NCP Surgical Theatre Gowns – Standard Gowns VJD4371, VJD4372 and VJD4373 (ICN 471)

Important Customer Notice NCP

Ref: 2018/471 ICN Number: 471

Further to the update below of 13 December 2018, an action plan has been agreed with the supplier that aims to address customer concerns raised on the Standard Gown. As part of this process, we are expecting samples of a revised gown and hand towel in mid-January, which we will evaluate in conjunction with some of the complainant trusts, with the evaluation process assured by the Clinical and Product Assurance team (CaPA).

Regarding concerns raised relating to strikethrough, this has not been a supported complaint. Please refer to the previous Important Customer Notice below dated 28 September, which advises customers to review the type of gown required for the intended procedure.

Please note, The NCP Surgical Theatres Gowns – Standard Gown met the standard specification under BS EN 113798:2001+A1:2013, which is the recognised technical standard. This specification states that the fabric must be able to resist liquid penetration of ≥20cm3 H20.

Clinicians requiring surgical gowns with a higher tolerance for fluid strike through should consider using an impervious or zone impervious gown. These gowns must meet a higher performance technical requirement and provide increased protection.

A further update will be issued by 31 January 2019.

Further to our published update of 3 December 2018, we have been investigating concerns raised by customers that Nationally Contracted Products (NCP) Standard Surgical Gowns are not fit for purpose due to current quality concerns. Following feedback of gowns ripping, we have reviewed the gown against the manufacturers data sheet. We have raised concerns with the supplier to confirm whether there is a manufacturing issue with the product, confirmation is anticipated imminently.

Additionally, sizing issues have been highlighted and to confirm the only sizes included in the NCP standard gown exercise were Large, Extra Large and Extra Large Extra Long. Small and Medium sized gowns were not included in the original procurement exercise. However, initial NCP communications, advised that the situation was being closely monitored and would be reviewed within three months of launch. These gowns are currently under review to identify if there is a need to add Small and Medium gowns to our catalogue.

In relation to the issues raised with the hand towel, stating that they are too small, not of the required absorbency for surgery, and not enough in number; we are currently in discussions with the supplier to source an appropriate alternative of the required size and absorbency. This alternative will be evaluated with trusts that have already raised complaints in response to the concerns raised.

Currently we are completing the complaints investigation. We expect an action plan from the supplier shortly, to put in place the necessary actions to ensure the NCP Standard Surgical Gown is of the required quality for use during indicated surgical procedures. We are working with Clinical and Product Assurance (CaPA) towards delivering a clinically assured solution. CaPA will engage with a selection of trusts who have registered issues regarding testing. We will issue a further update by 21 December 2018.

As stated in our previous update below, we have further information regarding the review of NCP Surgical Theatre Gowns. This update is to provide customers with more detailed information on the actions we are undertaking in the current review. This review is in response to quality issues with the NCP Surgical Theatre Gowns reported by customers.

At this stage our investigations are ongoing pending the below actions:

  • Checking samples against the agreed specification to determine if there are any variances.
  • Investigating all received comments and complaints with the supplier. We have directed the supplier to contact each trust who has raised an official complaint. The supplier will request samples of gowns, which have been subject to complaint to aid the investigations.
  • Reviewing sample gowns with the Trusted Customer to supplement supplier investigations.

Once our investigations are complete, we will provide further updates, which will be available by 10 December 2018. Where we anticipate having fully investigated the issues raised.

The NCP Surgical Theatres Gowns – Standard Gown met the standard specification under BS EN 113798:2001+A1:2013, which is the recognised technical standard. This specification states that the fabric must be able to resist liquid penetration of ≥ 20cmH20. The high-performance specification BS EN 113798:2001+A1:2013 requires a fabric resistance of ≤ 100cm H20.

Clinicians requiring surgical gowns with a higher tolerance for fluid strike through should consider using an impervious or zone impervious gown. These gowns must meet the high-performance technical requirements of BS EN 113798:2001+A1:2013 and provide increased protection.

Customers are advised to continue using NCP gowns for low risk clinical procedures and report any issues via your local NHS Supply Chain Account Manager or Clinical Nurse Advisor.

We are aware of some quality issues being reported on NCP Gowns, which includes the sizing and specification of the hand towel.

We are working with the Category Tower Service Provider and the Clinical and Product Assurance (CaPA) team to investigate these quality issues. We will update you with the outcome once we have concluded our investigations.

The NCP awarded gowns for Surgical Theatre Gowns – Standard Gown, are suitable for use in low risk clinical procedures e.g. Biopsy, Endoscopy, Anaesthesia.

As these surgical gowns are not fully impervious they are not appropriate for use in procedures that are not deemed low risk. In these circumstances, an alternative surgical gown should be selected that has been identified as being appropriate for the intended purpose. The NCP gowns comply with BS EN13795.

You should continue to use these gowns for low risk clinical procedures and report any issues via your Account Manager or Clinical Nurse Advisor.

  • Following customer feedback, the hand towel element within the NCP Surgical Theatre Gowns – Standard Gown is being reviewed.
  • The affected product codes are VJD4371, VJD4372, and VJD4373.
  • Discussions with the manufacturer are ongoing with a view to increasing the size and specification of the hand towel. These will be clinically reviewed before any amendments are made to the product range.
  • Further amendments, to include additional size gowns, are also being considered to complement the existing range of Large (L), Extra-large (XL) and Extra-large Extra-long (XLXL).
  • A further update will be provided when more information is available.

Purpose

This Customer Notice is intended to clarify the intended use of Surgical Theatre Gowns – Standard Gown, specifically for product codes VJD4371, VJD4372, and VJD4373. This is following the receipt of a number of complaints and/or exception requests relating to their use.

Background

Nationally Contracted Products (NCP) initiative is strategically co led by NHS Improvement and the Department of Health and is being operationalised by NHS Supply Chain.

NCP is a procurement tool that aims to implement the Carter Report recommendations to harness the national buying power of the NHS, remove “unwarranted product variation” and improve efficiency. The initiative is focused on driving savings through reducing variety at a sub category level and channelling national commitment to this reduced product range.

The NCP Surgical Theatres Gowns – Standard Gown met the standard specification under BS EN 113798:2001+A1:2013 which is the recognised technical standard. This specification states that the fabric must be able to resist liquid penetration of ≥ 20cmH20. The high-performance specification BS EN 113798:2001+A1:2013 requires a fabric resistance of ≤ 100cm H20.

Clinicians requiring surgical gowns with a higher tolerance for fluid strike through should consider using an impervious or zone impervious gown. These gowns have to meet the high-performance technical requirements of BS EN 113798:2001+A1:2013 and provide increased protection.

Clinical and Product Assurance (CaPA) Review

CaPA have conducted a review of the standard surgical gowns under the NCP process. The gowns offered match and exceed the standard technical specification within BS EN 13795:2011+A1:2013. Evidence seen from the company of the product matches, and in sections exceeded the technical requirement via the Wales testing laboratory.

Indications for Use

The NCP award for Surgical Theatres Gowns – Standard Gown, is suitable for use in low risk clinical procedures e.g. Biopsy, Endoscopy, Anaesthesia. As these surgical gowns are not fully impervious they are not appropriate for use in procedures that are not deemed low risk. In these circumstances, an alternative surgical gown should be selected that has been identified as being appropriate for the intended purpose.

Next Steps

Customers are advised to review the type of gown required for the intended procedure.

If higher than standard protection is required there are gowns available, which are intended for procedures with medium and or high fluid loss or high-risk procedures. These gowns have the following descriptors:

Sterile Reinforced (Impervious) Gowns
• Suitable for procedures that involve heavier blood/tissue loss and the need to apply pressure to the front of the gown against the operating table.
• Recommended for all procedures where breathable all-over protection is needed, such as long cardiological, orthopaedic and transplant surgeries.
• There are 114 gowns available in this section.

Sterile Zone Impervious Gowns
• Suitable for procedures that involve heavier blood/tissue loss and the need to apply pressure to the front of the gown against the operating table.
• There are 16 gowns available within this section.

Sterile Wet Procedures Gowns
• Suitable for procedures that involve heavier blood/tissue loss and the need to apply pressure to the front of the gown against the operating table.
• Gowns for specific procedures such as Urology are available in this section.
• There are 17 gowns available in this section.