Safety is absolutely paramount in the medical arena and, to achieve this, there are many standards that must be met before a product can be placed on the market. While approvals are necessary, in times of crisis they can slow down the delivery of new products to where they are needed.
The regulatory environment for medical power
There are a huge variety of medical devices available, with more being developed and introduced to the market at an ever-increasing rate, reflecting society’s interest in their own well-being. While an increasing number of devices are portable and battery-powered, a significant proportion of devices (especially those for use in professional scenarios such as hospitals and clinics) remain mains powered.
As various types of medical devices are attached to patients and some, such as electrocardiogram (ECG) machines incorporate electrically conductive pads that are directly affixed to the patient, there is the potential that a hazardous voltage could be applied to the patient during a fault condition.
Given this unique situation, the standards surrounding mains-powered medical equipment are unique and stringent, as one would hope. The main regulatory framework is IEC 60601 which comprises a number of standards that were originally developed in the 1970s and have been subsequently updated to meet changing needs and evolving technologies. Introduced in later editions, the concepts of ‘Means of Operator Protection’ (MOOP) and ‘Means of Patient Protection’ (MOPP) are used to define the design requirements to prevent any risk of unintended electrical current passing through the body of the patient or operator. Together, these Means of Protection (MOPs) rely upon physical separation and galvanic isolation for protection. The 3rd Edition of IEC 60601 requires two MOPs, meaning that two independent isolation barriers must be present, such that multiple and unrelated insulation system failures would need to occur before an operator or patient is put at risk.