World Health Organization 14 January 2019 Medical equipment maintenance Presented By [Presenter Name] [Presenter Title] Date

Introduction Topic placement Definition & importance of medical equipment maintenance Purpose of maintenance document Key Elements Maintenance programme planning Management Implementation Challenges, resources Working group session

To ensure improved access of safe, quality medical devices Research and development Innovative technologies Regulations Regulations of medical devices Research and development based on needs Approved high cost Medical devices Post market surveillance and Adverse event reporting Approved Medical devices lists Needs Assessments/ Selection Donations Installation, Inventories; CMMS, Maintenance User training and clinical effectiveness Health Technology Assessment Procurement Assessment Management Decommissioning, Replacement Human resources Policies Glossary on Medical devices Policies of medical devices Human resources for Medical devices

Definition Medical equipment maintenance is a set of activities conducted to keep a medical device in good working condition and consists of inspection, preventive maintenance, and corrective maintenance.

Importance Medical equipment maintenance, when well planned, managed, and implemented, allows for all the equipment in a health care institution to be reliable, safe, and available for use when it is needed for diagnostic procedures, therapy, treatments and the monitoring of patients. It also has the ability to prolong the useful life of equipment and minimize the cost of ownership.

Purpose of document To assist health-care organizations, especially those in developing countries, in planning, managing and implementing the maintenance of medical equipment. It was designed to be concise and flexible in its application, and can be adapted to various settings and levels of technical resources. It focuses on general principles rather than being a rigid model such that each country can design a programme to meet their own particular requirements.

Maintenance programme planning Inventory Methodology Financial resources Human resources Physical resources Workspace, tools, test equipment Supplies, replacement parts Operation and service manuals

Management Financial Personnel Operational Service contracts and vendors Training Operational IPM procedures, frequency, and scheduling Work prioritization models Record keeping, CMMS, tags & labels Effective communication Managing use and user error Travel

Management (cont'd) Performance monitoring Performance improvement IPM performance measures CM performance measures Performance improvement

Implementation Inspection and preventive maintenance Corrective maintenance Reporting Safety

Challenges Lack of financial resources Lack of human resources Build up expertise of in-house staff Share resources (e.g. test equipment) and knowledge between facilities Purchase spare parts or consumables in bulk keeping in mind expiration dates Lack of human resources Provide maintenance primarily from service contracts provided financial resources exist Prioritize devices receiving maintenance Share technical personnel keeping in mind workload and travel time

Challenges Lack of qualified personnel Provide maintenance primarily from service contracts provided financial resources exist Invest in training When purchasing equipment negotiate with manufacturer for training on new device operation and maintenance. Attempt to include training for other devices within facility from the same manufacturer. When receiving donations, require training from donor on all donated equipment Encourage development of local biomedical technology programmes

Challenges Lack of physical resources Lack of awareness Share resources (e.g. test equipment, tools) between facilities Purchase spare parts or consumables in bulk keeping in mind expiration dates Provide maintenance primarily from service contracts provided financial resources exist Prioritize devices receiving maintenance Lack of awareness Recommend (to facility management) awareness building for all health personnel. This would include promotion of improved communication between users and technicians and emphasis on the critical role of user in extending the lifetime of equipment

Resources available Association for the Advancement of Medical Instrumentation (www.aami.org) Biomedtalk (www.ecri.org/biomedtalk) ECRI Institute (www.ecri.org) Engineering World Health (www.ewh.org) Environment of Care Essentials (www.jcrinc.com) International Electrotechnical Commission (www.iec.ch) Infratech (infratechonline.net) Joint Commission / Joint Commission International (http://www.jointcommissioninternational.org/) National Fire Protection Association (www.nfpa.org)

Resources available American Hospital Association (www.aha.org) American College of Clinical Engineering (www.accenet.org) Biomedical Instrumentation & Technology (www.aami.org/publications/BIT/) Clinical Engineering Handbook by Joseph F. Dyro El Hospital (www.elhospital.com) 'How to Manage' series for health care technology (http://www.healthpartners- int.co.uk/our_expertise/how_to_manage_series.html) Journal of Clinical Engineering (journals.lww.com/jcejournal) Practicum for Biomedical Engineering & Technology Management Issues by Leslie R Atlas 24× 7 (www.24x7mag.com)

Working group session Assessment of three scenarios Groups identify best approach development of a maintenance programme given the particular circumstances Presentation of proposed options to the other groups Discussion on the pros and cons of each proposed option Development of proposed solution to the challenges for implementing an effective maintenance management programme Result could be presented to the participant's organization or MoH End

WHO Medical Device technical Series Training module of : Medical equipment maintenance programme overview Developed by Matthew Baretich and Frank Painter April 2011 Global Initiative on Health Technologies, WHO Supported by the Bill & Melinda Gates Foundation

Thanks! Contacts: http://www.who.int/medical_devices/en/ mailto:medicaldevices@who.int Phone: + 41 22 791 1239 Fax: +41 22 791 48 36 Skype: WHOHQGVA1 (then dial 11239) Other: (presenters name and email) Objective: to ensure improved access, quality and use of medical devices.