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.

Quality for Hospitals, are we there yet?

Quality in hospitals seems to be one of the  most talked about issues  of today. I can understand why it is so important with consumers being more  aware, with competition being as high as  it is  and  expected to increase  further  in the  future and  with legislation being the  way it is for hospitals. Process  improvement  , documentation and  SOP creation seem to be a bare essential for hospitals in the world of today . Honestly speaking i don’t quite know how the  past was in  an era before 2003 , however  the  impetus that  is laid on quality  ever since  that era  has  only  grown manyfold over the  years.

No ifs and buts about the importance of quality, However what bothers  me the  most is that quality seems to be the means  to an end for most administrators. Historically if we are to look at quality in hospitals , Initially it was the  selected few going in for JCI accreditation who sought the  ghost of quality, in the  lucrative  pursuit of medical tourism. Then there  were the  local champions seeking ISO and Crasyl  ratings, remember   those  times, when we had  representatives of accreditation firms shooting quality down our  gullets, and  of course the  most  recent  turn is NABH. This now  seems to be our  gold measure  for quality and  standardisation at least nationally .

But think about it if these are the reasons we seek quality then isn’t  the quality itself limited by these  reasons. What are  we  checking for  what  comes under the  purview  of quality is it just those 638 parameters  defined by NABH 2011 (which might be  revised to 736 unofficial sources)that an organisation is assessed against. Is that  all there is to quality then aren’t we  constraining quality in stray jackets of limited vision.

Quality when taken up  as  an end  in itself is more beneficial to an organisation. Yes i would be wrong in saying  go against the  norms  forget  NABH its not quality, because it is and  is very important . All I,m saying is that just don’t  limit yourself to these parameters. Quality is  about  consistency, its about clinical outcomes , is  about processes , but in the  end its about (includes but  is not limited to)Patient experience, Consultant  relation, Employee  experience, and  well about anything and anyone  that comes in contact with our organisation.

I think  a newer approach is required to quality  where quality supersedes everything and is  not subservient to accreditation. And that  is where  creativity, innovation, progress and  differentiation will come  in.  I think quality departments  need to evolve , they need to expand their visions and  grow. Quality parameters must be developed reassessed and  re-envisioned intrinsically. Newer methodology other  than the existing  reaccreditation inspections must  be  used to assess quality. Innovative cross industrial methods  like the  Mystery patient a  once  talked  about concept could be re looked at. Seeking VOC (Voice  of customer) to define these parameters could be  experimented with. Opening  channels of communication are  essential. Newer technologies  such  as  social media could  be experimented with not just  for Branding but also  to define quality. Its high time we as administrators redefined our quality rather  than just measuring it.

In the end Creating  freely communicating open organisations that seek quality  for the sake of quality is the  step forward  not just for your Organization but for the industry as a  whole. And yes  we might not quite be there  but surely it would be a move in that direction.


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  lets get some universal cognition into this. Thank you for your patience and  tolerance.