We regularly publish healthcare and cleanroom related articles, which can be viewed below. The articles span a wide range of topics and provide industry specific insight to allow for informed decisions. Should you have a specific question not answered in the articles below, please send us a message via the "Contact Us" page and we will be happy to help.
“Understanding your risk in using a device to enhance your level of protection. This is your right”
HOW WELL ARE YOU PROTECTED?
Traditionally, surgeons donned gloves to protect the patient from the transmission of microorganisms. Today, with the growing incidence of HIV, Hepatitis B and C infections, surgical gloves play an even more significant role in preventing the surgeon’s hands from the transmission of these blood-borne pathogens and viruses.
Although surgeons expect their gloves to serve as an effective barrier during use, surgical gloves can and do sometimes fail. Barrier failure is often unrecognised, resulting in the wearer’s exposure to potential pathogens and the patient, to potential microorganisms.
In a study* conducted at a Finland hospital, out of 694 gloves collected after surgical operations, 67 gloves (about 10%) were found to fail using the standardized watertight test. This failure could be due to holes created during operations or as a result of pin holes already existing in the gloves prior to use. As the cost and consequences of failure in surgical gloves barrier protection are astronomical to the healthcare system and its stakeholders, there is a need to have an indication on the limit of failure expected in surgical gloves usage.
*Green SE, RH: Gloves perforation during surgery: what are the risks? Ann R Coll Sur Engl1992; 74:306-308
“By selecting gloves manufactured with more stringent AQL, we could significantly enhance our personal protection”.
WHAT IS AQL AND WHY IS IT IMPORTANT IN ENHANCING PROTECTION?
When glove manufactures produce gloves, the operation is unable to guarantee ‘zero defects’. There will be gloves having some percentage of pin hole defects which are difficult to detect or weed out in spite of the stringent quality assurance checks during production.
AQL (Acceptance Quality Limit) for watertight test in gloves relates to the maximum number of gloves failure in watertight test conducted according to a simple plan procedure where a certain quantity of the gloves is randomly selected from every batch of production. The tighter the control, the lower will be the AQL.
If we agree that the gloves barrier performance is crucial during surgical procedures, then AQL is clearly an important factor to consider. By selecting gloves manufactured with a more stringent and lower AQL, we could significantly enhance our personal protection.
USING AQL IN GLOVE MANUFACTURING
Before determining the AQL in a surgical glove production, we first need to decide what will be the Lot Size and the inspection level.
Defining Lot Size
The lot size relates to the number of gloves produced in a production lot. If you order one product, the total quantity (in pieces) ordered will be the total lot size. For example, if the order is for 25,000 pairs (50,000 pieces) of size 7.5 iNtouch surgical gloves, the lot size will be 50,000 and this falls within the lot size of 35,001 to 150,000 units shown on the first row of table 1 below.
The inspection level will indicate the number of gloves to be randomly collected for testing. As outlined in the medical glove standard such as ISO 10282, EN 455 and ASTM D3577 the inspection requirement is General Inspection Level (GI) from table 1.
Once the lot size and the inspection level have been selected, we can then obtain the code letter from table 1. Once the sample size code has been determined, the quantity of samples to be drawn and tested shall correspond to table 2A.
Form the example of 25,000 pairs size 7.5 iNtouch order with a lot size of 50,000, the sample size or number of gloves to be tested shall correspond to the “Code Letter L” whereby 200pcs of gloves shall be drawn and tested for pin hole defects.
ISO 2859 (sampling procedures for inspection by attributes) is the most frequently used standard in determining the AQL value. Industrial norm for surgical glove AQL is defined at 1.5 as stipulated in the international standard such as ISO 10282, EN 455 and ASTM D3577.
With AQL of 1.5 and the samples size code letter L, the number of acceptable pin hole defects allowed is a maximum of 7 gloves out of 200 gloves samples tested. However, if you order iNtouch with its more stringent AQL of 0.65, then the number of acceptable pin hole defects allowed is a maximum of 3 gloves out of 200 gloves samples tested.
iNtouch gloves: you will have a lower risk, better protection and the need to purchase fewer gloves due to in-use failures.
WHAT ABOUT iNtouch, WHAT IS THE QUALITY GUARNTEE?
We virtually hand pick the gloves for you. Once the surgical gloves are produced, we go a step further than industrial norm, to ensure our defect on pin-holes is further reduced by subjecting the gloves to a 100% pneumatic air leak detection test through a machine using air pressure to blow up the gloves to check for holes.
At the same time the gloves are also visually inspected. Therefore, with iNtouch gloves you will have lower risk, better protection and the need to purchase fewer gloves due to in-use failures.
WHAT IS A PNEUMATIC AIR LEAK TEST MACHINE?
The pneumatic air leak test machine works by injecting each glove, which is fixed on a holder, with a certain volume of dry compressed air. The machine will measure the pressure decay in the gloves over the test duration. At the end of the testing duration, the system will automatically output the results of the testing. The results would be classified into 2 categories “GOOD” and “FAIL”. The machine works on an AQL detection of 0.065 where it does not accept any identified defects.
UNDERSTANDING YOUR RISK REDUCTION WITH iNtouch
The operating characteristic (OC) curve based on the Poisson Statistical formula, describes the probability of accepting a lot as a function of the lot’s quality. The graph explains in summary: