Toxicity Tested Supplies - The Solution to the Andrology Headache?

The Problem

When you’ve been speaking with most andrology services in the UK for as long as we have, you notice a universal problem they face. Every andrology lab is spending a lot of time and resources toxicity testing every batch of consumables it uses.

It makes sense to be rigorous in toxicity testing for andrologists; sperm is a ‘living’ cell and ensuring what spermatozoa encounter is not toxic to them, is obviously one of the most critical factors for a quality diagnosis. However, what doesn’t make sense is that:

Around the UK, labs are duplicating work testing the same batch of collection pots, or pipette tips as many separate services
Andrologists are having to assess toxicity using their own patients’ samples. These are often poor quality (after all, there’s a reason you visit an andrology department).
Assessments are mostly done manually, without the assistance of a CASA.

Time and time again, staff and managers were telling me how frustrating it was having to continually go through a toxicity testing process. I’ve even witnessed a service close its doors, because the burden of toxicity testing for such a small department took too much time to make it cost effective.

If you draw a parallel to fertility clinics, you can see it doesn’t have to be this way.

Fertility Clinics, like Andrology Labs, need supplies that are extremely safe for Sperm, Oocyte’s, Embryo’s, and their patients. As bad as a misdiagnosis from an andrologist, bad supplies in the IVF world could result in failed fertilisation, the wrong treatment plans, and failed pregnancies: all of which are emotionally and financially draining. But unlike andrology labs, a fertility laboratory will not individually test its batches of products for safety with embryos or other live substances. Instead, they rely on all the products they buy conforming to the Medical Device Regulations (MDR) and meeting European regulations pertaining to Class IIa and IIb medical devices. What this means in practice is that suppliers manufacture devices to rigorous ISO, EN, or BS standards and they can only supply to the market when authorised bodies, auditors, and other stakeholders have done their due diligence and signed the product off as safe. In the more privatised and financially lucrative world of IVF, it is the manufacturers that ensure supplies meet regulatory requirements.

The regulatory body for fertility clinics, the HFEA, will request certificates of conformity for every supply in a clinic, showing that it meets the high standards required of it. Things work slightly differently in andrology. Because andrology services are diagnostics only, the supplies they buy are In-Vitro Diagnostics (IVD) devices. Regulations are not as stringent for this category of medical equipment. But because of the uniqueness of handling live cells, UKAS assessors and ISO 15189 requirements for an andrology service stipulate labs must be responsible for ensuring the non-toxicity of their materials.

The Solution

A practice always develops before a standard, and in andrology there is currently no standard for assuring good quality in supplies – beyond a long-winded approach that ISO 15189 assessors are forced to take. Hawksley’s goal is to pave the way for a standard to emerge in this area. This is what has led us to release a range of Andrology Glassware and Plasticware evidenced to be non-toxic to sperm by a UKAS accredited lab. Once you have validated our results in your own lab, you’ll no longer need to do in-house testing of supplies – saving time and therefore, money. More than this, Hawksley can get on with the bigger task of looking at how temperature, time, and humidity effect the toxicity of consumables on sperm. This will be done on a much wider scale than a single andrology lab can do, so Hawksley develops the gold-standard of supplies for andrologists. designed with them.

The Range

As we developed this project, the number of variables we had to consider seemed to be growing exponentially - one of the most critical being which consumables to choose. Every lab has their own preferences when it comes to brand, size, shape, colour (the list goes on), so picking plasticware that both appealed to the majority while staying low on price was integral. In the end, we went for the democratic option and put it down to a vote, sending numerous samples of potential consumables to labs across the UK, asking them to grade each one on a list of factors. It was from this that we were able to build an optimal list of the highest quality products to offer as part of our range, shown below;

1ml Air Displacement Tip
200ul Air Displacement Tip
90ml Collection Pots - Leakbuster, Wide Neck, Sterile
60m Collection Pots - Leakbuster, Sterile
30ml Container
HiQA Coverslips No. 1 22 x 22mm
Claritex Slide, Twinfrost 1.0-1.2mm 90o Ground
1.5ml Microtubes - Sterile
Liquipette 3ml Graduated, Non-Sterile Pasteur
Rainin Pos-D 10ul Positive Displacement Pipette Tips
Rainin Pos-D 25ul Positive Displacement Pipette Tips
Rainin Pos-D 50ul Positive Displacement Pipette Tips
Rainin Pos-D 100ul Positive Displacement Pipette Tips
Gilson CP10 10ul PD Tips
Gilson CP25 25ul PD Tips
Gilson CP50 50ul PD Tips
Gilson CP100 100ul PD Tips
CellVision 100um Post-Vasectomy Disposable Slides
CellVision 20um Disposable Slides
CellVision Neubauer Improved Grid Disposable Slides

How to Order

As this range expands, the goal is that any lab, at any time, will be able to order their toxicity tested supplies and get them delivered to the door in a matter of days. However, while we’re building up our data and testing capacity, POs are being accepted incrementally throughout the year, after which testing and delivery commences. Now that our first orders have closed and are being processed, we’re looking towards the next. If you’re interested in learning more or getting toxicity tested consumables in your lab, please reach out to the Hawksley Team now and secure your place for the next incoming batch.