Minor  fault  in  device

No  Biomedical  Engineer:  No  avenue  for  in-­‐house  repair  

Lack  of  device  accountability

Delay  in  device  fault  reporting  

Procedural  delay

Poor  after  sales  maintenance  provision  

by  companies

No  Brand  loyalty  in  

government  hospitals

“Spanner In the Works”Maintenance of Medical Devices in the Health-Care Sector of India

Gupta V, Manaseki-Holland S, Diaconu K1. Introduction

Ø A medical device is an instrument that is used to diagnose/prevent/treat disease, without any chemical action on the body1.

Ø India has the second largest population in the world and a health care sector divided into government & private sectors.

Ø We aimed to explore maintenance and repair of existing medical devices across the two sectors in a province in India (2014).

Ø Maintenance of medical devices in India is contracted out to companies from which the device is bought under the Annual Maintenance Contract (AMC).

Ø Maintenance of devices has wide-ranging consequences as delays can greatly limit clinician work and management of patients.

“In government sector we don't have biomedical engineers. It's a big problem because sometimes there are small problems with equipment and we have to wait for company person to come which could be easily solved by biomedical engineer…” (Principal, Gov. Hospital)“You don’t have people with professional degrees. People with more hands on experience are there” (Director, Corporate Hospital)“…any Bio-medical engineer you hire, he reduces cost by at least ten times” (Superintendent, Govt. Hospital)”

Ø Site: North-West province of India, Middle-Income country, year 2014

Ø Sample: 31 Interviews with Superintendents, Principals, Directors, Clinicians, Biomedical-Engineers & Administrators in Government, Corporate and Small-Private Hospitals

Ø Sampling: Purposive, Convenient, Opportunistic and Snowball

Ø Process: Semi-structured interviews of 1 hour duration on device prioritization, selection, purchase, procurement, maintenance.

Ø Ethics: Ethical-approval in UK, Institutional & Participant consent

Ø Analysis: Data-led, thematic content analysis

3. Results: Issues Affecting Maintenance

“In the government side, the procedure is so large, a small screw will take 1-2 months to get fixed.... Which is not in the private sector. Reason is that whatever time it is not working, it is direct loss to him…Nobody is in a hurry in government hospitals” (Clinician, Private)

“For maintenance, Head of Department (HOD) writes to superintendent then file will go to clerk. Clerk will assess AMC, pass it to accountant. Again it will come to superintendent. Then again it will come to clerk who will make order, it will then go to HOD and superintendent to sign and only then it will be issued to company. Such a long process” (Principal, Gov. Hospital)

3.1 LACK OF BIOMEDICAL ENGINEERSBiomedical engineers: Individuals with specialist expertise in medical devices in-house repair .Ø Government Hospitals: Significant lack of Biomedical

Engineers Ø Private Hospitals: Only a few employed and without

proper training and qualifications

3.2 PROCEDURAL DELAYØ Government Hospitals:

Ø Lack of direct responsibility: Individuals not delegated device responsibility causing delay in fault identification, fault reporting

Ø Procedural Delay: Process of reporting device fault is �unnecessarily lengthy, �involves too many personnel �prone to communication failure.

Ø Private Hospitals: Motivated by business acumen, individuals cultivate urgency in device repair

“Maintenance is not good in government compared to private because companies do not bother about government. They think these are hospitals where nobody is responsible” (Superintendent, Gov. Hospital)

“Even companies that are very big are not responding to our calls whilst to private sector they are quicker as they think they could get more market from them” (Superintendent, Gov. Hospital)

3.3 COMPANY RESPONSEØ Government Hospitals:

Ø Delayed Payments: Companies receive delayed payments from government sector due to procedural delay.

Ø Private Hospitals:Ø Brand Loyalty: Companies provide better

service to private hospitals due to brand loyalty which Government hospitals cannot provide.

Increased  Device  downtime  and  delay

4. Discussion 5. Recommendation

Compounding effect àDELAY & DEVICE DOWNTIME

(predominantly in Government sector)

Poor Company Response

Procedural Delay

No Biomedical Engineers

Ø Effect on lower socioeconomic class: Device breakdown delays management of patients in government hospitals impacting primarily the lower socioeconomic class.

Ø Wastage of Resources: In government hospitals, purchase of new devices is preferred to repair of existing ones due to maintenance delay leading to substantial wastage of repairable devices.

Ø Lack of Regulation of companies: Discrepancy in company service provision between sectors highlights lack of regulation of companies & widens gap between healthcare sectors.

Ø Limitations of study: �Observer Bias- Participants guarded in protecting professional image �Researcher bias �Unable to carry out focus-groups – lack of triangulation �Language barriers

• Utilise expertise for fault repair, device selection/procurement

Employ Specialists : Biomedical Engineers

• Make individuals directly accountable

• Allow department leads to directly communicate with companies

Designate Responsibility

• Set up regulatory boards to ensure standardization of company service provision

Standardization of service provision

6. Conclusion ReferencesØ Problems embedded at each stage of the

maintenance process, predominantly affecting the government sector causing major delay.

Ø Delay impacts on clinician work, widens socioeconomic divide andleads to resource wastage.

Ø Increased accountability of device manufacturers and employment of Biomedical Engineers is recommended.

1. Kazunari Asanuma.  Definition  of  the  Terms  ‘Medical  Device’  and  ‘In  Vitro  Diagnostic  (IVD)  Medical  Device’. GHTF 2012

DisclosureØ Funding:  Arthur  Thomson  Trust,  Birmingham.  No  conflicts  of  Interest

2. Method

Reference ID: R341