MHRA Issues 3 Device Alerts: Clever Chek Apparently Not So Clever

As if to demonstrate the problem presented in keeping a handle on medical device safety, UK regulatory overlord the MHRA last week issued three quite distinct and eclectic alert notices.

The alerts issued are as follows:

Clever Chek TD4232 talking blood glucose meter, and test strips are manufactured by TaiDoc Technology Corporation. Find the alert here. According to the alert the device, designed for visually impaired people with diabetes, does not issue an audible alert when inadequate blood has been delivered to the device. Pretty fundamental design flaw one would have thought… and so would the UK distributor, BBI Medical, which has now stopped selling the device.

Next up, sterility, always likely to be on some radar somewhere. This time, in this alert, it’s Coloplast’s SpeediCath Complete intermittent urinary drainage catheters, which are all being withdrawn for the time being because of a concern about sterility being compromised.

Finally, again sterility related, a reprocessing issue when using endoscope washer disinfectors, which feature accessory holders. Apparently these accessory holders, from all manufacturers, while suitable for endoscope accessories, present a risk of contamination of other devices, equipment and processing media by retained soil and material from holder itself. That one can be found here.

Readers are advised to follow the links to the specific alerts for full information.

Source: MHRA