This document defines University Information Services (UIS) support for Biomedical Devices. Support for general-purpose computers and software, even when used for medical purposes, is covered under our Service Level Agreement for Computer & Software Support.
Definitions
Departmental Subject Matter Expert is the employee of the clinic using a biomedical device that is generally the expert on and responsible for that device. Typically the Subject Matter Expert is named when a Security Review and Agreement is signed, although that responsibility can be transferred between employees. In absence of such a document, the SME is generally the faculty or staff member most knowledgeable about the use of a given device. When an SME leaves the university or transitions to a new position, clinic management should assign that job duty to a new employee. (UIS suggests that vendors be given a generic clinic email address as a second contact to facilitate the change of vendor relationships when this job duty is transitioned to a new employee.)
Responsibilities
The responsibilities of UIS and the Departmental Subject Matter Expert are enumerated in the Security Review and Agreement that is signed when a new piece of biomedical technology is onboarded. In absence of specific guidance from the Security Review Agreement, however, responsibilities are generally as follows:
| Departmental Subject Matter Expert |
University Information Services |
| Maintain contact information for device vendor and manufacturer. Maintain information on warranties or support contracts. |
Asset tag devices and maintain entries in the UIS-maintained technology database. |
| Assist UIS in obtaining security information from vendor for security evaluation. |
Perform security evaluation for new devices. |
| Maintain information about the function, operation and established protocols for use of the device, and provide training on these for new users of the device |
Maintain information about how the device connects to other UIS-maintained technologies (e.g. network connection, connection to Harmony, connection to Optos Cloud Backup). |
| Schedule routine maintenance or recalibration as needed for the device (typically defined in the device's manual). |
Assist as needed with maintenance or recalibration. |
| Identify when software or firmware updates may be needed, based on recommendations from the manufacturer. (Typically vendors will email the Pacific purchaser of a device with patches for emergent security issues.) Create help tickets for these updates when needed. |
Perform software or firmware updates (when not performed by the vendor as part of normal service and support). Perform routine updates/patching of UIS supported standard software and operating systems. |
| Submit help tickets for hardware failures to the equipment manufacturer/vendor and/or to UIS. Order and pay for service calls when needed. Be present during service calls to provide access (in person or via remote support technologies) to the device. |
Provide a first look evaluation of technical issues (problem "triage") to determine what kind of issue is happening and if vendor support is suggested. Act as technical contact with the manufacturer/vendor on a help ticket. Attempt equipment repairs in some situations (see below). |
| Move biomedical devices (or arrange with Facilities for biomedical devices to be moved). |
Reconnect devices to the network after a move. Update technology property database records. |
| Work with clinic leadership to determine if a device is functioning well enough to be used in patient care. |
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Problem Triage Process for Biomedical Devices
Generally, the process for repair of a device would work as follows:
- Program staff notices a problem or error, reports it to SME for the device.SME checks to see if this is a known issue or user error.
- If not, creates a help ticket for UIS (using the "Request support for Biomedical Equipment or Clinical Imaging Systems" form).
- UIS staff checks the device, attempts basic troubleshooting, and if unable to fix the problem reports back to the SME with a preliminary diagnosis and recommendation.
- If needed, SME contacts the External Vendor for support, including UIS staff as a technical contact on the help request.
UIS Hardware Service for Biomedical Devices
UIS technicians are not generally trained in or qualified to do repairs to biomedical devices. Attempting to repair a biomedical device may void a warranty or support contract. UIS may attempt to repair a device if:
- Support from the vendor or manufacturer is no longer an option.
- University (ex. College of Optometry, College of Healthcare Professionals, Athletics) administration confirms that an attempted repair by a technician who is not a specialist in biomedical device hardware repair will not create any risks to patients (e.g. from a device that was put back together incorrectly providing incorrect readings).
- The device doesn't have any warnings about hazardous materials or components (e.g. radioactive materials, high-voltage capacitors).
Hardware repairs for biomedical devices are classed as "Partially Supported" which UIS defines as follows:
"These are technologies that UIS is not able to fully support .... We will only provide support in as much as doing so does not interfere with our ability to support Fully Supported technology."
UIS strongly recommends that departments purchase the longest extended warranty available for all new biomedical devices. Warranty coverage is encouraged to help limit or prevent unexpected costs if an issue arises requiring technology support from the manufacturer of the device.
Support for Scientific Instrumentation
UIS support for scientific instrumentation is similar to the support for biomedical devices described above. In some cases, scientific research may use the same devices as clinics use for patient care. As patient care is not directly impacted by service issues with scientific instrumentation, UIS support levels may be lower and response timelines may be longer for scientific instrumentation. As with biomedical devices, Departmental Subject Matter Experts for scientific instrumentation are best positioned to be able to interface with vendors, perform regular maintenance or recalibration, identify needed updates, and answer questions about the purpose and use of these devices.
See Also
Biomedical Instrumentation and Clinical Imaging Systems
Purchasing a Biomedical Device of Instrument
Biomedical Device Policy Procedures
Questions?
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