Risk management

Ensuring the safety of patients and medical carers

By Morand Fachot

Much needs to be safeguarded in healthcare. One aspect concerns the safety of the patients themselves. Equally important is the safety of those who operate the systems used to diagnose medical conditions. And, as systems become increasingly complex and physicians demand greater precision in diagnostics, so the static and electromagnetic fields of, for example, imaging equipment, are increasing in strength and with them, the associated potential health risks. This makes the question of patient and worker safety even more pertinent.

Pressure sensor Pressure sensor

Risks also concern homecare

Such risks are not confined to a hospital setting. Today, EMDs (electronic medical devices) are also used in private homes or workplaces to monitor medical conditions or assist with daily activities. Improperly connected networked devices could lead to incorrect monitoring and with it injuries and fatalities.

Connecting devices to medical facilities

Furthermore, EMDs frequently need to be interconnected and linked between homes or offices and a medical facility. Such connectivity requires better control of the protection, integrity and transmission of medical data.

IEC TC (Technical Committee) 62 meets these challenges by producing standards that ensure the safe operation of EMDs in medical practice. The committee was established in 1968. It has four SCs (Subcommittees) that deal with very distinct domains and issue all its publications.

A symposium centred around IEC 80001-1, Application of risk management for IT-networks incorporating medical devices - Part 1: Roles, responsibilities and activities, was organized in Brussels, Belgium, on 17-18 March 2011. This symposium brought together decision-makers from hospitals and health-care delivery organizations, as well as R&D, compliance managers and product managers from medical device manufacturers and providers of IT infrastructure and services.

In April 2011, IEC 60601-1-SER Medical electrical equipment – All parts, was made available on a single CD.

With greater reliance on technology to treat a growing aging population in many countries, the use of electrical devices and systems in the medical domain is bound to increase. It is to be expected that the work of IEC TC 62 and its SCs will follow a similar trend.

Preparing for a scan Preparing for a scan
Pressure sensor Pressure sensor
The CPAP (continuous positive airway pressure) is covered by SC 62D: Electromedical equipment. The CPAP (continuous positive airway pressure) is covered by SC 62D: Electromedical equipment.