PACS: An Ounce of Investment in Your Patients.

20 Dec

PACS: An Ounce of Investment in Your Patients.

All of our medical devices clients are being made aware about the importance of PACS from the FDA as well as patients point of view. Medical device companies should be aware that PACS (Picture Archiving and Communicating System) is not only about investing in the technology but also in the health and well being of the patients. As per Section 900.12(c) (4) (i) of the MQSA final regulations, if the facility fails to maintain the PACS, FDA may take compliance action against the facility.

Proper maintenance of PACS can help the facility to save money. For proper maintenance and upkeep of PACS a facility should have a proper backup system available with well trained staff on how to perform the backup. The software should be always up to date and the manufacturers requirements about the hardware should be followed.

If your PACS malfunctions or fails, in addition to reporting it to the MQSA Facility Hotline, you must report it to the PACS manufacturer, and also make a Medical Device Problem Report to the FDA. Please see the FDA web page Medical Device Reporting (MDR) for instructions and more details.

? Email us at [email protected] for more information and further guidance about this new development from the FDA and Ref: PACS: An ounce of Prevention…

PACS: An Ounce of Investment in Your Patients.