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Greetings,

The use ofHealthcare Information Technology/Systems continues to growand affect patient care and patient safety. In efforts to support a safeenvironment, the FDA's MedSun program is exploring problems related toHealthcare 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 theElectronic 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 hospitals ITinfrastructure, hand held devices and PDAs. Examples of problems include,but are not limited to, down time issues, data corruption (ex. Patient As resultlisted under Patient Bs record), Human factors issues, usability issues,interfacing issues, system support/upgrade issues, etc.

Examples of reported problems we have learned about concerningHealthcare 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 EDmanagement software, the hospitals core information system, and the laboratoryinformation system or LIS, all from different vendors. A software patch providedby the manufacturer of the ED management system solved the problem.

A complaint from a MedSun participating hospital that an OR management andcharting application software package frequently locked up during the course ofa surgical procedure, although it was not evident to the user that data collectionhad ceased. At the end of the surgical procedure, surgical procedure notes wereincomplete compromising the accuracy of the data as nurses had to manuallyre-enter from memory many of the surgical notes.

A Computed Radiography workstation which became extremely slow, delayingprocedures and causing X-ray techs to subject patients to repeat X-rays. Thecause was determined to be an issue with the workstation in which it developed

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these problems if a specific field in the patient work-list exceeds a certain numberof 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 sites

to participate in reporting these issues:

As we collect reported problems, we will make them available (de-identified) onour MedSun web site, http://www.fda.gov/cdrh/medsun, as well as to you in themonthly pdf Newsletter file we send. That way, all may learn from the types ofproblems being reported.

We ask that you please forward this e-mail to the appropriate personnelincluding: Nurse Managers, Informatics Nurses, IT professionals, BiomedicalEngineers, Risk Management/Quality Departments, Hospital Executives, etc.

If you, or anyone on your staff, has questions about what types of issues we areinterested in, or if you want to learn more about this effort, please call Chuck

McCullough at . Also, if you, or your staff, wishes to report aproblem by phone to us about Healthcare Information Technology/Systems,instead of using the MedSun software, please call Chuck and he will be happy totake the report over the phone.

Thank you, as always, for your participation in our MedSun program. You are thevoice of the clinical community to our Center within FDA about the use of medicaldevices!

Sincerely,

Marilyn Flack

Director, Division of Patient Safety PartnershipsOffice of Surveillance and BiometricsCenter for Devices and Radiological HealthFood and Drug Administration

The MedSun Program