Manufacturers Decontamination Guidance within their Instructions for Use (IFU’s)

PUBLISHED BY: Martin Williams

ON: 13 April 2022

CATEGORY: Latest Legislation

Do you encounter problems with decontamination instructions and guidance within these documents?

From time to time and, unbelievably in this day and age, you notice that the guidance provided for the decontamination of a particular medical device does not conform to UK requirements. If the device is actually in use, then that’s even more of a problem.

There are a number of critical questions that need to be asked:

  • Why wasn’t this discovered before purchasing the medical device?
  • Who purchased the device?
  • Were the Procurement / Supplies Team involved?
  • Was a Pre Purchase Questionnaire circulated to all key stakeholders including the Decontamination Lead?
  • Why is it in use and who approved the use?
  • Is the device being decontaminated without a correctly validated and compatibility process having been undertaken first?

As decontamination professionals, we need to be involved in the procurement and purchasing stages of all new medical devices in order to ensure, that we can actually decontaminate it efficiently, correctly, safely and compliantly before it is ever used on a patient.