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DC A Look at The Reuse of Insulin Needles WP en
DC A Look at The Reuse of Insulin Needles WP en
1 Becton Drive
Franklin Lakes, NJ 07417
www.BDdiabetes.com/us
As needles and their wall thickness become needles remained in good condition with a correlation between reuse and
smaller, reuse becomes more of a problem, repeated use. Therefore, skin type and lipodystrophy. While “lipos” are not
because of the potential of needle tips to bend injection technique may play roles in the frequently reported, it is estimated that 20-
into the form of a hook and break with degree of needle tip damage after use. In 45% of injecting patients with Type 1
repeated use. The needles are so fine that the actual practice though, all reuse must be diabetes mellitus and 3.6% with Type 2
tip damage cannot be seen with the naked eye. discouraged, as the damage occurs to such a diabetes mellitus will have “lipos” (Saez-de
It can only be seen with high-resolution small area of the needle tip that it cannot be Ibarra, Gallego 1998) once a search is
electron microscopes. detected without a high powered electron conducted. These are often easier to feel
INSULIN
microscope — even where the needle tip has than to see and can be disfiguring. People
Special Considerations for Pen Needles broken off. often prefer to inject into them because it
There are additional concerns when it comes to is less painful.
reuse of insulin pen needles. Reuse of insulin The study concluded that “patients should be While reused syringes were not included in this
pen needles is almost always accompanied by instructed to remove the insulin pen needle particular study, it is reasonable to assume that Lipodystrophy and Control
carrying the pen with the needle attached. For immediately after each injection and only the damage to reused syringe needles is even A study published at the 1997 International
greater convenience, some patients report using replace it with a fresh needle just before the greater than the damage to reused pen needles Diabetes Federation (IDF) conference,
only one pen needle for each disposable pen or next injection....If patients follow this simple and lancets, as syringe needles must go though Helsinki, Finland (Franzen, Ludvigsson, 1997)
insulin cartridge, carrying the device with the procedure and remove their needle after each the rubber stopper of syringe vials before each found that in the study group, versus control,
needle attached, between uses. Therefore, pen injection, the insulin pen is a safe, accurate skin penetration. HbA1C decreased with “lipo” decrease. The
users who carry their pens with the needle device.” average decrease was between 7.0 and 7.9% in
attached, risk micro-tissue damage. The same is Photographs showing the type of damage that the experimental group, versus no change in the
true of syringe users who reuse. A pen needle is There are some patients who do not carry their can occur with needle reuse.* control group. In the experimental group, the
a two-ended needle, with one end that punctures pens with the needle attached, but who do reuse improvement in lipohypertrophy and HbA1C
the insulin cartridge and the other end that the needles. For these patients there is an came about after intensified instruction
penetrates the skin. By leaving a needle additional issue with how they keep the back regarding injection technique (site rotation)
attached to a pen, even if the needle is covered, end of the needle clean between injections. and clean needle use while the control
patients are leaving an open-passageway into the New pen needles come with a paper seal over group received traditional instruction in
insulin cartridge. A study entitled The Kinetics the end of the needle that penetrates the insulin injection technique.
of Insulin Administration by Insulin Pens cartridge. Once this seal is removed to attach
(Ginsberg, Parkes, and Sparacino 1994) the needle to the pen, there is not a good way to FDA Guidelines
demonstrated that air enters insulin cartridges keep the needle clean between uses. Used needle Same used needle Recently there has been a great deal of media
when the pen needle is left on the pen and the magnified 370 times magnified 2000 times coverage about the practice of institutions
pen is exposed to alterations in temperature. When syringes are reused the needle is placed reusing medical devices that are labeled as
* Photographs from Dieter Look and Kenneth Strauss study:
into the bacteriocidal insulin solution between "Nadeln mehrfach verwenden?" Diabetes Journal 1998, 10: S. 31-34. being for single use. The FDA Compliance
When patients carry the pen from warm places uses. This may be why there are fewer infections Policy Guidelines Sec. 300.500 (1987) states:
to cool places (such as when they go outdoors in than expected. This is not true of pen needles in “Since disposable devices are not intended by
winter, or into an air-conditioned building in Medical Consequences of Needle Reuse
which bacteria are free to grow on the needles. “Reuse of Sharps in Diabetic Patients: Is It the manufacturer or distributor for reuse, any
summer) the insulin in the pen contracts, drawing institution or practitioner who re-sterilizes
air into the cartridge through the attached Completely Safe?” (Look, Strauss 1998)
Microscopy Findings analyzed the three studies conducted by D. and/or reuses a disposable medical device
needle. When there is added air in an insulin In three studies on reuse conducted at the must bear full responsibility for its safety
cartridge, the dose delivered is very inaccurate Look at the Klinik Hellbachtal in Molln,
Klinik Hellbachtal in Germany in 1997 patients Germany in 1997 and drew the following and effectiveness.
and up to 2/3 of the dose may not be delivered. were asked to save their pen needles and conclusions based on the evidence Insurance Concerns
0 lancets after use, and label them with the demonstrated in the studies.
number of times they had been used. Electron When patients who have been reusing syringes
micrographs were taken at the University of stop reusing, there are bound to be concerns
1. Tissue microtrauma: When a deformed needle about whether their insurance will cover the
Grenoble, France, during 1997 by Dr. Jacques is used, it lacerates tissue, causing
Garden of pen needles and lancets that had increased number of syringes that are required.
microtrauma. This can result in locally For example, if a patient takes three injections
AIR been used by patients, according to their own significant bruising and bleeding. Volunteers
normal reuse patterns in the treatment of their per day, and in the past has been using each
in the German studies who reused lancets syringe three times, his or her mail order plan
diabetes. The needles were then photographed were found to have more residual bleeding in
under microscopic powers ranging from 370x to may have been sending one box of 100 syringes
sites where a more heavily reused lancet was every three months. In this case, the plan may
5000x. The observers noted the following (Look, employed for the blood letting.
Strauss 1998): be dispensing one syringe per day, not because
Conversely, when patients carry the pen from cool 2. Embedded needle tips: The studies showed they expect their members to reuse, but because
• Significant tip damage can occur after only one that excessive reuse (>7 times/needle) was
places to warm places (such as when they go injection and was seen with all manufacturers they were never advised that the patient was
outdoors in summer, or into a heated building in often associated with a breaking off of the taking three injections per day. If a plan does
studied. microscopic end of the needle tip. The
winter), the fluid in the cartridge expands and leaks • The majority of needles and lancets showed cover syringes, however, it should cover the
out though the attached needle. If the cartridge medical consequence of embedded metal tips proper number that will allow the patient to use
tip damage when reused, despite the fact that is unknown at this time.
contains NPH either alone, or as part of a premix, pen needles only penetrate human skin with them according to the directions. Therefore, if
and the patient has not just re-suspended the 3. Correlation with greater incidence of patients are not being given enough syringes to
each use, not a vial stopper. lipodystrophy: According to the analysis of
insulin chances are that the crystals will be settled • Some needles were actually missing their tips use one syringe per injection, they should advise
on the bottom of the cartridge and what will leak the German studies cited above, local growth their pharmacist or plan of the number of
— raising the question of whether the tips factors may be released and join with insulin
out will be fluid without crystals. This will change might be imbedded in the patient’s skin. needles they need per day. To help avoid these
the concentration of the insulin that remains in the to form lumpy nodules called “lipodistrophy.” problems, prescribers should make it a practice
• Tip damage did not always increase Although at this time there is not proof that
cartridge, altering the effectiveness of future doses proportionately with the number of times the to indicate the number of needles needed per
from that cartridge or pre-filled pen. reuse leads to lipodystrophy (“lipos”), there is day on the prescription.
needle was used. There were patients whose
Reuse of Needles_White Paper 07D015070015 12/20/06 12:42 PM Page 5
As needles and their wall thickness become needles remained in good condition with a correlation between reuse and
smaller, reuse becomes more of a problem, repeated use. Therefore, skin type and lipodystrophy. While “lipos” are not
because of the potential of needle tips to bend injection technique may play roles in the frequently reported, it is estimated that 20-
into the form of a hook and break with degree of needle tip damage after use. In 45% of injecting patients with Type 1
repeated use. The needles are so fine that the actual practice though, all reuse must be diabetes mellitus and 3.6% with Type 2
tip damage cannot be seen with the naked eye. discouraged, as the damage occurs to such a diabetes mellitus will have “lipos” (Saez-de
It can only be seen with high-resolution small area of the needle tip that it cannot be Ibarra, Gallego 1998) once a search is
electron microscopes. detected without a high powered electron conducted. These are often easier to feel
INSULIN
microscope — even where the needle tip has than to see and can be disfiguring. People
Special Considerations for Pen Needles broken off. often prefer to inject into them because it
There are additional concerns when it comes to is less painful.
reuse of insulin pen needles. Reuse of insulin The study concluded that “patients should be While reused syringes were not included in this
pen needles is almost always accompanied by instructed to remove the insulin pen needle particular study, it is reasonable to assume that Lipodystrophy and Control
carrying the pen with the needle attached. For immediately after each injection and only the damage to reused syringe needles is even A study published at the 1997 International
greater convenience, some patients report using replace it with a fresh needle just before the greater than the damage to reused pen needles Diabetes Federation (IDF) conference,
only one pen needle for each disposable pen or next injection....If patients follow this simple and lancets, as syringe needles must go though Helsinki, Finland (Franzen, Ludvigsson, 1997)
insulin cartridge, carrying the device with the procedure and remove their needle after each the rubber stopper of syringe vials before each found that in the study group, versus control,
needle attached, between uses. Therefore, pen injection, the insulin pen is a safe, accurate skin penetration. HbA1C decreased with “lipo” decrease. The
users who carry their pens with the needle device.” average decrease was between 7.0 and 7.9% in
attached, risk micro-tissue damage. The same is Photographs showing the type of damage that the experimental group, versus no change in the
true of syringe users who reuse. A pen needle is There are some patients who do not carry their can occur with needle reuse.* control group. In the experimental group, the
a two-ended needle, with one end that punctures pens with the needle attached, but who do reuse improvement in lipohypertrophy and HbA1C
the insulin cartridge and the other end that the needles. For these patients there is an came about after intensified instruction
penetrates the skin. By leaving a needle additional issue with how they keep the back regarding injection technique (site rotation)
attached to a pen, even if the needle is covered, end of the needle clean between injections. and clean needle use while the control
patients are leaving an open-passageway into the New pen needles come with a paper seal over group received traditional instruction in
insulin cartridge. A study entitled The Kinetics the end of the needle that penetrates the insulin injection technique.
of Insulin Administration by Insulin Pens cartridge. Once this seal is removed to attach
(Ginsberg, Parkes, and Sparacino 1994) the needle to the pen, there is not a good way to FDA Guidelines
demonstrated that air enters insulin cartridges keep the needle clean between uses. Used needle Same used needle Recently there has been a great deal of media
when the pen needle is left on the pen and the magnified 370 times magnified 2000 times coverage about the practice of institutions
pen is exposed to alterations in temperature. When syringes are reused the needle is placed reusing medical devices that are labeled as
* Photographs from Dieter Look and Kenneth Strauss study:
into the bacteriocidal insulin solution between "Nadeln mehrfach verwenden?" Diabetes Journal 1998, 10: S. 31-34. being for single use. The FDA Compliance
When patients carry the pen from warm places uses. This may be why there are fewer infections Policy Guidelines Sec. 300.500 (1987) states:
to cool places (such as when they go outdoors in than expected. This is not true of pen needles in “Since disposable devices are not intended by
winter, or into an air-conditioned building in Medical Consequences of Needle Reuse
which bacteria are free to grow on the needles. “Reuse of Sharps in Diabetic Patients: Is It the manufacturer or distributor for reuse, any
summer) the insulin in the pen contracts, drawing institution or practitioner who re-sterilizes
air into the cartridge through the attached Completely Safe?” (Look, Strauss 1998)
Microscopy Findings analyzed the three studies conducted by D. and/or reuses a disposable medical device
needle. When there is added air in an insulin In three studies on reuse conducted at the must bear full responsibility for its safety
cartridge, the dose delivered is very inaccurate Look at the Klinik Hellbachtal in Molln,
Klinik Hellbachtal in Germany in 1997 patients Germany in 1997 and drew the following and effectiveness.
and up to 2/3 of the dose may not be delivered. were asked to save their pen needles and conclusions based on the evidence Insurance Concerns
0 lancets after use, and label them with the demonstrated in the studies.
number of times they had been used. Electron When patients who have been reusing syringes
micrographs were taken at the University of stop reusing, there are bound to be concerns
1. Tissue microtrauma: When a deformed needle about whether their insurance will cover the
Grenoble, France, during 1997 by Dr. Jacques is used, it lacerates tissue, causing
Garden of pen needles and lancets that had increased number of syringes that are required.
microtrauma. This can result in locally For example, if a patient takes three injections
AIR been used by patients, according to their own significant bruising and bleeding. Volunteers
normal reuse patterns in the treatment of their per day, and in the past has been using each
in the German studies who reused lancets syringe three times, his or her mail order plan
diabetes. The needles were then photographed were found to have more residual bleeding in
under microscopic powers ranging from 370x to may have been sending one box of 100 syringes
sites where a more heavily reused lancet was every three months. In this case, the plan may
5000x. The observers noted the following (Look, employed for the blood letting.
Strauss 1998): be dispensing one syringe per day, not because
Conversely, when patients carry the pen from cool 2. Embedded needle tips: The studies showed they expect their members to reuse, but because
• Significant tip damage can occur after only one that excessive reuse (>7 times/needle) was
places to warm places (such as when they go injection and was seen with all manufacturers they were never advised that the patient was
outdoors in summer, or into a heated building in often associated with a breaking off of the taking three injections per day. If a plan does
studied. microscopic end of the needle tip. The
winter), the fluid in the cartridge expands and leaks • The majority of needles and lancets showed cover syringes, however, it should cover the
out though the attached needle. If the cartridge medical consequence of embedded metal tips proper number that will allow the patient to use
tip damage when reused, despite the fact that is unknown at this time.
contains NPH either alone, or as part of a premix, pen needles only penetrate human skin with them according to the directions. Therefore, if
and the patient has not just re-suspended the 3. Correlation with greater incidence of patients are not being given enough syringes to
each use, not a vial stopper. lipodystrophy: According to the analysis of
insulin chances are that the crystals will be settled • Some needles were actually missing their tips use one syringe per injection, they should advise
on the bottom of the cartridge and what will leak the German studies cited above, local growth their pharmacist or plan of the number of
— raising the question of whether the tips factors may be released and join with insulin
out will be fluid without crystals. This will change might be imbedded in the patient’s skin. needles they need per day. To help avoid these
the concentration of the insulin that remains in the to form lumpy nodules called “lipodistrophy.” problems, prescribers should make it a practice
• Tip damage did not always increase Although at this time there is not proof that
cartridge, altering the effectiveness of future doses proportionately with the number of times the to indicate the number of needles needed per
from that cartridge or pre-filled pen. reuse leads to lipodystrophy (“lipos”), there is day on the prescription.
needle was used. There were patients whose
Reuse of Needles_White Paper 07D015070015 12/20/06 12:42 PM Page 3
1 Becton Drive
Franklin Lakes, NJ 07417
www.BDdiabetes.com/us