Patient Safety Tip of the Week
September 18, 2012 Insulin Pump Safety
Problems related to insulin pumps have been on our list of potential topics for some time. We’ve discussed infusion pump safety issues in general (see our April 27, 2010 Patient Safety Tip of the Week “Infusion Pump Safety”) but that dealt more with the various infusion pumps used in the hospital setting and did not focus on insulin pumps. But it took a description of an untoward event recently published by the California Department of Public Health (CDHP 2012) to remind us to do this column. That was an unfortunate case where a diabetic patient who used an insulin pump was admitted to a hospital with pyelonephritis and was given insulin by injections per a sliding scale regimen, with numerous caregivers assuming that the insulin pump had been turned off. The patient was later found unconscious with profound hypoglycemia and ultimately died. It was suspected that she was receiving both the insulin injections and insulin via her insulin pump.
Most hospitals, including the one in the above case, have policies on bedside storage of a patient’s own medications or self-administration of such medications by inpatients. Generally they require involvement by a pharmacist, oversight of storage of the medications, and perhaps integration into the hospital’s barcoding/bedside medication verification (BMV) system. (As an aside, note that the Pennsylvania Patient Safety Authority (Grissinger 2012) recently did a very good review on patients taking their own medications while hospitalized.) However, many such policies do not specifically address insulin pumps. The policy at the above hospital did not address them.
The plan of correction by the above hospital included temporarily disallowing use of insulin pumps until they were able to put in place a much more complete solution. They revised their policy on self-administered medications at the bedside to specifically address insulin pumps. If there was an alternate insulin regimen ordered by a physician, the insulin pump was to be removed from the room. It would no longer be allowed to simply tell the patient to turn the pump off. In addition, an endocrinologist would be required to provide an assessment of such patients. They did extensive staff training on insulin pumps (with development of competencies) and attempted to cohort patients with insulin pumps to one unit. In addition, Pharmacy would be involved in the care of any patient with an insulin pump.
A recent review of insulin pump therapy (Pickup 2012) discusses issues related to hospitalization. It recognizes that hospital staff are frequently inexperienced in dealing with insulin pumps and notes that most patients using insulin pumps as outpatients do prefer to continue with their pump therapy while an inpatient. The author recommends advice from the local insulin pump team and adherence to strict insulin pump protocols.
The group at the Mayo Clinic Scottsdale (Leonhardi 2008, Nassar 2010) has good experience with use of insulin pumps in hospitalized patients. They developed a policy and protocols for managing patients with insulin pumps who get hospitalized (Leonhardi 2008). They, too, note that most of their patients on insulin pumps wish to continue self-administration of insulin via insulin pump while hospitalized. However, hospital staff are often unfamiliar with use of the pumps and hospitals often lack supplies compatible with the pump systems. So they developed their program with 2 goals in mind: (1) maintain flexibility in allowing patients to continue use of their insulin pumps in hospital and (2) ensure patient safety. They developed a formal written policy for their hospital (available in the Leonhardi 2008 paper). It includes a list of contraindications to continued use of the pump in the hospital and a set of rules to guide the medical staff about insulin pump management. It includes requirement for identification of the pump, brand of pump and insulin type. The patient must sign a consent to continue the pump in the hospital and the physician uses a standardized order set (pre-printed or via CPOE). Consults by an endocrinologist, diabetes educator and nutritionist are required. An insulin pump/glucose monitoring flowsheet is kept at the bedside. The consent form requires the patient to bring their own pump supplies with them. (The Leonhardi 2008 paper also includes copies of the consent form, the order set, and the flowsheet.) Both papers summarize the experience with hospitalizations using these but we’ll just use the latter one since it has the most recent experience (Nassar 2010). There were 125 hospitalizations in 65 patients with insulin pumps and the insulin pump was able to be continued in two thirds during hospitalizations. Compliance with most elements of the policy was generally good. Consent agreements were signed in 83% of those continuing to use the pump in hospital and the order sets were used in 89%. Endocrinology consults were obtained in 89% and there was nursing documentation of the pump insertion sites in 89%. However, the bedside insulin pump flow sheets were found in only 55% (though this may reflect failure to scan these documents into the medical record). The mean glucose during the hospitalization did not differ between groups continuing the pump compared to those in which it was discontinued or used only intermittently. Other than one instance of a pump catheter kinking there were no other adverse events related to the pump therapy. Frequency of hypoglycemia was comparable in the “pump on” and “pump off” groups but slightly higher in the “intermittent pump” group.
The Mayo Scottsdale experience clearly demonstrates that it is feasible and safe to allow continuation of the insulin pump therapy during inpatient hospitalizations. Patients seem to like that. But it remains to be seen that this results in any better management of glycemia than one sees with conventional inpatient glycemia management. The authors had expected to see less frequent hypoglycemic events in the pump patients but this failed to be demonstrated. But if you are considering letting patients on the pump continue it in hospital, they have provided for you a great policy and set of documents to start with!
The biggest challenge the Mayo Scottsdale group noted was continually educating the staff. Not only is there nursing staff turnover but as an academic setting they also deal with new housestaff regularly. Good insulin pump programs provide extensive education and training not only for the patient but also for their families or caregivers. (Note that some of the deaths reported to the FDA in patients on insulin pumps occurred in settings where there was no caregiver available.) So would you provide any less education and training to your hospital staff? It might be impractical to provide the many hours of training needed to an entire hospital staff. So that is where the concept of cohorting pump patients on one unit might make sense. That would decrease the number of individuals who would need extensive training. But there is always the possibility that such units might need a “floater” or “temporary” nurse and you’d have to be sure they had the competencies for managing patients on the pump.
Another group found similar challenges in educating staff about the use of insulin pumps in hospitalized patients (Buchko 2012). In their early implementation of a quality improvement program on insulin pump use, in which the nursing educational program was not mandatory, they found few nurses completed the computer-based training and compliance with recommended practices were suboptimal and glycemic management was not improved. They subsequently enhanced the educational program for both nurses and physicians. In addition, they added daily rounds by 2 advanced practice nurses who were part of their multidisciplinary team to maintain constant vigilance of patients using the insulin pump. One of their key roles was to ensure that the patient was still capable of self-management at all times. We consider that latter point as critical. While patients may be alert and cognitively and physically capable of self-management of their insulin pump on admission, it is not uncommon to see deterioration of either capability during a hospitalization. Therefore, the type of daily surveillance implemented in the Buchko study makes great sense. And, indeed, they found significant improvement in their late implementation phase for both compliance with process metrics and glycemic control.
The Mayo Scottsdale team has also developed standard guidelines and a checklist for continuation of the insulin pump in the perioperative period (Boyle 2012). A sample set of protocols is summarized in the article. They had noted inconsistent documentation of pump use and glucose monitoring throughout the perioperative period, even for patients with prolonged anesthesia and recovery times, and it was often unclear whether the pump was in place and operational during the intraoperative period (Nassar 2012). Hence, they recommended development of guidelines for use of the pump in patients undergoing surgery and throughout the perioperative period.
But there are probably “little” issues that could have a big impact. If your policy specifies that patients bring in their own insulin pump supplies does that mean just the infusion set and catheters? What about battery replacements? Do nursing staff know what to do if the “low battery” alarm goes off?
And bigger issues. What if you don’t have an insulin pump team? Or even an endocrinologist? Even a small rural hospital that has no local patients on insulin pumps may from time to time get a pump patient who is visiting the area or passing through and develops a medical problem requiring hospitalization. In such cases, it is probably wisest to disconnect the pump and use alternative insulin regimens. However, those hospitals lacking pump expertise might consider developing telemedicine linkages to larger urban systems that do have endocrinologists and formal insulin pump teams. Or consider contacting the physician or insulin pump team from the patient’s home area.
One other problem we are seeing more and more is related to use of insulin U-500 preparations. Problems related to the insulin U-500 preparation are well known and include the issues of use of incorrect syringes, mistaken identity of U-500 vials for standard concentration vials, selection errors from computerized order entry screens, etc. (PPSA 2010, ISMP 2007). Because there are many problems associated with the use of that preparation many hospitals don’t even stock it. But patients on insulin pumps sometimes are using that preparation. When they get hospitalized, the hospital personnel often attempt to convert the patient to an equivalent dose of a different insulin preparation. Errors are often made during that conversion. However, just as likely are errors made at discharge when the conversion back to the U-500 preparation should be done.
The review by Pickup (Pickup 2012) has a good discussion of the indications and patient selection for using the insulin pump. Note that he recommends patients on insulin pumps should be managed by formal specialized insulin pump teams consisting of a physician, diabetes nurse, and a dietitian trained in pump procedures. He does not recommend initiation of insulin pumps by primary care physicians. The patient must be motivated and committed to frequent glucose self-monitoring, carbohydrate counting, and working with the team to learn pump procedures.
Adolescents represent an age group with some unique challenges. After the FDA received reports of 5 deaths in adolescents in one year related to insulin pumps they did a comprehensive review of cases identified in the MAUDE database over a 10-year period (Cope 2008). Over that time there were 1594 reports of events related to insulin pumps in patients aged 12-21, including 13 deaths. In half the cases, excess administration of insulin occurred. Factors common in adolescence that may have contributed in some cases were related to compliance, education, sports-related activities, and dropping or damaging the pumps. In some cases tampering or intentional overdose (eg. suicide attempt) occurred. They refer to one study that showed a substantial disparity between the number of adolescents claiming they were compliant with their pump use and actual compliance.
The FDA also recently addressed contributing factors to insulin pump errors in children, adolescents and adults (Clayton-Jeter 2012). Though many factors are common to all age groups, there are some that are unique to adolescents. Their review stressed the importance of patient selection (including assessment of motivation, the level of maturity, psychological and behavioral factors, and cognitive abilities) plus education and training and level of support from other caregivers. They note that peer-related activities may play a role in noncompliance with the pump. An example they note some teens expressed a desire to disconnect the pump when they wanted to get in a hot tub or pool beyond the recommended time limit.
The FDA has sponsored at least two insulin pump safety meetings (Klonoff 2009, Zhang 2010a) and done a hazard analysis on a generic insulin infusion pump model (Zhang 2010b). These have identified numerous areas in need of improvement (design, hardware, software, human factors, alarms, communication issues, displays, etc). Other investigations have even found that some systems might be vulnerable to hacking (Finkle 2011).
Another issue that hospitals (and freestanding imaging units) must deal with is the risk associated with insulin pumps in patients who need to undergo MRI. The risks and the appropriate measures to reduce or avoid those risks depend on the design, construction, and type of insulin pump (Shellock 2010). The very strong electromagnetic fields generated by MRI machines can interfere with the insulin delivery system and can even permanently damage the pump’s motor. In addition, the infusion sets from some manufacturers may also contain ferromagnetic elements (such as a steel surgical needle) that would need to be removed before any MRI study. The Shellock article lists information about the most commonly used insulin pump systems. In most cases the unit must be removed prior to the patient being taken into the MRI room. In cases where a patient with an insulin pump is inadvertently exposed to an MRI it is usually recommended that the pump be immediately disconnected and the manufacturer contacted for instructions. The Shellock article also advises the healthcare professional to contact the manufacturer ahead of time in each individual instance to get the most up-to-date safety information.
Insulin pump therapy has made a major impact on the lives and health of many diabetic patients. It has improved glycemia control and lowered HbA1c levels, reduced hypoglycemic episodes, and improved several indicators of patient quality of life. So the insulin pump is here to stay. It’s advisable for healthcare systems to develop teams to manage patients on insulin pumps and to develop protocols and procedures for those patients on insulin pumps who are hospitalized.
References:
CDPH (California Department of Public Health). Statement of Deficiencies/Plan of Correction. Insulin Pump case. Accepted 4/6/2011. Published August 2012
Grissinger M. Patients Taking Their Own Medications While in the Hospital. Pa Patient Saf Advis 2012; 9(2): 50-7
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2012/Jun;9%282%29/Pages/50.aspx
Pickup JC. Insulin-Pump Therapy for Type 1 Diabetes Mellitus. NEJM 2012; 366(17): 1616-1624
http://www.nejm.org/doi/full/10.1056/NEJMct1113948
Leonhardi BJ, Boyle
ME, Beer KA, Seifert KM, Bailey M, Miller-Cage V, Castro JC, Bourgeois PB, Cook
CB. Use of continuous subcutaneous insulin infusion (insulin pump) therapy in
the hospital: a review of one institution's experience. J Diabetes Sci Technol
2008; 2(6): 948–962
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2769830/?tool=pmcentrez
Nassar AA, Partlow
BJ, Boyle ME, Castro JC, Bourgeois PB, Cook CB. Outpatient-to-Inpatient Transition
of Insulin Pump Therapy: Successes and Continuing Challenges. J Diabetes Sci
Technol 2010; 4(4): 863–872. Published online 2010 July 1.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2909518/?tool=pmcentrez
Buchko BL, Artz B, Dayhoff S, March KS. Improving Care of Patients With Insulin Pumps During Hospitalization: Translating the Evidence. Journal of Nursing Care Quality 2012; 27(4): 333-340, October/December 2012
Boyle ME, Seifert KM, Beer KA, et al. Guidelines for application of continuous subcutaneous insulin infusion (insulin pump) therapy in the perioperative period. J Diabetes Sci Technol. 2012 Jan 1;6(1):184-90
http://www.ncbi.nlm.nih.gov/pubmed/22401338
Nassar AA, Boyle ME, Seifert KM, et al. Insulin pump therapy in patients with diabetes undergoing surgery. Endocr Pract. 2012; 18(1): 49-55
http://www.ncbi.nlm.nih.gov/pubmed/21803711
PPSA (Pennsylvania Patient Safety Authority). Medication Errors with the Dosing of Insulin: Problems across the Continuum. Pa Patient Saf Advis 2010; 7(1): 9-17
http://patientsafetyauthority.org/ADVISORIES/AdvisoryLibrary/2010/Mar7%281%29/Pages/09.aspx
ISMP (Institute for Safe Medication Practices). HUMULIN R CONCENTRATE U-500. ISMP Medication Safety Alert Community/Ambulatory Care Edition. 2007; August 2007
http://www.ismp.org/newsletters/ambulatory/archives/200708_2.asp
Cope JU, Morrison AE, Samuels-Reid J. Adolescent use of
insulin and patient-controlled analgesia pump technology: a 10-year Food and
Drug Administration retrospective study of adverse events. Pediatrics 2008; 121(5): e1133 -e1138
http://pediatrics.aappublications.org/content/121/5/e1133.full
Clayton-Jeter H. Contributing Factors to Insulin Pump Errors in Children, Adolescents and Adults. FDA Articles of Interest for Health Professionals (March 2012)
http://www.fda.gov/ForHealthProfessionals/ArticlesofInterest/ucm295562.htm
Klonoff DC, Reyes JS. Insulin Pump Safety Meeting: Summary Report. J Diabetes Sci Technol. 2009 March; 3(2): 396–402.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2771530/
Zhang Y, Jones PL, Klonoff DC. Second Insulin Pump Safety Meeting: Summary Report. J Diabetes Sci Technol. 2010; 4(2): 488–493 Published online 2010 March 1.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2864186/?tool=pubmed
Zhang Y, Jones PL, Jetley R. A Hazard Analysis for a Generic Insulin Infusion Pump. Journal of Diabetes Science and Technology 2010; 4(2): 263-283 March 2010
http://www.journalofdst.org/March2010/Articles/VOL-4-2-ORG1-ZHANG.pdf
Finkle J. Exclusive: Medtronic probes insulin pump risks. Reuters 2011; October 26, 2011
http://uk.reuters.com/article/2011/10/25/us-medtronic-cybersecurity-idUKTRE79O8EP20111025
Shellock FG. MRI safety: Patients with insulin pumps require special cautions. Diagnostic Imaging October 5, 2010
http://www.diagnosticimaging.com/mri/content/article/113619/1686437
http://www.patientsafetysolutions.com/