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. 2024 Mar 29;75(1):41-50.
doi: 10.2478/aiht-2024-75-3803. eCollection 2024 Mar 1.

Evaluation of the risk of occupational exposure to antineoplastic drugs in healthcare sector: part II - the application of the FMECA method to compare manual vs automated preparation

Stefano Dugheri  1 , Giovanni Cappelli  1 , Donato Squillaci  1 , Ilaria Rapi  1 , Niccolò Fanfani  1 , Fabrizio Dori  2 , Michele Cecchi  3 , Viola Sordi  3 , Andrea Ghiori  3 , Nicola Mucci  1
Affiliations

Evaluation of the risk of occupational exposure to antineoplastic drugs in healthcare sector: part II - the application of the FMECA method to compare manual vs automated preparation

Stefano Dugheri et al. Arh Hig Rada Toksikol. .

Abstract
in English, Croatian

Healthcare workers handling antineoplastic drugs (ADs) in preparation units run the risk of occupational exposure to contaminated surfaces and associated mutagenic, teratogenic, and oncogenic effects of those drugs. To minimise this risk, automated compounding systems, mainly robots, have been replacing manual preparation of intravenous drugs for the last 20 years now, and their number is on the rise. To evaluate contamination risk and the quality of the working environment for healthcare workers preparing ADs, we applied the Failure Mode Effects and Criticality Analysis (FMECA) method to compare the acceptable risk level (ARL), based on the risk priority number (RPN) calculated from five identified failure modes, with the measured risk level (MRL). The model has shown higher risk of exposure with powdered ADs and containers not protected by external plastic shrink film, but we found no clear difference in contamination risk between manual and automated preparation. This approach could be useful to assess and prevent the risk of occupational exposure for healthcare workers coming from residual cytotoxic contamination both for current handling procedures and the newly designed ones. At the same time, contamination monitoring data can be used to keep track of the quality of working conditions by comparing the observed risk profiles with the proposed ARL. Our study has shown that automated preparation may have an upper hand in terms of safety but still leaves room for improvement, at least in our four hospitals.

Zdravstveni radnici koji rukuju antineoplastičnim lijekovima u posebnim jedinicama za njihovu pripremu izlažu se zagađenim površinama i riziku od s njima povezanim mutagenim, teratogenim i onkogenim učincima. Da bi se smanjio taj rizik, u posljednjih se 20-ak godina ručna priprema intravenskih lijekova sve više zamjenjuje automatiziranom. Da bismo ocijenili rizik od zagađenja i kakvoću radnog okoliša zdravstvenih radnika koji pripremaju antineoplastične lijekove, oslonili smo se na metodu analize mogućih pogrešaka u postupcima i kritičnosti njihovih posljedica (engl. failure mode effects and criticality analysis, krat. FMECA) radi usporedbe prihvatljive razine rizika (engl. acceptable risk level, krat. ARL), koja je zbroj ocjena prioriteta rizika (eng. risk priority number, krat. RPN) pet utvrđenih načina pogreške s izmjerenom razinom rizika (engl. measured risk level, krat. MRL). Taj nam je model pokazao da antineoplastični lijekovi u prahu i spremnicima koji nisu zaštićeni vanjskim plastičnim omotačem donose povećani rizik, ali nismo utvrdili dosljednu razliku u riziku od zagađenja između ručne i automatizirane pripreme. Ovaj pristup može biti koristan u procjeni i kontroli rizika od profesionalne izloženosti u zdravstvenih radnika rezidualnim citotoksičnim spojevima, bilo da se radi o postojećim ili tek planiranim/novoosmišljenim postupcima pripreme lijekova. Podatci dobiveni redovitim nadzorom (monitoringom) istodobno mogu poslužiti za praćenje kakvoće radnih uvjeta tako što će se usporediti s predviđenim profilom rizika koji je utvrđen ARL-om. Iako je naše istraživanje pokazalo da automatizirana priprema ima prednost nad ručnom u smislu sigurnosti, prostora za njezino poboljšanje ima podosta, naročito u našim četirima bolnicama koje su sudjelovale u istraživanju.

Keywords: acceptable risk levels; analiza pogrešaka i kritičnosti posljedica; failure mode effects and criticality analysis; izmjerene razine rizika; measured risk levels; ocjena prioriteta rizika; prihvatljive razine rizika; risk priority number.

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Figures

Figure 1
Figure 1
FMECA analysis and the Acceptable Risk Level estimation process
Figure 2
Figure 2
Ishikawa diagram of failure modes
Figure 3
Figure 3
Risk levels strip for MRL comparison with ARL
See this image and copyright information in PMC

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