International Standards and Conformity Assessment for all electrical, electronic and related technologies

March 2011

 

Medical devices

Technology versus safety

by Philippa Martin-King

Technology plays an increasingly important role in health care and diagnosis. The array of medical equipment using electricity stretches from scanners and X-ray equipment to special lamps, lasers, warmers, operating tables, ventilating equipment, pumps and controllers. How do you manage risk? Do you favour more precise diagnosis with increased use of imaging equipment or curb use and limit human exposure? What about the safety of data transmission and systems linked to IT networks? How do you ensure that life-saving equipment remains interoperable and the network secure? Medical institutions and carers rely on an IT network of sophisticated equipment to make diagnostics, carry out operations and cover after-treatment care, both in hospital and at home.

 

As systems become increasingly complex and physicians demand greater precision in diagnostics, so the static and electromagnetic fields used, for example, in imaging equipment are increasing in strength. It makes the question of patient safety, and of the safety of the workers who operate the systems, even more pertinent. There's a delicate balance of risk management that needs to be maintained.

A dichotomy between two ideals

On the one hand, there's the benefit of being able to see better into tissues and organs. On the other, there’s the risk of exposure, not only for patients, but also for technicians who spend their entire day using such delicate equipment. The result is a dichotomy between two ideals. Should a doctor deprive the patient of a good diagnostic or, alternatively, increase the exposure level and obtain the desired high-level information?

 

The electrical element itself is so much an integral part of a broader system that it can rarely be singled out from the more extended context of care. Similarly, it is difficult to separate or isolate standardization of individual electrical components from the mechanical elements or other areas of health care. Frequently, therefore, the IEC shares its medical device expertise with its sister organization ISO (International Organization for Standardization). This is witnessed by the large number of JWG (Joint Working Groups) that make up IEC TC (Technical Committee) 62: Electrical equipment in medical practice. These cover all types of medical equipment from cardiac pacemakers to dental equipment and respiratory monitors.

IT Network security

There's another area of electrotechnical standardization that is also important to the safety and wellbeing of patients. As a growing number of hospitals and physicians carry out their diagnostics at distance and exchange knowledge and advice over the Internet, so the question of interoperability and network security becomes more important. In October 2010, SC (Subcommittee) 62A: Common aspects of electrical equipment used in medical practice, issued a new publication, IEC 80001-1, Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities.

 

This latest publication, the subject of a separate article in e-tech on risk management, underlines the importance not only of the safety of patients and operators of equipment, but equally well the safeguarding of personal, perhaps sensitive data, as it transits efficiently over the Internet. How is it possible to ensure that access to vital personal information remains controlled and private, while systems continue to operate smoothly and securely?

 

  • Increasingly, doctors carry out diagnosis and transmit medical data over IT networks.
  • An ECG monitor.
  • Philippa Martin-King, Managing Editor, e-tech.

 

 

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