What is Quality Assurance?

Quality Assurance (also known as QA) of medical displays is the process of monitoring, managing, and reporting on the status of all medical displays throughout a hospital enterprise. In most hospitals, quality assurance is the responsibility of the QA administrator or PACS manager.

Compliance with medical standards

Countries around the world have defined standards to regulate quality control and compliance of medical displays. Ensuring compliance with these standards is an important and complicated aspect within the QA process. 

Even though in many regions (e.g. Western Europe, North America and Japan), medical standards have been in place for years, they are becoming stricter. In Germany, for example, the new DIN standard (DIN 6868-157) defines strict requirements based on how (use cases) and where (room classes based on the level of ambient light) medical displays are used. 

At the same time, other regions, such as Central and Eastern Europe, the Middle East and countries in Africa and across Latin America are starting to define and enforce similar guidelines. Initiatives such as the Standards Alliance Project to promote regulatory practices in Latin America clearly demonstrate this evolution.

Which standards are in place?

  • Safety standards: e.g. CE, EMI, FCC, VCCI, UL, and IEC 
  • Environmental standards: e.g. RoHS, WEEE, REACh 
  • Standards for Quality Assurance: e.g. AAPM, ACR, SIIM, The Joint Commission, DICOM, DIN, EUREF, MQSA, JESRA, AdvaMed
  • Regulatory compliance: e.g. MDD, FDA

Challenges for QA admins and PACS administrators

Hospital consolidation 

Today’s healthcare systems are spread out across a large, geographically dispersed enterprise. One hospital can have multiple inpatient campuses and various sites with specialized clinical departments. This is driven by the need for consolidation of hospitals in order to control the long-term cost of care. The question is: how do you consistently manage the quality of IT systems and devices across these separate locations? 

Number of workstations 

With hospital consolidation comes an increase in the number of medical workstations to manage. In healthcare IT, the time spent on managing display quality is continuously increasing.
  

Reporting 

As the healthcare industry is heavily governed and regulated, reporting and auditing are inherent to the process of quality assurance (QA). In healthcare IT, PACS managers and QA admins spend more and more time on documenting and creating reports. 

Compliance 

For PACS admins and QA managers, it’s hard to keep up with changing regulatory and reporting requirements. For consolidated healthcare systems with multiple facilities medical compliance is an even bigger hurdle, as there can be differences between regions. 

Security 

New trends, such as home working, telemedicine and Bring-your-own-device (BYOD) are making quality assurance of medical display systems more complex.

How to simplify quality assurance of medical displays? Read more.

Conclusion

To deal with the challenge of managing quality and compliance of medical displays, QA administrators and PACS managers need a scalable and automated solution to handle quality assurance. Even though most medical display vendors offer QA tools, there can be differences in functionality. 

A good QA solution should use integrated technology to manage image consistency over time; it should allow management of all displays centrally and remotely to avoid manual intervention; it should assure compliance and generate the needed reports to prepare for audits; and ultimately, it should have self-healing and automatic reporting capabilities. Only then continuous uptime of all medical displays and compliance with set medical regulations can be guaranteed.

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