From 1999
Abstract
From September 1990 to October 1990, 15 patients who were admitted to four different departments of the National Taiwan University Hospital, including nine patients in the emergency department, three in the hematology/oncology ward, two in the surgical intensive care unit, and one in a pediatric ward, were found to have positive blood (14 patients) or pleural effusion (1 patient) cultures for Bacillus cereus. After extensive surveillance cultures, 19 additional isolates of B. cereus were recovered from 70% ethyl alcohol that had been used as a skin disinfectant (14 isolates from different locations in the hospital) and from 95% ethyl alcohol (5 isolates from five alcohol tanks in the pharmacy department), and 10 isolates were recovered from 95% ethyl alcohol from the factory which supplied the alcohol to the hospital. In addition to these 44 isolates of B. cereus, 12 epidemiologically unrelated B. cereus isolates, one Bacillus sphaericus isolate from a blood specimen from a patient seen in May 1990, and two B. sphaericus isolates from 95% alcohol in the liquor factory were also studied for their microbiological relatedness. Among these isolates, antibiotypes were determined by using the disk diffusion method and the E test, biotypes were created with the results of the Vitek Bacillus Biochemical Card test, and random amplified polymorphic DNA (RAPD) patterns were generated by arbitrarily primed PCR. Two clones of the 15 B. cereus isolates recovered from patients were identified (clone A from 2 patients and clone B from 13 patients), and all 29 isolates of B. cereus recovered from 70 or 95% ethyl alcohol in the hospital or in the factory belonged to clone B. The antibiotype and RAPD pattern of the B. sphaericus isolate from the patient were different from those of isolates from the factory. Our data show that the pseudoepidemic was caused by a clone (clone B) of B. cereus from contaminated 70% ethyl alcohol used in the hospital, which we successfully traced to preexisting contaminated 95% ethyl alcohol from the supplier, and by another clone (clone A) without an identifiable source.
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination
[UPDATED 02/11/2011] Triad Alcohol Prep Pads are packaged with devices manufactured by Neuro Resource Group. The Triad alcohol prep pads should not be used.
[UPDATED 02/07/2011] Triad Alcohol Prep Pads are a component of Extavia (interferon beta 1-b) packaging marketed by Novartis. The Triad alcohol prep pads should not be used.
[UPDATED 02/05/2011] Triad Alcohol Prep Pads are a component of a convenience kit distributed with Watson’s Trelstar (triptorelin pamoate for injectable suspension) product. The Triad alcohol prep pads should not be used.
[UPDATED 02/01/2011] FDA reminded healthcare professionals about the safe use of non-sterile alcohol prep pads to clean and disinfect the surface of the skin.
[UPDATED 01/28/2011] Triad Alcohol Prep Pads may have been included in U.S. packaging for Arixtra Starter Kits manufactured by GlaxoSmithKline (GSK). The Triad alcohol prep pads should not be used.
[UPDATED 01/26/2011] Triad Alcohol Prep Pads are packaged for use with the kit presentation of Relistor (methylnaltrexone bromide) Subcutaneous Injection in the U.S. The Relistor vial and other components of the kit are not affected by the defective Triad alcohol pad. Relistor sold in single vials also is unaffected by this recall. Pfizer and Progenics advise patients using the Relistor kit not to use the Triad alcohol prep pads included in the Relistor packaging for 1 X 7 kits and 1 X 2 starter kits. When preparing to take their Relistor injection, patients should use an alcohol prep pad from a company other than Triad, or use a sterile gauze pad with isopropyl alcohol.
[UPDATED 01/21/2011] Triad alcohol prep pads packaged for use in the U.S. with Betaseron (interferon beta 1-b) should not be used by patients. There is no involvement or potential contamination of the Betaseron vial or other components in the Betaseron U.S. packaging. This issue is confined to the actual Triad alcohol prep products. Triad alcohol prep products are not used in Betaseron packaging outside of the United States. Bayer has halted shipments of Betaseron to its distribution network, until it can affect a replacement for the alcohol prep pad.
Bayer is instructing patients using Betaseron to immediately discontinue using the Triad alcohol prep pads included in the Betaseron packaging and dispose of those pads in the trash. When preparing to take their Betaseron injection, patients should use an alternative alcohol prep pad that is not subject to this Triad recall or use a sterile gauze pad in conjunction with isopropyl alcohol.
[UPDATED 01/14/2011] The Triad Group alcohol prep pads are co-packaged and distributed with Genentech medicines Boniva Injection, Fuzeon, Nutropin A.Q.Pen, Pegasys, and TNKase to customers in the United States. Genentech medicines are not contaminated and may continue to be used in accordance with the package insert. Patients and healthcare providers should not use the alcohol prep pads packaged with these medicines and should instead use an alternate alcohol prep pad that is not involved with the Triad Group recall.
[Posted 01/06/2011]
AUDIENCE: Pharmacy, Consumer, Risk Manager
ISSUE: Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.
BACKGROUND: Alcohol prep pads, alcohol swabs, and alcohol swabsticks are used to disinfect prior to an injection. They were distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.
RECOMMENDATION: If a consumer has any of these types of products in their possession listing “Triad Group” as the manufacturer, they should not use the product and should return it to the place it was purchased for a full refund.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
* Complete and submit the report Online: www.fda.gov/MedWatch/report.htm1
* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178