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Safe Use of Insulin Pens

Notice type: Advisory

Date: 21/12/2010

   

Product name or type:
Safe Use of Insulin Pens

Reference:
SN2010(16)

Manufacturer Or Supplier:
Various

Target Audience:
All Hospital staff 
All Nursing Home staff 
Risk Managers 
Nursing Managers 
Hospital Pharmacists 
Diabetic Clinics/ outpatients 
Diabetic nurse specialists 
Diabetic departments 
Endocrinology units 
Endocrinology Consultants 
Paediatric wards 
Laboratory Managers 
Chief Medical Scientists 
Purchasing / Material Managers

Problem Or Issue:
The risk of bloodborne pathogen transmission when insulin injection pens are used on more than one patient

Background Information Or Related Documents:
Insulin pens are designed to administer accurate doses of insulin. The insulin pen is an injection device with a cartridge or reservoir containing several doses of insulin. Pens are available as pre-filled, disposable units or as re-usable pens, requiring replacement insulin cartridges. A sterile, disposable needle is attached to the pen for each use. 

Insulin pens are placed on the market with the “intended purpose” for “single-patient” use and are labelled accordingly. 

Using an Insulin pen on more than one patient is contrary to the guidance outlined in the device labelling / Summary of Product Characteristics (SPC). The use of these devices on multiple patients could result, possibly, in the transmission of pathogens (such as Hepatitis B or C or Human Immunodeficiency Virus (HIV) to patients who use the same pen, even when the needles are changed between patients 

Safe Use of Insulin Pens Document

Actions To Be Taken:
1. Ensure that this notice is communicated to the appropriate personnel within your organisation. 
2. Ensure that procedures are in place to ensure that 
a. single use devices are only used once. 
b. single patient use devices are not used on multiple patients 
3. Examine the guidance produced by Manufacturers in the “instructions for use” or the SPC before use. 
4. Ensure that facilities are in place to ensure the safe disposal of these devices. 

IMB REFERENCES 
SN2004(04) The “intended purpose” of a Medical Device 
SN2004(06) Instructions for Use provided by the Medical Device Manufacturer 
SN2010(14) Single Use & Single Patient Use Medical Devices 

Further Information:
All adverse incidents relating to a medical device or any adverse events or medication errors associated with the use of insulin pens or cartridges should be reported to HPRA: 

Health Products Regulatory Authority
Kevin O’Malley House 
Earlsfort Centre 
Earlsfort Terrace 
Dublin 2 

Telephone: +353-1-6764971 
Fax: +353-1-6344033 
E-mail: vigilance@imb.ie
Website: www.hpra.ie

Please click here to download a PDF version of the safety notice

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