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
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 repla...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Sciendo
2024-03-01
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| Series: | Arhiv za Higijenu Rada i Toksikologiju |
| Subjects: | |
| Online Access: | https://doi.org/10.2478/aiht-2024-75-3803 |
| _version_ | 1797229596275376128 |
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| author | Dugheri Stefano Cappelli Giovanni Squillaci Donato Rapi Ilaria Fanfani Niccolò Dori Fabrizio Cecchi Michele Sordi Viola Ghiori Andrea Mucci Nicola |
| author_facet | Dugheri Stefano Cappelli Giovanni Squillaci Donato Rapi Ilaria Fanfani Niccolò Dori Fabrizio Cecchi Michele Sordi Viola Ghiori Andrea Mucci Nicola |
| author_sort | Dugheri Stefano |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T15:15:06Z |
| format | Article |
| id | doaj.art-9129218748754337a87d256be5eccbe4 |
| institution | Directory Open Access Journal |
| issn | 1848-6312 |
| language | English |
| last_indexed | 2024-04-24T15:15:06Z |
| publishDate | 2024-03-01 |
| publisher | Sciendo |
| record_format | Article |
| series | Arhiv za Higijenu Rada i Toksikologiju |
| spelling | doaj.art-9129218748754337a87d256be5eccbe42024-04-02T09:28:46ZengSciendoArhiv za Higijenu Rada i Toksikologiju1848-63122024-03-01751415010.2478/aiht-2024-75-3803Evaluation 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 preparationDugheri Stefano0Cappelli Giovanni1Squillaci Donato2Rapi Ilaria3Fanfani Niccolò4Dori Fabrizio5Cecchi Michele6Sordi Viola7Ghiori Andrea8Mucci Nicola9University of Florence, Department of Experimental and Clinical Medicine, Industrial Hygiene and Toxicology Laboratory, Florence, ItalyUniversity of Florence, Department of Experimental and Clinical Medicine, Industrial Hygiene and Toxicology Laboratory, Florence, ItalyUniversity of Florence, Department of Experimental and Clinical Medicine, Industrial Hygiene and Toxicology Laboratory, Florence, ItalyUniversity of Florence, Department of Experimental and Clinical Medicine, Industrial Hygiene and Toxicology Laboratory, Florence, ItalyUniversity of Florence, Department of Experimental and Clinical Medicine, Industrial Hygiene and Toxicology Laboratory, Florence, ItalyAOU Meyer, Health and Safety Service, Florence, ItalyCareggi University Hospital, Pharmacy AD Preparation Unit, Florence, ItalyCareggi University Hospital, Pharmacy AD Preparation Unit, Florence, ItalyCareggi University Hospital, Pharmacy AD Preparation Unit, Florence, ItalyUniversity of Florence, Department of Experimental and Clinical Medicine, Industrial Hygiene and Toxicology Laboratory, Florence, ItalyHealthcare 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.https://doi.org/10.2478/aiht-2024-75-3803acceptable risk levelsfailure mode effects and criticality analysismeasured risk levelsrisk priority numberprihvatljive razine rizikaanaliza pogrešaka i kritičnosti posljedicaizmjerene razine rizikaocjena prioriteta rizika |
| spellingShingle | Dugheri Stefano Cappelli Giovanni Squillaci Donato Rapi Ilaria Fanfani Niccolò Dori Fabrizio Cecchi Michele Sordi Viola Ghiori Andrea Mucci Nicola 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 Arhiv za Higijenu Rada i Toksikologiju acceptable risk levels failure mode effects and criticality analysis measured risk levels risk priority number prihvatljive razine rizika analiza pogrešaka i kritičnosti posljedica izmjerene razine rizika ocjena prioriteta rizika |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | acceptable risk levels failure mode effects and criticality analysis measured risk levels risk priority number prihvatljive razine rizika analiza pogrešaka i kritičnosti posljedica izmjerene razine rizika ocjena prioriteta rizika |
| url | https://doi.org/10.2478/aiht-2024-75-3803 |
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