Medical Electrical Safety Testing is not your average PAT
Manufacturers of medical equipment are required to comply with IEC 60601 to ensure that the design of their equipment is intrinsically safe. As the IEC 60601 is a testing standard it describes a range of measures that are intended to prove the safety of an item of electromedical equipment during its lifetime. However, clearly safety testing at the design stage and at the end of production line is vitally important, but what about when the equipment enters into service?
The current IEC60601 does not provide any guidance in harmonising test requirements once an item of medical electrical equipment leaves the production line. This is where the IEC 62353 standard comes in. The IEC 62353 defines the requirements of ensuring the in-service safety of the equipment and systems. Specifically it seeks to provide a uniform and unambiguous means of assessing the safety of medical equipment, whilst maintaining the relation to IEC 60601-1
Unknown to most, is that by simply using a standard PAT test when the equipment is in-service, can potentially be damaging. Therefore, resulting in danger to patients.
Peter Averill of JPen Medical states: “Implementing the correct medical electrical safety testing will give you peace of mind that your medical equipment is ‘fit for purpose’ under the Best Practice guidelines. It only takes a small amount of current to cause major consequences, injury or death. Thus, showing the grave importance of having medical electrical equipment tested to the highest level”.
Most safety testing regimes for medical electrical equipment involve the measurement of certain "leakage currents", because the level can help to verify whether or not a piece of equipment is electrically safe. Once a medical device enters into service, a number of potential test scenarios arise. These are,
- Acceptance Testing; this is carried out prior to a new medical device being authorised for use and is undertaken to ensure correct and complete delivery.
- Routine Testing; this form of testing is often conducted at fixed time intervals, which vary between types of equipment.
- After Service & Repair Testing; is carried out following a repair or product upgrade.
The concern is that the majority of electrical patient connected devices in Doctor’s surgeries are routinely PAT tested by local electrical contractors rather than tested to a medical electrical specification. According to a Web-based Survey of Electro-biomedical Engineering (EBME) departments: 80% of respondents had uncovered at least one failure through routine testing. Of these, approximately 30% could have caused a hazard to the patient or operator.
The argument for Medical Electrical Safety Testing is that a PAT label stating the item has passed all its electrical tests in accordance to IEE recommendations is fine, however if the item is a medical device with patient connections it would be interesting to see what the leakage currents were measured at.
We need IEC 62353 for routine testing of medical devices used in healthcare in much the same way employers and HSE need a PAT standard for domestic, commercial and industrial appliance testing in the general workplace.
To ensure sustainability of your equipment, safety compliance and most importantly the health, safety and security of your colleagues, staff or patients don’t take the risk. Ensure you choose a qualified medical equipment testing company for all your medical device testing.