Mission
"No patient will be harmed from a drug infusion."
Vision
By 2016, adverse drug events will be rare because healthcare systems will have a fully integrated drug infusion delivery system that: seamlessly and immediately connects the physician order to the drug delivery mechanism; positively identifies the drug for each patient regardless of location; and is safe, effective and affordable. Patient safety will be assured by continuous detection of early triggers, with direct and appropriate notification to a patient rescue system.
How will we know we have been successful*
All infusion pumps will be reliably connected to an information network and clinical information systems:
-
Infusion systems will automatically acquire all IV drug/concentration information (via machine readable coding bar code, RFID tags) without manual transcription.
-
Infusion pump programming will be automatically compared to the medication order to ensure appropriate dose or rate.
-
All IV infusion data will be automatically recorded in each patient’s electronic health record
-
Critical lab values and missing lab values that impact IV infusions will be immediately communicated to the appropriate caregiver in a timely fashion requiring acknowledgement
-
All patients receiving high risk IV medications will be continuously monitored with appropriate vital sign monitoring
-
Critical infusion (and physiological) alarms associated with high risk IV infusions will be immediately presented to the appropriate caregiver
Clinical care providers will be confident about complex IV drug infusion protocol because the technology systems will be so highly reliable, intuitive and fatigue-proof that safety will not depend on the human accuracy of the caregiver
-
Clinical engineers and biomedical engineering technicians have measured a significant reduction in the volume of repair requests resulting in “no fault found.”
-
All of the necessary stakeholder groups have agreed to support a list of the 5 standardized priority changes (TBD in 2011) that will eliminate 90% of all drug medication errors (e.g., one example could be hard limits on heparin).
-
Hospitals have implemented standardized training, protocols, and checklists for all clinicians who have any contact with pumps.
-
Secure wireless networks are now a foundational capability for medical administration systems.
-
The global consensus for pump standards and regulatory guidance is so clear now that manufacturers are experiencing improved design and manufacturing processes, including safe and effective integration with clinical information systems and networks.
Industry has been freed up from regulatory challenges to use its internal resources on developing and launching the next generation of pump systems. Industry can now look forward and move from “seatbelts” to “airbags” rather than fixing problems with old models. By the same token, hospitals now understand the importance of replacing the "old" with the "new" as a key patient safety initiative.
-
Industry can see that its efforts to participate in the safety council have paid off from a regulatory standpoint because the old mistrust of their products has been replaced with greater regulatory respect, significantly fewer recalls, and faster speed to market.
-
Liability and malpractice insurance carriers are starting to take notice. They have agreed to reduce premiums because infusion system manufacturers and healthcare systems alike are implementing leading practices and standards resulting in fewer incidents. CMS and AHRQ are building these leading practices and standards into their requirements.
-
The FDA has been congratulated by Congress and the media for its excellent work in bringing forward a safety initiative with pumps.