Summary

The Centers for Disease Control and Prevention (CDC) has become increasingly concerned about the risks for transmitting hepatitis B virus (HBV) and other infectious diseases during assisted blood glucose (blood sugar) monitoring and insulin administration.

CDC is alerting all persons who assist others with blood glucose monitoring and/or insulin administration of the following infection control requirements:

• Fingerstick devices should never be used for more than one person.
• Whenever possible, blood glucose meters should not be shared. If they must be shared, the device should be cleaned and disinfected after every use, per manufacturer’s instructions. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared.
• Insulin pens and other medication cartridges and syringes are for single-patient-use only and should never be used for more than one person

Diabetes Care Resources

• FAQs: Blood Glucose Monitoring and Insulin Administration
• Clinical Reminder: Fingerstick Devices
• Clinical Reminder: Insulin Pens
• CDC Medscape Commentary– Don't Do It: Sharing Insulin Pens Jeopardizes Patients [Video]

Blood Glucose Monitoring and Insulin Administration

Monitoring of blood glucose levels is frequently performed to guide therapy for persons with diabetes. Blood glucose monitoring and insulin administration can be accomplished in two ways: self-monitoring of blood glucose and insulin administration, where the individual performs all steps of the testing and insulin administration themselves, and assisted monitoring of blood glucose and insulin administration, where another person assists with or performs testing and insulin administration for an individual.

Examples of settings where assisted monitoring of blood glucose and insulin administration may occur include:

• Hospitals or clinics
• Long term care settings such as nursing homes and assisted living facilities
• Senior centers
• Health fairs
• Correctional facilities
• Schools or camps

Unsafe Practices during Blood Glucose Monitoring and Insulin Administration

An underappreciated risk of blood glucose testing is the opportunity for exposure to bloodborne viruses (HBV, hepatitis C virus, and HIV) through contaminated equipment and supplies if devices used for testing and/or insulin administration (e.g., blood glucose meters, fingerstick devices, insulin pens) are shared.

Outbreaks of hepatitis B virus (HBV) infection associated with blood glucose monitoring have been identified with increasing regularity, particularly in long-term care settings, such as nursing homes and assisted living facilities, where residents often require assistance with monitoring of blood glucose levels and/or insulin administration. In the last 10 years, alone, there have been at least 15 outbreaks of HBV infection associated with providers failing to follow basic principles of infection control when assisting with blood glucose monitoring. Due to under-reporting and under recognition of acute infection, the number of outbreaks due to unsafe diabetes care practices identified to date are likely an underestimate.

Although the majority of these outbreaks have been reported in long-term care settings, the risk of infection is present in any setting where blood glucose monitoring equipment is shared or those assisting with blood glucose monitoring and/or insulin administration fail to follow basic principles of infection control. For example, at a health fair in New Mexico in 2010, dozens of attendees were potentially exposed to bloodborne viruses when fingerstick devices were inappropriately reused for multiple persons to conduct diabetes screening. Additionally, at a hospital in Texas in 2009, more than 2,000 persons were notified and recommended to undergo testing for bloodborne viruses after individual insulin pens were used for multiple persons.

Unsafe practices during assisted monitoring of blood glucose and insulin administration that have contributed to transmission of HBV or have put persons at risk for infection include:

• Using fingerstick devices for more than one person
• Using a blood glucose meter for more than one person without cleaning and disinfecting it in between uses
• Using insulin pens for more than one person
• Failing to change gloves and perform hand hygiene between fingerstick procedures

Best Practices for Assisted Blood Glucose Monitoring and Insulin Administration

The following are infection control recommendations that anyone who performs or assists with blood glucose monitoring and /or insulin administration should review to assure they are not placing themselves or persons in their care at risk.

These recommendations apply not only to licensed healthcare facilities but also to any setting where fingerstick procedures are performed and/or insulin is administered, including assisted living or residential care facilities, clinics, health fairs, shelters, detention facilities, schools, and camps. Protection from bloodborne viruses and other infections is a basic requirement and expectation anywhere healthcare is provided.

Fingerstick Devices

Fingerstick devices, also called lancing devices, are devices that are used to prick the skin and obtain drops of blood for testing. There are two main types of fingerstick devices: those that are designed for reuse on a single person and those that are disposable and for single-use.

• Reusable Devices: These devices often resemble a pen and have the means to remove and replace the lancet after each use, allowing the device to be used more than once. Some of these devices have been previously approved and marketed for multi-patient use, and require the lancet and disposable components (platforms or endcaps) to be changed between each patient. However, due to failures to change the disposable components, difficulties with cleaning and disinfection after use, and their link to multiple HBV infection outbreaks, CDC recommends that these devices never be used for more than one person. If these devices are used, it should only be by individual persons using these devices for self-monitoring of blood glucose.
   
  
• Single-use, auto-disabling fingerstick devices: These are devices that are disposable and prevent reuse through an auto-disabling feature. In settings where assisted monitoring of blood glucose is performed, single-use, auto-disabling fingerstick devices should be used.

 

A simple rule for safe care:
Fingerstick devices should never be used for more than one person.

Blood Glucose Meters

Blood glucose meters are devices that measure blood glucose levels.

• Whenever possible, blood glucose meters should be assigned to an individual person and not be shared.
• If blood glucose meters must be shared, the device should be cleaned and disinfected after every use, per manufacturer’s instructions, to prevent carry-over of blood and infectious agents. If the manufacturer does not specify how the device should be cleaned and disinfected then it should not be shared.

A simple rule for safe care:
If shared, blood glucose meters should be cleaned and disinfected after every use.

Insulin Administration

Insulin can be administered using an insulin pen that is designed for reuse on a single patient. It can also be administered using a needle and syringe after drawing up contents from an insulin vial.

• Insulin Pens: Insulin pens are pen-shaped injector devices for insulin that are intended for use by a single person.  The pens have an insulin reservoir, or an insulin cartridge, that usually contains enough insulin for an individual to self-administer several doses (injections) of insulin before the reservoir or cartridge is empty.  The individual changes the needle before each insulin injection.  Insulin pens are designed to be safe for a single person to use a single pen multiple times, with a new needle for each injection. 
  • Insulin pens should be assigned to individual persons and labeled appropriately. They should never be used for more than one person.
• Insulin Vials: Multi-dose vials of insulin should be dedicated to a single person whenever possible. If the vial must be used for more than one person it should be stored and prepared in a dedicated medication preparation area outside of the patient care environment and away from potentially contaminated equipment. Insulin vials should always be entered with a new needle and new syringe. Needles and syringes should never be used to administer insulin to more than one person and should be disposed of immediately after use in an approved sharps container.

Additional Information

For additional information on assuring safe care during blood glucose monitoring and insulin administration, consult the following resources.

• CDCs Diabetes and Viral Hepatitis: Important Information on Glucose Monitoring [at D-is-for-Diabetes]
• FDA: Information for Healthcare Professionals: Risk of Transmission of Blood-borne Pathogens from Shared Use of Insulin Pens
• FDA Communication: Guidance for Industry and Food and Drug Administration Staff - Blood Lancet Labeling
• FDA Communication: Letter for Manufacturers of Blood Glucose Monitoring Systems Listed with the FDA
• FDA Communication: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens
• FDA Patient Safety News: Preventing Bloodborne Infections When Using Fingerstick Device (YouTube Video)

References

For more information regarding bloodborne pathogen transmission associated with unsafe practices during assisted monitoring of blood glucose, consult the following resources.

Centers for Disease Control and Prevention. Nosocomial hepatitis B virus associated with spring-loaded fingerstick blood sampling devices - Ohio and New York City, 1996. MMWR 1997;46:217-221.

Centers for Disease Control and Prevention. Notes from the Field: Deaths from Acute Hepatitis B Virus Infection Associated with Assisted Blood Glucose Monitoring in an Assisted-Living Facility - North Carolina, August-October 2010. MMWR 2011;60:182.

Centers for Disease Control and Prevention. Transmission of hepatitis B virus among persons undergoing blood glucose monitoring in long-term-care facilities-Mississippi, North Carolina, and Los Angeles County, California, 2003-2004. MMWR 2005;54:220-223.

Counard CC, Perz JF, Linchancgo PC, et al. Acute hepatitis B outbreaks related to fingerstick blood glucose monitoring in two assisted living facilities. J Am Geriatric Soc 2010;58:306-311.

Khan AJ, Cotter SM, Schulz B, et al. Nosocomial transmission of hepatitis B virus infection among residents with diabetes in a skilled nursing facility. Infect Control Hosp Epidemiol 2002;23:313-318.

Klonoff DG. Improving the Safety of Blood Glucose Monitoring. J Diabetes Sci Technology 2011;5(6): 1307-1311

Klonoff DC, Perz JF. Assisted Monitoring of Blood Glucose: Special Safety Needs for a New Paradigm in Testing Glucose. J Diabetes Sci Technol 2010;4(5):1027-1031

Patel AS, White-Comstock MB, Woolard D, Perz JF. Infection Control Practices in Assisted Living Facilities: A Response to Hepatitis B Virus Infection Outbreaks. Infect Control Hosp Epidemiol 2009;30:209-214.

Polish LB, Shapiro CN, Bauer F, Klotz P, Ginier P, Roberto RR, Margolis HS, Alter MJ. Nosocomial transmission of hepatitis B virus associated with a spring-loaded finger-stick device. N Engl J Med 1992;326(11):721-5.

Quale JM, Landman D, Wallace B, Atwood E, Ditore V, Frucher G. Deja vu: nosocomial hepatitis B virus transmission and fingerstick monitoring. Am J Med 1998;105(4):296-301.

Southwick KL, Clement EJ, Konings F, VanZetta S, Johnson GS, Schaffzin JK. Cluster of hepatitis B infection among residents of an assisted living facility-New York, 2007. In Final Program and Abstracts. Sixth International Conference on Emerging Infectious Diseases. Atlanta, GA. March 16-19, 2008.

Thompson ND, Barry V, Alelis K, Gui D, Perz JF. Evaluation of the Potential for Bloodborne Pathogen Transmission Associated with Diabetes Care Practices in Nursing Homes and Assisted Living Facilities, Pinellas County. JAGS 2010;58:914-918.

Thompson ND, Perz JF. Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Techniques. [PDF 445 KB] J Diabetes Sci Technol 2009;3(2):283-288.

Thompson ND, Schaefer MK. “Never Events”: Hepatitis B Outbreaks and Patient Notifications Resulting from Unsafe Practices during Assisted Monitoring of Blood Glucose, 2009-2010. [PDF 1,118 KB] J Diabetes Sci Technol 2011;5(6):1396-1402.

* Disclaimer: Images provided on this page are examples only and do not represent an endorsement by the Centers for Disease Control and Prevention.