Cedar-Sinai the technology being used to fail. In

Cedar-Sinai(2008)The factors leading to radiationoverdose at Cedar-SinaiAlipayman RamazaniNewcastleuniversity(Student)Schoolof engineeringNewcastleUpon Tyne, [email protected]  Abstract Given the rapid improvements in technology and machinery thatare used in health Centre’s across the globe, companies face huge pressures todevelop and engineer new and more innovative products, with the aim of aidinghospitals and professionals to be more efficient when examining and diagnosingpatients. However, it should not come as a huge surprise for the technologybeing used to fail.

In this article, I will be investigating the main causesthat lead to 206 patients at Cedar-Sinai health center being examined forpotential stroke, where new CT machines recently installed was used that leadto these patients being to a dangerous dose of radiation eight times theprescribed limit, also I will be outlining the measures which are now in placeto reduce such incidents happening in the future.  Introduction Clinical medicine has without doubt been revolutionized with the aidof medical imaging. Modern-day imaging continues to provide detail and accuracybeyond believe, reflected in reduced hospital stays, more effective surgicaltreatments, improved treatment of cancer, elimination of exploratory surgeryand treatment of stroke patients just to list a few.

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 Thefirst Computed tomography scanner developed by Godfrey Hounsfield backed by EMICentral Research Laboratories based in Hayes, West London, produced its firstimage on the 1st October 1971 at Atkinson Morley’s Hospital, locatedin London, England. The image produced was an 80 x 80 matrix, taking roughly 5minutes to generate by the prototype scanner, however in today’s technology, CTscanners are able to produce images with a 1024 x 1024 matrix from a fewmillion data points, in a few seconds, making it a crucial and valuable assetto the medical centers around the world. 1,5 A computedtomography fires narrow beams of x-rays at a patient, while rotating around thebody, this results in signals which can be detected by the x-ray detectorslocated directly opposite the x-ray beams and is processed by the computer togenerate a cross-sectional “slices ” of the body part, given the termtomographic images, these images contain a greater amount of detail than thatfound in x-ray images making them very useful tools to physicians, the slicesproduced are then “stacked” in the order produced by the machines computer toproduce a three dimensional image showing the inner structures as you would seeif you were to physically perform a surgical operation, so the doctors canidentify and locate any abnormalities or damage to the patient’s internalorgans. Overtime CTscanners have become far more advanced the first clinical CT scanner wasdedicated to only producing head images only, as the effectiveness of thesemachines became more recognized around the world, in less than 6 years andthere are about 6000 Computed tomography scanners installed worldwide, and wereable to take whole body images. During its45-year history, Computed tomography functions at a far greater speed, andimprovement in resolution and patient comfort. As Computed tomography are ableto produce images faster, more anatomy can be scanned in far less time thanbefore this is important as it helps to eliminate any artefactsthat can arisefrom the patient motion.

 The CT machinesused to produce these images require the technicians to be fully trained inoperating them and understand the safe limits of radiation to which patientscan be exposed to, because of the dangerously high dosage of radiation thesemachines are capable and could be programmed to emit. But during aneighteen-month period at Cedars-Sinai Medical center, where 206 patients wereexposed to eight times the normal radiation dose, and 20% directly to theireye.  reports by IMV (Medical information division) in figure 2 shows therapid increase in the use of CT imaging in the United states, the radiationexposure associated with them over the last decade outline the dangers whichcould arise, clearly shown in the radiation overdose incident that took placeat Cedar-Sinai beginning February 2008 and after 18 months, for such a majorincident to occur indicates there are multiple causes which can be classifiedin two very different categories being the Medical Centre and the manufactures. Many sourcessuch as the ‘New York Times’ related the main cause to mainly human ‘error’,this came about as a result of thehospital started to use a new protocol for a specialized form of scan which was believed to provide doctors with more usefulinformation in their effort to treat stroke patients.

So that meant resettingthe CT machines to be able to override the pre-programmed instructions whichaccompanied the scanner when it was first installed.Once these newinstructions were programmed into the machines, they were essentially lockedin. The machine was used for other types of scans which the ‘error’ did noteffect.

 The 10’Swiss cheese’ model of organizational accidents, is anexcellent procedure which can be used to reduce the likelihood of accidentsoccurring in large organizations, the model is built on the idea of havingbarriers at each step in a process to eliminate any potential error before thefinal outcome, so in an event of a major error to occur all the holes will haveto line up this would be the case in a flawed system that would allow an erroror mistake at the beginning to reach and affect the outcome. So, to reduce thechances of an error effecting the outcome the more cheese slices used thesmaller the chances of errors and also the smaller the holes the better assmaller holes could imply a more detailed analysis at each stage of the processthat would ultimately catch or even stop the error becoming an accident. The incident at Cedar-Sinai could be linked to the system failing,because of the difficulty in detecting errors during the process of CT imaging,unlike errors that lead to physically visible outcomes, that can easily be found,an example being a plane engine failing due to internal faults causing it toexplode during the testing period, can be investigated quicker andinstantaneous safe guarding actions could be taken to prevent any casualties,however with CT scanners the accidents could take years before they aredetected, so it’s crucial the system in place has virtually no flaws and anyhuman errors don’t become accidents.

This is where the problem starts, 9’INSIDE SCIENCE’ reported that Medical Centre Cedar Sinai were not accreditedby American College of Radiology, who offers guidelines for standards andprotocols, and obviously the process used for CT scans at Cedar-Sinai was noteffective in preventing errors progressing through its successive layers ofdefense. The system as awhole failed because individual parts that make it did not carry out theirroles effectively and this could be linked to the team, management,individuals. individualtechnologist has responsibility to ensure patients under their care are notexposed to dangerous levels of radiation (ARRT Code of Ethics).

This impliespracticing with integrity, only using equipment that is serviced properly andmaintained locally or by vendor. Although in theinvestigation carried out by the FDA and GE healthcare the productmanufacturers, they did not find any faults with the machines itself, butrecommendations included there could have been an improvement in safetyfeatures built in the scanners, one of the obvious features the GE scanners hadis a feature called automatic exposure control. The feature automaticallyadjusts the radiation dose according to a person’s body part and their size sosmaller children receive less radiation, because their body is growing andradiation is more likely to cause cancer, rather than using a pre-determinedradiation level, the aim of the feature being to reduce the doses. But when thefeature is used with certain machine settings which governed image clarity, theeffect was to drastically increase the radiation dose delivered to thepatients.GEscanners have a feature called automatic exposure control. It automaticallyadjusts the radiation dose according to a person’s size and the body part beingscanned, rather than using a fixed, predetermined radiation level.

Its intentis to lower radiation doses. But when used in combination with certain machinesettings that govern image clarity, its effect was to significantly raise thedose of radiation delivered to a patient.Accordingto Cedar-Sinai the GE manual as part of the CT scanner failed to state thefeature was not designed to be used in brain scans. And the GE trainers failedto fully explain the feature.After manyhigh-profile incidents of radiation overdose leading to patient harm during CTimaging, it’s not a secret that ionizing radiation used by medical imaging havemany harmful effects associated to them, but their benefits to medical centersfar outweigh the risks posed.

However due to the heavily reported incident, atcedar-Sinai. National organizations such as the Medical Imaging and TechnologyAlliance, American College of Radiology and the joint Commission have devisedvarious standards linked to radiation safety. One of thechanges coming in the form of a SB 1237 in 2010 to ensure radiation dose are monitoredbetter for CT scans. The law going into effect from July 1st, 2012involve a number of components:Hospitals andclinics are required by law to record dose of every procedure performed using aCT scanner, Especially volume of volume of CT dose index. And the dose lengthproduct.The doseinformation has to be sent to the Picture Archiving and Communication System(PAC) when possible also the information must be part of the patient’s reporthelping to determine their radiation dose received over their lifetime.In an eventwhere patents receive excessive dose of radiation must be reported to theCalifornia Department of Public Health (CDPH); and radiation physicist toannually verify dose levels annually.

  Conclusion during an18-month period 206 suspected stroke patients underwent CT scans, as a resultof resetting the default settings on the machine, physicians being under theassumption that increasing the radiation dosage to supply eight times therecommended for the specific scan on the machines, believing it could providehighly detailed images, as the settings on the CT scanner was changed toreflect their theory, lead to the machine being locked in with the newsettings. Both the manufactures and Cedar-Sinai could have taken steps to helpprevent the accident occurring as ‘human error’ is essentially unavoidable, insuch high pressure and complexity situations. After patientsstarted reporting hair loss, the Health care center began their owninvestigation which found the incident was caused by the CT machine andtherefore investigation carried by the Food and Drug Administration (FDA)concluded the error was due to operator error, and the FDA issuedrecommendations to both the manufactures and Cedar-Sinai to help tackle suchincidents developing in the future. In my opinion,the main cause for the incident came about because there were not enough safetyfeatures that could have prevented the incident and the lack of regular machinechecks and failure to record the radiation dose patients were being scannedwith as one of the primary reasons the incident went unnoticed for 18 months, Icannot find a reason to why a product that is capable of providing dangerouslevels of radiation directly at specific body parts allows users to makechanges, or only allow lead technologists and supervisors access to changingsettings on the machine, it’s important that users are not fully locked out ofthe system as that’s impractical, considering the number of CT scans carriedout in health centers users should be allowed to make changes but not any thatcould pose a risk to the patient, as well as having warnings built in thesystem to alert users of changes to the protocols that could lead tooverexposure. I believe thechanges and new laws which are implemented as a direct result of the incidentat cedar Sinai will help reduce the incidents occurring in the future but Ibelieve these laws will only be effective if the medical centers are educatedin maintaining the CT machines, and the new technology used in them must beexplained to and be part of the manual issued to the medical centersfurthermore the manufacturers should perform frequent machine tests to test forany flaws or changes made to the system.    References:1  https://www.

radiologyinfo.org/en/info.cfm?pg=safety-hiw_04Accessed on 9thDecember 2017 2 http://www.impactscan.org/CThistory.htmAccessed on 9thDecember 2017 3 http://www.mcgeorge.

edu/Documents/Publications/08_HealthandSafetyMaster4-5-11.pdfproduced by health and safety author Christopher Braniff4 https://www.medpagetoday.com/Radiology/DiagnosticRadiology/16455  5 https://www.nibib.nih.gov/science-education/science-topics/computed-tomography-ct 6 http://www.imaginis.

com/ct-scan/brief-history-of-ct 7 http://www.nejm.org/doi/full/10.1056/NEJMra072149#t=article 8 http://www.imvinfo.

com/user/documents/content_documents/nws_rad/MS_CT_DSandTOC.pdf 9 https://www.insidescience.

org/news/medical-physicists-ct-scans-safe 10  “Swiss Cheese” Model – James Reason, 1990.  The bookreference is: Reason, J. (1990) Human Error. Cambridge: University Press,Cambridge. 11 http://patientsafetyed.

duhs.duke.edu/module_e/swiss_cheese.html 12 http://www.

thedoctorwillseeyounow.com/content/stroke/art3145.html 13 https://www.arrt.org/docs/default-source/Governing-Documents/arrt-standards-of-ethics.

pdf?sfvrsn=12 14 https://www.itnonline.com/article/states-making-difference-radiation-safetyby JEFF ZAGOUDISaccessed on 13 December 2017.   


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