Evaluating Safety Of Emr Systems. Essay

1434 words - 6 pages

In the past decade, the push to digitalize medical records has been in the forefront. Electronic Health records offer the potential to transform the health care system for the better. EHR’s can reduce cost; improve quality and efficiency of care. By having an EHR, medical staff can gain quick access to valuable medical information, to expedite the needed, even, critical life saving care in a timely manner. Currently, more and more healthcare providers are moving toward electronic health records instead of paper-based charts. These records are meant to reduce rates of miscommunication, and misdiagnosis. History has shown us that technology is a proverbial double-edged sword. Technology ...view middle of the document...

[3] Six people were gravely harmed by being overdosed on radiation, that is six people too many.
The Therac-25 was released on the market in 1983. [3] In 1987, all treatment with the device was suspended, due to the overdosing accidents. Before the release of the Therac-25 on the US market, the company who manufactured the device AECL obtained FDA approval to market the Therac-25 the approval from the FDA was based on pre-market equivalence. The software that ran the Therac-25 was based off of existing software already in use the Therac-25 bypassed the rigorous FDA testing procedures required at that time. The Therac-25 was FDA approved to be used on patients.
There are some highly valuable lessons to be learned from the causes of the Therac-25 accidents that can be applied to any software mechanism that can have an impact on human safety that includes EHR systems. The root causes of the Therac-25 disaster were attributed to poor software design and development, coding errors, and operator error of overriding “malfunction” error. The previous generations of the Therac-25 that used the same software had hardware differences. The previous generations of the Therac had hardware interlocks built in where the Therac-25 relied solely on software for safety. There were several contributing factors in the Therac-25 disaster, and valuable lessons to be learned from such a tragedy. Some of the lessons learned are having software code independently reviewed and tested with Installation Qualification, Operational Qualification, Design Qualification, and Performance Qualification protocols. [6] Proper documentation and training for operators in proper protocol for handling system errors. Also, realizing software is separate from hardware therefore; it should be tested on all hardware in which it will run, regardless of how mature the software is as it can perform differently on different hardware. In the Therac-25 case, the previous generations of the Therac had hardware interlocks that masked the software defects, so they had no way of reporting that they had been triggered, so there was no evidence of any software faults and six people paid the ultimate price for those oversights.
The problems of past systems should be a lesson for today’s medical systems. EHR systems are used for keeping medical records, but they are also used for dosing medication to patients. An example of how an EHR system could cause serious harm, is if the patient has pre-populated medication dosage for a certain procedure, would receive the dosage of that medication for that procedure, not all patients require the same dosage, even for the same procedure. The use of prepopulated fields could cause an over dose or under dose of a medication. If the wrong dosage amounts are given, it could lead to devastating consequences even death. In a recent study done by the Pennsylvania Patient Safety Authority found that 40% of errors using EHR systems were caused by...

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