“Physiological

Monitoring and
Device Interface”
Report By Jawia Mustapha
BSN2-A
In today’s healthcare climate of
increasing patient acuity, decreasing
resources, & increased financial
restraints, the use of medical devices
interfaced with each other as well as
the electronic health record are
imperative for the safety and quality
of care of today’s patients.

2
Meaningful use
• The HITECH Act allows eligible providers and eligible hospitals to
qualify for the Center for Medicare Mediacid Services (CMS) incentive
payments if they achieve “meaningful use” of certified HER
technology to provide patient care. EHR vendors are incented to
obtain ARRA certification for their EHR products. It is not enough for
healthcare providers to have purchased and implemented a certified
EHR, providers must also demonstrate meaningful use. Meaningful
use is a three-phased approach building upon each other. HITECH
doesn’t provide incentives specifically for medical device connectivity
in itself but connectivity drives the adoption of EHR use and thereby
meaningful use adoption.
3
Interoperability
• Medical device connectivity generally refers to the integration of medical
devices with hospital information system (HIS) to facilitate functions (ECRI
Institute, 2012). Advancements in technology have expanded medical
device connectivity from connecting a device to an EHR, to connecting
disparate medical devices so that they all may communicate with each
other also known as interoperability.
Standardized Communication
• The ability of medical devices to talk to each other requires a “standard language or
communication structure”, the most common in healthcare being HL7 OR Health Level
Seven. According to Interface, HL7 is by definition “an ANSI (American National
Standards Institute) standard for healthcare specific data exchange between computer
applications. The name comes from “Health Level 7”, which refers to the top player
(Level 7) of the Open Systems Interconnection (OSI) layer protocol for the health
environment.
4
Middleware
• Device connectivity and operability require middleware. Middleware
is a term with broad implications. It enables integration of data
between two or more programs, devices, or information systems. It
also facilitates communication and data sharing.
Integration Engine
• Often integration engine or interface engine are terms used
interchangeably. In the healthcare industry, integration engines use
HL7 to characterize their ability to manage all interfaces. The engines
aggregate and share data regardless of the transmission protocol.

5
 Gateway
• Data can also be transferred through a device gateway. There are
usually transferred through a central server that consolidates and
collates data then forwards the formation of the aggregator or HER
(Day, 2011).
Medical Device Data Systems
• Medical Device Data System (MDDS) are hardware or software
products that transfer, store, convert formats, and display medical
device data. Medical device connectivity are solutions are available
via the EHR vendor, medical device vendors, and third-party vendors.

6
 Class II Medical Devices
• Solutions that collect, process, and distribute medical device
data for surveillance, alarms, analytics, and decision support
are not considered an MDDS but are regulated by the FDA
as a Class II medical device. It is used for active monitoring is
utilized in the aforementioned ICU scenario as the software
that allows the remote clinicians to review real-time vital
signs, track and review trends and recognize changes.

Point of Care
• The bedside medical device and how data are transmitted
from the medical device characterizes point-of-care (POC)
connectivity solutions. The POC solution serves as
middleware where the POC device or component associates
the patient to the medical device to send to a server to be
translated into an appropriate inbound language, generally
HL7, for the EHR to accept and store.

7
Periodic/Episodic
Devices
• Periodic or episodic devices are those
that obtain a single set of measurements
from a patient at a single spoints in time
or spot checks. Episodic devices are
generally mobile and used with multiple
patients.

8
Continuous Devices
• Continuous devices are divided into
stand-alone or networked devices.
Continuous networked devices are
commonly stationed in a patient room
to treat a single patient over a
continuous time span. While the
Continuous Stand-Alone Devices are
used to continuously monitor a single
patient over a period of time but the
device is portable and not hardwired or
networked to a vendor-specific server,
thereby requiring a POC component
within the patient room or attached to
the medical device itself.
9
Patient-Centric Identification
• Involves associating a medical device with a patient based on a unique
patient ID number, often the patient’s unique medical record number.
In our scenario the patient in the ICU is associated to the physiological
monitor. The bedside nurse in our scenario manually entered the
patient’s unique ID number into the monitor when the patient to the
right device so the right data will be available for documentation.
Location Centric
• In location centric association the patient is typically identified by
a location such as a room or bed. This type of association can be
unreliable and thereby unsafe especially when a patient is moved
often such as in an emergency department or surgical area.
10
Data Validation
• Since data are continuously being sent to the EHR, the nurse must validate
which data are accurate and should be recorded within the permanent
patient medical record. This process of manual verification of data and
recording them into the medical record is known as data validation.
Connectivity Direction
• Historically device connectivity solutions were unidirectional, or the flow
of information was from the medical device to the EHR only; this is also
often referred to as classic or one-way connectivity. The emergence of bi-
directional connectivity is mounting quickly as a viable solution in
healthcare.

11
Smart Pumps
An emerging trend in acute healthcare settings is the use of
Smart Infusion Pumps and Interactive Smart Pumps. Smart
pumps use drug libraries which allow infusion pumps to perform
functions that assist with programing and calculating dose and
rate of delivery as adapted by a healthcare institution and to
patient care areas.
Smart Rooms
The smart rooms at UPMC use real-time real locations (RTLS) tracking
to bring patient information from the EHR to a computer in the
patient room. The clinicians were identified when entering the room
by ultrasound-enabled badges identifying them to the patient and
families, eliminating the need for white boards. Each patient room
has a patient and family centered screen that can be used to identify
the caregivers, provide a schedule of the ay activities for the patient,
as well as access to view educational programs.
12
Alarms
Alarms are intended to alert a caregiver
when an immediate or potentially adverse
event occurs or could occur. A caregiver is
then expected to acknowledge the alarm
and respond appropriately. As the number
of medical devices increases so has the
number of alarms generated from medical
devices.

13
CHALLENGES
While there have been huge advancements
in medical device integration there are just
as many challenges that still need
addressed as the industry matures.
 Cost
 Risk Management/Security
 Clinician Adoption

14
Health Information Technology:
Striving to Improve Patient Safety
INTRODUCTION
• The first Electronic Health Record (EHR) with Computerized Provider
Order Entry (CPOE) was introduced in 1971, over 40 years ago
(Goolsby, 2002). Since then, adoption of these systems in both acute
and ambulatory settings has been relatively slow, until the signing of
the American Reinvestment and Recovery Act (ARRA) in 2009. it
include the authorization of the Health Information Technology for
Economic and Clinical Health (HITECH) Act which allocated over $17
billion to stimulate the adoption of quality health IT systems or EHRs
that demonstrate meaningful use.
15
BACKGROUND— HEALTH IT SAFETY
• In 1999, the Institute of Medicine’s To Err Is Human has been a driving
force for improvements in patient safety across the nation. The
evidence cited clearly indicates the seriousness of the situation in
terms of lives lost and money wasted as a result of errors that occur in
our healthcare organizations. There have been multiple solutions
offered, but a common and resounding theme continue to be the use
of technology and the application of EHRs with CPOE systems. A
positive outlook has driven healthcare’s key stake holders to proceed
with development, adoption, and oversight, including EHR vendors,
hospitals, ambulatory practices, home health agencies, long-term
care facilities, and the federal government.

16
NATIONAL HEALTH IT SAFETY INITIATIVES
Institute of Medicine—Health IT and Patient Safety Report
• In November 2011, the IOM published “Health IT and Patient Safety:
Building Safer Systems for Better Care”. This 235-page document
provides a comprehensive description of the state of electronic health
records and their ability to improve safety with a goal of making
health IT-assisted care safer, putting our nation in the best position to
realize the potential benefits of health It.

17
The Institute for Safe Medication Practices
• The institute for safe medication practices (ISMP) is devoted entirely
to medication error prevention and safe medication use. They have
been in existence for over 30 years, helping healthcare practitioners
keep patients safe. Their mission is to lead efforts to improve the
medication use process. They have published multiple guidelines and
tips for the designers of EHRs as they configure medication orders and
order sets.

18
ECRI Institute
• For 45 years, ECRI Institute, a non-profit organization, has focused on
scientific research to discover the effectiveness of medical
procedures, devices, drugs, and processes, all to improve patient care.
ECRI Institute is also a PSO; in fact it is one of the first to be federally
certified.
Leapfrog Group
• Another CPOE opinion leader, The Leapfrog Group, represents a
coalition of healthcare purchasers that has been a driving force in the
improvement of healthcare quality.

19
HEALTH IT SAFETY TOOLS AND RESOURCES
• Resources for organizations to turn for help in not only
developing health IT safety strategic plans but for assessing
their current situation have been emerging over the last
several years. These tools provide excellent information for
those in charge of health IT safety with varying levels of
expertise.

20
That’s all. Thank you!.

21