Point of care medical device testing

5th March 2019

 

By 2019, professionals in general practice are highly familiar with using a range of point of care medical devices to generate speedy reliable diagnosis and to improve the quality of consultation with patients. Common types of point-of-care equipment used in General Practice support ongoing checks for cholesterol levels, blood glucose, blood coagulation levels and blood analysis.

As many point-of-care devices are often calibrated by the user, it’s often assumed that no maintenance is required. This means medical devices may not be safety tested, or if they are tested they are invariably and erroneously tested to portable appliance standards. Portable electrical appliances are subject to an entirely different test standard according to each class of appliance, and test standards are laid out in the IET Code of Practice for In-service Inspection and Testing of Electrical Equipment (Fourth Edition).

Record-keeping and equipment asset management can also present challenges to General Practices. Surgeries may not necessarily hold up-to-date registers of all equipment and devices. If devices are ‘rogue’ or not known to Practice management, the potential for defects increases. These defects could include infection control risks posed by surface cracks or damage, missing battery covers and split wiring.

A simple solution for point-of-care equipment safety

Manufacturers recommend a simple annual medical equipment safety test to IEC 62353 standards.  This ensures that diagnostic efficacy is correctly maintained across all point-of-care and other medical devices. Professionals in general practice can then be assured that clinical results generated by this equipment are 100% reliable.

Even more importantly, there are patient safety implications to consider. The CQC requires all General Practice electrical medical equipment is tested to IEC standards. These standards ensure that patients are safe from risk of harm, by checking earth resistance, insulation resistance, equipment leakage current and applied parts leakage.

Point-of-care medical equipment is usually transportable, portable and/or handheld instrumentation. Annual point-of-care equipment safety testing can be delivered rapidly and in-situ at Practices avoiding downtime and ensuring fully-documented evidence of compliance for all CQC audits.

And to help General Practices keep track of multiple devices, JPen Medical inspection engineers assign a unique asset number to each device. This is included in all inspection certificates. We provide Practice customers with a comprehensive asset list identifying each device and its safety certification status. This can be a major help for Surgeries preparing for CQC audit visits.