Technical Specifications of Medical Devices Mohammad Ameel Senior Consultant, Healthcare Technologies (Medical Devices) Collaborator, International Federation of Medical and Biological Engineering WHO Collaborating Centre for Priority Medical Devices & health Technology Policy National Health Systems Resource Centre Ministry of Health & Family Welfare, Government of India Fourth WHO Global Forum on Medical Devices

Disclosure/Announcements The presenters declare no conflict of interest with the materials provided Acknowledgement/Reference : USER GUIDE: WHO technical specification for medical devices Furthermore, we do not claim the following statements: 1. These technical specifications are exhaustive or error free 2. the technologies which are included will be embodied in future editions of technical specifications 3. the use of the technologies listed is, or will be, in accordance with the national laws and regulations of any country Fourth WHO Global Forum on Medical Devices

Fourth WHO Global Forum on Medical Devices Disclaimer Technical specifications should be tailored appropriately by users according to the specific situation Technical characteristics of technical specifications are generic in nature The number of accessories, consumables, spare parts and other components indicates usual and/or ideal number and is not a mandatory quantity. For tender purposes, you should consider not only medical equipment itself, but also related services in order to be able to use the equipment. Fourth WHO Global Forum on Medical Devices

Usability analysis for technical specifications User What required from TS? How to increase usability? Planner Guide on options available Fit well with intervention Simplicity of access Different levels of technology Medical staff Understandable Guide as to what is appropriate Simple language Local names Searchable Linked with intervention Biomedical Engineer Reference for internal TS development Simple to cross reference with other formats Clear, consistent format Procurement Department Copy and use for bids Adaptable for local use Not too many options to choose Simple contents Maintainer of database Easy to keep up Manageable quantity of devices Simple, relational database Industry Benchmarking of products Marketing Open access Facility to comment and object Fourth WHO Global Forum on Medical Devices

Methodology Procurement through GeM Approval from MoHFW GMDN Template Committee formation & review Website upload for comments Approval from MoHFW Procurement through GeM

TECHNICAL CHARACTERISTICS The Template MEDICAL DEVICE SPECIFICATION (Including Information on the following where relevant/appropriate, but not limited to)   Version no. : Date: Done by : (name / institution) NAME AND CODING GMDN name GMDN code(s) GMDN definition GENERAL 1 USE 1.1 Clinical purpose 1.2 Used by clinical department/ward TECHNICAL 2 TECHNICAL CHARACTERISTICS 2.1 Technical characteristics (specific to this type of device) 2.2 User's interface 2.3 Software and/or standard of communication(where ever required)

BIDDING / PROCUREMENT TERMS / DONATION REQUIREMENTS 3 PHYSICAL CHARACTERISTICS 3.1 Dimensions (metric)   3.2 Weight (lbs, kg) 3.3 Configuration 3.4 Noise (in dBA) 3.5 Heat dissipation 3.6 Mobility, portability 4 ENERGY SOURCE (electricity, UPS, solar, gas, water, CO2 ....) 4.1 Power Requirements 4.2 Battery operated 4.3 Tolerance (to variations, shutdowns) 4.4 Protection 4.5 Power consumption 5 ACCESSORIES, SPARE PARTS, CONSUMABLES 5.1 Accessories (mandatory, standard, optional); Spare parts (main ones); Consumables / reagents (open, closed system) BIDDING / PROCUREMENT TERMS / DONATION REQUIREMENTS 6 ENVIRONMENTAL AND DEPARTMENTAL CONSIDERATONS 6.1 Atmosphere / Ambiance (air conditioning, humidity, dust ...) 6.2 User's care, Cleaning, Disinfection & Sterility issues

TRAINING AND INSTALLATION 7 STANDARDS AND SAFETY 7.1 Certificates (pre-market, sanitary, ..); Performance and safety standards (specific to the device type);Local and/or international   8 TRAINING AND INSTALLATION 8.1 Pre-installation requirements: nature, values, quality, tolerance 8.2 Requirements for sign-off 8.3 Training of staff (medical, paramedical, technicians) 9 WARRANTY AND MAINTENANCE 9.1 Warranty 9.2 Maintenance tasks 9.3 Service contract clauses, including prices 10 DOCUMENTATION 10.1 Operating manuals, service manuals, other manuals 10.2 Recommendations for maintenance 11 NOTES 11.1 Service Support Contact details (Hierchy Wise; including a toll free/landline number) 11.2 Recommendations or warnings

Other service to be considered Delivery at Place Preliminary Acceptance Installation Supplier testing and commissioning Training to the maintenance personnel Training to the equipment users Provisional Equipment handing over Manufacturer Warranty Supplier/installer additional Warranty Final Taking over certificate After Warranty service Fourth WHO Global Forum on Medical Devices

Fourth WHO Global Forum on Medical Devices Progress So far… Equipment Domain Number of Specifications Neonatal and Pediatric ICU 33 SNCU 19 Lab and Radiology 20 Operation Theatre 22 Emergency Response System 29 Skill Lab 14 CT Scan and MRI 2 Drug vending Machine and SMS based monitor MMU & ASHA Equipment 18 RBSK 35 Lactation Management Centers 10 TOTAL 204 Fourth WHO Global Forum on Medical Devices

Specifications under review… Prepared/reviewed and under the process of approval Imaging Equipment 19 Cardio Pulmonary 11 ENT 16 Eye 29 Dental 23 Operation Theatre 10 Laboratory 56 Surgical Equipment 53 Physiotherapy Endoscopy 7 Anaesthesia 22 Radiotherapy 6 Sick New Born Care Unit 54 Post Mortem 9 Total 331 Fourth WHO Global Forum on Medical Devices

Fourth WHO Global Forum on Medical Devices Thank you Fourth WHO Global Forum on Medical Devices