The Delaware Division of Public Health (DPH) is issuing this health alert to all Delaware health care facilities and providers to notify them that a health care system in Maine has identified visible contamination in multiple lots of intravenous (IV) tubing. The situation is evolving and DPH will provide updates as more information becomes available. 

 

Summary

A health care facility in Maine has notified the Maine Center for Disease Control & Prevention (CDC) of visible contamination in multiple lots of IV tubing from the same manufacturer. At this time, DPH has not been notified of any affected products in Delaware. DPH is issuing this health advisory to notify health facilities and providers of a potential issue. This includes but is not limited to hospitals, health systems, dialysis centers, skilled nursing facilities, and Emergency Medical Services (EMS) providers.

 

Background

A health care facility in Maine has notified the Maine Center for Disease Control & Prevention (Maine CDC) of visible contamination in a lot of IV tubing. The kits show particulate matter floating in the chamber or contamination in the walls of the chamber.

The health care facility, through their investigation, has identified multiple lot numbers impacted from the same manufacturer. The manufacturer has been made aware, and Maine CDC is working with the reporting facility and the U.S. Centers for Disease Control and Prevention on this evolving investigation (US CDC). US CDC is contacting U.S. Food and Drug Administration (FDA) to hasten investigations with the manufacturer.

At this time, the impacted products appear to be limited to tubing manufactured by ICU Medical, distributed by Medline. Affected lot numbers are still being gathered. 

The ICU Medical product types include: 

  • Primary Set Piggyback with Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 100 Inch 
  • Primary PLUM Set CLAVE Port, CLAVE Y-Site, Secure Lock, 103 Inch 
  • Secondary Set Secure Lock, 34 Inch with IV Set Hanger 

 

Recommendations

DPH requests that health care facilities:

  1. Determine whether they are currently utilizing IV tubing products manufactured by ICU Medical and distributed by Medline.
  2. Thoroughly inspect IV tubing inventory as soon as possible for any visible contamination, including, but not limited to particulate matter floating in the chamber and/or small black dots within drip chambers or tubing components.
  3. Immediately remove from use and quarantine any products with suspected contamination in accordance with facility protocols.
  4. Notify DPH if your facility utilizes these products or identifies potentially affected inventory.
  5.  Review infection rates (e.g., blood stream infectious, central line infections) before and after kit use.

 

 Reporting

Health care associated infection outbreaks are reportable under Delaware Administrative Code, Title 16, even if an individual case of disease is not reportable. Reports and questions should be submitted to DPH’s Office of Infectious Disease Epidemiology (OIDE). The phone number is 302-744-4990, the fax number is 302- 622-4149, and email is reportdisease@delaware.gov.