In our April 6, 2010 Patient Safety Tip of the Week “Cancer Chemotherapy Accidents” we described several cases where patients received potentially lethal doses of chemotherapy when infusion pumps were inadvertently programmed to infuse the entire contents over several hours rather than over several days. That got us thinking again about infusion pump safety. Infusion pumps have been a wonderful addition to clinical care. They allow infusion of some medications that previously required a nurse or physician to physically administer over long periods. They allow infusion of large or small volumes of fluids to be administered in a controlled fashion. And they theoretically reduce the likelihood of overdose due to a “wide open” or “free-flow” infusion from a conventional IV setup. And “smart” pumps allow for safer and more accurate dosing. But we can expect unintended consequences with the introduction of any new technology and infusion pumps are no exception. And perhaps the problem is magnified because infusion pumps are often used for administration of high-risk medications such as chemotherapy agents, anticoagulants, and narcotic analgesics. And even the “advantage” of relieving clinical staff of physically doing the infusion themselves could become a “disadvantage” because those staff were also doing bedside monitoring of the infusion.
Just looking back through our Archives, we found several columns identifying patient safety issues related to infusion pumps. And, of course, infusion pumps are not just used for IV fluids and medications. They may also used for enteral feedings, epidural anesthesia and other procedures. These other uses also raise problems related to catheter misconnections. We won’t talk further about catheter misconnections in today’s column but those interested can go to our July 10, 2007 Tip of the Week “Catheter Connection Errors/Wrong Route Errors” and our What’s New in the Patient Safety World columns “November 2007 What’s New in the Patient Safety World”, “August 2009 Catheter Misconnections Continue to Occur”, and “April 2010 RCA: Epidural Solution Infused Intravenously”.
In our March 12, 2007 Patient Safety Tip of the Week “we noted that a data entry person may double press a key (or the key may become stuck) resulting in, for example, “88” instead of “8”. Also, during data entry it is possible to think one hit a decimal point but it fails to print out. Such data entry errors have recently been noted in programmable intravenous infusion pumps and there have been several occurrences of 10x overdoses with those pumps. Therefore, a policy of having a second independent observer verify the dosage or rate on such pumps makes sense (however, keep in mind that error rates from other industries tell us that one who oversees someone else’s work typically does so in error up to 10% of the time!).
In our September 9, 2008 Patient Safety Tip of the Week “Less is More….and Do You Really Need that Decimal?” we discussed 2 issues related to programming infusion pumps. The first was a significant and somewhat paradoxical problem with PCA pump programming outlined in an ISMP Safe Medication Alert “Misprogramming PCA concentration leads to dosing errors”. If one programs in too high of a concentration, the patient tends to get underdosed (so may suffer continued pain). If one programs in too low a concentration, the patient actually gets overdosed! This seems counterintuitive. But think about it – the patient asks for a certain dose of the narcotic and the pump delivers the volume it is programmed for to meet that request. If the concentration was erroneously too low, the pump has now given a higher volume and, hence, a higher actual narcotic dose. And often a warning on the pump that the concentration is too low may be overridden because the nurse or physician feels less concerned about “too low” than “too high”. ISMP makes some specific recommendations to reduce the risk of such errors. One is to make the “too low concentration” warning a “hard” warning that must be acknowledged and reprogrammed rather than simply being overridden. They strongly suggest organizations assess their current vulnerabilities to mistakes of this sort (perhaps do a FMEA on PCA pumps) and increase staff awareness of the results. Limiting stock to a single standard concentration of each of the PCA drugs may also help. They discuss numerous aspects of proper labeling and stress that there must be a very distinctive label for any nonstandard concentrations. They also recommend use of double checks and bar-coding and smart pump technology.
The second issue we raised in that September 9, 2008 Patient Safety Tip of the Week “Less is More….and Do You Really Need that Decimal?” was that when we do calculations we often include several digits after a decimal point that may be largely irrelevant yet expose our patients to a significant safety risk if the decimal point happens to be overlooked. You all know you should never use a “trailing zero”, i.e. a zero following a decimal point, because if the decimal point is not seen there is a risk of a 10-fold (or higher) overdose. But what about other numbers following a decimal point? They are important in certain circumstances (eg. a dose of 0.3 mg or 2.7 mg). However, at higher doses they become much less relevant. For example, let’s say you performed a calculation and the result was a recommended dose of a drug is 72.2 mg. Is there really a difference if the patient gets 72 mg. or 72.2 mg of most drugs? Yet ordering the latter dosage increases the risk that the decimal point may not be seen or not input into a computer or missed in a faxed order and the patient gets a 10x overdose. So we strongly recommend that in writing medication orders one specifically decides whether such fractional doses are important or merely place the patient at increased risk of an error.
Our May 12, 2009 Patient Safety Tip of the Week “Errors With PCA Pumps” dealt with a number of errors that may occur during use of patient controlled analgesia (PCA). That column dealt with a whole host of problems related to IV infusion of narcotic analgesics, including “PCA by proxy”, in which a family member or other caregiver pushes the button allowing narcotic administration, thereby bypassing the built-in safety mechanism where a patient becoming drowsy cannot self-administer more opioids. It is also critical that you have a good system for monitoring the level of sedation (using a sedation scale) in your patients on PCA.
”Smart” pumps are pumps having software programs that allow dosages ranges to be set up in attempt to prevent high doses being inadvertently programmed in. However, even with smart pumps one has to be careful. An erroneous “drug library” can cause an error to be propagated to multiple patients. Also, in the ISMP article “Smart Pumps Are Not Smart On Their Own” it is emphasized that the warnings on smart pumps can be bypassed by nurses and this may become a “normalized deviance” in some cultures. So periodically you need to monitor the actual use of your smart pumps.
One big problem we see is lack of standardization of pumps. If you are like most organizations, you probably don’t replace your current stock of IV pumps all at once. That results in having multiple different models and styles and manufacturers of pumps in your facilities at any time. This can be very confusing for your staff since the programming and use of one pump may be different from other pumps. Sometimes those differences are subtle but may have significant impacts. As with any equipment purchases, it is critical that you include on your “purchase decision team” many clinical members who will be end users of the equipment so that they can help identify features that may become a concern if standardization is not maintained.
Now the FDA is beginning to take a hard look at safety of infusion pumps. They have recently announced a new initiative collaborating with industry to make infusion pumps safer. The FDA has received 56,000 reports of adverse events related to infusion pumps between 2005 and 2009 and there have been 87 infusion pump recalls, many of which have been for serious safety problems. The main part of this new initiative will be working with manufacturers to improve design and engineering issues that have been identified as problematic. But many problems also occur at the user end. Their website has several excellent resources including examples of infusion pump problems (including software problems, alarm errors, user interface design issues, battery problems, fire risk, etc.) and risk reduction strategies for staff at several levels of your healthcare organizations, including home care nurses and even patients themselves. There’s even a brochure for patients on getting the most out of their pump. This is an excellent resource that every healthcare organization should become familiar with.
Below are some of the recommendations that we have plus many from the FDA:
Don’t ever put a potentially lethal dose of anything in an
Always ask yourself “what would happen if this entire dose were to infuse in over a few hours (or even shorter depending on the item to be infused)?”.
Do double checks
Even though we have emphasized that double checks are a relatively weak intervention (we know from all industries that the error rate when a supervisor checks someone else’s work may be 10% or higher), the literature supports a medication error reduction of about 30% when using a double check system (see our July 15, 2008 Patient Safety Tip of the Week “ ”). Also, for any high risk medications you need to do truly independent double checks (see our March 30, 2010 Patient Safety Tip of the Week “Publicly Released RCA’s: Everyone Learns from Them” for a description of independent double checks).
Label all lines/tubing
Sometimes in critically ill patients there are multiple lines connected to multiple different sources and sometimes these are temporarily disconnected (eg. during radiology procedures). Therefore, it is critical that good labeling be placed on all lines and sources.
Label IV bags and include volume and overfill
Pharmacists should obviously label IV bags appropriately but should also include the amount of any overfill on non-prefilled bags so that clinicians can account for the total bag volume.
Use drug libraries for smart pumps
Establish ranges (high and low limits) for high risk drugs and standardize concentrations within the drug libraries.
Infusion pump settings should be checked at all handoffs (change of shift, transfer to other services or sites, etc.). The recent trend toward doing bedside change of shift handoffs (see our April 13, 2010 Patient Safety Tip of the Week “Update on Handoffs”) encourages such checking of infusion pumps.
We’ve stressed the issue of alarm fatigue so many times we won’t even give you all the links. Suffice it to say that the most frequently ignored alarms in our experience are those related to IV’s. Make sure you include random checks of infusion pump alarms when you are doing your “alarm rounds” or patient safety rounds. And when you are doing those rounds don’t forget to check the battery status on any such pumps using battery power.
Double checks for calculation errors
Use double checks for any dosage calculations you are doing. True independent double checks must be done for any infusion involving high risk (see our March 30, 2010 Patient Safety Tip of the Week “Publicly Released RCA’s: Everyone Learns from Them” for a description of independent double checks).
9. Do a “mental approximation”. That’s where you do a simple calculation in your head that would say “this infusion is going to be done in 4 hours”, not in the 4 days that were intended”.
You need checklists to serve as reminders not only for programming and setting up the infusion pumps but also for examining the entire setup at all handoffs and whenever you change settings, hang a new bag of medications or fluids, or when new tubing is primed.
Have a backup plan
This is a good one (credit to the FDA on this one!). What do you do when you are infusing a critical medication and have an infusion pump failure? How long would it take you to get a replacement? How would you handle the infusion and monitoring in the interim? Those of you who have done FMEA’s (failure mode and effects analyses) on high risk medications such as anticoagulants and chemotherapy agents or narcotic infusions should go back and look to see if you included backup plans in those FMEA’s (we found several of our own that did not include this item). Most importantly, know ahead of time what you would do if there were an overinfusion.
In addition to whatever monitoring functions are built into your infusion pump setup, make sure you are monitoring you patient otherwise for both desired and undesired effects (eg. sedation scales for narcotic infusions, pulse oximetry, end-tidal CO2, etc.). And the FDA recommends you consider secondary methods of monitoring volumes infused (eg. time strip monitor or buretrol).
All staff using infusion pumps or even exposed to infusion pumps (eg. radiology department staff) need to be trained in the use of any infusion pumps at your facility. See our comments below on issues related to standardization or lack of standardization. And especially make sure that such training is done up front for key staff types like new hires, agency personnel, etc. Also be very wary when nursing or other personnel “float” from one unit to another where different pumps may be in use.
Make resources available at point of care
Make sure that appropriate manuals, troubleshooting guides, and training materials are available at all points of care. Make sure that staff know who and how to contact for advice.
Have an alert & recall surveillance system
You should have a defined system and responsible personnel for identifying alerts and recalls that affect your institution. Alerts and recalls should also be a standing item on your monthly patient safety agenda.
Beware of having different types of pumps in your organization. This increases the likelihood that errors will occur. Nevertheless, most organizations cannot afford to replace all their pumps at the same time so inevitably they have multiple types. So heed the advice above under “training”. And include in your “purchase decision team” clinical members that will be end users any time you evaluating new equipment.
Standardize drug concentrations
Concentrations of high risk drugs should be standardized wherever possible to help avoid dosage and rate calculation errors during infusions.
Audit use of infusion pumps
In the ISMP article “Smart Pumps Are Not Smart On Their Own” it is emphasized that the warnings on smart pumps can be bypassed by nurses and this may become a “normalized deviance” in some cultures. So periodically you need to monitor the actual use of your smart pumps.
If you identify problems related to infusion pumps, make sure that you report these to the manufacturer and to the FDA. Your serious incident response checklist (see our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist”) should also include sections for assigning who is responsible for doing that reporting. That checklist also should have a specific section on sequestering any equipment involved in incidents (so that such equipment is available for investigation and so that faulty equipment is not used on other patients).
The patient and caregivers need to be fully educated on how the pumps work and how to use them. Use the FAQ’s and brochure provided by the FDA and any information for patients provided by the manufacturer. They need to be taught how to monitor the status of the infusion and what to do if the pump fails or there is over- or under-infusion. Critically, they need to be provided with 24-hour contact information for questions and problems that arise.
Remember John Nance’s book “Why Hospitals Should Fly”
We love John Nance’s characterization of a culture in which every member really looks at each thing they do thinking “could what I am about to do be wrong?” (see our June 2, 2009 Patient Safety Tip of the Week “Why Hospitals Should Fly…John Nance Nails It!”).
ISMP. Misprogramming PCA concentration leads to dosing errors. Medication Safety Alert Newsletter (Acute Care Edition). August 28, 2008 http://www.ismp.org/Newsletters/acutecare/articles/20080828.asp
ISMP. Smart Pumps Are Not Smart On Their Own. ISMP Medication Safety Alert. Acute Care Edition. April 19, 2007
New FDA initiative on infusion pump safety
FDA infusion pump risk reduction strategies