Engaging with healthcare professionals

in India to improve medical device safety:

Medical Equipment Safety Workshop Series (India 2013)

ND Khambete* and A Murray†

*Sree Chitra Tirunal Institute for Medical Sciences and Technology, India niranjan@sctimst.ac.in

†Newcastle University, Newcastle upon Tyne, UK alan.murray@ncl.ac.uk

Pilot survey results

Percentage of ICU and OT clinicians (total 41) reporting direct experience

of compromise in safety with various types of medical equipment

Khambete et al, 2010, IET Seminar, London

Muscle Stimulator

Heart Lung Machine

ECG Recorder

Defibrillator

Anesthesia Machine

Sphygmomanometer

ICU Ventilator

Infusion pump

Suction Pump

Surgical Lamp

Patient Monitor

Motorised OT Table

Electrosurgery Equipment

3

5

10

13

15

15

18

26

28

28

31

54

64

MedEqSafe – INDIA, 2013

Pune

Jan. 20

Thiruvananthapuram

Jan. 16

Bengaluru

Jan. 17

Mumbai

Jan. 18

Nagpur

Jan. 21

Wardha

Jan. 22

Delhi

Jan. 23

Chandigarh

Jan. 24,

MedEqSafe – INDIA, 2013

Host Institutes

Kerala Institute of Medical Sciences, Trivandrum

St. John’s Medical College, Bangalore

Padmashree DY Patil University, Mumbai

Deenanath Mangaeshkar Hospital and Research Centre, Pune

NKP Salve Institute of Medical Sciences, Nagpur

Indira Gandhi Government Medical College, Nagpur

Government Medical College, Nagpur

Mahatma Gandhi Institute of Medical Sciences, Wardha

Association of Healthcare Providers (India), New Delhi

Postgraduate Institute of Medical Education & Research, Chandigrah

Organising InstitutesSree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST), Trivandrum

College of Engineering, Pune (COEP)

Survey Details

Respondees 456

Cities in which presentations made 8

Presentations made 11

Hospital beds of respondees 46 to 2500

Years experience of respondees 0.1 to 38 years

Device types surveyed 15

Incidents observed in these devices 1162

Respondees details

Hospital Type

26%

52%

20%Charitable Hospitals

Private Hospitals

Government Hospitals

Specialty

19 %

11 %

13 %

2 %9 %

10 %

36 %

Surgery

Medicine

Anaesthesia

Radiology

Paediatric

Obs. & Gyn.

Mixed (nurses)

Respondees details

Level of training

26 %

12 %

2 %

40 %

5 %

7 %

6 %

8 %

Practicing Doctors

Resident Doctors

UG Medical Students

Practicing Nurses

Nursing Students

Hospital Administrators

Clinical Engineers

Clinical Technicians

Results

Equipment incidents

14 %

16 %

18 %

20 %

21 %

22 %

23 %

25 %

27 %

27 %

28 %

29 %

29 %

33 %

35 %

Heart Lung Machine

Muscle Stimulator

Ultrasound machine

Laproscopic surgery

X-rays

Anaesthesia Machine

ECG Recorders

ICU Ventilators

Defibrillator

Motorised OT Table

Infusion Pupms

Patient monitors

BP Apparatus

Suction Pumps

Surgical Electrocuatery

Conclusions

� Increase awareness of medical device safety among healthcare professionals, authorities and policy makers

� Take urgent steps to establish Medical Device Regulatory Authority

� Establish a statutory body to regulate Clinical Engineering profession through accredited training and certification programmes

� Allocate financial resources to address the above challenges

Acknowledgements

� Medical Devices, WHO

� Director, SCTIMST

� All colleagues for patiently helping

in data entry and analysis

Thank you very much