Staying compliant: how lab scrubs meet industry regulations and standards

Australian companies involved in any lab work have to see to it that their lab scrubs meet industry standards and regulations to be considered safe, foolproof and effective. This article discusses all the different industry regulations and standards lab scrubs adhere to in Australia, why this compliance matters, and the best practices for maintaining compliance with lab scrubs.

The importance of compliance in the lab environment

Lab scrubs are a distinctive type of PPE (personal protective equipment) gear that professionals wear when doing any type of lab work. These are typically made of cotton and polyester blends and are commonly worn in lab environments.

Lab scrubs are different from lab coats. They’re basically the same as medical scrubs, and factors for choosing them range from comfort and durability to safety and eco-friendliness. Some have features like mesh inserts and wrinkle-resistant fabric with antimicrobial properties. Others are designed to be biodegradable. All of them must meet certain criteria to be industry-complaint.

Using lab scrubs that comply with industry regulations helps companies with the following:

• Producing accurate, reliable and consistent test results.
• Delivering more effective diagnosis, treatment, research or any public health purpose.
• Giving their lab workers, employees, subjects and patients protection against infection and hazardous substances.
• Reducing contamination risks and errors.
• Avoiding blowbacks like penalties, lawsuits, loss of accreditation or reputational damage.
• Maintaining high ethical standards where privacy and health safeguards are concerned.
   

This extensive range of benefits is why pharmaceutical, healthcare, research and biotechnology companies, among several others, use lab scrubs when performing various activities such as tests and sample studies.

The three major lab certifications in Australia

Before getting into compliance, it would be helpful — particularly for new entrants — for companies to familiarise themselves with laboratory certification in Australia. While laboratory certification isn’t mandatory for all, having one gives companies lots of benefits and a few important privileges.

There are three types of certifications that companies can acquire in Australia.

NATA accreditation

The National Association of Testing Authorities, or NATA, is Australia’s premier accreditation body offering accreditation to companies conducting lab activities or medical work. A NATA certification gives holding companies better control over their lab operations and ensures that lab work has a robust quality management system in place. Accredited labs also produce more accurate results, as NATA has strict standards in place for preserving sterile and clean environments in labs.

NATA/RCPA accreditation

Pathological labs, however, require a NATA/RCPA laboratory accreditation. These standards are regulated by the National Pathology Accreditation Advisory Council (NPAAC) and are based on the international standard ISO 15189 Standard for Medical Laboratories.

ISO 15189

The ISO 15189 standard applies to medical laboratories and dictates a set of prerequisites for acquiring the certification. The technical requirements extend to the quality of lab equipment and medical scrubs, environmental conditions, reporting of results and more. An ISO 15189-certified lab earns recognition for competence in the eyes of regulatory authorities and accreditation bodies.

How lab scrubs ensure compliance with industry standards and regulations

There is no specific mandate in Australia that requires a company operating a lab to adhere to codes. But it’s in these companies’ best interests to do their best with compliance if they want to reap the benefits of lab accreditation.

Accreditation organisations around the world consider lab worker safety paramount, which makes lab and medical scrubs one of the major drivers of compliance. And Australia is no different.

Depending on the type of lab a company is running or plans to run, different standards and regulations exist in their particular industry. Below is how lab scrubs ensure compliance with four types of industry standards and regulations.

Fulfilling TGA guidelines

The Therapeutic Goods Administration (TGA) has laid down guidelines for selecting and supplying PPE under the Therapeutic Goods Act. Lab scrubs are one of the PPE items that the TGA guidelines cover. The guidelines say that scrubs designed for use in hospital and medical care settings should be included in the Australian Register of Therapeutic Goods (ARTG).

Companies need to be vigilant and consider this when procuring lab scrubs. They must confirm if their selected medical scrubs are included in the ARTG or not.

Boasting a high-product quality

Medical scrubs conforming to industry standards only come from manufacturers serious about product quality. Apart from the aforementioned NATA and ISO 15189 certifications, other standards to watch out for are ISO 9001:2015 and ISO 13485:2016. Both standards govern quality management during construction, and scrubs with either of these certifications imply that scrubs have been manufactured with the utmost care.

Ensuring barrier performance

The TGA also mandates that all medical scrubs are manufactured and constructed in a controlled environment. It then directs scrub manufacturers to test their scrubs for barrier performance. This means that the most effective lab scrubs clear four types of barrier performance texts under the current testing standard, the AAMI:PB70:

• AATCC 42 Impact Penetration (Levels 1–4): Protection against water splashes
• AATCC 127 Hydrostatic Pressure (Levels 2–4): Protection against water hit with a considerable force
• ASTM F1670 Synthetic Blood Penetration Test (Level 4): Resistance of materials to penetration by synthetic blood through continuous liquid contact
• ASTM F1671 Viral Penetration Test (Level 4): Resistance of materials to penetration by blood-borne pathogens.

Adhering to labelling/IFU

The TGA Act requires lab scrubs to carry a label with detailed information and the ‘Instructions For Use’, or IFU. The information on labels typically includes the standards applied for testing, build material and IFU. Labelling information is how companies maximise their compliance when they select scrubs that are best for their specific use case.

Best practices for maintaining compliance with lab scrubs

Maintaining compliance with lab scrubs is as important as procuring scrubs that comply with the best industry standards. The following practices are crucial for ensuring that lab scrubs continue to remain compliant:

• Follow the IFU on the labels diligently. Handle them, store them and wash them as per the IFU.
• Check your lab scrubs regularly for damages along the seams, hems and bindings. Also inspect your scrubs for ruptures or rips and tears.
• Replace any damaged or stained scrubs immediately.
• Prohibit your employees or lab workers from wearing scrubs outside the lab environment, as it may compromise protection safeguards if the surface area comes into contact with air pollutants.
• Regulations and industry standards are always subject to revision. Always keep yourself abreast of any developments to remain on top of the actions you must take with your scrubs. Some suppliers keep their customers in the loop. If yours isn’t, it might be a good idea to ask them to keep you up to date.
• And lastly, follow your healthcare facilities’ infection control policies over scrubs and other PPE gear.

Conclusion

Compliance of lab scrubs with industry standards is a critical aspect of ensuring the highest level of safety and hygiene in laboratory settings. Companies involved in lab activities should always source their scrubs from reputable manufacturers that guarantee the highest compliance.

Medshop is a leading medical supplier, servicing the Australasian region with a wide range of medical supplies and a drive to exceed consumer needs.

Image credit: iStock.com/michaeljung