Single Use PPE and Medical Protective Consumables

Description

This is a Prior Information Notice (PIN) and not a call for competition, in advance of the procurement of a multi-supplier framework agreement for the supply of Single Use PPE and Medical Protective Consumables. The scope of requirements includes but is not limited to the following products designed to protect both clinicians, staff and patients from cross-contamination: single use gowns, drapes, respirators, face masks, eye protection, headwear, overshoes and other relevant medical protective wear. The products in this category are part of a mega-category; sterile intervention equipment and associated consumables which covers both medical equipment and commodity type products used in operating theatres, day surgery in acute / foundation trusts and community settings. Lot 1: Single Use Sterile Surgical Gowns This Lot comprises of surgical gowns these are Standard Lite, Standard, Standard high performance, Reinforced, Zone Impervious, Fully Impervious and must meet BS EN 13795-1:2019 or equivalent standard. Sterile gowns are Intended to minimise the transfer of infective agents between patient and healthcare staff during surgical and other invasive procedures. The use of surgical gowns with resistance to the penetration of fluids can also reduce the risk to healthcare staff from infective agents carried in blood or body fluids Lot 2: Single Use Non-Sterile Gowns This Lot comprises of non-sterile gowns such as isolation gowns and patient gowns. Any non-sterile gown under this lot must meet BS EN 13795:2019 or equivalent standard. An Isolation gown is worn as part of the PPE and is a non-sterile gown designed to protect the healthcare worker from infective agents carried in blood or body fluids of patients. A patient gown is worn to protect the modesty of a patient whilst having a medical or surgical procedure or examination. These gowns must be opaque to maintain the dignity of the patient. Lot 3: Single Use Patient and Equipment Drapes This Lot comprises of surgical patient and equipment drapes and must meet BS EN 13795:2019 or equivalent standard. A patient drape is defined as a medical device which covers the patient creating a sterile field around the surgical site and which acts as a barrier to prevent the risk of surgical site infection. An equipment drape is defined as a medical device which is used to cover non-sterile equipment for use in the sterile field. Design features on drapes, enable easy and efficient draping by one person, often specific to the needs of a particular surgery with adaptions for tubing, instruments and even the change of patient position, along with skin adhesives as appropriate, also includes equipment drapes which maintain the sterile field in surgery, differentiate the market offers and ensure greater stakeholder interest. Lot 4: Single Use Respirators and Fit Testing Solutions This Lot comprises of single use respirators and fit testing solutions. FFP respirators must meet BS EN 149:2001+A1:2009 or equivalent, the European standard on FFP mask requirements and test methods. FFP masks are Personal Protective Equipment designed to protect against particulates, infectious agents or pollutants in the form of aerosols, droplets, or small solid particles. FFP3 masks provide 99% filtering efficiency whilst FFP2 masks provide 94% filtering efficiency. Fit test kits and solutions are products to aid the fit testing of FFP masks. These products can be provided as a kit or standalone solutions. Lot 5: Single Use Surgical Face Masks Type II & Type IIR This Lot comprises of surgical masks and must meet EN 14683:2019 or equivalent, the European standard on surgical mask requirements and test methods. The main intended use of medical face masks is to minimise transfer of infectious agents (germs) by large particle droplets between healthcare staff and a patient during surgical procedures and other medical/healthcare settings with similar requirements (in the case of Type II masks). Additionally, in certain circumstances it is intended to protect the wearer against splashes of potentially contaminated liquids (in the case of Type IIR masks). These can be standalone masks or with a built-in visor. Lot 6: Single Use Eye Protection This Lot comprises of single use eye protection such as goggles/glasses and face shields/visor and must meet EN166:2002 or equivalent. Goggles/glasses are made with a flexible plastic frame and one or two lenses with a flexible elastic headband. Some can be worn with prescription glasses. Goggles/glasses give the eyes protection from all angles as the complete rim is in contact with the face. Goggles/glasses provide barrier protection to the eyes against exposure to liquid droplets and splashes. Glasses can be provided as single units or in 2 parts. Face shields/visors have one large lens with a frame and adjustable head harness or are mounted on a helmet. Most can be worn with prescription glasses. They provide barrier protection against liquid splashes to the face but do not fully enclose the eyes. Lot 7: Single Use Protective Wear This Lot comprises of theatre headwear, beard covers, overshoes, scrub suits and coveralls. Theatre headwear is worn to cover the head and hair, providing a barrier to minimise the direct transmission of contaminants into the surgical site. Beard covers are worn to cover facial hair, providing a barrier to minimise the direct transmission of contaminants into the surgical site. Overshoes and Over boots are designed to cover footwear, providing a barrier to minimise the direct transmission of contaminants into a designated clean area. Disposable scrub suits are mainly intended to provide a clean barrier in sterile environments and other clinical treatment environments and must meet BS EN 13795:2019 or equivalent. Coveralls/protective suits must be designed to cover the whole body except for the hands, feet and face area, providing a barrier to airborne and fluid-borne contaminants and pathogens. Type 4B must meet BS EN 14605:2005 + A1:2009 and class 6 of BS EN 14126:2003 or equivalent Type 5B must meet BS EN ISO 13982-1:2004+A1:2010 or equivalent Type 6B must meet BS EN 13034:2005 + A1:2009 and at least Class 2 of BS EN 14126:2003 or equivalent Thumb looped aprons are used for tasks where fully impervious non-sterile protection is needed and must meet BS EN 13795:2019 or equivalent. Warm up jackets are worn to keep the wearer warm whilst in an air-conditioned environment. Warm up jackets are non-sterile and must meet BS EN 13795:2019 or equivalent.