of the equipment. 6.6.2 PPM is the joint responsibility of equipment user and Biomedical Engineering Services. 6.6.3 The Biomedical Engineering Services personnel shall perform the following qualitative, preventive and quantitative activities as stated in PPM checklist on each regular inspection/maintenance of equipment where applicable (an example of a PPM is in Annex C). 6.6.3.1 The quantitative task The measurable tasks in specific values or ranges as specified by the manufacturer to determine the equipment functionality, safety and performances. Example of such tasks are: a) Performance test
Test as recommended by the manufacturer or as recommended by standard practices using appropriate test equipment as specified by the manufacturer. All qualitative measurement results shall be recorded onto the PPM checklist by the Biomedical Engineering Services personnel. (For an example of PPM checklist please refer Annex C).
b) Medical electrical safety test
The medical equipment electrical safety test shall conform to MS IEC 62353. It describes electro-medical equipment according to the type of protection provided against electric shock (defined as Class I, II, or III), and the degree of protection provided against electric shock (defined as Type B, BF, or CF). During PPM inspections, the Biomedical Engineering Services personnel shall perform a general safety inspection on all equipment and an electrical safety test, if applicable. In addition to pass or fail, numerical results of the electrical safety inspections shall be recorded.
c) Preventive maintenance task
Task that is performed to prevent future defects or deteriorations of equipment, such as the following:
i) Clean the equipment in areas not normally accessible to the user, and clean internal
components including blowers, filters, fans, and coils (remove corrosion, dirt, solutions, dust, lint, blood, or deposits.).
ii) Lubricate the unit, including motors, gears, bearings, casters, and other moving
components. Use only non petroleum-based, non-flammable lubricants on equipment that uses oxygen.
iii) Inspect and service or replace as necessary, batteries and battery compartments. iv) Service or replace all consumable devices such as filters and tubing. v) Align and tighten all moving components not specifically covered in the calibration
procedures, such as doors, drawers, panels, shelves, catches, latches, casters, and hinges.
vi) Replace the PPM kit if applicable or as recommended by the manufacturer.
6.6.3.2 The qualitative task The non-measurable tasks to ensure the quality of the equipment component or fixtures are in good conditions, such as: a) verify or test the equipment component, sub-component, accessories and any other
related feature on its physical and functionality conditions; and b) check or examine fittings/connectors, alarms/interlocks, label, cables, etc. 6.6.4 The Biomedical Engineering Services shall propose the maintenance time required and provide annual PPM schedule for all equipment. The user shall be given a copy of the yearly plan schedules.
6.6.5 The user shall inform Biomedical Engineering Services if there is any change in equipment location and any unavailability of equipment due to usage for the purposes of PPM rescheduling. 6.6.6 Biomedical Engineering Services shall request for approval from the user department for any rescheduling of PPM. 6.6.7 PPM should be performed with the component and accessories designated to the item being serviced. 6.6.8 Equipment which fails testing and/or inspection shall not be used until deficiencies are corrected. User shall be notified of the anticipated time of repair. Portable equipment shall be removed from use until repairs are completed. Equipment shall be tagged as “out of service” and user will confirm by signing the tag. Sample of tag is per Annex B. 6.6.9 When an item of equipment is well functioning but fails to meet the appropriate safety standards, affix a danger tag to the equipment until the problem is corrected. Sample of tags are as per Annex B. 6.6.10 The Biomedical Engineering Services personnel shall notify the user about the danger tag and remove the equipment from use. 6.6.11 PPM record shall be maintained for the life of the device. 6.6.12 During scheduled maintenance, Biomedical Engineering Services personnel shall evaluate the condition of equipment and verify that the equipment is fit to be used. 6.6.13 PPM work instruction shall refer to the manufacturer’s service manual. In the absence of the manufacturer’s work instruction, document from an established organisation shall be referred. 6.7 Calibration 6.7.1 Calibration is the measurement and adjustment of various device parameters to ensure its accuracy within prescribed standards. Calibration can be divided into two categories.
6.7.1.1 Equipment functionality calibration The calibration performed by Biomedical Engineering Services personnel or equipment user in accordance to manufacturer specifications as part of PPM activities if any of the quantitative result deviate from specified range. No certificate is required, however the calibration result shall be recorded in the PPM checklist or equipment log either written manually or by attaching the printed result (if feature available). This calibration can be classified into: a) built-in self calibration, designed as part of equipment feature; and b) manual calibration using appropriate calibration equipment, tools or test equipment. For specialised medical devices such as vaporisers and X-ray equipment, calibration certificates shall be maintained. 6.7.1.2 Calibration of measuring or test equipment The calibration shall be carried out by approved or authorised calibration centre conforming to nationally/internationally recognised accreditation body. Biomedical Engineering Services personnel are to ensure test equipment used for calibration of equipment is calibrated according to manufacturer’s specifications. 6.7.2 Biomedical Engineering Services personnel shall record and document all calibrations on the appropriate form or work sheet (PPM checklist). All calibration records and certificates shall be filed and kept by Biomedical Engineering Services and copy shall be provided to the user upon request. 6.7.3 Biomedical Engineering Services personnel shall enter the appropriate information for a completed calibration into the MMIS system or on the work order form. 6.7.4 The Biomedical Engineering Services personnel shall affix the calibration certificate/PPM tag/sticker in a location visible to the user. 6.8 User maintenance 6.8.1 User maintenance is important for effective operation of medical equipment. It helps prevent deterioration, defects and will increase the life of the equipment and its components. 6.8.2 The healthcare facility shall establish a schedule for routine inspection and user maintenance based on either manufacturer recommendation or standard practices. 6.8.3 The user shall have a user maintenance program to assure clean, sanitised, safe and functioning equipment. Part of the user maintenance activities are regular cleaning, disinfection, inspection, proper storage, etc. a) Cleaning and disinfecting
Equipment shall be cleaned and sanitised using recommended procedures given by the manufacturer or departmental standard operating procedures (if any).
The user shall ensure the equipment is inspected before each use and after cleaning; and check equipment functionality, tightness of connections and condition of parts (including accessories).
c) Storage
All equipments are to be stored in a clean and proper location to protect them from damage, contamination, dust, sunlight, extreme temperatures, excessive moisture, damaging chemicals, etc.
6.8.4 User that performs user maintenance at any circumstances shall not attempt to repair beyond those specified in the operation manual. User shall report all defects or faults and all repairs or adjustments are only to be carried out by Biomedical Engineering Services. 6.8.5 User maintenance training shall be given to the user either by the manufacturer/agent or Biomedical Engineering Services as required or as requested by the user. 7. Unscheduled maintenance 7.1 Biomedical Engineering Services shall ensure that all requests for unscheduled maintenance are entered into the MMIS system. 7.2 Biomedical Engineering Services shall assign work based on a priority system to each request. 7.3 While the priority of repair is determined locally, factors such as the type and importance of the equipment, availability of alternate equipment, and the effect of downtime on the medical service should be considered. 7.4 If the repair involves ordering repair parts, the Biomedical Engineering Services shall list all required parts on the work order and enter this information into the MMIS system. See Annex D for an example of work order form. 7.5 Biomedical Engineering Services shall document the parts needed on the work order. 7.6 Biomedical Engineering Services shall establish a method to monitor the status of work orders awaiting parts. The equipment shall be tagged to indicate the serviceability and facilitate traceability. An example of the tag is shown in Annex B. 7.7 Biomedical Engineering Services shall initiate the appropriate request for contract services if the equipment requires contract, warranty, or third party repair service. 7.8 After completing any unscheduled maintenance, Biomedical Engineering Services shall perform safety test in accordance with MS IEC 62353, performance and calibration check of the equipment. 7.9 Biomedical Engineering Services shall perform an electrical safety test, if the unscheduled maintenance involves replacement of defective electrical components or dismantling of equipment before releasing the equipment to the user.
7.10 The Biomedical Engineering Services shall brief the user on work carried out upon completion of repair prior to acceptance by the user. Both parties shall sign the work order to verify the completion of work. 7.11 The Biomedical Engineering Services shall file the work order sheet to ensure traceability. 7.12 Types of unscheduled maintenance 7.12.1 Corrective maintenance The defect in the operations or usage of equipment detected by the user or staff of Biomedical Engineering Services during operation or scheduled maintenance. The Biomedical Engineering Services shall initiate a request for maintenance. 7.12.2 Breakdown maintenance The defect in the operation or the usage of equipment is detected by user who takes the equipment out of service. The user shall initiate a request for maintenance. 7.12.3 Emergency maintenance 7.12.3.1 Emergency maintenance services shall be made available at all times to cater for emergency breakdowns. Maintenance staff list and contact information shall be made available to the users. 7.12.3.2 The user shall initiate a request for emergency maintenance. 7.12.3.3 On receiving a call for emergency maintenance the designated Biomedical Engineering Service staff shall promptly organise inspection and repair. 7.12.3.4 In the event that an emergency maintenance cannot be successfully done to the equipment within the required time, the user shall be informed such that alternative measures can be taken by the user to minimise clinical service disruption. 8. Acceptance testing Acceptance testing shall be carried out for all newly introduced (new or used) equipment before it is placed into clinical service and shall include visual inspection, electrical safety test and performance test.
8.1 The user shall notify Biomedical Engineering Services on the arrival of new equipment. 8.2 The user shall ensure that the correct item(s) are delivered in good condition based on the purchase document. The supplier shall provide a copy of the purchase document to the Biomedical Engineering Services during or prior to the acceptance testing. 8.3 The supplier shall declare the manufacturing date, and the date of the first release of the model into market.
8.4 The supplier shall carry out acceptance testing in the presence of Biomedical Engineering Services and the user. The results of the acceptance testing shall be verified by the Biomedical Engineering Services. Results shall be documented and handed over together with all relevant certificates to the Biomedical Engineering Services. 8.5 When a contractor installation is required, Biomedical Engineering Services shall verify correct installation is done based on the required specification. 8.6 Biomedical Engineering Services shall review the relevant contracts and literature for warranty provisions, and advice the user to complete the warranty registration data, if applicable, and forward it to the manufacturer. 8.7 Biomedical Engineering Services shall give unique identification for newly introduced equipment. The equipment shall be registered into a master list. 8.8 The supplier shall provide complete copies of the following items to Biomedical Engineering Services: a) user manual; b) service or maintenance manuals; c) circuit diagrams and drawings; d) parts list; e) PPM checklist according to manufacturer’s recommendation; and f) other necessary documents/items. 8.9 The supplier shall provide a list of required test equipment and special tools to Biomedical Engineering Services. 8.10 The user should ensure that initial inspection and acceptance test have been conducted on leased, loaned, consigned, or privately owned equipment to be used within healthcare facility. 8.11 If rectifications on the equipment are required to pass the acceptance test, the rectifications shall be carried out by the supplier or relevant parties and the equipment shall be subjected to acceptance test again. 8.12 Biomedical Engineering Services shall monitor the warranty period of the equipment. 9. Mechanisms to avoid failure or breakdown during use Biomedical Engineering Services shall provide mechanisms to avoid failure or breakdown of equipment during patient treatment, diagnosis and therapy. Biomedical Engineering Services shall review health alerts, equipment failures, incident reports, use errors, component failures and carry out corrective action.
9.1 Prepare, review and adjust preventive maintenance program and periodically assess the effectiveness of the program. 9.2 Perform equipment audit (when necessary), document review and advise users on proper handling during inspection visits. 9.3 Communicate and feedback to user on equipment maintenance status. 9.4 Coordinate with the user in the event of utility shutdown. 9.5 Provide training for user and Biomedical Engineering Services personnel to reduce hazards and to avoid potential risk/incident. Such training shall exclude clinical application. 9.6 Take prompt action in response to recall or hazard information. 9.7 Perform comprehensive maintenance. 9.8 Provide effective and responsive equipment repair including on-call services. 9.9 Undertake supervision, quality control and documentation of inspection, performance testing, preventive maintenance and repair services. 9.10 Advise user on the removal or disposal of hazardous, unserviceable, or unwanted equipment, accessories or consumables. 9.11 Annual evaluation report shall include equipment failures statistics and recommendation. 9.12 Assist in any recalls of equipment that may be required. 10. Uptime Achieve uptime targets as specified in Biomedical Engineering Services KPI for all equipment in service. 10.1 Biomedical Engineering Services shall identify applicable uptime target for the equipment with reference to KPI. A list of recommended uptime target is as per Annex E. Uptime calculation is as per Annex F. 10.2 Biomedical Engineering Services shall record applicable uptime target in equipment register. 10.3 Biomedical Engineering Services shall administer and monitor equipment compliance with uptime targets. 10.4 All maintenance time shall be recorded in MMIS. 10.5 Biomedical Engineering Services shall produce reports on uptimes for all equipment on a periodic basis for review.
11. Quality assurance program (QAP) QAP shall be developed for continuous improvement on Biomedical Engineering Services in healthcare facilities. 11.1 Biomedical Engineering Services shall identify the KPI of the services and set appropriate standards to be achieved. Example of the indicators are as follows:
a) percentage of PPM schedule completed as scheduled; b) percentage of asset meeting uptime target; and c) percentage of response time meeting target. 11.2 Standards set should be measurable qualitatively and quantitatively. These measurable standards should be set at the optimum achievable level, instead of the ideal level and it should be appropriate to the Biomedical Engineering Services. 11.3 KPI shall be agreed by the healthcare facility authority and Biomedical Engineering Services. 11.4 The QAP shall consist of: a) Structure
The Biomedical Engineering Services shall define the structure in which the QAP will work in terms of:
i) physical setting; ii) selection of equipment; iii) working environment; and iv) documentation and information systems.
b) Processes
Identify the methodology of the QAP as below: i) identification of problem;
ii) prioritisation of problem;
iii) problem analysis;
iv) identification of remedial actions;
v) implementation of remedial actions; and
vi) re-evaluation of the effectiveness of the remedial actions.
Outcome refers to the end result. 11.5 The healthcare facility authority shall review the QAP proposed by the Biomedical Engineering Services and comment accordingly. 11.6 Biomedical Engineering Services shall provide healthcare facility authority the agreed information and maintain accurate records, procedures and other documents in the QAP. The data collected shall be analysed for further improvement of the structure and processes. 12. Maintenance management information system (MMIS) MMIS is used to manage all aspects of the Biomedical Engineering Services.
12.1 Biomedical Engineering Services shall progressively develop and apply MMIS. 12.2 Biomedical Engineering Services shall train all relevant parties to use MMIS. 12.4 The MMIS should consist, but not limited to, the following modules and be accessible to authorised users: a) asset register module with links to other modules; b) work order module; c) planned preventive maintenance module; d) maintenance history module; and e) supplier-client register module. 12.6 Data back-up shall be carried out at periodic intervals. 12.7 An example of MMIS data and report is listed in Annex G. 12.8 Healthcare facilities without Biomedical Engineering Services shall maintain a manual maintenance management system. 13. Management of warranties The purpose of warranty management is to ensure that all faults occurring within the warranty period are detected, reported and repaired under warranty provisions where applicable as well as to ensure that all planned preventive maintenance covered under the warranty provision is carried out within the warranty period as per agreed schedule. 13.1 The warranty provider shall provide PPM schedule and warranty register shall be updated and maintained accordingly by Biomedical Engineering Services.
13.2 Biomedical Engineering Services shall refer to device warranty documents to determine the extent of scope of work and the responsibilities of each party. 13.3 PPM covered under the warranty provisions shall be monitored accordingly and notification shall be given to warranty provider to comply with warranty provisions. The user shall be informed if warranty provider fails to comply with warranty provisions. 13.4 PPM and corrective maintenance carried out by warranty provider shall be supervised and monitored. The details of maintenance work carried out by the warranty provider or its appointed party shall be recorded accordingly. 13.5 The warranty provider shall be responsible to ensure the medical device is in good working condition upon warranty expiry. Any fault reported during warranty period shall be rectified by the warranty provider or any party appointed by the warranty provider. 13.6 The user department shall inform the Biomedical Engineering Services at least 30 days prior to warranty expiry of any faults of the device that require rectification by the warranty provider. 14. Decommissioned equipment Decommissioned equipment is medical equipment that has been taken out of service pending disposal. 14.1 The user shall provide notification and the list of decommissioned equipment to the Biomedical Engineering Services and asset register shall be updated accordingly. 14.2 Biomedical Engineering Services and user shall ensure all equipment is safe for disposal. 14.3 Any ionising radiation equipment shall be decommissioned as per the Atomic Energy Licensing Act 304. 14.4 Biomedical Engineering Services shall remove all decommissioned equipment from use. All decommissioned equipment shall be placed into a designated area. 14.5 All decommissioned equipment shall be updated into MMIS. 15. Disposal of equipment 15.1 The user shall obtain appropriate approval for disposal of equipment from healthcare facility authority. 15.2 The disposal of potentially hazardous equipment, material or components such as batteries, X-ray tubes, vacuum tubes, pressure vessels, radioactive materials and devices that contain toxic materials such as lead, beryllium, mercury or other heavy metals, polychlorinated biphenyls and asbestos, shall be carried out according to established procedures as laid out in relevant national/international standards or national regulations.
16. Processes for handling hazardous/contaminated equipment Decontamination is the process of handling hazardous/contaminated equipment that may involve cleaning, disinfecting and sterilisation and may vary according to the equipment. Failure to decontaminate equipment properly may lead to post-operative infection and the spread of diseases. Failure to maintain equipment decontamination and sustain proper working practices can raise health and safety issues for staff and patients. 16.1 Procedure for handling hazardous/contaminated equipment 16.1.1 The user shall decontaminate any equipment such as aspirators, dialysis related equipment, surgical related equipment, laboratory equipment, or any equipment suspected to be hazardous or being contaminated prior to any maintenance activity. 16.1.2 The user shall declare in the maintenance request that the decontamination has been performed. 16.1.3 The decontamination process shall follow established procedures and be carried out by trained personnel. 16.1.4 Biomedical Engineering Services shall identify and set their own KPI for these activities. For examples of KPI in all government hospitals and institutions please refer to Annex H. 17. Incidents and hazards This procedure shall be followed in order to carry out investigation and corrective actions on incidents and notified hazards. 17.1 The user shall report immediately all incidents related to medical equipment to the safety officer and Biomedical Engineering Services and prepare a written report within 24 hours. 17.2 Respective equipment, its accessories and consumables shall be taken out of use, tagged and stored in a secured area. 17.3 All incidents involving the failure of equipment shall be investigated and all parties including Biomedical Engineering Services shall cooperate fully with the investigating body. 17.4 Biomedical Engineering Services shall manage equipment hazard alerts and recall notices provided by equipment suppliers and/or established organisations as per the following: a) Biomedical Engineering Services shall check equipment register for equipment items
identified in hazard alerts and recall notices; b) Biomedical Engineering Services shall disseminate hazard alert and recall notices to
relevant user and take appropriate action to eliminate identified hazards; and c) Biomedical Engineering Services shall take appropriate action to arrange for recall of
17.5 In the event of an incident that involve the same model of equipment in any country or location, the manufacturer or supplier shall inform the healthcare facility authority, user and Biomedical Engineering Services and take corrective action to ensure the equipment is safe to use. 18. User training Users shall be trained on the proper and correct usage and operation of the equipment. 18.1 Biomedical Engineering Services shall offer or coordinate training when a new equipment system is first issued and periodically as requested. 18.2 When the need arises, either requested or planned, Biomedical Engineering Services shall provide or coordinate training to users to cover among others the following: a) safety precautions in operating the equipment; b) proper operation including features unique to the particular manufacturer or model of
equipment; c) user maintenance; d) cleanliness and decontamination awareness; e) operational verification procedures; f) recognition and correction of common operational problems; g) recognition of defective equipment and potential hazards; and h) proper reporting procedures for maintenance requests. 18.3 Biomedical Engineering Services and users shall maintain training records. 18.4 Biomedical Engineering Services shall periodically analyse the maintenance record to see the need for further user training. Biomedical Engineering Services who see such problems should document the discrepancies, and offer user training to the relevant user department and equipment users. 18.5 Biomedical Engineering Services, the manufacturer, qualified third parties, or medical staff members can provide user training. 18.6 When procuring new equipment, healthcare facility authority shall include a requirement in the contract that the manufacturer or its representative shall provide training for both Biomedical Engineering Services and users. 19. Stock of genuine spares Stock of genuine spares is to guarantee the availability of genuine spare parts from the equipment manufacturer to meet uptime target and availability of equipment for minimal interruption of clinical services.
19.1 Biomedical Engineering Services shall survey all equipment and identify required spare parts. 19.2 Biomedical Engineering Services shall source required genuine or equivalent spare parts. 19.3 Biomedical Engineering Services shall recommend with supporting document to the healthcare facility authority or appointed authority on the use of equivalent genuine or original equipment manufacturer (OEM) spare parts authorisation. 19.4 Biomedical Engineering Services shall report to the healthcare facility authority or appointed authority in the event that the manufacturers do not assist in providing supporting document. 19.5 Biomedical Engineering Services shall maintain adequate stock of required genuine spare parts and practice good store management. 20. On-site library Biomedical Engineering Services shall maintain and manage an on-site library at an accessible and designated area. The library should consist of documents such as: a) operation and maintenance manuals; b) drawings; c) software; d) relevant standards and regulations; e) training materials; and f) other related documents. 21. Workshop setup Setting-up of an adequately equipped workshop facility for maintenance of medical equipment, safe storage for equipment under maintenance and efficient space utilisation. 21.1 Healthcare facility authority shall determine the requirement for establishing a Biomedical Engineering Services workshop. 21.2 In the event that a workshop is required, healthcare facility authority shall set up the workshop based on the size of the healthcare institution and the healthcare services available in the institution. 21.3 The workshop area shall be adequate in size (preferably 120 ft2 to 150 ft2 if documentation storage and parts storage is included into the immediate work area for every personnel). Refer Annex J for examples of workshop setup. Figure J1 indicates layout for a maximum of two personnel and Figure J2 indicates layout for a maximum of 6 personnel.
21.4 The workshop should be equipped with proper tools, and test equipment inventory (refer to Table 1 for lists of common test equipment that may be needed); and personal protective equipment (PPE) to perform the maintenance services. 21.5 Biomedical Engineering Services workshop may consist of the followings, where applicable: a) Environmentally controlled room: used to calibrate and maintain intricate sensitive
equipment such as anaesthesia equipment, fiber optic systems, lasers, and ventilators. b) Equipment storage area: secure area to store equipment awaiting parts or maintenance
without excessive dust, moisture, and other adverse environmental elements. c) Repair parts storage area: secure area to properly store repair parts. d) Administrative area: a well-lit area for administrative functions and customer service
(preferably one administration workstation for every two maintenance personnel). e) General work area: a well-lit area for technician workbenches (preferably one workbench
for every maintenance personnel). f) Proper mercury handling facility and procedure shall be established where applicable and
in compliance with relevant regulations. g) Equipment maintenance facility requirements may include multiple 240 V outlets and at
least one each 415 V, 60 A single and three-phase AC power outlet. Requirements also include earth leakage circuit breaker (ELCB), telephone service, emergency eyewash, internet and LAN connectivity, medical air, nitrous oxide and scavenging system (if it has analgesia or anaesthetic devices), vacuum system, ventilation and temperature control, and wash sink.
21.6 Keep the maintenance area clean and orderly. Equipment and work surfaces should be cleaned, waste removed and disposed off properly on a regular basis. 21.7 Ensure work flow and status of pending repair works are clearly indicated and recorded. 21.8 Accessibility 21.8.1 Locate the workshop facility where equipment can be brought in without unnecessary handling and exposure to bad weather. 21.8.2 Preferably the workshop shall be in the proximity of the critical clinical area of the healthcare facility.
21.9 Facilities for proper cleaning of equipment and hand washing shall be provided to prevent unnecessary exposure of potential hazard and infectious agents.
21.10 Ventilation in the work area shall comply with regulatory requirements related to the adequate dissipation of vapours associated with chemicals (fluids, agents, substances, compounds, etc.) that are used in the work area. 21.11 All recommended requirement are applicable to any party involved in carrying out Biomedical Engineering maintenance.
Collimator test tool 22. Advisory service 22.1 Advice on the following maintenance provisions shall be obtained from the Biomedical Engineering Services during the entire lifecycle of medical devices: a) selection of equipment; b) equipment installation; c) discontinuation of use of equipment; d) replacement of equipment; e) any adverse events; f) condition appraisal of equipment; and g) disposal.
22.1.1 Proposal for removal of equipment from operation Equipment may be proposed for removal from operation when it satisfies one or more of the followings: a) beyond economical repair:
i) cost of repair exceeds depreciated value; or
ii) accumulated maintenance cost plus the estimated cost of impending upcoming repairs exceeds the depreciated value of the equipment;
b) worn out - when the equipment would not function properly even though repairs are
carried out; c) unreliable - when it is not meeting up to its acceptable level of performance for its
intended use; d) obsolescence - when it is obsolete due to any of the following factors:
i) a new model of the same equipment has a design change resulting in a better efficiency and increased capacity;
ii) a new concept for the service provided by the equipment is introduced; iii) new safety requirements render the equipment unsafe; or iv) spare parts are no longer available;
e) changes in local policies for device use; f) absence of manufacturer/supplier support; g) increased capacity is required due to expanded operations or less labour available; h) possible benefits of new model (features, usability, more clinically effective, lower running
costs); or i) exceeded lifespan of the equipment as recommended by recognised organisation. 22.2 Recall Upon receiving recall notice, Biomedical Engineering Services shall advise the user and take appropriate action to the affected equipment. The equipment shall be isolated from use and tagged with appropriate label. 22.3 Upon request, Biomedical Engineering Services shall provide updated information regarding latest technology to user department. This information shall assist user for equipment procurement program. 22.4 As and when required, Biomedical Engineering Services shall provide advice to user department on equipment replacement plan.
22.5 Biomedical Engineering Services shall communicate relevant information about equipment failures and use errors to the relevant parties, as appropriate. 23. Procurement of equipment Healthcare facility authority shall ensure local policies for procurement of medical equipment addresses safety, quality, and performance are observed. Policies should include the need to establish advisory groups to ensure the procurement requirements take into account the needs of all parties involved in the use, commissioning, decontamination, maintenance and decommissioning of medical equipment. 23.1 Biomedical Engineering Services shall provide advice upon request by healthcare facility authority prior to procurement, such as: a) installation requirements, utility services and commissioning procedure; b) reliability and previous performance; c) past history of problems with the device or type of device; d) compatibility with other relevant equipment and systems; e) safety publications, manufacturer’s advisory notices or other relevant publications related
to the equipment; f) training needs (user and technical training); g) warranty coverage; and h) other support facilities 23.2 All equipment supplied to the healthcare facility shall conform to relevant international/national electrical safety standard; i.e. MS IEC 60601-1 for medical electrical equipment and MS IEC 61010-1 for laboratory equipment; and relevant product standards. 23.3 The medical equipment to be procured shall comply with Malaysian power supply rating of 240 V with a tolerance of +10 % -5 %, 50 Hz (single phase) and 415 V with a tolerance of +10 % -5 %, 50 Hz (three-phase). 23.4 The condition for purchase shall include provision for future modification of equipment and provision for software upgrades. 23.5 The criteria for selection shall be based on efficacy, effectiveness, performance, safety, reliability, features, ease of use, cost-effectiveness, service, training and continuous support for the user and equipment maintenance. 23.6 Supplier shall provide complete copies of the following items to the healthcare facility authority and Biomedical Engineering Services: a) user manual; b) service or maintenance manuals;
c) circuit diagrams and drawings; d) relevant software inclusive of access codes; e) parts list; f) PPM checklist according to manufacturer recommendation; and g) other necessary documents/items.
23.7 Supplier shall provide complete technical training to the Biomedical Engineering Services and user training.
23.8 Final payment shall be paid to the supplier upon meeting the terms and conditions of contract/purchase order and clearance from Biomedical Engineering Services.
Biomedical Engineering competency and career development guidelines A1. Introduction Biomedical Engineering is one of several professional disciplines contributing to safe, effective and economical health care. The role and primary responsibility of a Biomedical Engineering services are management of medical device technologies, including adherence to recognised safety, quality, cost, and efficiency standards. Biomedical Engineering is a learned profession that combines expertise and responsibilities in engineering, science, technology, and medicine. Since public health and welfare are paramount considerations in each of these areas, Biomedical Engineers shall uphold an appropriate level of competencies embodied in its professional practice, research, patient care, and training. The level of competencies shall reflect the standards of professional and personal practice for Biomedical Engineers. A2. Competency levels of Biomedical Engineer and Technician The Biomedical Engineering maintenance competency levels are categorised into four technical levels and one management level. To determine the individual competency levels, the guidelines shall be cross referred to the medical device maintenance specialisation classification, competency skills, breakdown maintenance level and management skills level of the Biomedical Engineer or technician. The details of the competency levels are as per the relevant matrix (refer Figure A1 and Tables A1 to A9). A3. Career development plan for Biomedical Engineer and Technician To ensure the career development and progress of the Biomedical Engineer and Technician in achieving various levels of competencies, a systematic career development plan shall be followed by the Biomedical Engineering Services organisation as a guideline. Details of the career development plan are as per the Biomedical Engineering career development matrix in Table A9. A4. Assessment of competence and commitment The biomedical engineer shall have their competence and commitment assessed through a Professional Competency Examination, conducted by the recognised Competency Certifying Body (CCB), authorised by the Engineering Services Division of the Ministry of Health Malaysia. The examination will be against the competence and commitment standards developed as per this Malaysian Standard and relevant national regulation. The decision whether or not to accept an applicant for competency examination registration shall be made by the CCB authorised by the Ministry of Health Malaysia, which is responsible for governing the competency registration. Details of the competency certification requirements are as per Table A9.
A4.1 The professional competency review shall include three components: a) a review of experiences documentary evidence; or b) continuous professional development in Biomedical Engineering; and c) an examination.
Table A1. Competency levels and device specialisation classification matrix
Biomedical Engineering maintenance competency levels Medical device maintenance specialisation classification
Level 1 Level 2 Level 3b Level 4c Managementd
1 Basic level medical device (refer to Tables A2 to A5e) X X X Optional X
2 Intermediate level medical device (refer to Tables A2 to A5e) - X X Optional Optional
3 High level medical device (refer to Tables A2 to A5e) - - Optional X a Optional
a Area of specialisation to be declared based on specific model of medical devices. b For Level 3 competency, the person is given an option to expand their specialisation level based on their training advancement and experiences.
c For Level 4 competency, the person at vendor and manufacturer are given an option to exclude the lower specialisation level.
d For management level, the manager is required to obtain a minimum competency on general/basic level medical device specialisation.
e The sample of medical devices specialisation are given in Tables A2 to A5 and subject to changes based on its complexity and cost of the equipment.
Basic Intermediate High Flowmetres, blood Gas sampling units Gasometres Lensometres Metal detectors Microgasometres Ophthalmometres Oximetres, pulse Perimetres, ophthalmic Phonocardiographs Plethysmographs Power supplies, line-voltage stabilization Printers, video Prism bars Projectors, cine Recorders Retinoscopes Scales Scanners, long term recording, ECG Sphygmomanometres, aneroid Sphygmomanometres, electronic Sphygmomanometres,mercury Television monitors Testers, pulp Thermometres
Ureterotomes Uroflowmetres Vectorcardiographs Video image processors View boxes, ultraviolet Visual field plotters * Subject to changes based on its complexity and cost.
Dental delivery units Duodenoscopes Ultrasound therapy/neuromuscular stimulation systems, physical therapy
Dental engines Ear/nose/throat treatment units Dental hand instruments, surgical Electrosurgical units Dermatomes Gastroscopes Desensitizers Gonioscopes Drills Heart-lung bypass units
Slit lamps Stimulators, caloric, physical therapy, fluidised medium Tables, examination/treatment Tables, operating Tourniquets, pneumatic Tracheal tube introducers Traction units Training manikins, cardiopulmonary resuscitation Transilluminators Trimmers. Model, dental Ultrasonic cleaning system Vacuum extractors, obstetrical Vacuum-mixing devices, dental Vibrators Warming units Water purification systems Welding units, orthodontic Wire drivers Apheresis units *subject to changes based on its complexity and cost.
Table A6. Biomedical Engineering maintenance competency levels and skills matrix
Competency levels Skills
Level 1 Level 2 Level 3 Specialist Management
Theory Understanding of the anatomy, physiologic and biomedical equipment classification for specific medical device (refer to table A2 to A5).
√ √ √ √ √
Understanding of specific medical devices operations and its applications. √ √ √ √ √ Operations
Identify and verify operation of all safety features for specific medical devices. √ √ √ √ √
Be able to perform an effective electrical safety procedure on the specific medical device. √ √ √ √ √
Safety Understanding of test fixtures and test equipment specific to the medical device. √ √ √ √ √
Understanding of manufacturer Planned Preventive Maintenance (PPM) procedures and follows appropriate steps to complete the task for specific medical devices.
√ √ √ √ √
Servicing Be able to perform an effective performance testing and calibration on the specific medical device. √ √ √ √ √
First line repair: Be able to identify and perform breakdown and corrective maintenance of the medical devices at the point of care.
√ √ √ √ √
Second line repair: Be able to identify intermediate corrective actions required for the corrective maintenance of the specific medical device up to module/board levels at maintenance workshop either internal or external.
- √ √ √
optional Repair
Third line repair: Be able to identify advance corrective actions required for the breakdown maintenance of the specific medical device up to component levels and complete overhaul at specialised or manufacturer facilities.
- - √ √
optional
Be able to complete accurately the necessary Biomedical Engineering related documentation. √ √ √ √ √
Understanding of Biomedical Engineering Maintenance Services management Level 1. Refer to Management Level Matrix. -
√ √ √ √
Understanding of Biomedical Engineering Maintenance Services management Level 2. Refer to management level matrix (Table A8). - optional optional
A Basic Biomedical Equipment Maintenance Certification. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 1)
B Intermediate Biomedical Equipment Maintenance Certification. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 2)
C1 Biomedical Equipment Specialisation Maintenance Certification in Radiology (Ionizing & Non-Ionizing) & Imaging medical devices. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 - Radiology and Imaging)
C2 Biomedical Equipment Specialisation Maintenance Certification in Laboratory equipment and devices. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 - Laboratory)
C3 Biomedical Equipment Specialisation Maintenance Certification in Diagnostic medical devices. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 -Diagnostics)
C4 Biomedical Equipment Specialisation Maintenance Certification in Therapeutic medical devices. Provided by competent certifying body recognised by MOH. (Certificate of Competency Biomedical Engineering Maintenance Level 3 - Therapeutic)
D
Advanced Biomedical Equipment Specialisation Maintenance Certification in any specialisation of medical devices. Provided by equipment manufacturer and endorsed by competent certifying body recognised by MOH. [Certificate of Competency Biomedical Engineering Maintenance Level 4 (by Medical Device Model)]
If there is evidence of body fluid contamination, submit the device for cleaning and decontamination before inspecting it. Wear appropriate Personnel Protection Equipment (PPE) during work.Wear grounded electrostatic wristband when handling PCB or electronic components.Refer to the safety procedure for additional precautions and guidance as per manufacturer guidelines. Make sure the test equipment used are duly calibrated.
PART 3 TEST APPARATUS
Tick ( √ ) where appropriate
PART 4 QUALITATIVE TASKS
ECG SIMULATOR
________________________________
________________________________
________________________________
DESCRIPTION ASSET NO / SERIAL NO CALIBRATION DUE ON
ELECTRICAL SAFETY ANALYZER
CHECKLIST NO: 16231-003
PPM YTD : ( 1 / 1 )
KEMENTERIAN KESIHATAN MALAYSIABEMS Planned Preventive Maintenance Checklist
By using an ECG simulator, supply of 60 bpm ECG to the unit and tracing set to 25mm/sec and 50mm/sec, the disctance between the peak to peak should be 25mm and 50mm respectively or within the tolerance limit.
CHECKLIST NO: 16231-003
PPM YTD : ( 1 / 1 )
Reference:MAC 1200/MAC 1200 ST service manual
CORRECTIVE MAINTENANCE REQUIRED FUNCTIONING NOT FUNCTIONING
WORK ORDER NO ____________________________________________ NEXT PPM DATE _________________
PPM has been performed in accordance to the checklist and the equipment is functioning to the intended purpose.COMPLETED BY :
Analysers P 12 6 96 % 92 % Amino acid P 12 6 96 % 92 % Bilirubinometres P 12 6 96 % 92 % Blood gas P 12 6 96 % 92 % Calcium P 12 6 96 % 92 % Clinical chemistry P 12 6 96 % 92 % Coagulation P 12 6 96 % 92 % Counter, gamma P 12 6 96 % 92 % Electrolyte P 12 6 96 % 92 % Immunoassay P 12 6 96 % 92 % Glucose P 12 6 96 % 92 % Heamatology P 12 6 96 % 92 % Platelet aggregation P 12 6 96 % 92 % Spectrophotometres P 12 6 96 % 92 % Atomic absorption P 12 6 96 % 92 % Atomic absorption units P 12 6 96 % 92 % Automatic blood grouping systems P 12 6 96 % 92 % Automatic microbiological systems P 12 6 96 % 92 % Blood bank centrifuges P 12 6 96 % 92 % Centrifuges P 12 6 96 % 92 % Cytometres P 12 6 96 % 92 % Chromatographs gas/liquid P 12 6 96 % 92 % Electrophonesis equipment P 12 6 96 % 92 % Flame photometres P 12 6 96 % 92 % Microscopes P 12 6 96 % 92 % pH metres P 12 6 96 % 92 % C = Critical equipment (including life support) P = Patient support equipment NOTE. Operating hours and operating days are indicative only. Medical services at healthcare institutions are provided at all times and the equipments may be used/operated at any time of the day or available for use at any time.
where, UPTIME is total time equipment is normally required to be in clinical use; and DOWNTIME is the time the equipment is unavailable for clinical use due to failure or out
of calibration. NOTES: 1. Upgrading time is time during which equipment is undergoing upgrading or replacement or when the equipment
is out of service for renovations or upgrading. 2. For equipments that are required only during normal office working hours, the Uptime Targets shall be based on
a maximum uptime of 2 340 h (i.e. 52 weeks X 45 h/week) per year.
3. For equipments that are required 24 hr everyday the Uptime Targets shall be based on a maximum uptime of 8 760 h (i.e. 365 days X 24 h/day) per year.
4. For other requirements the maximum uptime per year shall be determined based on the same principle
No. Report title Content 1. Asset listing − Asset number
− Asset description − Department − Section/division − Location code − Location description − Category − Type − Brand & model − Manufacturers serial no. − Cost − Date received/purchased − Supplier name − File reference number − Accessories − Signature of responsible officer − Date of signature − Location − Location changed to − Date of location change − Signature of location change − Checked − Date checked − Signature for checking − Number of − Description − Quantity − Manufacturer − Service agent − Responsibility − Area/department serviced − Warranty start date − Warranty completion date − Commissioning parameters − Membership of functional group − Functional group dependant − Registration certificate number − Disposal reference − Date disposed − Signature for disposal − Notes − Service history
2. Asset summary listing − Asset number − Asset description − Department − Section/division − Asset number − Asset description − Type − Cost − Date received/purchased − Area/department serviced − Membership of functional group − Functional groups dependant
No. Report title Content − Scheduled preventive maintenance reference − Registration certificate number − Disposal reference − Date disposed − Beyond economical repair tag
3. Work requests − Requisition number − Requested by name − Requested by position − Requested by department − Requested by telephone no. − Date of request − Time of request − Location of fault − Asset number − Works requested − Works request received by name − Works request received by date − Works request received by time − Works request completion verification by name − Works request completion verification by date − Works request completion verification by time − Works request assessment cause code − Works request assessment by name − Works request assessment by date − Works request assessment by time − Works request type code
4. Work orders − Requisition number − Requested by name − Requested by position − Requested by department − Requested by telephone no. − Date of request − Time of request − Location of fault − Asset number − Works requested − Works request received by name − Works request received by date − Works request received by time
− Spare parts used part number − Spare parts used number used − Spare parts used cost − Works order number − Works carried out by name − Works carried out start date − Works carried out start time − Works carried out finish date − Works carried out finish time
− Works carried out man hours − Response time − Down time − Up time − Request entered date − Request entered time − Priority code
5. Works orders summary − Requisition number − Requested by department − Date of request − Location of fault − Asset number − Works requested − Works order number
No. Report title Content − Works carried out finish date − Works carried out man hours − Response time − Down time − Up time − Number of works order
6. Works order summary in progress
− Requisition number − Requested by department − Date of request − Location of fault − Asset number − Works requested − Works order number − Works carried out finish date − Works carried out man hours − Response time
7. Works order completed summary
− Requisition number − Requested by department − Date of request − Location of fault − Asset number − Works requested − Works order number − Works carried out finish date − Works carried out man hours − Response time − Down time − Up time − Number of works order
8. Works order outstanding summary
− Requisition number − Requested by department − Date of request − Location of fault − Asset number − Works requested − Works order number − Works carried out finish date − Works carried out man hours − Response time − Down time
9. Common functions unit register
− CFU reference − CFU description − CFU causal assets listing − CFU total number of causal assets in CFU − CFU uptime target year 1, < 5 years old − CFU uptime target year 1, 5 to 10 years old − CFU uptime target year 2, < 5 years old − CFU uptime target year 2, 5 to 10 years old − CFU uptime target year 2, > 10 years old − CFU uptime target year 3 to 15, < 5 years old − CFU uptime target year 3 to 15, 5 to 10 years old − CFU uptime target year 3 to 15, > 10 years old − CFU status − CFU current uptime
10. Common functions unit status
− CFU membership listing − CFU disrupted from date − CFU disrupted from time − CFU disrupted to date − CFU disrupted to time − CFU target uptime − CFU uptime − CFU status
ACTIVITIES REQUIREMENTS KPI 1. To carry out scheduled and unscheduled maintenance for all medical devices. To provide effective and responsive repair on all equipment and provision of on-call and emergency services. To carry out acceptance testing as well as safety and performance characteristics on all incoming new equipment.
a) Compliance to relevant Malaysian statutory regulations.
b) All recommendations from manufacturers are to be followed.
c) Compliance to all safety requirements as stated in the IEC 60601 and collaterals, MS 838 for radiological equipment and relevant standards for nuclear and radiotherapy equipment.
d) At least 2 h on-site response time for repair calls, and shall not exceed 15 min on site response time for emergency calls.
e) 24 h on-call basis.
f) Calibration, performance, functional and safety checks to the manufacturer's recommendation shall be conducted after each repair work.
g) Guidelines on acceptance testing and in service testing of equipment, Ministry of health.
h) Compliance to guidelines on
Biomedical Engineering maintenance competency and career development.
a) Total preventive maintenance schedule (monthly).
b) Outstanding preventive
maintenance (backlog). c) Response time. d) Number of emergency calls
attended. e) Number of safety and
functional checks performed. f) Number of safety tests and
safety checks performed per year.
2. To provide mechanisms to avoid failure or breakdown during diagnosis or therapy.
Implement mechanism to avoid failure or breakdown during use.
ACTIVITIES REQUIREMENTS KPI 3. To carry out all works necessary to provide uptime guarantee on maintenance uptime
a) Critical (including life support): − 99% equipment uptime < 5 years − 95% equipment uptime 5 to 10
years − 90% service uptime for common
functional units. b) Patient Support machines :
− 96% equipment uptime < 5 years − 92% equipment uptime 5 to 10
years − 80% service uptime for common
functional unit.
i. % uptime ii. Uptime guarantee.
4. To implement the Hospital Engineering Quality Assurance plan.
a) Quality assurance program. b) Attain relevant MS/ISO quality
management standards certification.
a) Implementation of the program. b) MS/ISO certification.
5. To establish a computerised documentation system. To provide quarterly reports on maintenance activities. To notify departments of warranty expirations.
Associated basic modules for maintenance management work, i.e. work order, equipment register, stock control, budgetary control, and preventive maintenance.
a) Equipment inventory updated six monthly.
b) Number of equipment tagged
and entered in inventory. c) Number of warranty notifications.
6. To dispose/remove unwanted equipment.
Compliance to national/international standard and regulation on disposal of medical devices
Number of equipment disposed according to guidelines.
7. To implement procedures for dealing with hazardous matter and handling contaminated equipment.
Relevant MS/international Standards. Number of hazardous work carried out according to procedures.
8. To cooperate in the investigation of related incidents
Produce report on the status of the maintenance history of the equipment
Number of reported equipment related incident.
9. To train users on daily user maintenance procedure (excludes clinical procedure related to the equipment)
Identify the need for training on specific equipment and action taken.
Number of user training conducted.
10. To maintain a stock of genuine spares.
a) To assist in maintaining the uptime targets. b) Adequate supplies of maintenance kits.
Availability of critical and recommended spares.
11. Establish a library of user and service manuals.
All equipment engineering workshop shall have a documented list of service manuals.
Number of service manuals not available for critical care equipments.
Acknowledgements Members of Technical Committee on Code of Practice of Active Medical Devices and Low-Voltage Electrical Equipment/System for Healthcare Facilities Ir Dr Syed Mustafa Kamal (Chairman) Ministry of Health Malaysia (Engineering
Services Division) Ms Salbiah Yaakop (Secretary) SIRIM Berhad Ms Shamila Ariaratnam Association of Private Hospitals of Malaysia Ir Zuhari Yusoff/ Mr Abdul Rachit Md Ismail
Biomedical Engineering Association of Malaysia
Ms Haslin Ismail/ Ms Siti Noor Syahreen Kamaruddin
Faber Medi-Serve Sdn Bhd/Healthtronics Malaysia Sdn Bhd
Mr Abd Rashid Md Yusop Healthcare Technical Services Sdn Bhd (KPJ) Dr Sabarul Afian Mokhtar Hospital Universiti Kebangsaan Malaysia Prof Ir Dr Mohamed Amin Alias Independent expert Ms Sasikaladevi a/p Tangavelu
Ministry of Health Malaysia (Medical Device Bureau)
Ms Zarina Abdul Hamid/ Ir Nik Azran Abd. Hadi
Pantai Medivest Sdn Bhd
Ms Fatimah Mohamad Nor Radicare (M) Sdn Bhd Ir Gnana Sakaran R Sistem Hospital Awasan Taraf Sdn Bhd Dr Ahmad Nazlim Haji Yusoff Universiti Kebangsaan Malaysia (Faculty of
Allied Health Sciences) Assoc Prof Dr Fatimah Ibrahim/ Mr Mohd Yazed Ahmad
Universiti Malaya (Department of Biomedical Engineering)
Assoc Prof Dr Nik Abdullah Nik Mohamad Universiti Sains Malaysia (Medical Campus) Assoc Prof Dr Jasmy Yunus Universiti Teknologi Malaysia (Faculty of
Electrical Engineering) Ms Nor Haliza Yusof/ Mr Kamarul Azraii Noh
