Hazard Identification & Risk analysis concerning to Medical Equipment in Hospital

The following are few examples of adverse events I have encountered in Hospitals due to faulty medical equipment.
“The patient gets burn injury due to malfunctioning of patient plate in electrosurgical unit in operating room.”
“The medication error to patient due to non-calibrated syringe pumps in ICU”.
I am sure you too might have faced similar issues at your hospital.
The goal of this blog is to facilitate hospital team especially medical administration, Biomedical engineer (also referred as clinical engineers), clinicians, nursing & paramedical team on safe usage of medical equipment.
The ever evolving role of technology in healthcare services now allows Hospital to diagnose faster, with greater accuracy than ever before and increasingly in a manner which is least invasive. It allows Hospital to treat better and helps patients recover faster. In most of clinical areas in hospital of high risk like Operating room, Intensive care area, the processes involve usage of medical equipment. But the faulty medical equipment or use of equipment in a manner other than the equipment intended to use may lead to serious disability or death of patient. The Indian National Accreditation Board for Hospitals and Healthcare providers (NABH) accreditation standard ROM 6a mandates top management of Hospital should ensure proactive risk management across the organization .As per Joint Commission International ( JCI) standard FMS 2 & NABH accreditation standard FMS 1a, the hazard identification and risk analysis (HIRA) exercise is to be conducted by hospital and should take all the necessary steps to eliminate or reduced such hazards and associated risks. It is mandatory to monitor adverse events, near misses, and sentinel events in hospital as per both NABH & JCI accreditation standard.
The failure mode and effect analysis (FMEA) is one of the tools that can be used for performing HIRA on processes involving medical equipment. The FMEA like any other process improvement methodology is a team activity wherein relevant members from different department will be involved. The goals of FMEA are as follows:
• To identify the failure modes in the process involving medical equipment
• Establish the risks and the consequences of these failure modes
• Identify and implement mitigation strategies for the effects
• Assess the success of the mitigation strategies
• Implement modifications to hospital procedures as appropriate
The roadmap for implementation of FMEA is as follows:
• Select a process or sub process involving medical equipment
• List the potential failure modes i.e. how it may fail.
• List the potential effects of the failure.
• Estimate the Severity number (S) i.e. a numerical measure as given in table 1 of how serious is the effect of the failure to the patient.
• List potential causes or mechanism of failure.
• Estimate the occurrences number (O) i.e. a numerical measure as given in table 1.It is a measure of probability that a particular failure mode will actually happen.
• Estimate the detection number ( D ) i.e. a numerical measure as given in table 1 .It is measure of probability that particular failure mode would be detected by process members.
• Compute the risk priority number ( RPN = S X O X D)
• Determining Corrective and Preventive Actions i.e. mitigation strategies for the effects including list of individual responsible for completing the action.
• Prioritizing Actions Based on the RPN.
• Recomputed RPN after corrective actions to hospital procedures as appropriate are computed.
The following FMEA case study was done on to eliminate the possible failure modes in the use of defibrillator in multispecialty Hospital in North India. Defibrillators apply an electric shock to establish a more normal cardiac rhythm in patients who are experiencing ventricular fibrillation or another shock able rhythm.The defibrillator is lifesaving equipment used in emergency situations and any failure /wrong use while applying electric shock can lead to first or second degree burns or death of the patient .
The process of using defibrillator using external paddle whenever code blue in Hospital initiated is shown below. The failure mode for each sub process is tabulated along with effect of each failure, its severity. Occurrence & detectability. The possible cause of failure & mitigating strategies is also filled. The rating for S, O & D are fixed based on detailed brainstorming session between nursing team, Clinicians, Head of Emergency Department & Clinical Engineering (also referred as Biomedical Engineering). The risk priority number for each failure is calculated to understand which sub process needs to be focused on priority.
As we can notice the following sub process needs improvements based on calculated RPN.
• Switching on defibrillator
• Positioning of paddles on patient chest & deliver shock
• Application of conductive gel on paddle
The team assigned responsibility to relevant member to work on mitigating strategy. The team decided to review the sub process again after three months based corrective action taken & revisit RPN.


There is plenty of scope for hospital to do HIRA studies on medical equipment like Ventilators, diathermy unit, syringe pump. I would encourage all my e-friends who are working on safety issues in hospital to take such activity in their hospitals. In case anyone is performing HIRA study using other tools instead of FEMA, kindly shares your methodology.

Going Cellular on healthcare – an exploration

According to mobile analytics firm Flurry India’s connected device installed (smart phones and tablets for the uninitiated) base grew by a whooping 160% from April 2012 to April 2013. According to the latest report of IAMAI and IMRB, till Oct. 2012there  are a total of  76 million mobile internet users  ie accessing internet from their  mobile devices  in India and this doesnt include  dongles and data cards.  This number is expected to reach 130.6 million by march 2014 and 164.8 million by march 2015.

Now those  are  crazy  stats but the  question here  is  are  you on the  smart phone  yet. Applicability for   smart devices in hospitals is just  at its infancy but the  possibillities are just enormous.

A Hospital Based  App  –  this is for marketers as well as for  operational convenience. Though i have thought of other  applicability ill leave that for another post.

Developing one  basic downloadable hospital application with various utility parameters set into it. So lets get my thoughts straight here these  are just some random ideas that  i have  worked  upon or come across which work or should work you can always add  more in the  comment section.

a) Pill Reminders  – once a  prescriptions been filled  out and dispatched from the pharmacy this application can be downloaded and it will remind you when you need to take your  medicines  could be used for both in and  outpatient. I think this application is already being used  by Wallgreen  (part of the wall mart enterprise)

b) Health check reminders once you have booked  a  health checkup this does a basic count down to the  health check reminding you from three days  prior to the HC . and  one day before it sends you details as to what is expected from you . Also allows  you to give an online feedback

c) Virtual consultant  feed your query get an answer and  tie in for fixing up an appointment

d) Appointment  scheduler no calls required like an online consultation allows you to choose a speciality a consultant and an available time slot maybe about a  month in advance again a  reminder system can be put in for when your consultation is due

e) Diet check – basic calorie / special need diets  includes interesting recipes as well as  a basic calorie calculator such apps already exist on  the  ios and  android markets and can be integrated they are  for free  usually.

f) im not to sure if this can be done but basically an emergency helpline number that  the  app can directly feed into your mobile and  which will be  accessible at the  touch one button

g) Promotions any new  promotion pass it on  to your existing customer , though this is a  bit of an issue but can be

h) Disease research  – if you need to know anything about a  particular disease  get the data here

i) Patient connect  – connecting with patients suffering from similar disorders successfully treated by the  hospital with contacts if required like mobile testimonials and brand ambassadors. also mention best times to contact.

Thats  just the  tip of the iceberg i am certain as we go ahead we can find more utility.

Whats important for a particular app to be successful is that its  patient centric and understands  what purpose in patient care or patient  information provision it serves.  The  App has to be utility focussed and  not just there because  everyone is moving onto the  mobile platform or because  you want  to push messages to your community  from your hospital. If thats the  approach you have  then even if people do  download your app  they will get  rid of it faster than you can say flu. So remember friends utility is king and thats the only way you can create a  successful app.

Disclaimer: The views expressed in this  post are my own and  are  not meant to be derogatory  to any institution or organisation. These are just my thoughts and  these are open for further  discussion and  development. Please do comment and  share and  let’s get some universal cognition into this. Thank you for your patience and  tolerance.