© 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
Pediatric Diabetes 2016: 17: 160–163 doi: 10.1111/pedi.12266 All rights reserved
Pediatric Diabetes
Case Report
Two case reports of retained steel insulin pump infusion set needles Plager P, Murati MA, Moran A, Sunni M. Two case reports of retained steel insulin pump infusion set needles. Pediatric Diabetes 2016: 17: 160–163.
Phillip Plager, Michael A. Murati, Antoinette Moran and Muna Sunni
Insulin pumps are common in the management of type 1 diabetes (T1D). We report two cases of metal insulin infusion set needles which broke off the tubing and remained embedded in the soft tissue of two boys with T1D (five needles in one case, and one needle in the other). The patient with five retained needles was asymptomatic and had a normal physical examination, and the missing needles were only detected using pelvic X-ray; the second patient had only mild discomfort. While these are the first such cases reported in the medical literature, there may be other cases which have gone unnoticed, suggesting the potential need to explore the safety of this product further.
Department of Pediatrics, University of Minnesota Masonic Children’s Hospital, Minneapolis, MN 55454, USA Key words: Contact™ Detach infusion set – metal infusion set – needles – Sure-T® infusion sets Corresponding author: Dr. Muna Sunni, Department of Pediatrics University of Minnesota Masonic Children’s Hospital, East Building Room MB671, 2450 Riverside Ave, Minneapolis, MN 55454, USA. Tel: 612-624-5409; fax: 612-626-5262; e-mail: [email protected] Submitted 17 September 2014. Accepted for publication 23 January 2015
Insulin pumps are commonly used in the management of type 1 diabetes (T1D) in adults and children. They deliver insulin via an infusion set which is composed of a thin plastic tube of variable length that connects the insulin reservoir to a flexible plastic (Teflon) cannula or a thin metal needle which is manually inserted into the subcutaneous tissue, and which is replaced every few days. Several types of infusion sets are commercially available, and they are all generally considered to be safe (1). We report two cases where infusion set metal needles were found to be retained in the soft tissue of two children with T1D, captured on plain film X-ray imaging.
Case report 1 The patient is a 7-yr-old boy with T1D diagnosed in January 2009 at the age of 20 months, who has
160
been on an insulin pump (Animas®, West Chester, PA, USA) since shortly after diagnosis. He had been using Contact™ Detach metal infusion sets (Osted, Denmark) (8-mm needle) since February 2012, using his gluteal region for insertion, and changing the set every 2–3 d. He presented with his mother, a registered nurse, for his routine quarterly diabetes follow-up appointment. She reported that on three different occasions over the previous 4 months, the needle on the infusion set was missing from the end of the tubing when it was taken out of his buttocks at the time of set change. However, because his set changes most often took place while he was bathing, and because they did not notice any evidence of discomfort, erythema, or other skin changes, his parents believed that the tiny needle had fallen into the bathwater and been lost. Physical examination showed a healthy boy with a normal growth pattern (weight, 75th percentile; height,
A rare complication of metal insulin infusion sets
Fig. 1. Patient 1. (A) The anteroposterior view of a pelvic radiograph demonstrates three needles (8 mm long) projecting over the right obturator foramen, inferior pubic ramus and femoral neck (arrows). On the left, two needles project over the left inferior buttock. (B) The lateral view close-up image demonstrates all five needles in the soft tissue of the buttocks approximately 3.5 cm from the surface.
60th percentile; and body mass index, 75th percentile). The patient’s hemoglobin A1c was 7.6%. Examination of the infusion set insertion sites in the gluteal region did not show any erythema, induration, irritation, or tenderness. Anteroposterior (AP) and lateral pelvic radiographs revealed five needles in the soft tissue of the buttock (Fig. 1A, B). Following referral to a pediatric surgeon, and discussions involving the pros and cons of removing the needles vs. leaving them alone, this child’s parents decided to proceed with surgical removal of the needles. The needles were removed by a pediatric surgeon with fluoroscopic guidance under general anesthesia. All five needles were recovered and removed. The patient was discharged to home the same day. His parents no longer use metal infusion sets with his pump to deliver insulin; they have opted to revert to Teflon sets.
Case report 2 This patient is a 13-yr-old boy with T1D diagnosed in 2003 at 2 yr of age, who had been on an insulin pump Pediatric Diabetes 2016: 17: 160–163
Fig. 2. Patient 2. The lateral view close-up image demonstrates an L-shaped metallic linear density over the posterior aspect of the distal sacrum/proximal coccyx.
(Medtronic®) since 2008. He had been using Medtronic MiniMed Sure-T® infusion sets (Unomedical, Osted, Denmark) for nearly 2 yr (since 2010). He developed mild discomfort in his gluteal region where he places his infusion sets, for which he was evaluated at an outside facility. He vaguely recalled that his insulin pump tubing got caught up recently while he was rushing out the door, forcefully pulling the set out. He did not notice that a needle was missing in the process. A lateral hip X-ray showed a retained needle. They attempted to remove the needle at the outpatient clinic using local anesthesia, which was unsuccessful, leaving a mild local swelling and bruising. On his routine quarterly diabetes follow-up appointment the following day, his physical examination showed that he was healthy with a mild bruising and swelling in the corresponding gluteal region, without induration, discharge, or significant tenderness. The patient’s hemoglobin A1c was 9.3%. A lateral X-ray revealed an L-shaped metallic linear density over the posterior aspect of the distal sacrum/proximal coccyx, consistent with a retained needle bent at a right angle (Fig. 2). A referral for a consultation with a pediatric surgeon was made to discuss management options; the decision was made to leave the needle in the place.
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Plager et al.
Discussion Continuous subcutaneous insulin infusion via insulin pumps has been used in the management of patients with T1D for decades (2–6). Recent estimates from the T1D Exchange clinic registry indicate that in the United States, 46% of children with T1D under the age of 18 yr are on insulin pumps (7). Insulin pumps require infusions sets to deliver insulin from the pump reservoir to the subcutaneous tissue and include the presence of an indwelling cannula or needle. Early insulin pumps in the 1980s used metal needles which were often considered to be large and uncomfortable. During the last two decades, these were replaced by Teflon catheters, which were more comfortable but less durable than needles. Recently, insulin sets with very tiny, ultrafine needles have been introduced in the United States and Europe, and are gaining in popularity. Although there are individual reports of various needle breaks with infusion set needles used for other purposes and also a case report of breakage of an insulin syringe needle in the soft tissue of a young girl (8), this is the first report in the medical literature, to our knowledge, of soft-tissue retention of insulin infusion set needles. In addition to these cases, there is a single case reported on the Manufacturer and User Facility Device Experience database (MAUDE) of a needle which broke off inside a patient while the patient was attempting to replace the Contact™ Detach set (9), and there are two anecdotal reports by parents on insulin pump forums which mention a similar issue with the Medtronic MiniMed Sure-T® infusion set (10, 11). Unomedical, a leading manufacturer of disposable infusion sets for insulin pumps, makes the metal needle sets used by the two major manufacturers of insulin pumps in the United States, including the Contact™ Detach set used with Animas insulin pumps and the Sure-T® set used with Medtronic MiniMed insulin pumps (Medtronic®, Northridge, CA, USA). Attempts to obtain information from Unomedical about retained insulin pump needles were unsuccessful. However, in June 2012, Unomedical issued a field safety alert regarding a different set, the neria™ steel infusion set, warning that in rare cases the needle could break during use (12), and this was followed by a medical device alert in August 2012 issued by the Medicines and Healthcare Products Regulatory Agency (MHPRA, London, UK) of the United Kingdom (13). Of note, these infusion sets were intended for use in patients with Parkinson’s disease, primary immune deficiency, and thalassemia, and were not intended for use in diabetes (13). Teflon cannulae and metal needle insertion sets each have pros and cons, and superiority of one type over the other has not been established (14).
162
Metal infusion sets have some advantages that may make them an attractive option for pump users: they are easy to insert, comfortable, less expensive and a good option for patients who have allergic reactions to Teflon (15). Moreover, metal sets eliminate the risk of kinking which may make them more reliable (15). Potential adverse effects previously noted with the use of metal infusion sets include needle bending, an allergic reaction to the needle or to the adhesive, or blood or air blocking the tubing or needle (16). The first patient (case 1) in this report had switched from Teflon to metal sets owing to frequent kinking of the cannulae and the need for very frequent set changes. Over the last 2 yr, his family and his medical team had been satisfied with the performance of the metal sets. While his parents had noted three of the needles to be missing over the recent 4-month period, it is not clear whether the other two needles broke off in this same period or earlier. Thus, these could have been a part of a ‘bad batch’ of infusion sets (he receives a 3-month supply at one time), or it may be a more pervasive problem. Further, based on the location of the needles on X-ray imaging, it must be noted that the sites that were being used for the metal insulin pump infusion sets appeared to be at a more inferior location than would routinely be recommended. More superior locations are generally favored and recommended, to avoid areas of pressure/compression on the cannula (sitting on it), discomfort, and soft-tissue damage. A plethora of publications in the medical literature describe various approaches for the management of retained surgical needles; yet, no consensus on clear guidelines exists (17). Given the obvious similarities and the lack of data specifically describing retained broken metal infusion sets in the skin and soft tissues, surgical information was extrapolated to draw inferences relevant to the cases discussed earlier. An individualized approach to decision-making regarding surgically removing small asymptomatic needles is recommended. Retained small surgical needles, generally, do not seem to pose major health risks (18). They are inert and, therefore, are less likely to cause tissue irritation (19), and their very small size renders them unlikely to cause discomfort, although case 2 in this report experienced mild discomfort. It is possible, however, that the discomfort in case 2 was a result of the shearing force when the set got pulled out, rather than the needle retention per se. Attempting to remove such needles surgically may lead to unnecessary tissue injury, not to mention the cost of surgery. Therefore, one could argue that leaving them in is justifiable and reasonable. Of note, given that insulin pump infusion set needles are made of stainless steel and are therefore, ferromagnetic, similar to surgical needles, they pose negligible risk of injury during exposure to magnetic resonance imaging (MRI) Pediatric Diabetes 2016: 17: 160–163
A rare complication of metal insulin infusion sets (19). On the other hand, these needles could potentially lead to chronic discomfort and pain (20–23), and although the risk is low, they could migrate over time and potentially cause damage to internal organs and blood vessels (19, 24).
Conclusion Insulin infusion sets with metal needles have historically been considered safe and effective. We report two unusual cases where needles broke off the infusion set on six different occasions while inserted into a children’s soft tissue. The fact that these patients were relatively asymptomatic with no initial signs on physical examination begs the question of whether there are other similar cases which have simply gone unnoticed. Further examination of the safety of this product may be warranted.
Conflict of interest The authors have no conflicts of interest to report and no financial interests to disclose. Besides the authors, no other contributors to the manuscript were identified.
References 1. Insulin Pump Therapy: Best Practices in Choosing and Using Infusion Devices: American Association of Diabetes Educators 2011 (available from http://www. diabeteseducator.org/export/sites/aade/_resources/pdf/ research/12-30-11-AADE_Insulin_WhitePaper_Print .pdf accessed on 30 June 2014). 2. Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med 2008: 25: 765–774. 3. The Diabetes Control and Complications Research Trial Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993: 329: 977–986. 4. Nixon R, Folwel R, Pickup JC. Variations in the quality and sustainability of long-term glycaemic control with continuous subcutaneous insulin infusion. Diabet Med 2014: 31: 1174–1177. 5. Bell DS, Ovalle F. Improved glycemic control with use of continuous subcutaneous insulin infusion compared with multiple insulin injection therapy. Endocr Pract 2000: 6: 357–360. 6. Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ 2002: 324: 705–709. 7. Beck RW, Tamborlane WV, Bergenstal RM et al. The T1D exchange clinic registry. J Clin Endocrinol Metab 2012: 97: 4383–4389. Pediatric Diabetes 2016: 17: 160–163
8. Sood A, Miglani S, Moorthy D. Breakage of insulin syringe needle in subcutaneous tissue. J Pediatr Endocrinol Metab 2001: 14: 101–102. 9. MAUDE Adverse Event Report. Animas Corporation (Johnson & Johnson) Contact Detach Infusion Set 2012 (available from http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id= 2421567 accessed on 30 June 2014). 10. Weird Sure-T Problem. Anyone else? 2010 (available from http://forums.childrenwithdiabetes.com/show thread.php?59869-WeirdSure-T-problem-Anyone-else accessed on 30 June 2014). 11. Sure-T Problem, Broken cannula: Insulin Pump Forums 2014 (available from http://www.insulinpump forums.com/index.php?showtopic=5552 accessed on 30 June 2014). 12. Unomedical. Field Safety Notice 2012 (available from http://www.mhra.gov.uk/home/groups/fsn/ documents/fieldsafetynotice/con155721.pdf accessed on 7 July 2014). 13. MHRA, Medical Device Alert: Neria Steel Cannula Infusion Sets Manufactured by Unomedical (MDA/2012/055) 2012 (available from http://www. mhra.gov.uk/home/groups/dts-bs/documents/medical devicealert/con178610.pdf accessed on 7 July 2014). 14. Patel PJ, Benasi K, Ferrari G et al. Randomized trial of infusion set function: steel versus Teflon. Diabetes Technol Ther 2014: 16: 15–19. 15. Heinemann L, Walsh J, Roberts R. We need more research and better designs for insulin infusion sets. J Diabetes Sci Technol 2014: 8: 199–202. 16. Schmid V, Hohberg C, Borchert M, Forst T, Pfutzner A. Pilot study for assessment of optimal ¨ frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010: 4: 976–982. 17. Ruscher KA, Modeste KA, Staff I, Papasavas PK, Tishler DS. Retained needles in laparoscopic surgery: open or observe? Conn Med 2014: 78: 197–202. 18. Hariharan D, Lobo DN. Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl 2013: 95: 87–92. 19. Gibbs VC, Coakley FD, Reines HD. Preventable errors in the operating room: retained foreign bodies after surgery – Part I. Curr Probl Surg 2007: 44: 281–337. 20. Jayadevan R, Stensland K, Small A, Hall S, Palese M. A protocol to recover needles lost during minimally invasive surgery. JSLS 2014: 18: e2014.00165. 21. Malhotra N, Roy KK, Sinha A. Forgotten needle – an unusual cause of chronic pelvic pain. Arch Gynecol Obstet 2003: 269: 68–69. 22. Hosli I, Tercanli S, Holzgreve W. Complications of lost needle after suture of vaginal tear following delivery. Arch Gynecol Obstet 2000: 264: 159–161. 23. Kleinpeter SJ, Kline RC, Finan MA. Retained surgical needle in the perineum. Report of a case with a novel method of search and rescue. J Reprod Med 1997: 42: 303–305. 24. Reinmuth N, Forster R, Scheld HH. From the neck to the lung: pneumothorax caused by a lost needles. Eur J Cardiothorac Surg 1995: 9: 216–217.
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Pediatric Diabetes 2016: 17: 160–163 doi: 10.1111/pedi.12266 All rights reserved
Pediatric Diabetes
Case Report
Two case reports of retained steel insulin pump infusion set needles Plager P, Murati MA, Moran A, Sunni M. Two case reports of retained steel insulin pump infusion set needles. Pediatric Diabetes 2016: 17: 160–163.
Phillip Plager, Michael A. Murati, Antoinette Moran and Muna Sunni
Insulin pumps are common in the management of type 1 diabetes (T1D). We report two cases of metal insulin infusion set needles which broke off the tubing and remained embedded in the soft tissue of two boys with T1D (five needles in one case, and one needle in the other). The patient with five retained needles was asymptomatic and had a normal physical examination, and the missing needles were only detected using pelvic X-ray; the second patient had only mild discomfort. While these are the first such cases reported in the medical literature, there may be other cases which have gone unnoticed, suggesting the potential need to explore the safety of this product further.
Department of Pediatrics, University of Minnesota Masonic Children’s Hospital, Minneapolis, MN 55454, USA Key words: Contact™ Detach infusion set – metal infusion set – needles – Sure-T® infusion sets Corresponding author: Dr. Muna Sunni, Department of Pediatrics University of Minnesota Masonic Children’s Hospital, East Building Room MB671, 2450 Riverside Ave, Minneapolis, MN 55454, USA. Tel: 612-624-5409; fax: 612-626-5262; e-mail: [email protected] Submitted 17 September 2014. Accepted for publication 23 January 2015
Insulin pumps are commonly used in the management of type 1 diabetes (T1D) in adults and children. They deliver insulin via an infusion set which is composed of a thin plastic tube of variable length that connects the insulin reservoir to a flexible plastic (Teflon) cannula or a thin metal needle which is manually inserted into the subcutaneous tissue, and which is replaced every few days. Several types of infusion sets are commercially available, and they are all generally considered to be safe (1). We report two cases where infusion set metal needles were found to be retained in the soft tissue of two children with T1D, captured on plain film X-ray imaging.
Case report 1 The patient is a 7-yr-old boy with T1D diagnosed in January 2009 at the age of 20 months, who has
160
been on an insulin pump (Animas®, West Chester, PA, USA) since shortly after diagnosis. He had been using Contact™ Detach metal infusion sets (Osted, Denmark) (8-mm needle) since February 2012, using his gluteal region for insertion, and changing the set every 2–3 d. He presented with his mother, a registered nurse, for his routine quarterly diabetes follow-up appointment. She reported that on three different occasions over the previous 4 months, the needle on the infusion set was missing from the end of the tubing when it was taken out of his buttocks at the time of set change. However, because his set changes most often took place while he was bathing, and because they did not notice any evidence of discomfort, erythema, or other skin changes, his parents believed that the tiny needle had fallen into the bathwater and been lost. Physical examination showed a healthy boy with a normal growth pattern (weight, 75th percentile; height,
A rare complication of metal insulin infusion sets
Fig. 1. Patient 1. (A) The anteroposterior view of a pelvic radiograph demonstrates three needles (8 mm long) projecting over the right obturator foramen, inferior pubic ramus and femoral neck (arrows). On the left, two needles project over the left inferior buttock. (B) The lateral view close-up image demonstrates all five needles in the soft tissue of the buttocks approximately 3.5 cm from the surface.
60th percentile; and body mass index, 75th percentile). The patient’s hemoglobin A1c was 7.6%. Examination of the infusion set insertion sites in the gluteal region did not show any erythema, induration, irritation, or tenderness. Anteroposterior (AP) and lateral pelvic radiographs revealed five needles in the soft tissue of the buttock (Fig. 1A, B). Following referral to a pediatric surgeon, and discussions involving the pros and cons of removing the needles vs. leaving them alone, this child’s parents decided to proceed with surgical removal of the needles. The needles were removed by a pediatric surgeon with fluoroscopic guidance under general anesthesia. All five needles were recovered and removed. The patient was discharged to home the same day. His parents no longer use metal infusion sets with his pump to deliver insulin; they have opted to revert to Teflon sets.
Case report 2 This patient is a 13-yr-old boy with T1D diagnosed in 2003 at 2 yr of age, who had been on an insulin pump Pediatric Diabetes 2016: 17: 160–163
Fig. 2. Patient 2. The lateral view close-up image demonstrates an L-shaped metallic linear density over the posterior aspect of the distal sacrum/proximal coccyx.
(Medtronic®) since 2008. He had been using Medtronic MiniMed Sure-T® infusion sets (Unomedical, Osted, Denmark) for nearly 2 yr (since 2010). He developed mild discomfort in his gluteal region where he places his infusion sets, for which he was evaluated at an outside facility. He vaguely recalled that his insulin pump tubing got caught up recently while he was rushing out the door, forcefully pulling the set out. He did not notice that a needle was missing in the process. A lateral hip X-ray showed a retained needle. They attempted to remove the needle at the outpatient clinic using local anesthesia, which was unsuccessful, leaving a mild local swelling and bruising. On his routine quarterly diabetes follow-up appointment the following day, his physical examination showed that he was healthy with a mild bruising and swelling in the corresponding gluteal region, without induration, discharge, or significant tenderness. The patient’s hemoglobin A1c was 9.3%. A lateral X-ray revealed an L-shaped metallic linear density over the posterior aspect of the distal sacrum/proximal coccyx, consistent with a retained needle bent at a right angle (Fig. 2). A referral for a consultation with a pediatric surgeon was made to discuss management options; the decision was made to leave the needle in the place.
161
Plager et al.
Discussion Continuous subcutaneous insulin infusion via insulin pumps has been used in the management of patients with T1D for decades (2–6). Recent estimates from the T1D Exchange clinic registry indicate that in the United States, 46% of children with T1D under the age of 18 yr are on insulin pumps (7). Insulin pumps require infusions sets to deliver insulin from the pump reservoir to the subcutaneous tissue and include the presence of an indwelling cannula or needle. Early insulin pumps in the 1980s used metal needles which were often considered to be large and uncomfortable. During the last two decades, these were replaced by Teflon catheters, which were more comfortable but less durable than needles. Recently, insulin sets with very tiny, ultrafine needles have been introduced in the United States and Europe, and are gaining in popularity. Although there are individual reports of various needle breaks with infusion set needles used for other purposes and also a case report of breakage of an insulin syringe needle in the soft tissue of a young girl (8), this is the first report in the medical literature, to our knowledge, of soft-tissue retention of insulin infusion set needles. In addition to these cases, there is a single case reported on the Manufacturer and User Facility Device Experience database (MAUDE) of a needle which broke off inside a patient while the patient was attempting to replace the Contact™ Detach set (9), and there are two anecdotal reports by parents on insulin pump forums which mention a similar issue with the Medtronic MiniMed Sure-T® infusion set (10, 11). Unomedical, a leading manufacturer of disposable infusion sets for insulin pumps, makes the metal needle sets used by the two major manufacturers of insulin pumps in the United States, including the Contact™ Detach set used with Animas insulin pumps and the Sure-T® set used with Medtronic MiniMed insulin pumps (Medtronic®, Northridge, CA, USA). Attempts to obtain information from Unomedical about retained insulin pump needles were unsuccessful. However, in June 2012, Unomedical issued a field safety alert regarding a different set, the neria™ steel infusion set, warning that in rare cases the needle could break during use (12), and this was followed by a medical device alert in August 2012 issued by the Medicines and Healthcare Products Regulatory Agency (MHPRA, London, UK) of the United Kingdom (13). Of note, these infusion sets were intended for use in patients with Parkinson’s disease, primary immune deficiency, and thalassemia, and were not intended for use in diabetes (13). Teflon cannulae and metal needle insertion sets each have pros and cons, and superiority of one type over the other has not been established (14).
162
Metal infusion sets have some advantages that may make them an attractive option for pump users: they are easy to insert, comfortable, less expensive and a good option for patients who have allergic reactions to Teflon (15). Moreover, metal sets eliminate the risk of kinking which may make them more reliable (15). Potential adverse effects previously noted with the use of metal infusion sets include needle bending, an allergic reaction to the needle or to the adhesive, or blood or air blocking the tubing or needle (16). The first patient (case 1) in this report had switched from Teflon to metal sets owing to frequent kinking of the cannulae and the need for very frequent set changes. Over the last 2 yr, his family and his medical team had been satisfied with the performance of the metal sets. While his parents had noted three of the needles to be missing over the recent 4-month period, it is not clear whether the other two needles broke off in this same period or earlier. Thus, these could have been a part of a ‘bad batch’ of infusion sets (he receives a 3-month supply at one time), or it may be a more pervasive problem. Further, based on the location of the needles on X-ray imaging, it must be noted that the sites that were being used for the metal insulin pump infusion sets appeared to be at a more inferior location than would routinely be recommended. More superior locations are generally favored and recommended, to avoid areas of pressure/compression on the cannula (sitting on it), discomfort, and soft-tissue damage. A plethora of publications in the medical literature describe various approaches for the management of retained surgical needles; yet, no consensus on clear guidelines exists (17). Given the obvious similarities and the lack of data specifically describing retained broken metal infusion sets in the skin and soft tissues, surgical information was extrapolated to draw inferences relevant to the cases discussed earlier. An individualized approach to decision-making regarding surgically removing small asymptomatic needles is recommended. Retained small surgical needles, generally, do not seem to pose major health risks (18). They are inert and, therefore, are less likely to cause tissue irritation (19), and their very small size renders them unlikely to cause discomfort, although case 2 in this report experienced mild discomfort. It is possible, however, that the discomfort in case 2 was a result of the shearing force when the set got pulled out, rather than the needle retention per se. Attempting to remove such needles surgically may lead to unnecessary tissue injury, not to mention the cost of surgery. Therefore, one could argue that leaving them in is justifiable and reasonable. Of note, given that insulin pump infusion set needles are made of stainless steel and are therefore, ferromagnetic, similar to surgical needles, they pose negligible risk of injury during exposure to magnetic resonance imaging (MRI) Pediatric Diabetes 2016: 17: 160–163
A rare complication of metal insulin infusion sets (19). On the other hand, these needles could potentially lead to chronic discomfort and pain (20–23), and although the risk is low, they could migrate over time and potentially cause damage to internal organs and blood vessels (19, 24).
Conclusion Insulin infusion sets with metal needles have historically been considered safe and effective. We report two unusual cases where needles broke off the infusion set on six different occasions while inserted into a children’s soft tissue. The fact that these patients were relatively asymptomatic with no initial signs on physical examination begs the question of whether there are other similar cases which have simply gone unnoticed. Further examination of the safety of this product may be warranted.
Conflict of interest The authors have no conflicts of interest to report and no financial interests to disclose. Besides the authors, no other contributors to the manuscript were identified.
References 1. Insulin Pump Therapy: Best Practices in Choosing and Using Infusion Devices: American Association of Diabetes Educators 2011 (available from http://www. diabeteseducator.org/export/sites/aade/_resources/pdf/ research/12-30-11-AADE_Insulin_WhitePaper_Print .pdf accessed on 30 June 2014). 2. Pickup JC, Sutton AJ. Severe hypoglycaemia and glycaemic control in type 1 diabetes: meta-analysis of multiple daily insulin injections compared with continuous subcutaneous insulin infusion. Diabet Med 2008: 25: 765–774. 3. The Diabetes Control and Complications Research Trial Group. The effect of intensive treatment of diabetes on the development and progression of longterm complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med 1993: 329: 977–986. 4. Nixon R, Folwel R, Pickup JC. Variations in the quality and sustainability of long-term glycaemic control with continuous subcutaneous insulin infusion. Diabet Med 2014: 31: 1174–1177. 5. Bell DS, Ovalle F. Improved glycemic control with use of continuous subcutaneous insulin infusion compared with multiple insulin injection therapy. Endocr Pract 2000: 6: 357–360. 6. Pickup J, Mattock M, Kerry S. Glycaemic control with continuous subcutaneous insulin infusion compared with intensive insulin injections in patients with type 1 diabetes: meta-analysis of randomised controlled trials. BMJ 2002: 324: 705–709. 7. Beck RW, Tamborlane WV, Bergenstal RM et al. The T1D exchange clinic registry. J Clin Endocrinol Metab 2012: 97: 4383–4389. Pediatric Diabetes 2016: 17: 160–163
8. Sood A, Miglani S, Moorthy D. Breakage of insulin syringe needle in subcutaneous tissue. J Pediatr Endocrinol Metab 2001: 14: 101–102. 9. MAUDE Adverse Event Report. Animas Corporation (Johnson & Johnson) Contact Detach Infusion Set 2012 (available from http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id= 2421567 accessed on 30 June 2014). 10. Weird Sure-T Problem. Anyone else? 2010 (available from http://forums.childrenwithdiabetes.com/show thread.php?59869-WeirdSure-T-problem-Anyone-else accessed on 30 June 2014). 11. Sure-T Problem, Broken cannula: Insulin Pump Forums 2014 (available from http://www.insulinpump forums.com/index.php?showtopic=5552 accessed on 30 June 2014). 12. Unomedical. Field Safety Notice 2012 (available from http://www.mhra.gov.uk/home/groups/fsn/ documents/fieldsafetynotice/con155721.pdf accessed on 7 July 2014). 13. MHRA, Medical Device Alert: Neria Steel Cannula Infusion Sets Manufactured by Unomedical (MDA/2012/055) 2012 (available from http://www. mhra.gov.uk/home/groups/dts-bs/documents/medical devicealert/con178610.pdf accessed on 7 July 2014). 14. Patel PJ, Benasi K, Ferrari G et al. Randomized trial of infusion set function: steel versus Teflon. Diabetes Technol Ther 2014: 16: 15–19. 15. Heinemann L, Walsh J, Roberts R. We need more research and better designs for insulin infusion sets. J Diabetes Sci Technol 2014: 8: 199–202. 16. Schmid V, Hohberg C, Borchert M, Forst T, Pfutzner A. Pilot study for assessment of optimal ¨ frequency for changing catheters in insulin pump therapy-trouble starts on day 3. J Diabetes Sci Technol 2010: 4: 976–982. 17. Ruscher KA, Modeste KA, Staff I, Papasavas PK, Tishler DS. Retained needles in laparoscopic surgery: open or observe? Conn Med 2014: 78: 197–202. 18. Hariharan D, Lobo DN. Retained surgical sponges, needles and instruments. Ann R Coll Surg Engl 2013: 95: 87–92. 19. Gibbs VC, Coakley FD, Reines HD. Preventable errors in the operating room: retained foreign bodies after surgery – Part I. Curr Probl Surg 2007: 44: 281–337. 20. Jayadevan R, Stensland K, Small A, Hall S, Palese M. A protocol to recover needles lost during minimally invasive surgery. JSLS 2014: 18: e2014.00165. 21. Malhotra N, Roy KK, Sinha A. Forgotten needle – an unusual cause of chronic pelvic pain. Arch Gynecol Obstet 2003: 269: 68–69. 22. Hosli I, Tercanli S, Holzgreve W. Complications of lost needle after suture of vaginal tear following delivery. Arch Gynecol Obstet 2000: 264: 159–161. 23. Kleinpeter SJ, Kline RC, Finan MA. Retained surgical needle in the perineum. Report of a case with a novel method of search and rescue. J Reprod Med 1997: 42: 303–305. 24. Reinmuth N, Forster R, Scheld HH. From the neck to the lung: pneumothorax caused by a lost needles. Eur J Cardiothorac Surg 1995: 9: 216–217.
163
