Patients warned after devices misused

Barrels of pens, lances apparently reused

Mark KaufmanA clinic in Madison, WI has contacted 2,345 patients to advise them they may have been exposed to bloodborne pathogens after finding an employee was inappropriately using insulin pens and finger stick devices during patient training.

An internal review found that a former Dean Clinic employee was inappropriately using the devices during some patient visits between 2006 and 2011. The clinic patients are receiving phone calls and letters from Dean, which has a team ready to answer patients' questions. The clinic released a statement saying it takes responsibility for any needed testing and will coordinate follow-up care and support patients' needs.

In response to request for more information by Hospital Infection Control & Prevention, Mark Kaufman, MD, Chief Medical Officer at Dean Clinic provided the following answers via email:

HIC: Just to clarify, are you recommending that all of these 2,345 patients be tested or that they contact you for consultation about the need to be tested?

Kaufman: "Before making any testing recommendations, we first wanted to interview these patients. To date, we have reached out to 100% of the patients potentially impacted and we have interviewed 92%. After conducting initial patient interviews, we have determined that 25% of those we spoke with do not need testing for hepatitis B, hepatitis C or HIV.

HIC: The press release mentions this as an "isolated incident," but notes that the facility is "reeducating patient care staff on the proper use of these types of devices, enhancing our auditing and monitoring procedures related to these devices and improving our process for routinely observing the clinical practices of our staff." Was there some kind of educational gap that resulted in this worker improperly using and/or reusing the devices? What level of training did this person have?

Kaufman: "The former employee is a registered nurse who was also certified in diabetes education. An internal review found this was the result of one employee acting outside of standard nursing practice. While we do not believe there was an educational gap, we are taking the time to ensure that every staff member is clear on the proper handling of these devices."

HIC: What kind of program was this? Were these patients considered diabetics or thought to be at risk of diabetes?

Kaufman: "The former employee saw patients with diabetes or at risk for diabetes to help them gain the knowledge and skills needed to modify their behavior and successfully manage the disease and other conditions related to it. The former employee was using both insulin demonstration pens and finger stick devices. An insulin demonstration pen is intended to be used on a pillow-like item to show how to inject insulin. The finger stick device is used to obtain a blood sample to monitor blood sugars."

HIC: What specifically was the "inappropriate use" and how was it discovered in the internal review?

Kaufman: "An insulin demonstration pen, when used correctly, is intended to be used on a pillow-like item to show how to inject insulin. A demonstration pen is not intended for human use. The former employee did use these at times on patients. While the former employee always changed needles with each use, the same barrel of the demonstration pen may have been used on multiple patients. The finger stick device is used to obtain a blood sample to monitor blood sugars. While the former employee always changed the lancets (sharp end that pierces the skin) with each use, the individual may have used the same barrel of the finger stick device on more than one patient. The finger stick devices, including the barrel, are meant to be 'single patient use' instruments. The 'inappropriate use' was brought to our attention by a fellow employee. We then conducted an internal review."

HIC: What specific policies have been changed as a result of this incident?

Kaufman: "The issues involved are basic nursing and infection control principles. We have reviewed our existing policies. This includes our bloodborne pathogen policies and our injection policies. Those polices have been assigned to be re-reviewed by all clinical staff members. We have also pulled out the basic principles and policy specifics that were relevant to this incident and had all clinical staff attest that they have read and understood."