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1.
PDA J Pharm Sci Technol ; 59(3): 200-5, 2005.
Article in English | MEDLINE | ID: mdl-16048119

ABSTRACT

The sterilizing agent commonly used to sterilize materials for an isolator is a peracetic acid (PA) and hydrogen peroxide (HP) mixture. The permeation of this agent through ambulatory pumps should reveal a potential toxic risk for the patient and a stability modification of the drug by a pH change. Six wrapped and six unwrapped ambulatory pumps from each laboratory were introduced in the transfer chamber for the sterilizing process over 2 h 45 min. The presence of PA and HP were determined by using analytical strips. If the analytical strips of HP were positive, the level of HP was determined by using a specific spectrometric kit. No acid permeation was found in all wrapped pumps. Acid permeation was found in two samples of Ultraflow unwrapped series and in one unwrapped sample of Easypump series by the analytical strips. In other unwrapped samples, no acid permeation was detected. In four unwrapped ambulatory pumps (Accufuser, Infusor, Ultraflow, and Easypump), the analytical strips of HP were positive in the range of 0.5 to 25 mg/L, varying by laboratory. In only one sample (Surefuser), no detection of HP was found. The quantitative dosage of HP by spectrophotometry confirmed the permeation risk inside all pumps except the Surefuser. Our investigation shows that the permeation risk inside ambulatory pumps is real when pumps are unwrapped and exposed at high levels to PA and HP mixture. The results of our study recommend retaining the wrapping for the peracetic acid sterilization of the ambulatory pumps.


Subject(s)
Hydrogen Peroxide/chemistry , Infusion Pumps/standards , Materials Testing , Peracetic Acid/chemistry , Sterilization/methods , Permeability , Risk , Sterilization/standards
2.
Ann Pharmacother ; 37(12): 1789-92, 2003 Dec.
Article in English | MEDLINE | ID: mdl-14632591

ABSTRACT

BACKGROUND: Cyclophosphamide (CYP) is used to treat cancers in combination with mesna to prevent cystitis. The use of extemporaneously prepared admixtures of these drugs must be supported by documentation of their chemical stability. OBJECTIVE: To evaluate the chemical stability of CYP and mesna admixtures in dextrose 5% polyethylene infusion bags. METHODS: The drugs were diluted in 100-mL dextrose 5% infusion bags to final concentrations of CYP 10.8 mg/mL with mesna 3.2 mg/mL (solution A) and CYP 1.8 mg/mL with mesna 0.54 mg/mL (solution B). Six infusion bags from each solution were stored at 4 degrees C and 6 were stored at room temperature. Triplicate HPLC determinations were performed on each bag to measure drug concentrations at 0, 1, 2, 4, 6, 12, 24, 48, and 96 hours. RESULTS: At 96 hours, drug concentrations in all solutions stored at room temperature were found to be <80% compared with the initial concentrations. The solutions stored at 4 degrees C retained at least 90% of the initial drug concentrations at 48 hours. The pH of solutions A and B stored at room temperature decreased significantly by 4.44 and 4.31 units, respectively. The pH of the refrigerated infusion bags decreased significantly by 1.46 units for solution B. CONCLUSIONS: Admixtures stored at 4 degrees C (pH 7.90 +/- 0.004; mean +/- SD) are stable for 48 hours. The CYP and mesna combination can be infused at room temperature over 6 hours without significant degradation of the drugs. Stabilities are dependent on pH, temperature, and/or concentration.


Subject(s)
Cyclophosphamide/analysis , Infusion Pumps/standards , Mesna/analysis , Polyethylene/analysis , Cyclophosphamide/chemistry , Drug Stability , Mesna/chemistry , Pharmaceutical Solutions/analysis , Pharmaceutical Solutions/chemistry , Polyethylene/chemistry
3.
Gastrointest Endosc ; 58(2): 226-9, 2003 Aug.
Article in English | MEDLINE | ID: mdl-12872090

ABSTRACT

BACKGROUND: The use of disposable biopsy forceps seems to be effective and safer than reusable biopsy forceps with respect to the risk of infection transmission. The results of cost analysis studies comparing reusable versus disposable biopsy forceps are conflicting. This study compared the cost of reusable versus disposable biopsy forceps. METHODS: A cost-minimization analysis was carried out from the viewpoint of a hospital. Direct costs were included. The study design was retrospective. For reusable biopsy forceps, the evaluation of costs included purchase prices, cleaning (chemicals, equipment, technician time), and a fee for sterilization in a centralized facility. The cost evaluation for disposable biopsy forceps included acquisition and destruction costs. Costs were expressed in United States dollars. RESULTS: The mean number of uses was approximately 90 per reusable forceps. The cost per use of reusable biopsy forceps was 6.84 US dollars (acquisition 3.59 US dollars, cleaning 2.28 US dollars, centralized sterilization fee 0.97 US dollars). The cost per use of disposable biopsy forceps varied from 10.72 US dollars to 15.63 US dollars. Additional cost per use of disposable biopsy forceps ranged from 3.88 US dollars to 8.79 US dollars. CONCLUSIONS: From a strictly economic point of view, the use of reusable biopsy forceps is advantageous. However, additional factors should be considered. It would be essential to take into account the potential risk of infectious disease transmission related to the use of both types of forceps, which remains uncharacterized.


Subject(s)
Biopsy/economics , Biopsy/instrumentation , Disposable Equipment , Endoscopy, Gastrointestinal/economics , Surgical Instruments/economics , Costs and Cost Analysis , Equipment Reuse , Humans , Retrospective Studies , Sensitivity and Specificity , United States
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