Greetings,

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 medical
devices (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 result
listed 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 laboratory
information 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 collection
had 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 patient
safety related to Healthcare Information Technology/Systems, the MedSun
program 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) 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 e-mail to the appropriate personnel
including: Nurse Managers, Informatics Nurses, IT professionals, Biomedical
Engineers, Risk Management/Quality Departments, Hospital Executives, etc.
• If you, or anyone on your staff, has questions about what types of issues we are
interested 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 a
problem by phone to us about Healthcare Information Technology/Systems,
instead of using the MedSun software, please call Chuck and he will be happy to
take the report over the phone.
Thank you, as always, for your participation in our MedSun program. You are the
voice of the clinical community to our Center within FDA about the use of medical
devices!
Sincerely,

Marilyn Flack
Director, Division of Patient Safety Partnerships
Office of Surveillance and Biometrics
Center for Devices and Radiological Health
Food and Drug Administration
The MedSun Program