1. 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

2. 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

3. 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

4. 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

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

6. 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)

7. BIDDING / PROCUREMENT TERMS / DONATION REQUIREMENTS3
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

8. TRAINING AND INSTALLATION7
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

9. 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

10. 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

11. 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

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