SMTL Blog

European Medical Glove Standard EN 455-3 updated

En 455-3 has been published. This is the first revision in 9 years, and replaces EN 455-3:2006.

The main change is related to the fact that the principle of reduction of risk to “as low as practically possible,” (ALARP)  is in conflict with the Medical Device Directive which does not allow economic considerations. Therefore the protein and chemical requirements have been re-written to refelect this.

Annex ZA has been rewritten, and reduces the number of Essential Requirements with which compliance can be presumed.  

Monograph 4.5 (leachable proteins) now requires that "The manufacturer shall strive to minimize the leachable protein level." (replacing the previous requirement of 'The leachable protein level shall be "As Low As Reasonably Practicable" (ALARP).')

SMTL are UKAS accredited to test against the requirements of monographs 4.3 (endotoxins), 4.4 (powder), 4.5 (leachable proteins) of the new standard.

 

 

 

SMTL, in a joint bid with NWSSP Procurement Services and Lymphoedema Network Wales,  are delighted to have won the "GO Procurement Innovation or Initiative of the Year Award" as part of the Government Opportunities (GO) Excellence in Public Procurement Awards.

GO Award Trophy Image

The project covered the procurement of lymphoedema compression garments for the Welsh NHS, and demonstrated joint working between Welsh Government, clinicians, the Lymphodema Newtwork Wales group under Melanie Thomas, Procurement Services, and SMTL, providing a range of products which met the clinical and technical requirements of the Welsh NHS, whilst also reducing variation, delivering cost savings, and complying with the Prudent Healthcare agenda of Welsh Government.

Our colleagues in Procurement were present on the night to receive the award.

GOAwardsWinners GO-Innovation Health2015-0077

 

SMTL, in a joint bid with NWSSP Procurement Services and Lymphoedema Network Wales, are delighted to have been chosen as a finalist in the Government Opportunities (GO) Excellence in Public Procurement Awards 2015/16.

The project which was submitted covered the procurement of lymphoedema compression garments for the Welsh NHS, and demonstrated joint working between Welsh Government, clinicians, Procurement Services, and SMTL, providing a range of products which met the clinical and technical requirements of the Welsh NHS, whilst also reducing variation, delivering cost savings, and complying with the Prudent Healthcare agenda of Welsh Government.

The winners of the award will be announced at the National GO Awards 2015/16 Award Ceremony, Manchester, on the 26th February.

SMTL have recently performed a project for NHS Supply Chain assessing the quality of a selection of single-use and reusable surgical instruments in accordance with the suite of British Standards  BS 5194 Surgical instruments

We are pleased to welcome two new staff to SMTL:

  • Elise David - Quality Manager
  • Jess Bodman - IT system administrator

Elise has previously worked in the pharmaceutical industry as a quality manager, as well as a spell in the NHS.  She replaces Bruce Fisher who retired in August 2014, and who worked in the laboratory for over 30 years.

Jess has been working within ABMU Health Board in the SSD service for a number of years, and previously worked in Linux administration in the financial services industry.  She replaces Matt Moore, who ran our IT system for 3 years and has gone on a role managing web servers for an international organisation.

 

 

 

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