Skip to main content
Log in

Implementing a new scale for failure mode and effects analysis (FMEA) for risk analysis in a radiation oncology department

  • Original Article
  • Published:
Strahlentherapie und Onkologie Aims and scope Submit manuscript

Abstract

Purpose

Patients and staffs are endangered by different failure modes during clinical routine in radiation oncology and risks are difficult to stratify. We implemented the method of failure mode and effects analysis (FMEA) via questionnaires in our institution and introduced an adapted scale applicable for radiation oncology.

Methods

Failure modes in physical treatment planning and daily routine were detected and stratified by ranking occurrence, severity, and detectability in a questionnaire. Multiplication of these values offers the risk priority number (RPN). We implemented an ordinal rating scale (ORS) as a combination of earlier published scales from the literature. This scale was optimized for German radiation oncology. We compared RPN using this ORS versus use of a rather subjective visual analogue rating scale (VRS).

Results

Mean RPN using ORS was 62.3 vs. 67.5 using VRS (p = 0.7). Use of ORS led to improved completeness of questionnaires (91 vs. 79%) and stronger agreement among the experts, especially concerning failure modes during radiation routine. The majority of interviewed experts found the analysis by using the ORS easier and expected a saving of time as well as higher intra- and interobserver reliability.

Conclusion

The introduced rating scale together with a questionnaire survey provides merit for conducting FMEA in radiation oncology as results are comparable to the use of VRS and the process is facilitated.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

References

  1. Steiniger B, Berger R, Eilzer S et al (2017) Patient-related quality assurance with different combinations of treatment planning systems, techniques, and machines : A multi-institutional survey. Strahlenther Onkol 193:46–54. https://doi.org/10.1007/s00066-016-1064-y

    Article  PubMed  Google Scholar 

  2. Guckenberger M, Baus WW, Blanck O et al (2020) Definition and quality requirements for stereotactic radiotherapy: consensus statement from the DEGRO/DGMP Working Group Stereotactic Radiotherapy and Radiosurgery. Strahlenther Onkol. https://doi.org/10.1007/s00066-020-01603-1

    Article  PubMed  PubMed Central  Google Scholar 

  3. Kriz J, Baues C, Engenhart-Cabillic R et al (2017) New quality assurance program integrating “modern radiotherapy” within the German Hodgkin Study Group. Strahlenther Onkol 193:100–108. https://doi.org/10.1007/s00066-016-1048-y

    Article  CAS  PubMed  Google Scholar 

  4. Bundesministerium der Justiz und für Verbraucherschutz (2018) 126 Risikoanalyse vor Strahlenbehandlungen. In: Verordnung zum Schutz vor der schädlichen Wirkung ionisierender Strahlung

    Google Scholar 

  5. DIN EN 60812:2015-08 (2015) Fehlzustandsart- und -auswirkungsanalyse (FMEA) (IEC 56/1579/CD:2014)

  6. Huq MS, Fraass BA, Dunscombe PB et al (2016) The report of Task Group 100 of the AAPM: application of risk analysis methods to radiation therapy quality management. Med Phys 43:4209. https://doi.org/10.1118/1.4947547

    Article  PubMed  PubMed Central  Google Scholar 

  7. (2015) General guidelines on risk management in external beam radiotherapy. In: EC Radiation Protection report 181. Luxemburg

  8. (2015) Empfehlungen von BfS, DEGRO, DGMP und DGNzur Risikoanalyse bei therapeutischen Strahlenanwendungennach Artikel 63 Buchstabe b der EU-Direktive 2013/59/Euratom

  9. Ford EC, Gaudette R, Myers L et al (2009) Evaluation of safety in a radiation oncology setting using failure mode and effects analysis. Int J Radiat Oncol Biol Phys 74:852–858. https://doi.org/10.1016/j.ijrobp.2008.10.038

    Article  PubMed  PubMed Central  Google Scholar 

  10. Frewen H, Brown E, Jenkins M, O’Donovan A (2018) Failure mode and effects analysis in a paperless radiotherapy department. J Med Imaging Radiat Oncol 62:707–715. https://doi.org/10.1111/1754-9485.12762

    Article  PubMed  Google Scholar 

  11. Yang F, Cao N, Young L et al (2015) Validating FMEA output against incident learning data: a study in stereotactic body radiation therapy. Med Phys 42:2777–2785. https://doi.org/10.1118/1.4919440

    Article  CAS  PubMed  Google Scholar 

  12. Perks JR, Stanic S, Stern RL et al (2012) Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy. Int J Radiat Oncol Biol Phys 83:1324–1329. https://doi.org/10.1016/j.ijrobp.2011.09.019

    Article  PubMed  Google Scholar 

  13. Dietzel CT, Jablonska K, Niyazi M et al (2018) Quality of training in radiation oncology in Germany: where do we stand? : Results from a 2016/2017 survey performed by the working group “young DEGRO” of the German society of radiation oncology (DEGRO). Strahlenther Onkol 194:293–302. https://doi.org/10.1007/s00066-017-1250-6

    Article  CAS  PubMed  Google Scholar 

  14. Zurl B, Bayerl A, De Vries A et al (2018) ÖGRO survey on radiotherapy capacity in Austria : status quo and estimation of future demands. Strahlenther Onkol 194:284–292. https://doi.org/10.1007/s00066-017-1240-8

    Article  PubMed  Google Scholar 

  15. Rah J‑E, Manger RP, Yock AD, Kim G‑Y (2016) A comparison of two prospective risk analysis methods: traditional FMEA and a modified healthcare FMEA. Med Phys 43:6347. https://doi.org/10.1118/1.4966129

    Article  PubMed  Google Scholar 

  16. Ogrinc G, Davies L, Goodman D et al (2016) SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf 25:986–992. https://doi.org/10.1136/bmjqs-2015-004411

    Article  PubMed  Google Scholar 

  17. Schuller BW, Burns A, Ceilley EA et al (2017) Failure mode and effects analysis: a community practice perspective. J Appl Clin Med Phys 18:258–267. https://doi.org/10.1002/acm2.12190

    Article  PubMed  PubMed Central  Google Scholar 

  18. Vorwerk H, Zink K, Schiller R et al (2014) Protection of quality and innovation in radiation oncology: the prospective multicenter trial the German Society of Radiation Oncology (DEGRO-QUIRO study). Evaluation of time, attendance of medical staff, and resources during radiotherapy with IMRT. Strahlenther Onkol 190:433–443. https://doi.org/10.1007/s00066-014-0634-0

    Article  CAS  PubMed  Google Scholar 

  19. Schnürch H‑G, Ackermann S, Alt-Radtke CD et al (2019) Diagnosis, Therapy and Follow-up of Vaginal Cancer and Its Precursors. Guideline of the DGGG and the DKG (S2k-Level, AWMF Registry No. 032/042, October 2018). Geburtshilfe Frauenheilkd 79:1060–1078. https://doi.org/10.1055/a-0919-4959

    Article  PubMed  PubMed Central  Google Scholar 

  20. Sawant A, Dieterich S, Svatos M, Keall P (2010) Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems. Med Phys 37:6466–6479. https://doi.org/10.1118/1.3517837

    Article  PubMed  PubMed Central  Google Scholar 

  21. Younge KC, Wang Y, Thompson J et al (2015) Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery. Int J Radiat Oncol Biol Phys 91:1003–1008. https://doi.org/10.1016/j.ijrobp.2014.12.033

    Article  PubMed  Google Scholar 

  22. Ford EC, Smith K, Terezakis S et al (2014) A streamlined failure mode and effects analysis. Med Phys 41:61709. https://doi.org/10.1118/1.4875687

    Article  PubMed  Google Scholar 

  23. Huq MS, Fraass BA, Dunscombe PB et al (2008) A method for evaluating quality assurance needs in radiation therapy. Int J Radiat Oncol Biol Phys 71:S170–S173. https://doi.org/10.1016/j.ijrobp.2007.06.081

    Article  PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Andrea Baehr.

Ethics declarations

Conflict of interest

A. Baehr, M. Oertel, K. Kröger, H.T. Eich and U. Haverkamp declare that they have no competing interests.

Ethical standards

For this article, no studies on animals or human participants were performed by any of the authors. All studies perfomed were in accordance with the ethical standards indicated in each case. Informed consent was obtained from all individual participants included in the study.

Caption Electronic Supplementary Material

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Baehr, A., Oertel, M., Kröger, K. et al. Implementing a new scale for failure mode and effects analysis (FMEA) for risk analysis in a radiation oncology department. Strahlenther Onkol 196, 1128–1134 (2020). https://doi.org/10.1007/s00066-020-01686-w

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00066-020-01686-w

Keywords

Navigation