FDA reaches out on Usability of EHRs

The use of Healthcare Information Technology/Systems continues to grow and affect patient care and patient safety. In efforts to support a safe environment, the FDA's MedSun program is exploring problems related to Healthcare Information Technology/Systems that may affect patient safety.These problems may be detected within the hospital environment by IT/IS professionals, end-users, super-users, management or others.

The scope of Healthcare Information Technology/Systems includes the Electronic Health Record, CPOE, Laboratory Information Systems,Pharmacy Information Systems, Radiology Information Systems,Anesthesia/OR Information Systems, PACS, etc., as well as medicaldevices (ex. Monitoring equipment) used with the hospital’s IT infrastructure, hand held devices and PDA’s.

Examples of problems include,but are not limited to, down time issues, data corruption (ex. Patient A’s resultlisted under Patient B’s record), Human factors issues, usability issues,interfacing issues, system support/upgrade issues, etc.

Examples of reported problems we have learned about concerning Healthcare Information Technology/Systems:
• An ED management software package where a lab test ordered for one patient,returned the results for another. The report involved interfaces between the ED management software, the hospital’s core information system, and the laboratoryinformation system or LIS, all from different vendors. A software patch provided by the manufacturer of the ED management system solved the problem.
• A complaint from a MedSun participating hospital that an OR management and charting application software package frequently “locked up” during the course of a surgical procedure, although it was not evident to the user that data collectionhad ceased. At the end of the surgical procedure, surgical procedure notes were incomplete – compromising the accuracy of the data as nurses had to manually re-enter from memory many of the surgical notes.
• A Computed Radiography workstation which became extremely slow, delaying procedures and causing X-ray techs to subject patients to repeat X-rays. The cause was determined to be an issue with the workstation in which it developed these problems if a specific field in the patient work-list exceeds a certain number of characters.

Next Steps: In efforts to increase our effectiveness in ensuring patientsafety related to Healthcare Information Technology/Systems, the MedSunprogram seeks to raise awareness in this area and invite our MedSun sitesto participate in reporting these issues:

• As we collect reported problems, we will make them available (de-identified) on our MedSun web site,http://www.fda.gov/cdrh/medsun, as well as to you in the monthly pdf Newsletter file we send. That way, all may learn from the types of problems being reported.• We ask that you please forward this to the appropriate personnel including: Nurse Managers, Informatics Nurses, IT professionals, BiomedicalEngineers, Risk Management/Quality Departments, Hospital Executives, etc.


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