Non-CE Marked Medical Equipment

Non-CE marked x-ray equipment: risk not reward

We have seen a resurgence of non-CE marked x-ray equipment (frequently from China) appearing in the UK and on which we have had to provide Dental RPA advice regarding equipment safety, performance and suitability.

Whilst the cost savings of such equipment may appear appealing, it is not designed to the relevant European standards and Critical Examination and Acceptance Testing prior to first use can reveal a multitude of issues.   Three common issues are

-X-ray tubes with too little shielding for ‘leakage’ radiation, which results in addition radiation exposure to the patient and staff

-Very technologically basic X-ray generator designs, with significant ‘warm-up’/filament preheat, which means they emit radiation prior to the ‘exposure proper’.  This means they do not restrict exposure so far as reasonably practicable and are unsuitable for digital imaging (which employs short exposure times)

-Exposure switches which do not ‘dead-man’, i.e. stop the exposure if the button is realised.

In conclusion, when purchasing equipment always check it is CE (or post Brexit – UKCA) marked and if in doubt consult your appointed Dental Radiation Protection Adviser for advice.

You can read more about some historic non-CE marked equipment here:

https://webarchive.nationalarchives.gov.uk/ukgwa/20141206113424mp_/http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con173763.pdf