The US Food and Drug Administration (FDA) sent a letter to Baxter Healthcare Corporation on 30 April 2010, demanding that the company recall and destroy all of its 200,000 Colleague Volumetric Infusion Pumps in use in the US. The recall, based on the long-standing failure of the medical device manufacturer to correct many serious problems with the pumps, affected hospitals across the country.
But the problem is not restricted to just one manufacturer; indeed, in the past five years the FDA has received more than 56,000 reports of adverse events associated with the use of infusion pumps, including serious injuries and more than 500 deaths.
Between 2005 and 2009, 87 infusion pump recalls were initiated to address identified safety concerns, and an analysis of these incidents has uncovered software defects, user interface problems, and mechanical and electrical failures. Despite the problems caused for manufacturers and hospitals obliged to replace thousands of malfunctioning pumps, Stuart Levine, informatics specialist at the ISMP, believes something good will come of the catastrophe. Indeed, healthcare providers are already moving towards using the industry's most up-to-date smart infusion pumps.
"I'd say the recalls are the reason why we've seen such an increase in the use of smart infusion pumps over the past couple of years," Levine says, adding that hospitals have an ongoing budget for the maintenance and replacement of pumps, something that isn't in place for many types of technology, such as computerised prescription order entry (CPOE) systems. "There's always some money in the budget to move forward and upgrade the system, and I'd say the use of smart pumps has increased by about 60% in the US."
Older infusion pumps function simply through a nurse dialling in a rate – this is the only information that the pump receives and it means the device does not operate in the context of either the patient or the medication.
"The best you can do is hope that your rate is correct based on the information you have," says Levine. "You may have an independent double check by another healthcare practitioner, but this is not in the context of the drug or the patient."
On the other hand, smart pumps – which are also known as intelligent infusion devices – are manufactured with software that can alert users to potential errors and allow organisations to create a library of medications that provides dosing guidelines by establishing concentrations, dose limits and clinical advisories. Drug libraries can be tailored to the specific needs of a hospital, and customised for different patient groups within it based on location, acuity or weight. The devices can be used for continuous infusions, intermittent infusions and bolus injections.
Many intravenous medications are classified as 'high-alert medications' and are more likely to cause harm if an error occurs during administration. One of the benefits of smart pump technology is that the devices can reduce administration errors associated with miscalculated doses. They can also provide a check of manual calculations and ensure the dosing formula selected is appropriate to the medication and the patient. Moreover, the alerts and stops provided by smart pumps allow clinicians to recognise the programming errors and miscalculated doses that could have otherwise resulted in patient harm. But although the advantages of the technology are clear, hospitals are facing challenges installing smart infusion pumps on a large scale.
"Not every hospital has a wireless system," Levine explains. "If you don't have one, you have to physically touch each pump and hook it up to a laptop to upgrade the library, which can be a time-consuming process depending on the size of the organisation. Many hospitals started this process very early on – before wireless capability existed – so they're still in the process of trying to upgrade their system. This takes a while, so sometimes the hospitals that are at the leading-edge in terms of smart pumps are now behind because of a lack of wireless infrastructure."
Despite the costly installation process in older facilities, the industry is slowly catching on. The ultimate goal for Levine is to integrate the electronic medical record, barcode point-of-care and CPOE systems.
"Those pieces should be in communication with each other and have two-way interfaces so the information can travel back and forth in real time," he adds.
In 2009, the ISMP published specific guidelines for the safe implementation and use of smart infusion pumps, including a summary of what hospitals should look for from their suppliers. Unsurprisingly, wireless capability was high on the list of priorities.
"We're looking for connectivity between systems," Levine notes. "The wireless system must be able to integrate with the pump and then, eventually, we'd like to see that system integrate with both CPOE and Bar Code Medication Administration systems. It's about trying to make sure that practitioners are directed to the library when the device is turned on."
The latest devices are not yet foolproof; there is still a risk of choosing the wrong medication from stock or selecting the wrong medication from the smart pump's library. The only way to reduce this possibility is to ensure that smart pumps possess barcode functionality that will access the patient's drug profile, identify whether the medication has been ordered for the patient and then select the appropriate medication and concentration from the drug library when a barcode label on the IV bag is scanned.
While companies are working on this, there are still only a few sites boasting full integration. However, a Louisiana-based 700-bed hospital sets the precedent that Levine hopes will soon be commonplace across the US. Our Lady of the Lake Regional Medical Center integrated its infusion pumps with a barcode point-of-care system.
The auto-programming process uses a set of barcodes on the patient's wristband, medication bag and infusion pump to pull data from the electronic health record and confirm the so-called 'five rights' of medication administration – right drug, right dose, right patient, right time and right route of administration. Using a handheld device, the caregiver scans the three barcodes and confirms the order on the pump to deliver the medication as ordered in the electronic health record.
A recent study carried out by human factors specialist Dr Patricia Trbovich, and published online in the journal Quality and Safety in Healthcare in April 2010, testifies to the advantages of integrating smart pumps with barcode technology.
The report, The impact of traditional and smart pump infusion technology on nurse medication administration performance in a simulated inpatient unit, found that nurses remedied 'wrong patient errors' more often when using the barcode pump (88%) than when using the traditional pump (46%) or the smart pump (58%). Furthermore, the number of nurses who remedied 'wrong dose, hard limit' errors was higher when using the barcode pump (79%) and the smart pump (75%) than when using the traditional pump (38%).
Trbovich concluded that, until barcode pumps are integrated with other systems within the medication administration process, their role in enhancing patient safety will be limited and further improvements to pump technologies are needed to mitigate risks associated with intravenous infusions.
Other examples of 'desirable functionality' in the ISMP's guidelines include: routing practitioners directly to the drug library when the device is turned on; the ability to update the drug library in the background while the pump is in use; and the ability to extract data stored in the device while the pump is in use. But, more importantly than these recommendations, the report emphasises that smart pumps' drug libraries must be big enough to handle the requirements of healthcare facilities.
"You have to be able to ensure there are enough entries so that every medication that might be administered through the pump can be stored in the pump's library," Levine explains. "Some libraries are relatively small compared to the number of drugs and concentrations nurses are administering at hospitals. We're waiting for vendors to upgrade the software, increasing the amount of space for entries."
Produced as a result of collaboration with vendors, users, biomedical engineers and pharmacists, the ISMP guidelines outline the basic smart pump principles applicable to any organisation, but the medical device industry is also keen to encourage the creation of additional legislation.
The way forward
"I'm not sure what the exact responsibilities are as far as the FDA goes but there has been a lot of discussion recently about having the body more involved in the use of smart pumps," Levine remarks.
Indeed, on 5-6 October 2010, the Association for the Advancement of Medical Instrumentation and the FDA met for a summit focusing on critical issues surrounding infusion devices. The aim of the meeting was to build consensus among key stakeholders on action plans that will improve the design, engineering, manufacturing and use of infusion pumps, including data collection, user interface, safety standards, insulin infusion, and design and human factors. With the number and severity of infusion pump recalls continuing to increase, manufacturers are also keen to help in any way they can.
"The vendors are very involved in training in hospitals," Levine notes. "They will walk the hospitals through the steps needed to prepare the library, train the nursing staff and help with data collection. One of the most critical things is collecting the data from the pumps and using it to improve care."
Often, the ISMP will go into the hospitals after installation to check the clinical decision support and assess how the libraries are working.
"We'll look for soft stops, we'll look for hard stops and we'll see how they're being used in the process, and make recommendations about changes," says Levine. Looking to the future, he hopes manufacturers will follow the ISMP's advice and increase the amount of space in smart pumps' drug libraries.
"When nurses go to give anything intravenously, we want to make sure they go right to the pump," he emphasises. "They must always use the error reduction software to minimise the risk of error in administration of medication. That's not to suggest that smart pumps will get rid of every IV error that can possibly occur, but they will certainly reduce the potential of these errors occurring. Although we don't have any numbers to say how many errors have been reduced, we've heard many reports describing near misses – where nurses catch things before they get to the patient and where alerts go off. They would have got through had the practitioner not been alerted via smart pump technology."
The medical device industry is responding in the best possible way to the furore caused by the recalls of thousands of infusion devices: vendors, healthcare practitioners and regulators are banding together to improve patient safety. And despite the problems faced by hospitals and manufacturers, the future of smart infusion technology looks bright – and, above all, integrated.