Surgical Apparel – Clothes Labels can be More Than Just a Brand Name

Labelling has long been an important part of the manufacturing of medical devices.  We often think about drugs, surgical tools and equipment when we think about labelling regulations in the healthcare and pharmaceutical industries.  But under the Medical Devices Directive, operating theatre textiles, specifically surgical gowns and surgical drapes, are now considered to be class one medical devices. 

This means, in order for these items to be approved for use in NHS hospitals and care homes in the UK, they must be CE certified and include the CE mark, which demonstrates that the medical items meet the essential requirements of the Medical Devices Regulations.

The Importance of Surgical Apparel Labelling

The requirement for the CE mark brings into play the importance of the labels on these items.  Labelling clearly has to be resilient in order to stand up to the normal washing, sterilising, and wear and tear that these items will endure on a regular basis.  Damage to the label would result in critical information no longer being visible.  To that end, each gown or drape, including the label, must be traceable throughout the item’s lifecycle, and has to withstand washing at 71 degrees centigrade followed by steam sterilisation at 137 degrees centigrade at least 75 times.

In addition to the CE label and CE mark, the label should also include text that provides historical information about the product, such as the roll of fabric from which it was made, the manufacturer and the date it was produced, how many products were made from that roll of fabric, the intended purpose of the item, and the name of the customer. 

This history and other data on the label become important if there is a failure (or suspected failure) on the part of that garment.  If a surgical drape or gown experiences a breakdown, such as medical fluid leaking through it, the item would be quarantined and its history investigated to try to determine the reason for the malfunction.   It might come down to the wrong apparel being worn for the job, a variance in the fabric, or incorrect laundry procedures being used.  In any case, the label is an important tool that helps investigators get to the bottom of the problem.