Ethics
Lack of Equipment Failure and Potential Resolution
A major problem within a clinical trial is an equipment failure. In a clinical trial related to cardiovascular diseases, Electrocardiogram (ECG) is a major equipment used to study particular heart defects. Failure or inaccuracy of the equipment may lead to improper treatment or even lead to fatal issue and death in rare cases. EKG readings form the basis for interpretation of a particular hear defect. ECG is required for detecting electrical activity in the heart, this in turn if not functioning properly may produce inaccurate results. ECG malfunctioning was reported due to battery failure as well. Improper EKG graphs were reported which may be due to possible software glitches or internal circuit issues within the ECG device. This will have potential effect on patients and eventually a stand still on the current study.
Impact on Patients
Equipment failure can cause major economic losses to the sponsor concerned. The main sufferers are patients involved in the study. Patients with cardiovascular ailments may be treated with different medications since EKG results were different due to improper functioning ECG. Malfunctioning in the ECG due to battery failure lead to a halt in patient heart analysis. In case of a critical condition, immediate ECG is required to detect the heart activity. Improper functioning of ECG can lead to an increase in severity of patient’s health and in severe cases lead to death. Improper sensitivity of ECG can record accurate data and sometimes produce false positives. This in turn may result in a wrong prescription or unnecessary worry among patients with cardiovascular diseases. A false result depicting due to improper sensitivity by an ECG device may result into heart defects in a healthy individual. (John Reiling et al; 2008)
Problems with the ECG equipment
Most of the Electrocardiograms are helpful in the diagnosis of potential heart diseases. ECG’s help in recording heart activity in patients undergoing drug treatment or any particular therapy. Most ECG’s failed to work due to battery failure or improper maintenance. Major problems observed in ECG malfunctioning can be categorized into 5 major categories. These include under-sensing of activity in the heart. This problem was mostly caused due to an inappropriately programmed sensitivity mechanism. Lead dislodgment or lead failure due to an insulation breakage or a conductor fracture can cause under-sensing in ECG. Alternatively, over-sensing was seen in some of the devices. Over-sensing may be caused due to lead failure or poor or improper connection of the cable. An exposure to an external electrical or magnetic interference can lead to over-sensing in ECG.
Lead failure, lead dislodgment, lead output or lead maturation can lead to a state called non-capture. In this case, EKG graphs show no particular evidence of depolarization after pacing effect. Non capture is mostly seen in heart defects like myocardial infraction or drug therapy in patients. The previously mentioned reasons due to improper functioning of ECG can lead to claim of false positives in healthy patients.
The next two causes of ECG malfunctioning or improper sensitivity are no output or pseudo-malfunction. No output may be caused due to circuit failure within the device that can be unpredictable. Lead failure and poorly connected block to the device can lead to no output. No output can cause complete malfunctioning of the ECG device and should to be checked by the manufacturing company immediately. The last reason termed as pseudo-malfunction which is unusual or eccentric. This is unexpected causing a major halt in diagnosis and analysis of patient’s health in the current study. Pseudo-malfunction can also be caused due to battery failure or even a circuit failure arising from voltage fluctuations.
Non-malfeasance and Misconduct
Non malfeasance or misconduct are one of the ethical principles in a clinical trial and are mostly laid down in violation of certain norms regarding data manipulation, recording or tampering of an equipment. In this particular trial regarding patients with cardiovascular disease and the use of ECG for diagnosis, the ECG equipment failed to work properly due to low maintenance and negligence. This violates the ethical principle of Misconduct. Maintenance and changing of equipment from time to time are the duties of the sponsor and the necessary changes have to be informed by the Principal investigator at the earliest. (The office of Research integrity, Government website)
The principle investigator and the sponsor are sole responsible for any equipment failure or malfunctioning during a clinical trial. In this case there was a moderate to high impact on patients enrolled for the study. Some cases also showed false positives (indicating disease) in a healthy individual as well due to sensitivity failure in the ECG equipment. Misconduct in form of negligence, improper and low maintenance of equipment and impact on patient health was seen. The Principal investigator could have informed the sponsor prior to breakdown or malfunctioning of the ECG unit. In this case, the Principal investigator (PI) is sole responsible for misconduct and negligence in a study trial. It is the duty of the PI to notify the sponsor for an equipment failure. The sponsor can be questioned regarding issues in equipment failure. (Principal investigator roles, Washington edu)
According to FDA, Part 58, Subpart D, 58.63, (Good lab practices and equipment management) Maintenance and repair of any equipment during a clinical trial is responsibility of the PI and the sponsor of the study trial. It also states that records of non-maintenance and repair or change of any equipment (in this case ECG) should be kept safely and be reported in a timely manner to the ethics or governing body. (Code of federal regulations, Title 21)
Rationale of Ethical Principle and Implementation of Resolution
Equipment’s management is one of the most critical issues in conducting a clinical study trial. Improper or malfunctioning of an equipment can lead to losses in millions of dollars since there is an initial large amount of money invested in a clinical trial. Proper interventions in Management and maintenance of equipment is highly recommended to avoid economical losses, patient health burden and also cancellation of the study license by the ethics or governing body. (Stacy, 2012)
As an associate in a clinical trial, it is likely possible to advice the PI for an immediate change in the equipment (in this case ECG). Minor issues like Battery’s failure, cord changes or software updates, should be immediately notified and corrected. In the same time during repair and replacement alternatives or use of another ECG equipment to treat patient burden is required. In case the entire unit has to be replaced prior order for new equipment should be placed in order to avoid halt in patient diagnosis and health care.
SWOT analysis can also be carried out for previous equipment failure or malfunctioning in order to avoid future mistakes in case of ECG equipment failure. If in case of emergency, other interventions or possible equipment should be used for analysis of heart activity of a patient. Professional and certified individuals for maintenance of ECG equipment is highly recommended. New or latest ECG equipment from the parent company is highly desirable. Other companies offering high end equipment’s at reasonable rates should be considered first. Latest technology in ECG like wireless transmission of data, computer database recording and mobile data analysis through smartphones can be used for possible interventions. In some cases, companies providing ECG devices also provide an in-built monitor detecting any hardware issues or software updates. Such possible resolutions should be carried out in ECG malfunction. (B. N. Dhawan, 2011)
Implementation and Evaluation
ECG equipment failure should be considered immediately in case of cardiovascular disease clinical trial. The sponsor should look for either replacement or repairs of affected ECG devices. This is required in order to avoid cancellation of study license and patient health care burden.
The first step would involve determining any endorsements or grants available for purchasing new equipment. The sponsor can appeal to the authorized body and send in an application for new equipment in the clinical trial. This should be done 2 months before the first purchase. Minor problems like battery failure and cable attachments should be checked which might have been caused due to human error. This basic and first step of implementation towards equipment failure or malfunction is carried out in most clinical trials. Recruiting professionals for care and maintenance of such equipment would be ideal. Associates and registered practitioners can be recruited for maintenance of equipment. ECG device is delicate, and lead nodes should be checked on a daily basis. Surface surrounding the device should be checked for possible electrical or magnetic interference which might lead to over or under sensitivity of the device. Software updates and cleaning of the equipment serves essential part of proper functioning. The patient health history should be counter-checked to avoid confusion with ECG malfunctioning.
Secondly, if there is a major breakdown within the ECG device or sensitivity changes due to voltage fluctuations, immediate action should be taken by contacting site engineer or company directly to avoid data loss. It is ideal to order for latest ECG devices with new technology and updated software. This enables accurate and precise readings along with appropriate data collection. (National Health and Medical Research Council)
Evaluation and Budget Considerations
The necessary changes mentioned in the implementation plan can only be executed provided the sponsor can proceed in purchasing or repairs of ECG devices within the stipulated budget which was decided at the start of the clinical trial. The sponsor along with the PI, trial coordinator and clinical study nurse decide will decide the budget for purchase and repair costs towards new ECG devices. (Fundamentals of clinical trial budget, University of Michigan)
The cost of repairing each ECG device should be determined and verified with the cost for purchasing an entire new set of ECG devices. Although purchasing new devices would cost more, but considerations for precision, new technology and lower maintenance should also be noted. The sponsor has the right to make any changes in purchase of new ECG equipment. Analysis of effective diagnosis and faster procedures by implementing latest and new ECG devices should be discussed with the PI. The cost for purchase should not exceed the starting budget since this will incur losses. An automated ECG system is more cost-effective in comparison to manual or conventional ECG systems. The purchase of latest automated ECG devices will reduce the cost ten-fold by lowering man-power, increasing precision and accuracy. Also, the number of diagnosis in a single day can be increased using computerized automated ECG devices.
Purchase of new automated devices should be considered since this will reduce labor cost as well as increase the amount of tests done on a daily basis. The initial costs for the implementation would be high. In later stages the cost would surpass the amount utilized in paying trained professionals in handling and use of ECG equipment. Overall budget would increase to around 20,000$ for 50 new ECG devices. This would, lower labor charges and increase the budget in a timely duration. (Carel RS., 1982)
Community impact
The major patients enrolled for the clinical trial either suffered from cardiovascular ailments or were diagnosed and had predictive heart defects. In such cases, the use of ECG devices is critical, and problems related to malfunctioning and breakdown should be noted at the earliest.
The major problem was seen in patients with treatment either through drug interventions or therapy faced unnecessary burden. The malfunctioning of ECG device with over sensing due to circuit problems resulted in detecting heart abnormalities in patients with a healthy or treated heart ailment. This led to discomfort among patient group and also rose probable doubts against effective medications. In some cases, the patient community also faced a negative impact of EKG results that showed no heart defects due to similar reasons. This led for confusion between possible treatment and also rising health issues in current patients. In a rare case, due to improper cable connectivity, misinterpretation of results of EKG was notified and rectified at the earliest. (Khouzam RN., 2005)
Another community health problem was observed in cases of patients with implanted pacemakers. ECG analysis report potential problems of the heart or the improper functioning of the device. An over-sensed or an under-sensed ECG device reported un-appropriate EKG graphs which resulted in different treatment and therapy interventions. Also, this unusual result caused unnecessary worry among patients that worsened the health scenario. Moreover, elderly patients found it more difficult to attend the clinical study all over again. Patients also had to carry their medical history documentation due to data loss in within the ECG device. Interpretation of such data led to more confusion among the patients, PI as well as the study coordinator. The use of ECG is thus useful in the interpretation of results in critically ill patients. (Barold SS and Herweg B, 2011)
Action Plan in community problems
The failure of ECG devices was due to lack of maintenance and negligence. Patients would suffer from unnecessary worry due to inaccurate results. Elderly patients suffered the most since repeated test and interpretation of results on basis of medical history created confusion and calculation errors.
A possible and best way to avoid such errors and miscommunication in a trial is to use sophisticated and possibly new ECG devices. Computerized ECG device are more accurate and also include lower costs compared to conventional devices. These new systems also are energy efficient and have encrypted data security features. These systems use different algorithms and annotations to detect signals from the heart, which are supposedly meant to be accurate and reliable. Also, another advantage is the large storage of patient data into the system. This enables the investigator to study patient history and present medical scenario in a few minutes. Patients need not carry medical history documents for every visit since these new advanced systems record and store data. (Ma T et al; 2012)
The implementation plan can be changed using only new ECG devices, contrasting the use of repaired devices by technicians. This will not only reduce of a possible break down in the future but also assure data security, accuracy and lower costs for labor. The new implementation plan will recognize individual patient needs, possible outcomes and also accurate results for proper treatment or therapy. The PI along with the coordinator should ensure that the new devices be maintained properly and serviced on a timely basis. Contacting the site engineer in cases of emergency or unusual breakdown should be done immediately. Contacting the ethics committee for any change in equipment is necessary to avoid cancellation of study license. (Drezner JA et al; 2012)
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