Interoperability and Standards
According to Tim Gee, “The medical device companies are becoming chimeras, where
they’re part IT company, and they’re part embedded system company,” Gee noted. But,
as long as their mindset remains that of an embedded system company trying to protect
the “black box” of proprietary system design, it will be difficult to move forward.”
From Wireless Monitoring & Mobility…To Chasing Data
Wireless solutions have enhanced monitoring by adding more flexibility through increased
mobility. But now that the wires are gone, the challenge is to “Ensure” real-time data
collection without interference not loses!
As networks become more open, data encryption becomes more vital.
The “Winning” key for new solution is “Operability Enhancement”
Solutions that allow Hospital expand the use of their current systems are expected to not
only gain ground but also shape the future of Medical Device/IT industry.
Example: OBS Medical’s VISENSIA (OBS Medical is the North American Subsidiary of UK’s Oxford Biosignal)
- Compatible with existing Monitoring Solutions Regardless of Brand
- Utilizes a Fusion of 5 vital signs to trigger Alarms
Patient Monitoring Companies:
• GE Healthcare
• Philips Healthcare
• Datascope (Mindray)
• Draeger Medical
• Spacelabs IT & Micro-Computing Companies:
• Nihon Kohden • Cisco
Healthcare IT Companies: • Intel
• Mobile Access
• Integra Systems
• Meru Networks
Competitive Landscape (Cont.)
Undoubtedly, the most notable competitive trend is the acquisition of IT vendors by major
Medical Device Companies.
By acquiring successful Healthcare IT firms, Medical Device companies are able to
strengthen their Enterprise Solutions, morphing into “One-Stop” shops for all medical
• Philips Healthcare Acquires Emergin
• GE Healthcare Acquires Agility
• Cisco becomes a Registered Medical Device Vendor
This Standard specifies general requirements for the application of risk management of IT-
networks incorporating medical devices that achieve essential properties such as safety,
effectiveness, data & system security and interoperability. It defines responsibilities for
parties such as medical device manufacturers, non-medical device manufacturers, the
responsible organization, IT-network integrator, and potentially others, engaged in
installing, using, reconfiguring, maintaining and decommissioning IT-networks
incorporating medical devices. This Standard addresses risks related to patients,
operators and / or third parties. (To Buy a Copy go to aami.org)
IEC 80001 is a Risk Management Process Standard for Medical Device and IT vendors as
well as Healthcare Providers.
It’s Ultimate Goal is to help maintain Network Safety and Effectiveness as Changes are made
in the Medical Device – IT systems.
The Process beings from Pre-Purchase to Installment, Maintenance and Upgrades
Although not Mandatory, IEC 80001 may become a requirement by accreditation bodies such
as the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) or
Center for Medicare & Medicaid Services (CMS).
FDA & MDDS
• MDDS or Medical Device Data Systems are applications that used to Transfer,
Exchange, or Display medical device info.
• Feb. 2008: FDA published the 1st proposed draft to redefine or reclassify some of the
medical device data application.
• SUMMARY: The Food and Drug Administration (FDA) is proposing to reclassify, on its
own initiative, the Medical Device Data System (MDDS) from class III (pre-market
approval) to class I (general controls). This action does not include medical device data
systems with new diagnostic or alarm functions. FDA is also proposing that the MDDS be
exempt from the pre-market notification requirements when it is indicated for use only by
a healthcare professional and does not perform irreversible data compression.
• Healthcare IT and Medical Device (Especially Patient Monitoring)
is becoming more integrated driving the rapid evolution of
• The confusion caused by this rapid change is normal and by time
the industry will arrive at more clear state.
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Exciting New Patient Monitoring Topics Published!
• Emerging Medical Device Markets: The Grass IS Getting
Greener on the Other Side! – Available to Vital Sings Subscribers
• North American Hospital Wireless Patient Monitoring Market –
• North American Home Healthcare and Disease Management
Market – April 2008
• North American Fetal & Neonatal Monitoring Markets – Summer
• Cardiac Monitoring Products and Services: Market Outlook
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