Measurement of ethylene oxide at a medical sterilization site.

Asakawa, Fumiyuki; Jitsunari, Fumihiko; Suna, Shigeru; Manabe, Yoshiki; Fukunaga, Ichiro; Takeda, Noriaki

doi:10.1539/joh1959.35.413

Cited by 5 publications

(4 citation statements)

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“…According to OSHA substance safety data sheet for ethylene oxide [25], workers who carry out the unloading task need to wear oxygen mask to protect them from exposing to ethylene oxide gas. Similar results were obtained by a team of researchers in the measurement of ethylene oxide at one of medical sterilization sites in Japan [26].…”

Section: As Shown Insupporting

confidence: 84%

Laboratory Validation and Field Verification of Silica Gel Sampling Tube for Measuring Ethylene Oxide in Air

Chong¹,

Ibrahim²,

Goh³

2012

MJS

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A sampling and analytical method for the measurement of ethylene oxide (EtO) level in air was developed. The procedure was based on the entrapment of ethylene oxide in an activated silica gel adsorbent inside a sampling tube. The ethylene oxide was desorbed by distilled water and the eluent was analyzed by gas chromatography with flame ionization detector. Parameters such as breakthrough volume, method detection limit, desorption efficiency and storage tests for 14 days in ambient temperature and refrigerator were determined. Field samplings were performed at two factories in Kulim and Pulau Pinang respectively, which use ethylene oxide gas as sterilization substance. The desorption efficiency of ethylene oxide from silica gel tube was determined to be 87.8% over concentration range of 0.2 -4.0 ppm in 3 liters of air sample. The method detection limit was determined to be 1.0 ppm whereas the precision of procedure was 10.7%. All the parameters were shown to be meeting OSHA requirements. ABSTRAKSatu kaedah persampelan dan analisis untuk mengukur tahap etilena oksida dalam udara telah dibangunkan. Prosedur ini berasaskan pemerangkapan etilena oksida dalam penjerap gel silika yang telah diaktifkan dalam suatu tiub persampelan. Etilena oksida telah didejerap dengan menggunakan air suling dan eluen tersebut dianalisis dengan gas kromatografi yang dielengkapi dengan pengesan pengionan nyala. Parameter seperti keberkesanan pendejerapan etilena oksida daripada tiub silika, isipadu penembusan, had pengesanan kaedah, keberkesanan pendejerapan dan ujian penyimpanan selama 14 hari pada suhu ambien (27 0 C) dan suhu peti sejuk (4 0 C) telah ditentukan. Persampelan lapangan telah dilakukan di dua buah kilang masing-masing di kulim dan Penang yang menggunakan etilena oksida sebagai bahan pensterilan. Keberkesanan pendejerapan etilena dioksida daripada tiub gel silica telah ditentukan sebagai 87.8 % pada julat kepekatan 0.2-4.0 ppm untuk tiga liter sampel udara. Had pengesanan kaedah telah ditentukan sebagai 1.0 ppm manakala kejituan prosedur adalah 10.7 %. Semua parameter yang dikaji menunjukkannya memenuhi syarat OSHA.

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Section: As Shown Insupporting

confidence: 84%

Laboratory Validation and Field Verification of Silica Gel Sampling Tube for Measuring Ethylene Oxide in Air

Chong¹,

Ibrahim²,

Goh³

2012

MJS

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“…These residues are potentially toxic, mutagenic, and carcinogenic substances 3–6. Therefore, it is imperative to remove them from the devices to avoid adverse effects in patients.…”

Section: Introductionmentioning

confidence: 99%

Sterilization of medical devices by ethylene oxide, determination of the dissipation of residues, and use of Green Fluorescent Protein as an indicator of process control

Dias

Ishii

Nogaroto³

et al. 2009

J Biomed Mater Res

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Ethylene oxide (EO) is used to sterilize Oxygenator and Tubing applied to heart surgery. Residual levels of EO and its derivatives, ethylene chlorohydrin (ECH) and ethylene glycol (EG), may be hazardous to the patients. Therefore, it must be removed by the aeration process. This study aimed to estimate the minimum aeration time for these devices to attain safe limits for use (avoiding excessive aeration time) and to evaluate the Green Fluorescent Protein (GFP) as a biosensor capable of best indicating the distribution and penetration of EO gas throughout the sterilization chamber. Sterilization cycles of 2, 4, and 8 h were monitored by Bacillus atrophaeus ATCC 9372 as a biological indicator (BI) and by the GFP. Residual levels of EO, ECH, and EG were determined by gas chromatography (GC), and the residual dissipation was studied. Safe limits were reached right after the sterilization process for Oxygenator and after 204 h of aeration for Tubing. In the 2 h cycle, the GFP concentration decreased from 4.8 (63.2)% to 7.5 (62.5)%. For the 4 h cycle, the GFP concentration decreased from 17.4 (63.0)% to 21.5 (66.8)%, and in the 8 h cycle, it decreased from 22.5 (63.2)% to 23.9 (63.9)%. This finding showed the potentiality for GFP applications as an EO biosensor. '

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“…(15) In this study, the environmental concentrations and the personal exposure levels of EO in six workplaces of ve hospitals were measured to understand the actual working conditions of the EO gas sterilization process in Japan and make comparisons with reported data. Based on the results, countermeasures to reduce environmental EO concentration and personal exposure levels are discussed.…”

mentioning

confidence: 99%

Personal Exposure Level and Environmental Ethylene Oxide Gas Concentration in Sterilization Facilities of Hospitals in Japan

Hori

Yahata

Fujishiro

et al. 2002

Applied Occupational and Environmental Hygiene

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Personal and environmental (stationary) ethylene oxide (EO) gas concentrations in gas sterilization facilities were measured at six workplaces in five hospitals. An ethylene oxide gas monitor (3M #3551) was used for both personal and stationary samplings. A gas detector tube was also used for instantaneous sampling. In most workplaces, the personal exposure levels of EO were below the detection limit of the gas monitor. Most of the time-weighted average (TWA) concentrations by the stationary sampling were below the threshold limit value of EO (TLV-TWA = 1 ppm), but in one workplace, more than 4 ppm of EO were detected in front of the sterilizer in a clean room during a 24-hour measurement, although all the personal exposure levels were below the detection limit. Method of aeration after the sterilization was very important for reducing the EO exposure. The EO gas concentrations in two workplaces where sufficient aeration was carried out were below the detection limit in all the stationary samples. In one workplace where insufficient aeration was performed, EO was detected from 16 of 17 stationary samples, and more than 90-200 ppm of EO was determined by the gas detector tube near the worker's face at the moment when the door of the sterilizer was opened and the sterilized materials were removed.

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Measurement of ethylene oxide at a medical sterilization site.

Cited by 5 publications

References 0 publications

Laboratory Validation and Field Verification of Silica Gel Sampling Tube for Measuring Ethylene Oxide in Air

Laboratory Validation and Field Verification of Silica Gel Sampling Tube for Measuring Ethylene Oxide in Air

Sterilization of medical devices by ethylene oxide, determination of the dissipation of residues, and use of Green Fluorescent Protein as an indicator of process control

Personal Exposure Level and Environmental Ethylene Oxide Gas Concentration in Sterilization Facilities of Hospitals in Japan

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