The intent of USP <800> is to protect staff members who come in contact with hazardous medications. Occupational exposure to hazardous materials can lead to an increased risk of the development of malignancies, and wipe sampling is one way to ensure that current practices minimize unintended exposure.
The chapter states that environmental wipe sampling for hazardous drug (HD) surface residue should be performed routinely—initially as a benchmark, and at least every 6 months, or more often as needed, to verify containment. Note that while sampling every 6 months is the current minimum expectation, each institution should perform its own risk assessment and adjust the timing of wipe sampling accordingly. In order to determine which locations to sample, it is important to involve staff and observe their workflow. Do not concentrate on the pharmacy alone; instead, monitor the entire process from receipt of the drug to administration in the patient areas so that the locations at highest risk of contamination can be identified.
One area to sample is immediately outside of the ISO 5 workspace within the compounding aseptic containment isolator, including the airlock surface, the door latch on the airlock, work surfaces where drug products are staged prior to and immediately after compounding, and the inner and outer door handles of the hazardous drug compounding room. When using biological safety cabinets, our hospital expanded HD surface sampling to nursing areas, such as tray tables used at the bedside and IV pump keypads.
Ronald P. Villamaria, PharmD, is the director of pharmacy at Munson Healthcare Manistee Hospital in Manistee, Michigan.
The ChemoGLO Wipe Kit is an easy-to-use hazardous drug (HD) surface wipe sampling kit that can test 6 different areas. It offers a choice of 24 of the most commonly used HDs, including a panel of the most widely used hormone drugs. Samples ship at room temperature, and reports provide quantified results for each drug selected. The kit is USP <800> compliant and meets USP requirements for medical surveillance guidelines on semi-annual surface wipe testing.
ChemoAlert from Bureau Veritas is a complete surface sampling solution, designed to make it easy to collect samples of hazardous drugs (HDs) to help achieve compliance with USP <800>. The chapter describes how health organizations should manage the risks associated with HD surface contamination, and recommends surface sampling as a way of measuring the effectiveness of their actions. With the ChemoAlert analytical method, users can test for up to 14 HDs from a single sample (including platinum-containing drugs) with a detection limit of 5 ng/sample, including 5-fluorouracil, carboplatin, cisplatin, cyclophosphamide, doxorubicin, epirubicin, etoposide, etoposide phosphate, ifosphamide, irinotecan, methotrexate, oxaliplatin, paclitaxel, and vincristine.
The benefits of ChemoAlert include multiple HD results from a single swab, verified sample integrity during shipping and storage, reliable analytical sensitivity and specificity, verified HD recovery from typical workplace surfaces, and a turnaround time of 10 to 15 business days with optional rush analysis available.
The HD Check System from BD is a rapid detection test for select hazardous drugs (HDs). Able to identify HD surface contamination in less than 10 minutes, the system can reliably deliver easy-to-read results, enabling immediate corrective action. The handheld design makes testing easy and convenient; users can integrate the BD HD Check system into their daily workflow and track contamination levels over time. The system can also help facilities monitor their compliance with aspects of USP <800> and other safe handling guidelines. The BD HD Check system is a quick and reliable solution to detect HD surface contamination and help facilitate routine monitoring in health care institutions.
HDClean from ChemoGLO is a two-step wiping system using presaturated towelettes that effectively decontaminate surface areas by removing hazardous drug (HD) surface contamination. HDClean towelettes are laboratory tested and proven to remove HDs from surfaces. The wipes are sterile, have no overpowering odor, and clean up to an 8 square-foot area; in addition, the system is USP <800> compliant and meets the requirements for USP <800> presaturated decontamination wipes for use in preparation and administration areas.
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