MHRA announce recall of rectal / pharyngeal temperature sensors

Rectal / pharyngeal (orally inserted) temperature sensors manufactured by Teleflex are a part of a recent recall published by the Medicines and Healthcare Regulatory Authority (MHRA).

The issue with the devices may lead to a misdiagnosis where an inaccurate temperature reading is noted by a medical professional.

With body temperatures often being pivotal to medical diagnosis, this recall is a serious one where patients may be at risk of incorrect advice and treatment off the back of inaccurate temperature readings.

Medical professionals can only be as good as the instruments they are provided with on some occasions. They must rely on technology in order to properly help people in many scenarios, so where technology goes wrong, patients are at risk of the professionals getting it wrong as well.

An incorrect diagnosis off the back of an inaccurate temperature reading could be serious.

Many severe illnesses and ailments can be identified using a temperature readout, so getting this wrong could lead to serious complications for patients who are incorrectly diagnosed; especially where treatment is delayed or not administered as a result.

Teleflex, the manufacturer of the product, have initiated a voluntary recall and listed the product codes affected by the recall in their Field Safety notice that can be found here: https://mhra.filecamp.com/public/file/2ooe-mf8r0cbl

The affected devices are described as “transurethral balloon catheters and rectal/pharyngeal catheters with integrated temperature sensors”. The Field Safety Notice references a number of complaints received over inaccurate and deviating temperature readouts, and they recognise the seriousness of a potential misdiagnosis for a patient.

This recall is a clear example of how such a small thing can have massive consequences. We hope no one suffers as a result of the problems, but one incorrect diagnosis can, in practice, lead to a patient suffering serious complications, and it can even lead to fatalities.

In no way are trying to “work-up” the seriousness here; it is an indisputable fact that a misdiagnosis can be very severe indeed.