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 .
HIRA_v1
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.

HIRA2

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.

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Analysis of Nature of Complaints In Medical Equipment

Dr.Rawat ,Medical superintendent of multispecialty Hospital had tough time with financial head Mr.Swamy for seeking approval of spare part for Gastroscopy as total maintenance budget had exceeded the yearly projected budget. We face this kind of situation in most of the hospital.

One of the important cost head in hospital annual budget is on repair & maintenance. The challenge as medical administrator faces is lack of control on medical equipment maintenance cost .Even though the annual Operational budget is given to management, most of the time it is based on gut feeling of Biomedical engineering manager (also referred as clinical engineering manager) .There are forecasting techniques in statistics to address this issue but no attempt is been done to analyze the nature of complaints & there correlation with spare & accessory replacement.

Downtime is the period of time during which equipment is not in a condition to perform intended function.
The maintenance cost index is the ratio of total maintenance cost and equipment capital cost. The maintenance cost is the summation of cost incurred on equipment spares, repair and annual maintenance cost.

The Hospital Biomedical Manager should always ensure to have lower downtime for all medical equipment without increase of maintenance cost index. The historical data on medical equipment provides lot of insight to hospital team to address the issue on maintenance cost.

The following case study conducted in one of the leading tertiary care hospital in western part of India.The data analysis is carried out to know percentage of complaints related to each block of medical equipment as explained below.

The typical medical equipment consists of following blocks:

Slide1

Stimulus: In many measurements, the response to some form of external stimulus is required. The stimulus may be visual (e.g. a flashlight), auditory (e.g. a tone) or direct electrical stimulation.

The Transducer: The transducer is a device capable of converting one form of energy to another. In medical equipment the transducer may measure temperature, pressure, flow, or any other variable that can be found in the body, but its output is always an electrical signal.

Signal-conditioning: The part of the instrumentation system that amplifies, modifies, or in any other way changes the electrical output of the transducer is called signal-conditioning equipment.

Display: The display equipment may include monitor or chart recorder to view the desired signal.

Recording, Data processing, and Transmission: This is used to record the measured information (e.g. Floppy disk, magnetic disk) for possible use later or to transmit it from one location to another in hospital.

Control devices: This usually consists of feedback loop in which the output from the signal condition or display equipment is used to control the operation of the system in some way.

The data on spare part replaced in non-operational equipment is collected for one year from equipment maintenance tracker software from multispecilality Hospital. The data analysis is carried out to know percentage of complaints related to each block of medical equipment. Based on the analysis, maintenance strategy was prepared by team of Biomedical Engineers & presented to hospital management.

The following are the important conclusions drawn from the above case study.
(1) The equipment failure due to electronic part is double than due to mechanical parts failure. In some of the area wherein equipment were nonfunctional had issues related to stable power & temperature. The matter was addressed with engineering team.
(2) The mechanical parts failure (like compressor unit in ventilator, gear assembly in film processor, motor unit in saw) can be reduced by identifying major mechanical parts for each medical equipment & prepare check list of same. In some equipment the preventive maintenance schedule was skipped. The Biomedical manager was asked to closely monitor PM schedule vs executed.
(3) In electronic parts of medical equipment, the transducers are highly susceptible for failure due to the fact that they do come in contact with patient and are handled by nursing staff & technician. Making nursing staff & technician understand the Do’s & Don’ts of equipment & routine calibration of transducers can reduce these failures. The continual training program should be prepared, coordinated & implemented by Biomedical Engineers.

Slide2

(4) The electronic failures in other section can be reduced by regular routine preventive maintenance servicing of equipment as per standard checklist given in the service manual of medical equipment. The few examples of failure of electronic parts are failure of preamplifier section in ECG machine, motherboard in syringe pump, pressure transducer in patient monitor, hardiest of computer section of MRI etc.

(5) The Biomedical manager & medical administrator got clear views on which all area’s the biomedical engineering team can focus like user training ,adhering to preventive maintenance schedule, ensuring proper environment for equipment to function etc. The operational budget was done considering these factors into account.

It is suggested to perform similar analysis in your hospital to understand which all issue related to medical equipment to be addressed so that maintenance cost can be monitored and controled & maintenance budget can be properly forecasted.

Medical Equipment Layout Design in Hospital Facility Planning

The following are few examples of problems faced by Hospital authority while commissioning the new facilities wherever medical Equipment is involved.
 The new EMG system installed in Neurology Department was not able to perform test properly due to continuous artifacts as dedicated ground/earthling was missing.
 The brick walls of Mammography unit was found less than 9 inch & doors were not lead lined as it is mandatory to have same wherever X-Ray based equipment are used.
 The total six numbers of electrical sockets were provided per cubicle new cardiac Intensive care unit. It was found insufficient while in use on certain patients.
 The heater coil of Steam autoclave was repeatedly failing due to pH level of incoming water not within prescribed specification by service provider.
 MRI scanner getting aborted frequently due to increased temperature in equipment room against prescribed specification by service provider.
This is more common in Hospital’s where the inputs from Clinical Engineering Department are missing during facility planning stage. This may result in rework in the particular facility. The hospital should actively involve In House Clinical Engineers during any new/renovation of facilities construction.
The Clinical Engineer should review the following checklist after understanding requirement from Equipment supplier before providing inputs to Hospital project planning dept.
1. The patient factor:
a. Space for patient movement through trolley, Wheelchair into Equipment room.
b. Patient positioning during test with reference to interfacing of equipment with patient& also ensuring that patient privacy are maintained during testing.
c. Availability of services like medical gases, Nurse Call bell, Crash Cart with Defibrillator inside the equipment room.
2. The equipment electro-mechanical factor:
Exact location of equipment based on dimension of room, equipment footprint, location of periphery equipment and housing of cables.
a. Type (i.e., single phase or 3 phases, Raw/UPS / DG back up) & Number electrical points needed for equipment and periphery equipment based on power consumption of equipment.
b. Equipment grounding specification like need of dedicated grounding or hospital grounding.
c. Air-conditioning details to be provided based on heat dissipated in equipment operating temperature & % humidity level accepted by equipment.
d. Specific consideration like Piped Medical Gas System, dedicated computer network cable, exhaust fan, drainage duct, plumbing lines etc depending on type of equipment.
e. Government Statutory requirement with respect to equipment.
3. The material factor:
a. Provision in room to keep equipment accessories like patient electrode, probes, transducers, instruction & service manuals, spare parts.
b. Provision to keep essential drugs, medicines etc.
4. The Human factor:
a. Sitting positioning of equipment technician, nursing staff during patient test on equipment.
5. The Equipment maintenance factor:
a. Provision for keeping space in equipment room to carry out routine calibration by technician, preventive and breakdown service by manufacture service engineer.
6. The building factor:
a. Weight bearing capacity of building structure with reference to dimension and weight of equipment.
b. Interior of room like type of flooring, ceiling, lighting etc.
c. Compliance of equipment room as per government bodies regulation.
d. Routing of Equipment from landing at Hospital till arrival at designated room.
7. The change factor:
a. Includes provision flexibility in layout design considering possible up gradation of equipment.
biomedarticle_a1
The systematic planning of all medical equipment area by Clinical Engineering Department in consultation with service provider & facility engineering will help Hospital project planning & execution team to reduce blunders during execution stage. This will help hospital to save cost in rework on account of change in MEP plan when equipment arrives to hospital site.