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Insulin Pens: CMS Issues New Survey and Certification Letter on Single-Person Use

by Published On: May 22, 2012

The Centers for Medicare and Medicaid Services (CMS) has issued Use of Insulin Pens in Health Care Facilities, a Survey and Certification Letter in response to reports of inappropriate multi-person use of insulin pens by healthcare facility staff. 

The letter emphasizes the single-person use of insulin pens and advises that sharing of these devices among more than one resident or patient will be cited under the provider and supplier oversight process in the same manner as re-use of needles or syringes. 

What's in the Use of Insulin Pens in Health Care Facilities letter?

Here is a summary of what's in the Use of Insulin Pens in Health Care Facilities letter:

  • CMS has reportedly received notice of insulin pens being inappropriately used by healthcare facility personnel for more than one patient/resident.

  • While designed for multiple applications, insulin pens are meant for single-person use, i.e., “…Regurgitation of blood into the insulin cartridge after injection will create a risk of bloodborne pathogen transmission if the pen is used for more than one patient/resident, even when the needle is changed.”

  • CMS advises that sharing of insulin pens “…is essentially the same as sharing needles or syringes, and must be cited, consistent with the applicable provider/supplier specific survey guidance, in the same manner as re-use of needles or syringes.”

  • In the event of insulin pen use for more than one resident/patient, surveyors are directed to “…focus on the overall infection control practices in the facility. The facility plan of correction should include notification of the local health department or state epidemiologist for determination of the need for post-exposure follow-up of patients and residents.”

  • The letter also advises that providers and/or suppliers using insulin pens should review the following recommendations of the FDA to prevent transmission of bloodborne infections in the patients/residents under their care:
    • Insulin pens containing multiple doses of insulin are meant for single patient/resident use only, and must never be used for more than one person, even when the needle is changed.
    • Insulin pens must be clearly labeled with patient/resident’s name or other identifiers to verify that the correct pen is used on the correct patient/resident.
    • Healthcare facilities should review their policies and procedures and educate their staff regarding safe use of insulin pens.

  • The link to updated reference material is on the CDC website and they also issued a clinical reminder.  

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