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ISOPP specifies that only “Airtight” and “Leakproof” devices prevent chemical contamination:
- a product described as a closed-system must be “leakproof and airtight”—therefore vented, filtered devices are not closed. A product cannot be “semi-closed;”
- filters with a diameter of 0.22 mm and HEPA filters DO NOT retain the vapor of cytotoxic products;
- to avoid confusion, it is strongly recommended that if a device claims to prevent chemical contamination it should be airtight and leakproof.
ISOPP stipulates that all manufacturers of transfer and administrative devices for chemotherapy should disclose the following to potential users of these products:
- whether the device covers all steps in the preparation process and in which routes of administration the containment is guaranteed. If the device covers only some of the steps, the manufacturer should clearly indicate where the closed properties are not retained;
- if the device retains its closed characteristics when more than one vial is used for a particular preparation (i.e. over multiple manipulations);
- studies that show that the device eliminates or reduces contamination in daily practice, can retain its closed characteristics when more than one preparation or administration is performed and to what degree.
To prevent exposure to hazardous drugs, ISOPP has created the following Hierarchic Order of Protection. It is imperative that the sequence of protection starts with Level 1 and ends at Level 4 (top to bottom):
Level 1: Elimination, substitution, replacement Level 2: Isolation of the hazard/source containment (i.e. a CSTD) Level 3: Engineering controls/ventilation Level 3B: Administrative controls/organization methods Level 4: Personal Protective Equipment (PPE)
Source: ISOPP Standards of Practice. Journal of Oncology Pharmacy Practice. 2007; 13 Suppl: 1-81. View: ISOPP Homepage
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