The FDA released this alert a few days ago:
What??? Are you serious? We use these products to disinfect areas such as skin, injection ports, connectors, etc… prior to injection or venipuncture or entry and if contaminated can introduce bacteria into the patients.
The products, sterile and non-sterile forms made by Triad Group have been recalled because of possible contamination by Bacillus cereus bacteria. This recall has been initiated due to concerns from a customer about potential contamination of the products with the bacteria following a non-life threatening skin infection. The company, out of an abundance of caution, are recalling these lots to ensure that they are not the source of these contamination issues.
The products were all manufactured by Triad Group but have been marketed in the U.S., Canada, and Europe under a number of different labels, including:
- Cardinal Health
- PSS Select
- Moore Medical
The products are sold in boxes and are also packaged with other products such as central line dressing change kits, IV insertion kits, and self injection kits for medications like Extavia (interferon beta-1b) by Novatis, and Betaseron (interferon beta-1b) by Bayer Healthcare Pharmaceuticals and others. It is also important to note that alcohol with B. cereus, can contaminate specimens collected for microbiological cultures.
Although B. cereus is normally associated with food poisoning, other infections caused by these bacteria have been documented in patients with weak immune systems, such as cancer patients or patients that have had surgery…in other words, the patients who we use alcohol swabs, pads, or swabsticks.
Perhaps thinking that outbreaks from contamination from antiseptics and disinfectants can’t possibly happen, think again, there are articles that have described Bacillus cereus found in alcohol used for disinfection.
- Weber et al Outbreaks Associated with Contaminated Antiseptics and Disinfectants. Antimicrob Agents Chemother. 2007 December; 51(12): 4217–4224
- Po-Ren Hsueh et al Nosocomial Pseudoepidemic Caused by Bacillus cereus Traced to Contaminated Ethyl Alcohol from a Liquor Factory. J Clin Microbiol. 1999 July; 37(7): 2280–2284.
What to do next?
- Check your alcohol prep pads/swabsticks/swabs. If you have the recalled products, call the Triad Group Customer Service Monday through Friday between the hours of 8:30 A.M. and 4:00 P.M. Central Time: 262.538.2900. They will issue you a return authorization number and make all return arrangements.
- Check your pre-packaged kits too. For patients with self injection kits with the contaminated alcohol pad, according to Novartis and Bayer, do not use the alcohol pad but the rest of the items in the kit should be safe to use.
- Take a proactive approach, if you think you have used any of these products prior to this recall, monitor the patients closely.