CCE Prep Sample Questions

In this column we are providing sample questions and information regarding preparation for the CCE exam. The sample questions are based on topics from the ACCE Body of Knowledge survey and the CCE Study Guide, version 9. Note that the instructors for the ACCE CCE Prep courses, and the writers for this column, do NOT have any affiliation with the CCE Board of Examiners and have no access to the actual exam questions. If you have specific topics you would like us cover please contact editor@accenet.org.

Sample Questions:

You have been tasked by Medical Center Leadership to investigate if there is a frequency band in the community interfering with your telemetry system. Which organization would be the best to contact?

A. American Hospital Association (AHA) B. The Joint Commission (TJC) C. Federal Communication Commission (FCC) D. Healthcare Information and Management System Society (HIMSS)

Correct Answer: C

Explanation: The Federal Communication Commission (FCC) determines electromagnetic spectrum allocations. There are 3 frequency bands for Wireless Medical Telemetry Service (WMTS) – 608-614 MHz (most commonly used), 1395-1400 MHz, 1427-1432 MHz. It is important as a Clinical Engineer to understand the electromagnetic spectrum allocations to ensure interference with vitally important medical systems does not occur.

References: https://www.fcc.gov/, Accessed 5/17/2021 https://www.fcc.gov/wireless/bureau-divisions/mobility-division/wireless-medical-telemetry-service-wmts, Accessed 5/17/2021 https://www.ashe.org/wmts, Accessed 5/17/2021 Ishida, K., Fujioka, T., Endo, T. et al. Evaluation of Electromagnetic Fields in a Hospital for Safe Use of Electronic Medical Equipment. J Med Syst 40, 46 (2016). https://doi.org/10.1007/s10916-015-0411-3

2. An anesthesia machine failure led to the death of a patient in the Operating Room at Hospital X. You are the Healthcare Technology Manager for Hospital X and asked to provide the 3500A form to the correct entities. Within what timeframe and to which groups do you need to submit this form?

A. FDA & Device Manufacturer – 15 Days B. FDA & Device Manufacturer – 10 Days C. FDA Only – 10 Days D. Device Manufacturer Only – 15 Days

Correct Answer: B

Explanation: The Safe Medical Device Act (SMDA) of 1900 requires user facilities (i.e. hospitals) to report device related deaths to the FDA and device manufacturer within a specific timeframe. This requirement is also a condition of the Joint Commission under EC.6.10 EP7. 10 working days is a required timeframe and the paperwork must be filed by the Healthcare Technology Manager or hospital designee. This process should be done in close contact with the hospital Risk Manager. These medical device reports (MDRs) are stored in an FDA Database called the Manufacturer and User Facility Device Experience (MAUDE). The MAUDE Database is a helpful resource if trying to review trends with specific medical devices or medical device manufacturers or when evaluating a device for purchase.

References:

https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/medicaldevice-reporting-regulation-history, Accessed 5/17/2021 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm, Accessed 5/17/2021

Elena Buckley elena.buckley@va.gov