Study of Reporting System for Adverse Events Related to Common Medical Devices at a Tertiary Care Public Sector Hospital in India
Advances in the use of health care technology have
resulted in increased adverse events (AEs) related to the use of
medical devices. The study focused on the existing reporting systems.
This study was conducted in a tertiary care public sector hospital.
Devices included Syringe infusion pumps, Cardiac monitors, Pulse
oximeters, Ventilators and Defibrillators. A total of 211 respondents
were recruited. Interviews were held with 30 key informants. Medical
records were scrutinized. Relevant statistical tests were used.
Resident doctors reported maximum frequency of AEs, followed
by nurses; and least by consultants. A significant association was
found between the cadre of health care personnel and awareness that
the patients and bystanders have a risk of sustaining AE. Awareness
regarding reporting of AEs was low, and it was generally done
verbally. Other critical findings are discussed in the light of the
barriers to reporting, reasons for non-compliance, recording system,
and so on.
[1] Thomas AN, Galvin I. Patient safety incidents associated with
equipment in critical care: a review of reports to the UK National Patient
Safety Agency. Anaesthesia. 2008 Nov; 63(11):1193–7.
[2] Beydon L, Conreux F, Le Gall R, Safran D, Cazalaa JB. Analysis of the
French health ministry’s national register of incidents involving medical
devices in anaesthesia and intensive care. Br J Anaesth. 2001 Mar;
86(3): 382–7.
[3] Beydon L, Ledenmat PY, Soltner C, Lebreton F, Hardin V, Benhamou
D, et al. Adverse events with medical devices in anesthesia and intensive
care unit patients recorded in the French safety database in 2005-2006.
Anesthesiology. 2010 Feb; 112(2):364–72.
[4] Medical Device Regulations-Global review and guiding principles,
Internet. cited 2011 May 11. Available from: http://www.who.int/
medical_devices/publications/en/MD_Regulations.pdf
[5] QualityandsafetyinhealthcareHS-227-PromotingPatientSafetyatHealth
Care.pdf Internet. Cited 2011 Sep 11. Available from:
http://www.searo.who.int/LinkFiles/QualityandsafetyinhealthcareHS-
227-PromotingPatientSafetyatHealthCare.pdf
[6] Amoore J. Quality improvement report: Learning from adverse incidents
involving medical devices. BMJ. 2002 Aug; 325(7358):272–5.
[7] Hefflin B. Estimates of medical device-associated adverse events from
emergency departments*1. American Journal of Preventive Medicine.
2004 Oct; 27(3):246–53.
[8] Samore MH, Evans RS, Lassen A, Gould P, Lloyd J, Gardner RM, et al.
Surveillance of medical device-related hazards and adverse events in
hospitalized patients. JAMA. 2004 Jan 21;291(3):325–34.
[9] Kingston MJ, Evans SM, Smith BJ, Berry JG. Attitudes of doctors and
nurses towards incident reporting: a qualitative analysis. MEDICAL
Journal of Australia. 2004;181:36–9.
[10] Coyle YM. Effectiveness of a graduate medical education program for
improving medical event reporting attitude and behavior. Quality and
Safety in Health Care. 2005 Oct 1;14(5):383–8.
[11] Purnima. S. Tripathi. Death in the incubator. 2001 Dec 24 (cited 2011
May 9); 18(24). Available from: http://www.hinduonnet.com/
fline/fl1824/18240370.htm
[12] AIIMS. 53rd Annual Report, AIIMS Publications, 2008-2009, New
Delhi. [13] McConnell EA, Fletcher J. Agency registered nurse use of medical
equipment: an Australian perspective. Int J Nurs Stud. 1995 Apr;
32(2):149–61.
[14] McConnell EA. How and what staff nurses learn about the medical
devices they use in direct patient care. Res Nurs Health. 1995 Apr;
18(2):165–72.
[15] Gardner S, Flack M. Medical Device Provisions of FDA Modernization
Act > Designing a Medical Device Surveillance Network (Internet).
(cited 2012 Aug 21). Available from: http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDevi
ceProvisionsofFDAModernizationAct/ucm168938.htm#4.1
[16] Lawton R, Parker D. Barriers to incident reporting in a healthcare
system. QualSaf Health Care. 2002 Mar; 11(1):15–8.
[17] Barach P. Reporting and preventing medical mishaps: lessons from nonmedical
near miss reporting systems. BMJ. 2000 Mar 18; 320(7237):
759–63.
[18] Liu A-P, Zhang L-M, Yan W, Zhang J-H, Zhu Y-P. (Analysis on
evaluation of medical device adverse events monitoring and some
factors influencing MDAE’s reporting by medical personnels).
Zhongguo Yi Liao Qi XieZaZhi. 2008 Jan; 32(1):47–9.
[19] Evans SM, Berry JG, Smith BJ, Esterman AJ. Anonymity or
transparency in reporting of medical error: a community-based survey in
South Australia. Med. J. Aust. 2004 Jun 7; 180(11):577–80.
[20] Garg R, Bhalotra A, Pruthi A, Bhalotra P, Anand R, Gupta N.
Awareness among resident doctors with regards to cardiac defibrillators.
Saudi Journal of Anaesthesia. 2010; 4(3):182.
[21] Brown AS. To what extent does medical device maintenance pose
clinical risk? Clinical Risk. 2008 Mar 1; 14(2):59–62.
[22] Pittet D. Challenging the world: patient safety and health care-associated
infection. International Journal for Quality in Health Care. 2006 Feb 1;
18(1):4–8.
[1] Thomas AN, Galvin I. Patient safety incidents associated with
equipment in critical care: a review of reports to the UK National Patient
Safety Agency. Anaesthesia. 2008 Nov; 63(11):1193–7.
[2] Beydon L, Conreux F, Le Gall R, Safran D, Cazalaa JB. Analysis of the
French health ministry’s national register of incidents involving medical
devices in anaesthesia and intensive care. Br J Anaesth. 2001 Mar;
86(3): 382–7.
[3] Beydon L, Ledenmat PY, Soltner C, Lebreton F, Hardin V, Benhamou
D, et al. Adverse events with medical devices in anesthesia and intensive
care unit patients recorded in the French safety database in 2005-2006.
Anesthesiology. 2010 Feb; 112(2):364–72.
[4] Medical Device Regulations-Global review and guiding principles,
Internet. cited 2011 May 11. Available from: http://www.who.int/
medical_devices/publications/en/MD_Regulations.pdf
[5] QualityandsafetyinhealthcareHS-227-PromotingPatientSafetyatHealth
Care.pdf Internet. Cited 2011 Sep 11. Available from:
http://www.searo.who.int/LinkFiles/QualityandsafetyinhealthcareHS-
227-PromotingPatientSafetyatHealthCare.pdf
[6] Amoore J. Quality improvement report: Learning from adverse incidents
involving medical devices. BMJ. 2002 Aug; 325(7358):272–5.
[7] Hefflin B. Estimates of medical device-associated adverse events from
emergency departments*1. American Journal of Preventive Medicine.
2004 Oct; 27(3):246–53.
[8] Samore MH, Evans RS, Lassen A, Gould P, Lloyd J, Gardner RM, et al.
Surveillance of medical device-related hazards and adverse events in
hospitalized patients. JAMA. 2004 Jan 21;291(3):325–34.
[9] Kingston MJ, Evans SM, Smith BJ, Berry JG. Attitudes of doctors and
nurses towards incident reporting: a qualitative analysis. MEDICAL
Journal of Australia. 2004;181:36–9.
[10] Coyle YM. Effectiveness of a graduate medical education program for
improving medical event reporting attitude and behavior. Quality and
Safety in Health Care. 2005 Oct 1;14(5):383–8.
[11] Purnima. S. Tripathi. Death in the incubator. 2001 Dec 24 (cited 2011
May 9); 18(24). Available from: http://www.hinduonnet.com/
fline/fl1824/18240370.htm
[12] AIIMS. 53rd Annual Report, AIIMS Publications, 2008-2009, New
Delhi. [13] McConnell EA, Fletcher J. Agency registered nurse use of medical
equipment: an Australian perspective. Int J Nurs Stud. 1995 Apr;
32(2):149–61.
[14] McConnell EA. How and what staff nurses learn about the medical
devices they use in direct patient care. Res Nurs Health. 1995 Apr;
18(2):165–72.
[15] Gardner S, Flack M. Medical Device Provisions of FDA Modernization
Act > Designing a Medical Device Surveillance Network (Internet).
(cited 2012 Aug 21). Available from: http://www.fda.gov/
MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDevi
ceProvisionsofFDAModernizationAct/ucm168938.htm#4.1
[16] Lawton R, Parker D. Barriers to incident reporting in a healthcare
system. QualSaf Health Care. 2002 Mar; 11(1):15–8.
[17] Barach P. Reporting and preventing medical mishaps: lessons from nonmedical
near miss reporting systems. BMJ. 2000 Mar 18; 320(7237):
759–63.
[18] Liu A-P, Zhang L-M, Yan W, Zhang J-H, Zhu Y-P. (Analysis on
evaluation of medical device adverse events monitoring and some
factors influencing MDAE’s reporting by medical personnels).
Zhongguo Yi Liao Qi XieZaZhi. 2008 Jan; 32(1):47–9.
[19] Evans SM, Berry JG, Smith BJ, Esterman AJ. Anonymity or
transparency in reporting of medical error: a community-based survey in
South Australia. Med. J. Aust. 2004 Jun 7; 180(11):577–80.
[20] Garg R, Bhalotra A, Pruthi A, Bhalotra P, Anand R, Gupta N.
Awareness among resident doctors with regards to cardiac defibrillators.
Saudi Journal of Anaesthesia. 2010; 4(3):182.
[21] Brown AS. To what extent does medical device maintenance pose
clinical risk? Clinical Risk. 2008 Mar 1; 14(2):59–62.
[22] Pittet D. Challenging the world: patient safety and health care-associated
infection. International Journal for Quality in Health Care. 2006 Feb 1;
18(1):4–8.
@article{"International Journal of Medical, Medicine and Health Sciences:69521", author = "S. Kurien and S. Satpathy and S. K. Gupta and S. K. Arya and D. K. Sharma", title = "Study of Reporting System for Adverse Events Related to Common Medical Devices at a Tertiary Care Public Sector Hospital in India", abstract = "Advances in the use of health care technology have
resulted in increased adverse events (AEs) related to the use of
medical devices. The study focused on the existing reporting systems.
This study was conducted in a tertiary care public sector hospital.
Devices included Syringe infusion pumps, Cardiac monitors, Pulse
oximeters, Ventilators and Defibrillators. A total of 211 respondents
were recruited. Interviews were held with 30 key informants. Medical
records were scrutinized. Relevant statistical tests were used.
Resident doctors reported maximum frequency of AEs, followed
by nurses; and least by consultants. A significant association was
found between the cadre of health care personnel and awareness that
the patients and bystanders have a risk of sustaining AE. Awareness
regarding reporting of AEs was low, and it was generally done
verbally. Other critical findings are discussed in the light of the
barriers to reporting, reasons for non-compliance, recording system,
and so on.
", keywords = "Adverse events, health care technology, public sector
hospital, reporting systems.", volume = "8", number = "7", pages = "445-6", }
