Computer-aided recording of automatic endoscope washing and disinfection processes as an integral part of medical documentation for quality assurance purposes

Krakamp, B; Kirschberg, Oliver; Scheding, Andreas; Emmerich, Dieter; Klein, Stefanie; Saers, Thomas

doi:10.1186/1471-230x-10-76

Cited by 4 publications

(3 citation statements)

References 6 publications

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“…To overcome the obstacles of paper-based documentation, new technologies are emerging to support the documentation process. Speech recognition [24,25], automated data recording [26,27], and DPP technology [14] are examples of this. Handwriting recognition is improving and being implemented in standard office software suites, but it can still lead to errors [28,29].…”

Section: Discussionmentioning

confidence: 99%

Analysis of Digital Documentation Speed and Sequence Using Digital Paper and Pen Technology During the Refugee Crisis in Europe: Content Analysis

Kehe

Girgensohn

Swoboda

et al. 2019

JMIR Mhealth Uhealth

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Background The Syria crisis has forced more than 4 million people to leave their homeland. As a result, in 2016, an overwhelming number of refugees reached Germany. In response to this, it was of utmost importance to set up refugee camps and to provide humanitarian aid, but a health surveillance system was also implemented in order to obtain rapid information about emerging diseases. Objective The present study describes the effects of using digital paper and pen (DPP) technology on the speed, sequence, and behavior of epidemiological documentation in a refugee camp. Methods DPP technology was used to examine documentation speed, sequence, and behavior. The data log of the digital pens used to fill in the documentation was analyzed, and each pen stroke in a field was recorded using a timestamp. Documentation time was the difference between first and last stroke on the paper, which includes clinical examination and translation. Results For three months, 495 data sets were recorded. After corrections had been made, 421 data sets were considered valid and subjected to further analysis. The median documentation time was 41:41 min (interquartile range 29:54 min; mean 45:02 min; SD 22:28 min). The documentation of vital signs ended up having the strongest effect on the overall time of documentation. Furthermore, filling in the free-text field clinical findings or therapy or measures required the most time (mean 16:49 min; SD 20:32 min). Analysis of the documentation sequence revealed that the final step of coding the diagnosis was a time-consuming step that took place once the form had been completed. Conclusions We concluded that medical documentation using DPP technology leads to both an increase in documentation speed and data quality through the compliance of the data recorders who regard the tool to be convenient in everyday routine. Further analysis of more data sets will allow optimization of the documentation form used. Thus, DPP technology is an effective tool for the medical documentation process in refugee camps.

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Section: Discussionmentioning

confidence: 99%

Analysis of Digital Documentation Speed and Sequence Using Digital Paper and Pen Technology During the Refugee Crisis in Europe: Content Analysis

Kehe

Girgensohn

Swoboda

et al. 2019

JMIR Mhealth Uhealth

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“…Researches have shown that Salmonella, Pseudomonas and Mycobacterium are the most common species transmitted by endoscopy [3], many other virus and bacterium species like HCV, HBV or even some Miscellaneous Organisms can be transmitted by endoscopy, too [4]. To prevent such medical accidents, the endoscopes must be reprocessed after being used, exactly cleaning and disinfection processes should be carried out before the next use [5] [6]. Generally, there are three brief stages for the endoscope reprocessing which are preliminary cleaning, high-level disinfection and the final cleaning [4] [7].…”

Section: Introductionmentioning

confidence: 98%

A RFID-based tracking system of endoscopes

Duan

Lü

et al. 2011

2011 4th International Conference on Biomedical Engineering and Informatics (BMEI)

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The cleaning and disinfection of the endoscopes are extremely important for reducing endoscopic transmission of infections in hospitals. There have been many such cases of medical accidents reported in the history and most are caused by poor management. According to the Technical Specifications for the Cleaning and Disinfection of Endoscopes (2004) of China, this paper has presented a tracking system based on the radio frequency identification (RFID) technology to provide a better management of the endoscopes. It can efficiently prevent the potential medical errors by recording and checking the current state of the endoscopes, and it can provide a better traceability of the daily operations of the endoscopes by saving the historical using, cleaning and disinfection records. Preliminary clinical application was tested in the endoscope center of a 2200-bed hospital in Hangzhou, China. The result has expectantly demonstrated that it can effectively standardize the operation procedures and reduce the medical errors. Further evaluation of its usefulness and the user satisfaction will be done in the future.

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“…For example, "Eminent Spine LLC" received a warning letter in 2010 because they had not validated the cleaning procedure from their instructions to ensure that the cleaning procedure effectively removes body fluids and tissue debris [212]. Eminent Spine LLC told the FDA that their new validation testing would include the surgical instruments, which are considered to be the worst-case because they are the most difficult to clean [213].…”

Section: Medical Devicesmentioning

confidence: 99%

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

Reifschneider

2018

Preprint

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The U.S. Food and Drug Administration ("FDA") regulates all medical devices in the United States. As part of its regulatory duties, the FDA provides guidance documents on various regulatory topics as mandated by the U.S. code of federal regulations. Since 2015, the FDA has begun to issue many substantial revisions to their guidance documents that directly affects the regulatory framework on biocompatibility, reprocessing, and sterilization.These regulatory issues are of paramount importance for many companies because of the potential high costs involved in changing their internal design, controls, manufacturing, and quality systems. This master’s thesis examines the various changes made by the FDA in recent years on the inter-related topics of biocompatibility, reprocessing, and sterilization. Some of the major changes by the FDA involve an increase in the importance of chemical characterization, a reduction in the use of animal testing, a requirement for an independent validation of the user instructions for reusable devices, and increased usability testing.The principal reasons for these major policy changes by the FDA are shown to be the major device scandals that recently involved duodenoscopes, metal-on-metal hip implants, and vaginal surgical mesh implants. Along with several other regulatory failures that made national news headlines in the United States, the FDA began to revise several of their previous medical device guidances. The information from this master’s thesis can be used by medical device developers and manufacturers, especially when they are located outside of the United States and lack sufficient regulatory affairs resources to provide independent advice and recommendations on these important FDA changes. A thorough analysis is made of the new FDA guidances to clarify several potentially difficult questions for medical device manufacturers, specifically the following: (1) "Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", (2) "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", and (3) "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile". This master’s thesis is intended to provide not only an overview of the current FDA requirements, but to function as a guide for both researchers and engineers to improve their medical device design and development process.

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Computer-aided recording of automatic endoscope washing and disinfection processes as an integral part of medical documentation for quality assurance purposes

Cited by 4 publications

References 6 publications

Analysis of Digital Documentation Speed and Sequence Using Digital Paper and Pen Technology During the Refugee Crisis in Europe: Content Analysis

Analysis of Digital Documentation Speed and Sequence Using Digital Paper and Pen Technology During the Refugee Crisis in Europe: Content Analysis

A RFID-based tracking system of endoscopes

The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices

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