Advanced Sterilization Products Successful Journey

Delivering innovative infection prevention technologies

Nilesh Shah, Vice President/General Manager Commercial Advanced Sterilization Products

1) Advanced Sterilization Products has a long history of planning and conveying innovative infection prevention solutions. How do you think this would raise the level of healthcare and safety?

Every day, millions of people around the world visit a healthcare facility. It may be a mother giving birth, a grandfather receiving routine treatment, or a parent visiting a sick child. What they all have in common is a desire to leave the hospital as healthy or healthier than when they arrived. The care and handling of instruments used to treat patients is vital to their health outcome and there is no room for error. But sadly, hundreds of millions of patients are affected by healthcare-associated infections worldwide each year, leading to significant mortality and financial losses for health systems1. And COVID-19 only exacerbated an existing sterilisation and disinfection problem, with a recent poll indicating nearly 80 per cent of responders spend over 75 per cent of their time on COVID-19 infection prevention efforts2.

At Advanced Sterilization Products (ASP), we are dedicated to designing and delivering innovative infection prevention technologies to protect patients during their most critical moments.

In addition to healthcare professionals, we work with additional bodies in Asia Pacific that support the prevention of hospitalacquired infections, to work towards better access and reduced infection-related burdens. For example, in Hong Kong, we partner with the Hong Kong Sterile Supplies Management Association and Infection Control Nurses’ Association to organise conferences and educational seminars.

2) Could you tell our readers how the medical equipment is processed in Advanced Sterilization Products Systems?

Sterilisation offers the greatest margin of safety to device reprocessing, yet conventional high-temperature methods such as steam are not suitable for all devices. The materials that comprise some advanced surgical instruments, and their complex design, necessitates the use of Low-temperature Sterilisation (LTS) to maintain device integrity.

The STERRAD® by ASP exploits the synergism between hydrogen peroxide and low temperature gas plasma (an excited or ionised gas) to rapidly destroy microorganisms. At the completion of the sterilisation process based on this technology, no toxic residues remain on the sterilised items3.

3) With the best technology available, how would you simplify buying and operating infection prevention products and services for medical facilities globally?

ASP offers the ASP ACCESS® Technology – an informationsharing technology that empowers an ecosystem across ASP devices. It is designed to enhance compliance, automating the documentation of the sterile process, and integrate with leading Instrument Tracking Systems. This greatly improves efficiency as it enables real-time access to sterilisation records that can be used within different departments in a healthcare institution.

4) Can you throw some light on STERRAD® Systems and how they are useful to the current situation prevailing today?

Busy medical facilities need to maintain stringent sterilisation protocols and the current pandemic placed people and resources under extra pressure across the health systems. COVID-19 also caused numerous product shortages and delay in supply chains in the beginning, and possibly affected medical device sterilisation between patients.

When facilities and operators are overwhelmed, there is a risk that they may feel rushed to return medical devices to service with an elevated possibility of skipping or forgetting steps necessary for complete sterilisation. Similarly, issues may arise if people do not have enough resources to engage in the proper sterilisation protocols.

Hence, the pandemic spotlighted the need for sustainable solutions for disinfection needs with shorter turnaround times.

STERRAD® Sterilisation Systems enable faster instrument turnover, as they do not require lengthy aeration and offer a rapid sterilisation cycle (24–60 minutes), saving time and increasing efficiency. This means that instruments can be re-used much sooner, alleviating the costs associated with holding a large number of instrument sets in inventory.

STERRAD® Sterilisation Systems rapidly and safely sterilise medical devices and materials, avoiding exposing users and patients to unnecessary health risks by utilising a combination of H2O2, which is non-carcinogenic, and gas plasma, which eliminates H2O2 residues to leave only water and oxygen. With no toxic emissions or byproducts result, because hydrogen peroxide breaks down to water, STERRAD® avoids the need for expensive abatement systems, and adherence to strict regulatory guidelines associated with preventing and detecting exposure, such as for EtO and FO.

5) With the COVID-19 pandemic affecting millions of people around the world, what role does Advanced Sterilization Products have in protecting patients and healthcare workers?

ASP is committed to protecting patients and healthcare workers with infection prevention solutions. Our products are highly involved in disinfection & sterilisation practices and our teams are doing what is humanly possible, to make them broadly available where needed.

For example, we created an online Coronavirus Resource Center on our website to help our EMEA healthcare communities navigate the significant challenges they are facing in this time of great uncertainty. With important facts and information that is updated, we want to become a resource in combatting COVID-19 and other infections.

Under what the World Health Organisation has called ‘force majeure’, hospitals are looking for solutions outside the ordinary to protect their medical staff and patients. On the quest to find ways to sterilise single use Personal Protective Equipment (PPE) or other materials currently in shortage due to the extreme demand, our STERRAD® low temperature sterilisation systems have been involved in several locally initiated & executed studies.

All sterilisation systems and disinfectant solutions that ASP provides have been tested against enveloped viruses, the family of viruses that includes coronavirus. Furthermore, some of our products, including CIDEX® OPA, have been directly tested against coronavirus, and have been demonstrated to be efficacious.

The pandemic offers huge opportunities to learn lessons for health system preparedness and resilience.

6) What is Advanced Sterilization Products focused on when helping to provide the safest possible environments for patients and healthcare individuals worldwide?

Success of infection prevention and control in health facilities is always due to multiple factors.

ASP has a history of innovation in High Level Disinfection and Low Temperature Sterilisation. ASP developed and introduced CIDEX® OPA to the market over 20 years ago and created the first hydrogen peroxide terminal sterilisation system, STERRAD®.

7) Could you tell which medical device types are at high contamination risk of coronavirus and why?

In a hospital or the course of healthcare set-up, medical devices and instruments will encounter patients infected with coronavirus. To prevent patient-to-patient transfer of the coronavirus, reusable medical devices must be sterilised or thoroughly disinfected between uses.

Devices such as bronchoscopes, ENT flexible endoscopes and laryngoscopes are used for the diagnosis and treatment of patients with advanced coronavirus infections. These devices are reusable and must be disinfected or sterilised between uses. A high number of patients needing advanced care for coronavirus could result in a single device being used multiple times a day.

Medical devices such as blood pressure cuffs, thermometers, monitoring equipment and ventilators, which are used at the bedside will also need to be disinfected or sterilised between uses.

8) How is Advanced Sterilization Products partnering with global regulators, logistics professionals and healthcare providers to expedite products to the field?

ASP is actively working with regulators and healthcare providers across the world to provide products that can aid in reducing or preventing the spread of infection.

In 2020, to mitigate the impact of the COVID-19 pandemic, the Chinese FDA announced it would have a temporary program in place to fast-track devices that assisted in the fight against COVID-19. We were able to satisfy the requirements to bring the AEROFLEX™ Automatic Endoscope Reprocessor (AER) to market early. The AEROFLEX AER has a built-in function to check minimum concentration levels of solution prior to every scope being processed.

9) Which product of Advanced Sterilization Products as per you is effective against Coronavirus and its significance?

Although ASP has not specifically conducted testing of CIDEX® OPA Solution against 2019-nCoV, CIDEX® OPA Solution has been tested for efficacy against human coronavirus. Testing was performed using the United States EPA Virucide Assay Method. Testing was also completed using a diluted strength CIDEX® OPA formulation to present adequate challenge to CIDEX® OPA. The results showed that even at a diluted concentration, CIDEX® OPA Solution inactivates Human Coronavirus.

Additionally, coronaviruses such as SARS-CoV 2 are lipid viruses (enveloped viruses). Lipid viruses are typically, susceptible to various low and medium disinfection modalities according to the guide of the hierarchy of biocide resistance published by the Centers for Disease Control and Prevention (CDC).

References:

1 WHO, Health care-associated infections fact sheet, www.who.int/gpsc/country_work/gpsc_ccisc_fact_sheet_en.pdf
2 Stevens MP, et al. Impact of COVID-19 on traditional healthcare-associated infection prevention effort. Infect Control Hosp Epidemiol 2020. Apr 16, doi: 10.1017/ice.2020.141
3 STERRAD 100NX Sterilizer with ALL Clear™ Technology, FDA Indications for Use, ASP, 2017

--Issue 53--

Author Bio

Nilesh Shah

Nilesh Shah is the Vice President/General Manager Commercial of Advanced Sterilization Products and is responsible for growth worldwide. Nilesh brings over 20 years of global experience in P&L management, marketing, new business model innovation, engineering and product management. Nilesh has a strong track record of global leadership in the healthcare industry.

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