Healthcare delivery has become increasingly reliant on state of the art medical devices and the multimodal data they produce. As a result, Healthcare Information Technology (HIT) Infrastructures have become vital to the collaboration and communication required to provide high quality care.

The United Stated Food and Drug Administration (FDA) examination of modern medical device networks and computer infrastructures, has led to the classification of most Healthcare IT infrastructure as a Class I medical device.

FDA classified these as Medical Device Data Systems (MDDSs).  MDDS devices are intended to transfer, store, convert from one format to another according to preset specifications, or display medical device data. MDDSs perform all intended functions without controlling or altering the function or parameters of any connected medical devices.

MDDS Manufacturers must comply with FDA’s published requirements according to the following schedule:

  •  The MDDS rule became effective April 18, 2011.
  • MDDS manufacturers must register and list their device(s) with FDA by May 16, 2011
  • Manufacturers must establish and implement an FDA compliant Quality System within 12 months of the Rule’s effective date
  • MDDS manufacturers must implement a Medical Device Reporting (MDR) system for their devices no later than April 18, 2012.

The Agency also issued guidance on Mobile Medical Apps for review by industry.

FDA is not alone in driving Hospitals to better control and manage their HIT infrastructures. To address this growing concern, the International Electromechanical Commission (IEC) in collaboration with International Standard Organization (ISO) recently issued IEC 80001-1 “Application of risk management to information technology (IT) networks incorporating medical devices.” This global standard provides a framework with defined roles and responsibilities for Hospitals, Medical Device Manufacturers and IT Suppliers to ensure the safety, effectiveness of data and system security.

For its part, Joint Commission has issued an Alert detailing specific steps Healthcare providers should implement to prevent patient harm related to the implementation and use of HIT and converging Technologies. According to the Commission’s’ Sentinel Event Alert, Issue 42: “As health information technology (HIT) and “converging technologies”-the interrelationship between medical devices and HIT-are increasingly adopted by healthcare organizations, users must be mindful of the safety risks and preventable adverse events that these implementations can create or perpetuate.”

Related Content:

The Inside Scoop on FDA Healthcare IT Regulation  Interview with Casper Uldriks, FDA’s Associate Director for Regulatory Guidance and Government Affairs (RET) and currently Counsel at OFW Law in Washington, DC.

The Impact of MDDS on Healthcare IT Suppliers, a Thought Leaders Perspective   This article provides a digest of Dan’s interactions with thought-leaders at Healthcare Providers, the FDA, and the HIT Industry on on the impact of the MDDS rule on manufacturers of IT systems marketed to Healthcare providers.

When is a Hospital a Medical Device Manufacturer?   This article provides a digest of Dan’s interactions with thought-leaders at Healthcare Providers, the FDA, and the HIT Industry on the impact of the MDDS rule on Hospitals and Healthcare providers.

FDA Classifies Healthcare IT Infrastructure as a Medical Device  To my surprise, most HIMSS11 participants were unaware of this Game-Changing regulation affecting Healthcare providers.

New FDA Rule Regarding Medical Device Data Systems Takes Effect  by: Brian T. Horowitz, eWeek

Healthcare IT Grows Up  by: Samuel Greengard, Baseline Magazine

Is Medical Device Interoperability Sufficient  by Rick Schrenker, Systems Engineering Manager in the Massachusetts General Hospital Department of Biomedical Engineering, provides his perspective on interoperability standardization efforts and their impact on ensuring medical device safety and dependability.

Cybersecurity for Networked Medical Devices is a Shared Responsibility” FDA issued a reminder to Medical device manufacturers, hospitals, medical device user facilities, healthcare IT and procurement staff, medical device users, biomedical engineers.

References:

Medical Device Data Systems (MDDS) Final Rule

FDA MDDS Website

Mobile Medical Applications - Draft Guidance for Industry and Food and Drug Administration Staff