Medical equipment should have electrical certification

When using any type of medical electrical equipment or system, medical professionals want assurance that the equipment they are using will not cause harm to themselves or their patients. The goal of the SPE-3000 Model Code is to mitigate the risks that can be associated with such equipment through a comprehensive evaluation, specifically to medical electrical equipment (MEE) and medical electrical systems (MES) sold in limited quantities in Canada.

With the model code in effect, and the SCC now allowing accredited inspection bodies to perform field evaluations to SPE-3000, those across the medical community including doctors, dentists, medical distributors and others should take the necessary steps to make certain that the products that they use which fall under the scope of SPE 3000 meet the requirements of the code.

This would include equipment which is sold on a non-repetitive basis, custom built equipment for special applications, equipment not obtainable as “certified” under a regular certification program, and equipment purchased in quantities of not more than 500 on a national basis, per model, per year, per field evaluation body.

For those with these types of equipment in their facilities, it is crucial to ensure that they meet the requirements of SPE 3000 or risk being put out of service by an Authority Having Jurisdiction (AHJ) if it is found to not be in compliance.

Working with a qualified inspection body that is accredited by the SCC provides assurance that the limited quantity MEE and MES used in your offices and hospitals has undergone the proper testing to ensure that it has been designed and manufactured to the requirements of SPE 3000, to safeguard both you and your patients against electric shock, fire, and mechanical hazards.

Having an accredited body conduct a field evaluation can help save both time and money by ensuring that your equipment and systems meet the requirements of the model code, thus allowing them to stay in service once they are installed, as they would not be deemed unsafe by an AHJ.

It is important for all involved to remember that while there many MEE and MES imported into and sold in limited quantities in Canada, they may not necessarily meet the requirements of SPE-3000. This is due to the fact that manufacturers outside of Canada developing medical electrical equipment and systems may not take these types of regulations into account with their products. It is your responsibility to ensure that your MEE or MES complies with the requirements of SPE-3000.

As an SCC accredited inspection body, Intertek provides the capability to perform field evaluations of your MEE and MES to SPE-3000, providing confidence and peace of mind that those products in your hospitals and offices which fall within the scope of SPE-3000 are safeguarded against fire, electric shock, and mechanical hazards.

This is the third in a series of articles on CSA SPE-3000 which will serve to inform the medical community on this new model code, its requirements and what it means for medical electrical equipment. For more information, see http://www.intertek.com.