What do sterile services departments need to know about the UK Medical Devices Regulations? Jack Walters provides an insight into the ‘UK MDR for Healthcare Organisations’ and discusses how this applies to the reprocessing of surgical instruments
Statutory Instrument 2002 No. 618 "The Medical Devices Regulations 2002" has something of a murky applicability to Sterile Service Departments (SSDs). Clearly reprocessable medical devices purchased by healthcare organisations need to be compliant with these regulations. However, what about the surgical instrument sets that are put together? Is the SSD "manufacturing" a procedure pack? If so, how and when are they "placed on the market"? In addition, how does this relate to what kind of controls, including third party certification and registration, the SSD needs?
You would be forgiven for thinking that healthcare organisations offering the decontamination of reusable medical devices to another legal entity are subject to the requirements of the UK MDR. Perhaps this is something you were told at some point by your auditor or perhaps you read it in your "Health Technical Memorandum".1,2 However, did you know this is in direct contradiction with guidance published by the Medicines and Healthcare products Regulatory Agency (MHRA)?
The MHRA states that:
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