If you are interested in Medical Devices and Patient Safety, please also check out these other related topics:

• Patient Safety & Quality Outcomes
• e-Prescribing
• Clinical Decision Support

Welcome to the Medical Devices and Patient Safety topic area of HIMSS. The content in these pages represents the work of the Medical Devices Patient Safety Task Force. Focus and deliverables of this Task Force will be coordinated with the efforts of the HIMSS Clinical Engineering-Information Technology (CE-IT) Community www.ceitcollaboration.org.

Mission: The mission of the Medical Devices Patient Safety Task Force will be to leverage medical device technology to positively impact patient safety, specifically, the significance that human engineering has on use of and impact of medical devices in patient care, and to evaluate safety and quality benefits of medical devices that exchange data with other clinical electronic systems (e.g. other medical devices, electronic medical records, electronic medication administration systems).

Scope: The medical/healthcare sector represents about 20 cents of every dollar spent in the United States. The rapidly increasing use of software to control medical devices makes the development and production of medical device software and systems a crucial issue; both for the U.S. economy and to assure safe advances in health care delivery. Stakeholders in healthcare technology are looking for ways to improve the design, certification, and operation (by both health care professionals and consumers) of medical device software and systems that will result in better, safer, and more cost-effective medical care.

With the introduction of the American Recovery and Reinvestment Act in 2009, $17-$19 billion USD were earmarked to incentivize practitioners to adopt qualifying electronic health record systems in a meaningful way. Qualified EHRs, such as CCHIT-certified systems, do not include ease of use as evaluation criteria. Therefore, it is crucial that consumers of EHR technology understand the importance of human factors and the important role it plays when defining meaningful use.

The use of health information technology (HIT) can lead to unintended and unwanted consequences. This is not a new phenomenon in medicine, as iatrogenesis, or unintended harm caused by clinicians is often documented in the literature. Electronic iatrogenesis, e-Iatrogeneis, is now being documented as unintended consequences through the use of computerized provider order entry (CPOE). These consequences can include: more or new work (e.g., non-standard cases call for more steps in ordering), extended workflow (e.g., extra time to enter orders), system demands (e.g., need for continuous equipment upgrades), communication (e.g., determining when face to face discussion is needed), emotions (both positive and negative), new kinds of errors (e.g., entering orders on the wrong patient), power shifts (e.g., decisions made by ancillary clinical staff), and dependence on the system (e.g., downtime creates a major issue). Per the Joint Commission’s (JCAHO) sentinel event, “As health information technology (HIT) and “converging technologies”—the interrelationship between medical devices and HIT—are increasingly adopted by health care organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate.”

Task Force - Areas of Focus

• Creation of a “Quick Start Guide” of what to consider when implementing an EHR in conjunction with other medical devices
• “What to Know” regarding the IEE 80001 medical devices standard
• Intersection of medical devices and patient safety relative to the IHE Point-of-Care Infusion Verification profiles from Integrating the Healthcare Enterprise (IHE) Patient Care Device (PCD) domain
• Creation of an ideal electronic Medication Administration Record (eMAR) system, connecting all facets of the five rights of medication delivery

Medical Devices Patient Safety Task Force
Chair, Medical Devices Patient Safety Task Force
Jennifer Jackson, MBA, CCE

Interested to volunteer?

Contact:
Pat A. Johnson
Manager, Healthcare Information Systems
pjohnson@himss.org
312-915-9264

David Collins
Director, Healthcare Information Systems
dcollins@himss.org
Twitter: collinsdavid
804-550-1619

Latest News:

AHRQ Study Shows Using Bar-Code Technology with eMAR Reduces Medication Administration and Transcription Errors
Using bar-code technology with an electronic medication administration record (eMAR) substantially reduces transcription and medication administration errors, as well as potential drug-related adverse events, says a new study funded by the Agency for Healthcare Research and Quality (AHRQ).