Spotlight On: Medication Safety – A Patient Safety Pioneer’s Perspective

Dr. Nathaniel Sims is a Cardiac Anesthesiologist and Advisor to Biomedical Engineering at Massachusetts General Hospital (MGH), and Associate Professor, Anesthesiology, Harvard Medical School. He is also a pilot and an inventor, and for 40 years, he has been working to significantly improve patient safety around the world.

He holds multiple patents and has both invented and made major contributions to many advances in intravenous medication safety. As a young cardiac anesthesiologist in the late 1980’s, he was determined to improve a hospital’s capability for safe transport of patients needing an unexpected return to the operating room after major surgery. This transport normally involved bulky patient care vital signs monitors and infusion pumps which impeded safe care. He also wanted a system that did away with the practice of ad hoc compounding of drugs by the caregivers, resulting in the all-too-frequent dosing errors.
He worked to miniaturize and advance the obsolete equipment by leveraging the latest in microprocessors, low power motors, better batteries, and software to ease the burden of error-prone computations of drug dosing. Dr. Sims also advocated with his hospital’s pharmacy to pre-prepare the life-critical medications in ready-to-use form, matched to the software in the pumps. In 1992, Dr. Sims and two engineers from Baxter wrote the patent for “Smart Drug Infusion Pumps”. These devices were first implemented at MGH in 1997 and later became widely adopted throughout the developed world.

Earlier this year at our 7th annual World Patient Safety, Science and Technology Summit, Dr. Sims highlighted a commitment by Partners Healthcare System in Boston. The commitment, in a news release from Brigham Health1 included 3 key components:

  • Standardization on one drug infusion pump platform across 13 hospitals.
  • A ‘seamless digital pathway’ sending accurate instructions from the hospital’s electronic order system, to the pumps without errors in translation, and sending data from the pumps back into the care documentation system, capturing all the dosage adjustments made by the caregivers.
  • Standardizing the drug formulary and drug giving practices, for hundreds of medical conditions, across the enterprise, assuring uniform high-quality care, according to recognized best practices. Founded in 1994 by Brigham and Women’s Hospital and Massachusetts General Hospital, Partners HealthCare includes community and specialty hospitals, a health insurance plan, a physician network, community health centers, home care and long term care services. Several of their hospitals are teaching affiliates of Harvard Medical School. It has 73,000 employees and is recognized as a national leader in biomedical research.

Dr. Sims is not an engineer by training but he has always felt it was important for those on the “front lines” of patient care to both recognize patient safety opportunities and help innovate solutions. Dr. Sims and his team wanted the ‘seamless digital pathway’ that disseminates ‘best practices’ to the front lines of care, and they knew they had a challenge ahead, but failure was not an option.

For decades, Dr. Sims’s work has focused on the elimination of medication errors in intravenous administration of life-critical drugs, such as anesthetics and cardiac/circulatory support drugs. These drugs are given in surgical, interventional, and critical care settings where seconds count. This is when small errors can be fatal to the patient, and the powerful medications are metered into the body and constantly adjusted. The goal of the adjustments is to continuously tune the patient’s physiological state into an optimum condition, for example re-activating the heart after cardio-pulmonary bypass.

In 2005, Partners Healthcare announced 5 Signature Initiatives with a target completion date of 2010. One of these was Patient Medication Safety and included:

  • Computerized order entry with decision support
  • An electronic medication administration record with bar coding
  • Electronically-integrated “smart” infusion pumps at every patient bedside

The late Dr. James Morgan, who was the President of Partners HealthCare at the time, not only made medication safety a priority, but also a kind of litmus test for organizational maturity. He believed that if the Partners hospitals could actually achieve excellence in medication safety, they could achieve the other ambitious ‘Signature Initiatives’, as well, leading to ‘High Performance Medicine’ in every care setting.

The timing goal that the Partners Healthcare medication safety teams had set was aggressive, and by 2010 it was clear that the electronic integration of infusion pumps would need more time. There was need for additional complex technologies for pump integration, including reliable, fast, secure wireless communication, more sophisticated user interfaces on the pumps, and a shift to a new clinical information system. At the 2014 World Patient Safety, Science and Technology Summit, Dr. Sims and William Churchill, Pharmacy Director at Brigham and Women’s Hospital, revised the Partners Healthcare timeline to 2018 for data exchange between pumps and clinical information systems, providing auto-programming and auto- documentation.

In November, 2018, Partners HealthCare publicly announced that after hundreds of hours of demonstrations, 1,500 user evaluations, plus simulations, interoperability, and cybersecurity analyses completed by the Partners Medical Device Plug and Play Lab, a single vendor had been chosen as the system wide drug infusion platform. A trajectory towards full electronic integration of the pumps with the clinical information systems was defined, as follows: “The transition is part of a system-wide goal of wireless, auto-pump programming and auto- documentation in Partners eCare. These efforts will help to enhance the safety of IV pump programming. Brigham Health is the first institution to “go live” … and other Partners institutions will follow in a phased approach.”2 Installation of the first 3,800 of the new, integration-capable pumps was completed at Brigham and Women’s Hospital, on May 19th, 20193.

Despite the widespread success of “smart pumps”, a feature of the 1992 patent that was central to Dr. Sims’s dream of the “seamless digital pathway,” has never seen wide adoption. This concept was for a data carrier (for example a 2D bar code, or an RFID chip) on each drug container label, that can automatically prompt the pump to select the correct drug from the many hundreds in the library and push the correct settings to the pump screen without errors.

Indeed, in 2019, ECRI Institute has listed infusion pumps among the “Top Ten Health Technology Hazards”, noting: “Mistakes such as entering the intended flow rate into an infusion pump’s dose rate field can lead to dangerous medication administration errors. Clinicians tell us that such wrong-field programming errors occur relatively frequently (though such errors often go unreported). Even “smart pumps” that incorporate a dose error reduction system can be mis-programmed in a way that could lead to patient harm…. The surest way to eliminate manual-entry errors is to implement auto-programming of your infusion pumps.4”

Over the next several years. Sims will continue to work on pump integration, leveraging whatever systems and technologies will realize the dream. The final solution will arise from effective partnerships between hospitals and industry, continually advancing towards the goal of “zero errors / zero preventable harm”.

As a cardiac anesthesiologist, Sims has a particular interest in electronic documentation occurring automatically in the busy operating room settings, to capture the nuances of care in such complex, event driven, dynamic environments. He also forsees future systems that can provide powerful assistance in the control human physiology, such as the anesthetic state, based on special processing of the brain-waves (EEG) and other signals. Dr. Sims believes that the ultimate goal was, is and will always be ZERO preventable patient deaths from medication errors.

To view Dr. Sims’s presentation, please visit: https://youtu.be/V0V5J1Perrg

REFERENCES and LINKS
1. https://www.brighamandwomensfaulkner.org/about-bwfh/news/new-iv-pumps-promise-streamlined-education-and-training-more-efficient-integration-with-epic-costs-savings-and-improved-patient-safety
2. https://bwhbulletin.org/2019/05/09/large-volume-infusion-pump-transition-5-things-to-know/
3. https://bwhbulletin.org/2019/05/23/get-pumped-brigham-completes-infusion-pump- transition/
4. https://www.ecri.org/Resources/Whitepapers_and_reports/Haz_19.pdf