Device, Network Pairing Raises Issues for FDA, Health Care Providers

An increasing number of clinics and hospitals are integrating medical devices into wireless data networks for management purposes, Computerworld reports.

In response, FDA is considering regulating such networks as medical devices.

Regulation Details

In 2008, FDA published its Medical Device Data System proposal, which would define medical devices as anything that electronically handles medical device data through:

  • Conversion;
  • Display;
  • Exchange;
  • Retrieval;
  • Storage; or
  • Transfer.

In November, the International Electrotechnical Commission and the Association for the Advancement of Medical Instrumentation finalized the IEC 8001-1 Risk Management Standard, which addresses management risks related to health IT networks.

Karen Delvecchio, lead systems designer with GE Healthcare, said the standard aims to protect patient safety, ensure data security and promote effectiveness of care.

Todd Cooper -- a member of the International Organization for Standardization and IEC joint work group -- said the work group is seeking to produce follow-up documents to the standard later this year that will touch on issues related to:

  • Communication of security risks and requirements;
  • Risk management for health care organizations; and
  • Wireless networks.

Issues for Health Care Providers

To adhere to the 8001 standard, hospitals would have to designate a risk management facilitator to develop procedures and analyze what needs to be done, which could carry significant costs, according to Computerworld.

According to Rick Hampton -- wireless communications manager at Partners HealthCare in Boston -- hospitals also face difficulty in obtaining from vendors the requirements a network must meet to ensure medical devices work properly.

Hampton added that facilities need staff who are trained to maintain the networks (Mearian, Computerworld, 1/10).

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