Supplyline Online Magazine May 2020

MAY 2020

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NZSSA New Zealand Sterile Sciences Association

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Business Card Directory

A QUICK AND HANDY DIRECTORY OF OUR STERILE SERVICES SUPPLIERS

Maryanne Coyle

CLINICAL ACCOUNT MANAGER

Kevin Ankcorn

Mobile: 021 552 091 Telephone: (03) 385 0828 Fax: (03) 385 0829 Freephone: 0508 654 258 Email: mcoyle@remsystems.co.nz

Shirleyann Gray

PRODUCT SPECIALIST

Customer Services Direct Lines T: (09) 570 3288 F: (09) 570 3287

027 279 7597 kevin@downs.co.nz

PO Box 90147, Victoria Street West, Auckland 1142, New Zealand

SOUTH ISLAND MANAGER

+64 274 328 967 shirleyann@downs.co.nz

www.downs.co.nz

www.downs.co.nz

www.remsystems.co.nz

David Hunt

Sales and Service Specialist - South Island

dhunt@device.co.nz D +64 3 925 8567 | P +64 9 913 2000

Mitch Varnam

F +64 9 913 2009 | M +64 21 197 2472 47 Arrenway Drive, Albany, Auckland 0632 NEW ZEALAND

Product Specialist Infection Prevention

mvarnam@device.co.nz

D +64 9 215 0974 P +64 9 913 2000 F +64 9 913 2009 M +64 21 521 981 www.device.co.nz

Cheryl Hughes Clinical Educator

chughes@device.co.nz

D +64 9 215 0977 P +64 9 913 2000 F +64 9 913 2009 M +64 21 589 886 www.device.co.nz

Creating a difference in healthcare

DESIGN PROOF

DESIGN PROOF

SIGN-OFF Alan Bryant REQUIRED Instrument Technician abryant@device.co.nz

D +64 9 215 7860 F +64 9 913 2009 M +64 21 589 819 www.vearsurgical.co.nz

a difference Attention: Creating Damian Draperin/ healthcare Jason Hopper

SIGN-OFF REQUIRED Attention: Date: 29 September Damian Draper 2015 / Jason Hopper

Surgical & Medical Systems

Date: 29 September 2015

From: Andrea Surgical Rickerby & Medical Systems Proof: 1

Richard Murray buscard.indd 2

From: Andrea Rickerby 5/11/18 3:07 pm

Page: 1 of 2 Dustin Habeck dustin.habeck@gallay.co.nz New Zealand Manager t. +64 (0)9 282 4266 Please: TICK relevant box m.below +64 (0)21 280 6889 Endoscopy

SIGN if you are happy to proceed 8F Enterprise Drive Henderson, 0612 Zealand FAX a signed copy back New to us Laboratory Medical & Infection Control

& Pharmaceutical

Page: 1 of 2

INTERMED MEDICAL LIMITED

TICK relevant box below Leonie Jack SIGN if you are happy to proceed 021 246 4444 FAX a signed copy back to us 71 Apollo Drive, Albany 0632 , PO Box 33268 , Takapuna 0740 , Auckland

Please:

NZSSA Member/Graduate Product Specialist - CSSD

New Zealand

T 09 415 4800 F 09 415 9045 FREE 0800 333 444 W www.intermed.co.nz

www.gallay.co.nz

Proof: 1

E leonie@intermed.co.nz

Damian Draper

Damian Draper

+64 274 972 445

+64 274 972 445

P

0508 SURMED (0508 787 633) F +64 3 376 4046 PO Box 1336, Christchurch 8140, New Zealand www.surgicalsystems.co.nz

P

A

A

Operations Manager

JAMES HENDERSON 027 543 2266 | jhenderson@nzvalidation.co.nz 615 Peacockes Road, RD 2, Tamahere, Hamilton nzvalidation.co.nz

Operations Manager

damian@surgicalsystems.co.nz

damian@surgicalsystems.co.nz

Craigs Design & Print

0508 SURMED (0508 787 633) F +64 3 376 4046 PO Box 1336, Christchurch 8140, New Zealand www.surgicalsystems.co.nz

Editor’s Note Kia ora koutou katoa, as I was reading through an article, to be published in the Zentral Sterilization Journal this year, regarding reprocessing of traditional reusable medical devices the saying on this picture made me think of the rapidly changing and challenging times that have required us to pull together and be even more adaptable than usual to keep pace with developments. We have been put under pressure to deal with first an eruption, Whakaari White Island, and now a pandemic! With the restrictions imposed by the pandemic it is therefore timely that this first edition for 2020 is also the first edition of the Supplyline journal that is being bought to our members as an electronic journal with no hard copy printing.

The future is here and as an organisation and industry we

need to use the technology available and have a sustainable approach through reduction of waste by eliminating printed material and packaging where possible. Enjoy this new future for your journal.

To close I will quote a saying that is being used widely at the moment “we are in this together”. As we continue to focus on the health of our wider community, remember it is still important to look after our own wellbeing. Be kind to one another.

Tracey Kereopa

President’s Message Hi Everyone It is a trying time for us all. As essential workers we are relied upon to turn up to work and continue to do what we have always done. We are in a rather envious position. PPE for us is the norm; it is in our sterile technician genetic makeup.

In our decontamination rooms we don PPE every day and treat everything as contaminated. Unfortunately some of our colleagues in the operating theatre (anaesthetists) are having to learn the art of wearing PPE and it does not come naturally to them. Also we do not have and should not be having any patient contact unless working in some endoscopy units and even there you should be wearing full PPE. Ensure that you clean your departments thoroughly wiping down all hard surfaces every day including keyboards scanners, computer mouse and the touch screens on washers and autoclaves.

Keep you and your colleague’s safe in the workplace.

Remember that we do not need to do anything different from what we do every day in our roles as technicians.

Unfortunately due to Covid 19 the March Leaders Forum in Wellington had to be cancelled as has our Annual Conference which was due to be held in Christchurch in September.

Cancelling the conference was not a decision taken lightly.

We could not plan ahead as companies and speakers, overseas and local, were not willing to make commitments

to conferences this year. As an Association we ran the risk of losing money if we made deposits on venues etc. However the good news is we have rescheduled for Christchurch in September 2021. In the meantime we are looking at alternative methods to deliver educational seminars to you.

One way we are considering is by producing webinars. We will keep you informed re these on the website.

For those of you who are studying this is the ideal time to get your work done. Well at least that is what I am telling myself. Fortunately or unfortunately the weather has been so nice that it is tempting to be outside rather than studying, but the sooner we do it the sooner we will be finished.

Look after yourselves and your families, remember to socially isolate and stay safe.

Shelagh Thomas

VACANCY - Canterbury District Health Board CDHB has a vacancy for an Educator within our Sterile Services Department. If you are interested in this role please follow the link supplied here. The link is below, and closes on 3rd May 2020. https://cdhb.careercentre.net.nz/Job/Educator-Sterile-Services/Christchurch/16728 the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

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NZSSA Executive Update This year has seen the resignation of Helen Chedwidden and Jenny Carston from the Executive. Helen has moved into a career as an anaesthetic technician and we wish her well with her new directions. Jenny has stepped down from the executive so that she can focus her energies on the developments at Tauranga Hospital.

I extend my thanks to both these executive members who have given valuable time and energy to the Association.

A special thanks to Jenny for her time given to the Secretary role.

To resolve one of these two vacancies the Executive has appointed Joel Enoka to the role of Executive Member.

Joel’s bio is below. June Isted has stepped into the position of Secretary, thank you June for putting your hand up for this role. These changes will be ratified at the NZSSA Annual General Meeting to be held later this year.

The remaining vacancy on the Executive will be carried through to 2021 when the next election of the executive is to be completed. If you have any queries do please contact me.

Shelagh Thomas NZSSA President

all of these downs, I found a few ups and regained my lust for life.

Joel Enoka Team Leader, Sterile Services Nelson Hospital

I was born in Seattle in July of 1978. I lived in several different states with my two brothers and parents over the years. Eventually, we were lucky enough to move to Boulder, Colorado in 1996 just as I finished high school. After taking a year off of school to work, I enrolled in university in 1997 to begin studying biology.

I earned a B.A. in Biology and I was subsequently hired as a professional research assistant at the University of Colorado at Boulder. I was working in the Department of Integrative Physiology researching human aging. I continued down this track for nearly a decade as I truly enjoyed the team(s) I had been part of. In early 2008, I began applying to graduate schools to study zoology. I was selected to attend an interview in November, 2008.

On my way home from that interview, five minutes from my house, I fell asleep while I was driving and was involved in a serious car accident. I will spare you all the details, but this led to two years of on-going facial reconstructive surgeries and a failed strabismus. Over the next several years, I had to learn to live again. During

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My dad was born in New Zealand and lived here up until 1972, when he moved to Seattle to pursue a graduate degree and eventual doctorate in kinesiology. He comes from a family of six boys. Although worlds apart, our family remained close despite the distance. We were the American contingent to our New Zealand Family.

Seven years ago, we all met in Nelson for a family reunion. Amongst all the family-filled activities, I met a very special person. We hit it off and maintained a close relationship over the next few years. After coming to visit me in Colorado a couple of times, I moved to Nelson in February of 2016. I proposed to her at Cape Reinga in December of 2017, and we were married January 23, 2019. I am now a husband and step-dad to three boys.

I was hired as a sterilisation technician at Nelson Hospital in May of 2017. To be completely honest with you, it had never even entered my mind that such a job existed. Like all of us, initially, I was overwhelmed with information.

After getting my feet under me, I embraced my role with the passion I try to live every moment with. I applied for the Team Leader position and was successful in March of 2018. I was recently explaining to one of my wife’s friends how challenging that the Level 5 Course was, when he asked me what I was going to do next. I replied that I will continue to run the Nelson Hospital TSU, and hopefully there is something I can contribute on a National Level.

I appreciate you taking the time to read this and for your consideration to have me join you on the Executive Board.

Joel A. Enoka

S U P P LY L I N E – D E C E M B E R 2 0 1 9

Why you should choose an independent Validation and Compliance Service?

Validation and compliance is all we do, we are experts in this field.

We strive for consistency throughout New Zealand sterile services industry.

We are independent providers with no sales interests.

James Henderson, Director 027 543 2266 jhenderson@nzvalidation.co.nz www.nzvalidation.co.nz

NZVS_A5Graphic.indd 1

9/04/20 10:06 AM

COMPETITION The Executive is going to run two competitions for the benefit of NZSSA members.

One competition will be for individual members with a prize for the individual member and one competition for the team with the prize being a benefit for the whole department. The Executive needs to know what prize would be of value to you as an individual or your department.

The competition will go live in the July edition and the prize notified in the December edition.

Here are some ideas – Conference registration for two in 2021, Travel assistance to regional meetings in 2021 What would you like for your service as a prize or yourself as a NZSSA member?

Get your ideas to Shelagh Thomas by 1 June 2020: shelagh.thomas@huttvalleydhb.org.nz the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

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NZSSA Conference Scholarship Recipient This year the NZSSA conference was held in Wellington at Te Papa Museum.

Being a member of the NZSSA Association and receiving the Supplyline, it gave me information on the outline of topics that the various speakers would be covering this year. My last time attending a conference was back in 2000 in Auckland, I remember on coming away from that conference and a previous one feeling inspired with fresh knowledge. I had set attending this year’s conference as my personnel goal, to achieve personal growth within our profession. I applied for a scholarship via the NZSSA website.

A few of my hospital colleagues found my dumbfounded expression on receiving the news I had received the scholarship quite hilarious.

Okay this was the first baby step for me. Alison Stewart then contacted me about arranging flights from Hamilton to Wellington, and she also booked the accommodation which was only a 7min walk (great for someone who can easily get lost).

Also the scholarship paid for my registration and dinner on the Thursday night.

Wednesday night was a chance to go along and see trades exhibitions set up, given a satchel with some bits and pieces inside, and we picked up our ID tag.

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our instruments in prime condition is exciting as it reduces the waiting time in theatres, and also lowers the stress levels between theatres and CSSD’s.

We had the conference buffet dinner, the theme for the evening being maskquerade ball, wow there were some awesome masks, some of us won a theatre hat for our efforts, the dinner was lovely, and music was provided by a band named Shenanigans.

Day 2- Again we had a variety of speakers, we were lucky to have a speaker from Germany, he was describing a centralised sterilising unit where items from hospitals arrived to go through the sterilising process, and this meant that some hospitals didn’t have their own sterilising units.

All re-useable instruments were delivered to this centralised sterilising unit, processed and packed and sent back to the hospitals sterile.

We heard about prion proteins which are misfolded proteins with the ability to transmit their misfolded proteins onto normal variants of the same protein. These are very sticky making them extremely hard to kill, but our ISO guidelines are a good tool to adhere to, ensuring we are providing the right elements to eliminate the threat of these proteins which if left can be transmitted on instruments via eye surgery, spinal surgery and neuro surgery.

Another topic discussed is the importance of the water hardness in our WD. This plays a huge role in ensuring instruments aren’t pitted, discoloured, have water spots, all of which would break down the integrity of the instruments over time costing the hospital a lot of money to replace.

On Thursday and Friday there was a question and answer session, I attended the Friday session, wow I really enjoyed this, a chance to have questions answered, to have advice given on handling situations, and common knowledge shared by all, and this is such a powerful tool for all of us.

To sum up - what did I gain from the conference?

Thursday morning Shelagh Thomas NZSSA President welcomed everyone, and gave an opening speech, after which speakers covered principles of problem solving, H202 Sterilizers and Instrument compatibility, and basics of steam sterilising. I was amazed at the slide shows that each of the speakers presented and worked from, some of us were trying to take photos of the slides on our cameras, I can honestly say I am not great at making notes fast enough.

Meeting and talking with different trades’ people is a great way to introduce new devices into our work areas to enhance the quality of our work and to maintain high standards with our sterilising procedures. Instruments are costly, and a lot of them are highly complex so maintaining them to a high standard for our surgeons is important.

During tea breaks and the lunch breaks we could use the time to visit the trade stands of which there were 29. What a fabulous chance to see the latest technology on the market, I saw equipment that we could use and incorporate in our department, also thinking about the future requirements for replacing equipment, I was able to see possibilities for our hospital. Being able to use the trades’ exhibition for being shown equipment to enhance the quality of keeping

Meeting Shelagh, Alison and Tracey, being amazed at the amount of knowledge held between all of these people, especially the vast knowledge of the ISO guidelines

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I was able to bring some information back for some devices that may be useful to our department

Wanting to upskill my education level and help others too.

Deborah Fowler Sterile Services Technician NZSSA Conference Scholarship Recipient 2019 S U P P LY L I N E – D E C E M B E R 2 0 1 9

EVENT SAVE A DATE

46th NZSSA ANNUAL CONFERENCE 22 – 24 September 2021 Building for the future

VACANCIES Capital & Coast District Health Board, Wellington Sterile Services Manager - closes 18 May 2020 Capital & Coast District Health Board is seeking a new manager for their busy sterile services department. If you are interested click on this link: STERILE SERVICES MANAGER at CCDHB

Bay of Plenty District Health Board, Tauranga Sterile Supply Technician - 0.8FTE - closes 20 May 2020 Bay of Plenty District Health Board is looking for a part-time sterile supply technician to be based at Tauranga Hospital. The role is being advertised on seek.

If you are interested click on this link:

BOPDHB Sterile Supply Technician https://www.seek.co.nz/job/41305241

the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

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MAIN ARTICLES | Performance Test for Sealing Capability of Rigid Container

Original Article

Corresponding author*: Samuel Tat Hong Law (B.S.) Zentralsterilisation Tuen Mun Hospital und Pok Oi Hospital Hongkong lawth@netvigator.com ª Central Sterile Supplies Department, Tuen Mun Hospital, Hong Kong b Central Sterile Supplies Department, Pok Oi Hospital, Hong Kong

Conflict of interest: All authors confirm that there is no conflict of interest according to the guidelines of the International Committee of Medical Journal editors (ICMJE).

Performance Test for Sealing Capability of Rigid Containers in Central Sterile Supply Departments in Tuen Mun Hospital and Pok Oi Hospital in Hong Kong S. T. H. Lawab*, C. K. Leeab, W. C. Yeungb, N. L. Mokb, W. K. Tangb, W. S. Nga, K. W. Cheunga, C. T. Tanga, S. Y. Yipa, Y. M. Chua

Abstract: Rigid sterilization containers are designed as a sterile barrier system to preserve the sterility of the enclosed contents. Although they are claimed to have a lengthy life span, it is a concern the sealing capability along the gasket seal because wear and tear may compromise the sealing capability. Container manufacturer recommends checking the container cover and the container by naked eye in between the packing process. Considering that visual inspection alone can never effectively check the performance of the sterile barrier system, this study aims at exploring the practical approach to validate the sealing capability of the sterilization container from a clinical user perspective.

30 new containers were served as conKeywords Validation of container Performance qualification Sterilization container Sealing capability Smoke test

Citation: Law STH, Lee CK, Yeung WC, Mok NL, Tang WK, Ng WS, Cheung KW, Tang CT, Yip SY, Chu YM. Performance Test for Sealing Capability of Rigid Container in Central Sterile Supplies Department in Tuen Mun Hospital and Pok Oi Hospital in Hong Kong. Zentr Steril 2019; 27 (5): 316–324

Manuscript data: Submitted: 6 June 2019 Revised version accepted: 29 August 2019 316 8

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Zentralsterilization | Volume 27 | 5/2019

trol group while 1826 in use containers of different sizes and years of usage were examined in the Central Sterile Supplies Departments (CSSD) of Tuen Mun Hospital (TMH) and Pok Oi Hospital (POH) in Hong Kong. Smoke test was developed to evaluate the sealing capability of these containers with the aid of a smoke gun. At the same time, paper test and water leakage test were conducted for a comparative purpose. It was found that the three methods generated a different pass and fail level.

Overall failure rate for smoke test was recorded ranging from 2.3% to 6.37%.

Besides, the containers with usage over

11 years generated a higher fail rate in comparing with those using within 7 years. It is crucial that this study identified a standard method to measure the sealing capability of a container. Our study shows that the smoke test can serve as a supplement to validate the sealing capability of container as it can simulate the airborne transmission and the result is not affected by the external force and gravity.

1. Introduction Surgical site infections (SSIs) are one of the most common hospital-associated infections (HAI) worldwide. They have been shown to increase the morbidity and mortality for patient undergone surgery, and bring additional economic burden on our healthcare system [1].

A key strategy for reducing such infections during an operation is to provide the medical devices that are free of viable microorganisms at the point of use.

To maintain the sterility of these devices, sterilization in conjunction with an aseptic packaging system is paramount [2-3].

Nowadays, rigid sterilization container is one of the best sterile barrier systems to maintain the sterility of surgical instruments and medical devices after steam sterilization. This system was marketed for more than 30 years with a variety of designs, mechanics and construction materials. But even so, all kinds of sterilization container systems are used for essentially the same purposes - to preserve the sterility of the enclosed contents, protect them from physical damage and eliminate tears or punctures associated with other packaging systems [4-5].

A rigid sterilization container typically has a filter mechanism which allows sterilant to enter and exit the conS U P P LY L I N E – D E C E M B E R 2 0 1 9

tainer during sterilization process and inhibit the contamination of the sterilized contents thereafter [6]. Apart from the filter retention system, the gasket also plays a vital role in preventing the airborne transmission of microorganisms and dirt, until the container is opened at the point of use. When the container is closed and latched, the lid gasket is compressed. Contact pressure between the gasket and the flanges will create a tight seal between the lid and the container bottom [7].

Although containers are claimed to have a long life span, their exact performance may be compromised for various reasons. For example, mismatched lids and bottoms may form gaps; wear and tear may reduce the capability of gasket to maintain a proper seal; the aging of the silicone seal may loss the elasticity of the seal; any single incident occurred during repeated reprocessing may cause the flange to become distorted or the latch to become loosened. It has been suggested that inspection and testing should be performed on a regular basis to evaluate the sealing capability of sterilization containers; however, it can be challenging and has been a focus of discussion in the literature for many years [8].

Standards and recommended practices were established to provide guidelines on how to examine the integrity of packaging systems via the visual inspection [9-12]. However, whether the visual checks of sterilization containers are sufficient to evaluate their functionality remains questioned. Dunkelberg and Fleitmann conducted a study to examine the microbial barrier effectiveness of sterilization containers from various hospitals in Germany [13]. It was found that holes and cracks in containers could be as small as 80µm. Given the fact that the smallest object identified by human eye is about 100µm, one cannot assume that passing the visual inspection can guarantee a perfect sterile barrier system.

Water leakage test could be performed to assess whether water inside the sterilization container would leak through the gasket seal [14]. In addition, the dollar bill seal check was proposed to evaluate the pull-out resistance of a piece of paper between the seal and the container [15]. It is a known function test which was initiated to check the door seals in real life.

2. Background Although the container manufacturer claimed that the container could be used for over 10-15 years, the end of a container’s service life depends much on its degree of damage and wear.

Therefore, validation the sealing capability of the container is of paramount importance to ensure the proper seal between the lid and the bottom. Ultimately, patient safety can be assured.

With reference to the manufacturer’s guideline, the critical parts of the containers are examined during each reprocessing cycle. However, it is difficult to detect the sealing incapability based on the visual inspection alone.

In Hong Kong, hospital services are delivered among seven clusters in order to streamline the hospital services within the same geographical region. A cluster CSSD manager has to manage the sterilization services within the same cluster. In the New Territories West Cluster (NTWC), the principal investigator of this study was a cluster CSSD manager who had to manage three CSSDs in 3 cluster hospitals.

As the CSSD of Pok Oi Hospital (POH) and CSSD of Tuen Mun Hospital (TMH) within NTWC involved in this study have been intensively using the sterilization container as the sterile barrier system since 2007 and 2011 respectively, it is necessary to develop a standard method to standardize the validation process of the container system in use.

In accordance with Clause 4.4.2 of ISO 11607 Part 1, it stipulates the requirement of validation test on packaging system. These includes the establishment of a rationale for the selection of the appropriate tests for the packaging system; the establishment of acceptance criteria; the determination of test method repeatability; the determination of test method reproducibility; and the establishment of test method sensitivity for integrity tests. In March 2018, TMH CSSD and POH CSSD developed a smoke test to assess 1187 containers of different sizes and years of usage. Simultaneously, paper test and water leakage test were also conducted for comparison. The study was completed by the end of August 2018 and over 65% of in use containers in both CSSDs were undergone these performance tests. This container performance test was conducted from 14 March 2018 to 31 August 2018. After the first test

the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

phase, we had to focus on the smoke test alone in order to check the remaining 35% containers to assure the integrity of the all in use containers. The second phase of the study was completed in February 2019.

3. Description of the Sterilization Containers’ Reprocessing Cycle Similar to the surgical instruments, sterilization containers would undergo reprocessing cycle once the soiled sets are returned to CSSD after use. To begin with, the containers are placed in washer-disinfector for cleaning and thermal disinfection. Detergent with a neutral pH is used, and the containers are thermally disinfected with an A0 value of at least 600. After drying, the containers can be used again for the assembly of medical devices. After inspection, assembling and packaging (IAP), the containers are subjected to 134ºC moist heat sterilization for 3.5 minutes.

Finally, all containers are kept in the sterile store with the controlled temperature within 18°C to 22°C and the relative humidity within 30% to 70% in accordance to the Hong Kong guidelines until the point of use.

4. Methodology 4.1 Sterilization Containers Investigated

In TMH CSSD and POH CSSD, sterilization container system is the major sterile barrier system for steam sterilization of the surgical instrument and medical devices. Aesculap® sterilization containers have long been using to hold and protect these surgical instruments for over years. As shown in Figure 1, each of them consists of a solid aluminum base and a polymerplastic lid with a pair of latches for locking. The lid is equipped with one or two filter retention plates, depending on the size of the sterilization container. Polytetrafluorethylene (PTFE) reusable filters are locked in place to act as a microbial barrier. To enhance the traceability of instrument sets, a unique identifying system was adopted in these two hospitals separately as shown in Figure 2. A specific instrument code was assigned to each container lid and its base such that the same parts could be paired up and reassembled the original configuration after every decontamination process, and the number of reprocessing cycles could be recorded by a computerized tracking and tracing system.

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MAIN ARTICLES | Performance Test for Sealing Capability of Rigid Container

Details of the tested sterilization containers are listed in Table 1. In this study, 1187 containers of different sizes and years of usage were withdrawn routinely from IAP Room for examination from March 2018 until the end of August 2018. The tested containers were recorded using their unique identity codes to prevent duplication of test. In addition, 30 new containers of the same brand were served as controls such that a total of 1217 containers were examined.

All tests were performed on the empty sterilization containers and carried out in IAP Room of CSSD. The temperature and relative humidity of IAP Room was controlled at 18°C to 22°C and 30% to 70% respectively in accordance with the “Hong Kong Guidelines on Disinfection and Sterilization of Reusable Medical Devices for Operating Theatre” and the particulate level was meeting the standard of ISO Class 8 standard in BS EN ISO 14644-1.

4.2 Smoke Test

If the gasket of the container cannot be properly sealed, dirt or fine suspended particulates may enter the container

when there is pressure difference inside and outside the container. To simulate the movement of fine suspended particulates, smoke can be used to validate the sealing capability of sterilization container with the use of a commonly found device. In this study, an air flow indicator, smoke gun, from Drager (Model: 6400761), which was originally used for checking the air flow between adjacent room by infection control team, was adopted as a tool to generate the artificial smoke for testing the sealing capability of the containers. It was used as a leak detection device to check the airflow outside the gasket. When the air flow indicator was turned on, it created heat and activated the enclosed ampoule. The ampoule contains a fluid that was a special mixture of alcohol; smoke generated by smoke gun floated freely and easily as it had the same density as ambient air. As shown in Figure 3, the air flow indicator was placed at the center of the container base and switched on to produce a continuous cloud. Smoke generation time per ampoule is approximately 3 minutes; if the

Figure 1: Aesculap® sterilization containers in different sizes

sealing capability of the container was compromised, slight air current would transmit through the sealing area and leaks could easily be identified.

Prior to the smoke test, a preliminary study was conducted in both CSSDs aiming at determining the standard holding time for the smoke circulating inside different sizes of the sterilization containers. The schematic diagram of artificial smoke test is shown in Figure 4. After the lid was closed and latched, the testing personnel with a stopped watch would detect if there was any leak of the smoke around the container and the lid. Contrasting background was arranged so that the smoke could be identified clearly. In most of the cases, smoke could be seen after 5 seconds for those failure containers. To have a more accurate result, the measuring time was prolonged to 60 seconds for evaluating the standard holding time. The result would be regarded as pass if no leakage of smoke was observed. Of-course, smoke coming out from the gasket of a

Figure 2: The lid and bottom with the unique identifier

Table 1: Details of the tested sterilization containers

Size

Outside Dimension (L × W × H, mm)

No. of new container (As controls)

Small

300 × 274 × 135

Medium

TMH within 7 years of usage

POH over 11 years of usage

7

364

199

470 × 274 × 135

7

373

198

Large

592 × 274 × 135

8

267

322

Extra large

592 × 274 × 187

8

84

19

30

1088

738

Total 318 10

No. of in use container

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Figure 3: Activated air flow indicator in the sterilization container

Figure 4: The schematic diagram of artificial smoke test

Table 2: Circulating time for smoke test.

Figure 5: Paper test performed on a sterilization container

Size

Holding Time

Small

10 seconds

Medium

16 seconds

Large

21 seconds

Extra large

39 seconds

Table 3: Water level and the corresponding water volume for water leakage test.

Figure 6: Water leakage test performed on a sterilization container

Size

Water Level

Water Volume

Small

5mm

300ML

Medium

5mm

500ML

Large

5mm

650ML

Extra large

5mm

650ML

container would be regarded as fail. Finally, a standard holding time table for different sizes of containers was listed in Table 2.

In addition to the smoke test, paper test and water leakage test were also conducted which would be discussed in the next section as comparison to assess the sealing capability of sterilization containers.

the base and the latches were closed, leaving half of the paper outside the sealed container. As shown in Figure 5, the A4 paper was lifted to a height that allowed the container to hang freely. Any movement of the folded paper would be regarded as a failure of the paper test. The same procedure was used to test along the entire length of the seal.

4.3 Paper Test

4.4 Water Leakage Test

Paper test was conducted with reference to the Dollar Bill method. A sheet of 80 gsm A4 paper was placed halfway across one side of the container base. The lid was then attached to

With reference to the Association Franรงaise de Normalisation (AFNOR) test protocol FDS 98-053 published by a French standardization organization, water leakage test was designed to per-

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form on the sterilization containers to assess the intact sealing of the container system. Water was poured into the container to reach a height of 5 mm water level. Subsequently, the lid was closed and latched. As illustrated in Figure 6, the container was placed on one side for 30 seconds over an absorbent paper for the observation of water leakage. The container would consider to have passed if no leakage was observed.

In contrast, any leakage from the gasket would be regarded as a failure. Water level and the corresponding water volume for the test were listed in Table 3, the same procedure was used to test all four sides of container.

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4.5 Smoke Test (Second Phase)

During the period from March 2018 to August 2018, 1187 in use containers out of 1826 containers from both CSSDs were tested and the testing rates in TMH CSSD and POH CSSD were 61.67% and 69.92% respectively. The result of the first phase demonstrated that the smoke test failure rates for the containers with 7 years usage and containers with 11

years usage were 1.94% and 7.2% respectively. As most of the container sets without testing were less frequently used, it was necessary to kick off the second phase of the smoke test so that all containers in both CSSDs were validated. In the second phase of the study, we only concentrated our effort to perform the smoke test without paper test and

water leak test starting from September, 2018. We needed to get the infrequently used sterilized container sets from the shelf for testing and we had to re-sterilize the sets after testing. Finally, by the end of February 2019, we achieved 100% testing all in use container sets in order to assure the sealing capability of the containers in both CSSDs.

Table 4: Test equipment Equipment

Function Flow Check Air flow Indicator(Smoke Gun) (Brand: Drager, Model: 6400761)

Drager Flow Check produces a cloud of harmless smoke that floats freely and easily because it has the same density as ambient air.

Consequently, slight air currents become visible to easily identify leaks and test the integrity of air-tight systems.

The device consists of an instrument for producing clouds and an ampoule containing smoke generating fluid. The ampoule contains a fluid that is a special mixture of alcohol developed at Drager Flow Check. A small heating element in the head of the instrument heats the fluid which condenses when contacting with ambient air.

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Ampoules (special mixture of higher alcohols)

An alcohol mixture contains smoke generating fluid that is harmless to the environment.

Timer

To count the circulating time.

Pressure Sensor (Brand: Ebro Model : EBI 10-TP230)

A pressure sensor measures the pressure change inside a container from the 2nd floor to the 13th floor in TMH.

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Table 5: Pass-fail results obtained in the three tests In Use Containers Research CSSD

TMH CSSD

POH CSSD

Years of usage

Within 7 years

Over 11 years

Control Both CSSD

TMH CSSD 0 year

Overall Smoke Test (From March 2018 to February 2019) Container Tested

1088 out of 1088 (100%)

738 out of 738 (100%)

1826 out of 1826 (100%)

30

Pass

1063 (97.7%)

691 (93.63%)

1754 (96.06%)

30 (100%)

Fail

25 (2.3%)

47 (6.37%)

72 (3.94%)

0

671 out of 1088 (61.67%)

516 out of 738 (69.92%)

1187 out of 1826 (65%)

30

Pass

658 (98.06%)

479 (92.8%)

1,137 (95.79%)

30 (100%)

Fail

13 (1.94%)

37 (7.2%)

50 (4.21%)

Pass

631 (94.04%)

327 (63.37%)

958 (80.71%)

30 (100%)

Fail

40 (5.96%)

189 (36.63%)

229 (19.29%)

0 (0%)

Pass

353 (52.61%)

208 (40.31%)

561 (47.26%)

22 (73.33%)

Fail

318 (47.39%)

308 (59.69%)

626 (52.74%)

8 (26.67%)

First Test Phase (From March 2018 to August 2018) Container Tested Smoke Test

Paper Test

Water Leakage Test

4.6 Experimental Personnel

10 frontline staff were recruited to conduct the experiment. Training and guidance were provided to ensure the strict compliance. In addition, re-demonstration assessment was conducted prior to the study, in order to make sure that all testing personnel demonstrated competency in performing the three tests.

4.7 Experimental Time

Time required to perform the paper test, water leakage test and smoke test were 20 - 30 seconds, 2.5 minutes and 10 -39 seconds respectively. In fact, the actual required time for the three tests depended on their testing methods as described in section 4.2-4.4. Normally, all the three tests could be finished within five minutes for each container.

4.8 Experimental Cost

For the research study, we have purchased four smoke guns, 400 ampoules of mixture, and four reams of paper for completion of all the tests. The unit cost of the aforesaid items were HK$6237, HK$100 and HK$35 respectively. The total consumable and equipment cost for the research study was HK$65,088.

Excluding the reusable smoke gun, the consumables cost for each container was HK$21.6.

4.9 Test Equipment

Equipment used in this study was illustrated in Table 4.

5. Results and Discussion In the first test phase, the pass and fail results obtained in the smoke test, pa-

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per test and water leakage test are listed in Table 5. In TMH CSSD, 1088 containers are currently in use. 671 of them had undergone smoke test, paper test and water test. In POH CSSD, 738 containers are currently in use while 516 of them had undergone smoke test, paper test and water test. The tested container rates in TMH CSSD and POH CSSD are 61.67% and 69.92% respectively. Not all containers in the CSSD POH and CSSD TMH have undergone the three tests as some of the container sets have been put on standby while some others are in use in the Operating Theatre.

Comparing the pass and fail results generated by the in use containers with different years of usage, the containers with over 11 years of usage generated a higher fail rate as compare to those

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within 7 years of usage. It indicated that the container sets underwent a lot of wear and tear; it is essential for the clinical user to build up a practical and hands-on test to evaluate the sealing capability.

In examining the overall testing performance, three tests were performed on the same containers. Among the three methods, it was found that different testing methods generated a different pass and fail level. Failure rates were recorded ranging from 1.94% to 59.69%. It proved the importance of using an established standard testing method to measure the sealing capability.

In daily operation routine, all of the frontline staffs were instructed to examine the containers during each reprocessing cycle according to the guideline provided by the container manufacturer. As such, all of the containers withdrawn from IAP room had passed the visual inspection. However, it was found that certain containers failed in paper test, water leakage test and smoke test at the same time. It indicated that the visual inspection was not sufficient to check the integrity of container in clinical practice. During the visual inspection, it was not easy to spot out tiny cracks on the gasket and distorted flange even with the magnifying accessories. Not to mention the human mistakes as the defect might be overlooked.

For the control test, all new container sets were assumed with good sealing capability and the three types of tests were expected to generate the pass results. By reviewing the actual pass and fail rate in the table above, pass results were shown in paper test and smoke test but fail result was obtained in water leakage test. In the control test, 8 out of 30 new containers were failed in the water leakage test. It is believed that the gasket itself in the water leakage test was subjected to a side load due to the internal water pressure. Leakage of water was induced by its weight, and this test was evaluating the water tightness but not the air tightness. From the overall research result, more than half of the tested containers were failed in the water leakage test. Therefore, result generated from the water leakage test was affected by the gravity and the testing result might be over-estimated.

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The water leakage test did not simulate the air leakage in real situation.

An average failure rate of 19.29% was recorded when the containers were subjected to paper test. However, the paper test has some limitations as the result of the paper test is influenced by several external factors. Firstly, the paper test cannot cover the corners of the containers. Some blind spots cannot be tested and the paper test is not good enough to examine the integrity of the seal. Secondly, the force applied to test the seal depends greatly on the weight of the containers. As a result, containers in extra-large size may have a higher tendency to generate a fail result. Thirdly, the weight as a force to test the container may be inadequate.

Even if the paper cannot be pulled out between the lid and container base, it

container, the higher the force exerting on the gasket. Therefore, the paper test cannot provide an air flow environment to simulate the airborne transmission in real situation.

Under normal storage condition in the sterile store, there should not be any change of pressure inside or outside a container. Hence, there should not be any air going in and coming out from a container. However the pressure stability may vary by the environmental changes such as the mal-functioning of air condition system in the sterile store or the change of altitude during transportation of container. If there is any gap along the gasket, the dirt and air may enter into a container through the improperly sealed gasket instead of routing through the bacterial retentive filter.

Figure 7: Picture captured during the smoke test only indicates that the static friction among the gasket, paper and edge of the container is equal to or greater than the weight of container. The rougher surface of gasket, paper and the container edge are, the greater the static friction would be generated. As a result, motion is resisted when they are sliding past each other. In addition to this, with a paper in between, it is impossible to evaluate whether the gasket is able to flow into any irregularities in the flange. The paper test result was affected by the weight of the different sizes of container. The bigger the size of

To illustrate the potential risk of air exchange through the gasket during the transportation of container system among different altitudes, another study by using a data-logger to measure the pressure changes between different floors was conducted in TMH as shown in Appendix I. It was found that there was more than 5 mbar pressure difference between the 2nd floor against the 13th floor. The lower floors had higher pressure whereas higher floors had lower pressure. Driven by the pressure difference between different floors, there is a risk that the airborne microS U P P LY L I N E – D E C E M B E R 2 0 1 9

organisms and contaminates may enter through the crack and pinholes of the sterilized containers when transporting the sterilized surgical instrument from higher altitude to lower altitude.

To simulate the similar phenomenon of air leakage from in use container system, the artificial smoke test adopted in this study acts as an air flow indicator to simulate the airborne transmission. If the smoke cannot come out from the sealed container, no microorganism or dust can go inside the sterilized containers. As shown in Figure 7, smoke was easily recognized during the test; the smoke test has an advantage to become more detectable.

By reviewing the actual pass and fail rate, the smoke test generated the lowest fail rate among the three testing methods. However, it does not indicate that this method has the lowest sensitivity to detect the seal failure as no external force is affecting the results like the paper test and water leakage test do. It is believed that the artificial smoke test can serve as a supplement to detect the sealing capability in the container system.

Some sterilization containers are designed without the bacterial filter such as the microStop® sterilization containers from KLS Martin Group. The sterile barrier of this type of container is a flow inhibition system based on a principle discovered by Louis Pasteur [16]. The smoke will become condensate during the filtering process, so the smoke test cannot detect the smoke leak even with the container leakage. Therefore, the application of smoke test to this type of container is not suitable, and the alternative validation method should be de-

veloped to test the sealing performance of this system.

In the research study, we focused on testing the containers with reusable filter as we have been using the same kind of container system in both CSSDs. For the container with single-use filter, we borrowed five containers with different types of single-use filter from other departments to perform the smoke test.

We found that some smoke would come out from the paper filter or non-woven filter but it would not affect the principle of the smoke test in validating the sealing capability of the gasket. However, it would be necessary to develop a new set of holding time for different types of single-use filters as the amount of smoke generated inside the container might require to increase in order to test whether there was any leakage from the container gasket.

6 Recommendation and Conclusion With nearly one-year research study and joint effort from staff of both CSSDs, all the 1826 in use containers were tested. This study shows that testing other than the visual inspection should be added as a component to validate the functionality of a new and in use containers in future. Considering that the visual inspection alone cannot effectively evaluate the container’s sealing capability, this paper introduces smoke test as a method of choice to validate the sealing performance of in use containers in CSSD. Owing to the limitation of the smoke test and experiment equipment in the hospital setting, a more precise study on the biological aspect to validate the reliability of the smoke test is also rec-

ommended in the future. All failure containers have been sent back to the manufacturer for repair. There was no smoke leakage from these containers after repair.

According to the research result in this paper, the smoke test should be adopted at regular interval as a performance qualification for validating the sealing capability of the container.

Since there is significant failure rate of 2.3% for 7-year in use containers, it is highly recommended changing the silicone gasket routinely less than every 7 years. Given the fact that silicone’s physical properties are adversely affected by prolonged exposure to high temperature during steam sterilization, the life expectancy of silicone gasket should be considered as a risk factor affecting the sealing capability of container. According to ISO 17664:2017 of “Processing of health Care products – Information to be provided by the medical device manufacturer for the processing of medical devices”, container manufacturer should provide information to user how frequent the container gasket should be changed and they should also provide the gasket exchange services to the users.

In addition, centralization of sterilization services within a large catchment area is very common nowadays that sterile goods require lengthy transportation distance. Further study on the risk of transferring the sterile containers especially with different altitudes is also recommended to identify the potential hazard as the variance in pressure gradient with different altitudes might induce air coming out and going into the container center through the sterile barrier system.

This is the first attempt in Hong Kong CSSD to investigate the sealing capability of the container in clinical setting.

We hope that it will provide an overview of the clinical considerations related to the use of the reusable rigid sterilization containers as a sterile barrier system for medical devices. In the future, more studies and discussions are expected.

References

Appendix I: Air Pressure Difference between different floors after inserting smoke gun in the container system, Pressure difference between 13/F to 2/F the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

[1] Ignatavicius DD, Workman LM, Rebar CR, LaCharity LA, Kumagai CK: Study guide for medical-surgical nursing: Concepts for interprofessional collaborative care. St. Louis, MO: Elsevier 2018.

[2] Luebbert PP: How do you know if your sterilized instruments remain sterile?

Retrieved from https://pdfs.semantic-

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[3]

[4]

[5]

[6]

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scholar.org/presentation/91ff/5aa8d84cd6839be92d6aabed565c168caa92. pdf, 2016.

Dancer SJ, Stewart M, Coulombe C, Gregori A, Virdi M: Surgical site infections linked to contaminated surgical instruments. Journal of Hospital Infection, 2012; 81(4), 231–238.

Kneedler JA, Moss R, Spear JM, Whalen MT: All you need to know about rigid sterilization containers. Retrieved from https:// www.pfiedler.com/ce/1270/files/assets/ common/downloads/All%20You%20 Need%20to%20Know%20About%20 Rigid%20Sterilization%20Containers.pdf Rigid sterilization containers in the OR. Practice Greenhealth 2011. Retrieved from: https://practicegreenhealth.org/ sites/default/files/upload-files/gorimpmod-rigidsterilcont_r5_web_0.pdf Recommended practices for selection and use of packaging systems for sterilization.

AORN Journal 2007; 85(4), 801–812.

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[7] Guidelines for safe seal usage – flanges and gaskets, ESA 009/98, European Sealing Association, 1998.

[8] Seavey R: Packaging for sterilization.

Managing Infection Control 2008; 8:82–97.

[9] Recommended Practices for Maintaining a Sterile Field. AORN Journal 2006; 83(2), 402–416.

[10] ISO 11607-1:2006, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems.

[11] ASTM F1886, Standard test method for determining integrity of seals for flexible packaging by visual inspection, ASTM International, West Conshohocken, PA, 2016, www.astm.org.

[12] BS EN 868-8:2009, Packaging for terminally sterilized medical devices.

Re-usable sterilization containers for steam sterilizers conforming to EN 285.

Requirements and test methods.

[13] Dunkelberg H, Glende F: Measurement of the microbial barrier effectiveness of sterilization containers in terms of the log reduction value for prevention of nosocomial infections. AJIC: American Journal of Infection Control 2006; 34(5), 285–289.

[14] Leak test demo. Halyard Health. Retrieved from: https://www.halyardhealth.com/media/276877/Rigid-Container-Leak-Test-Demo.pdf, 2016.

[15] Are my ridig contaienrs maintaining sterility? Halyard Health. Retrieved from: https://www.halyardhealth.com/ media/233195/are-your-rigid-containers-maintaining-sterility.pdf [16] microStop® sterilization containers.

KLS Martin Group. Retrieved from: https://www.klsmartin.com/en/products/sterilization-containers/microstop/

S U P P LY L I N E – D E C E M B E R 2 0 1 9

World Congress 2019 – The Hague, Nederland I was one of the two fortunate candidates who won a scholarship to the World Congress 2019 which was held in The Hague, The Nederlands. Kim Edmonds from Christchurch joined Shelagh Thomas, manager CSSD HVDHB and myself as representatives from NZSSA. In The Hague each Morning at breakfast time was our team discussion time. There onwards we attended presentation/talks together, and split during break times to investigate what we could learn and bring back from the various company stalls around the conference hall.

The congress was held in the “World Forum” which was a huge and beautiful building. It was big enough to accommodate around 1700 candidates from around 75 countries. While the speakers were delivering their speeches we the participants could forward our questions via internet direct to the speakers. I found this was interesting as we did not have to stand up and ask questions.

The first session was about Flexible scopes. As they pointed out there were two e-coli outbreaks in the Nederland’s and they were due to incorrect reprocessing of Endoscopes; not using correct brushes and not positioning Endoscopes correctly. Pentax, Fuji and Olympus Endoscopes were related with these outbreaks.

In all, it was pointed out that there were two two main causes for the contamination and these were, difficulty in re-processing and human error. Suggested solutions for this was “improved quality assurance”.

In the Nederland’s they recycle used stainless steel instruments and make metal baskets etc. Perhaps we as a country need to look at such options for minimising our footprint.

It was heartening to learn that we are all in one universal belief when it comes to the key areas of sterile sciences.

Most importantly we all agree on improved patient safety comes through correct re-processing practices and quality management systems etc.

For all the Sterile Services educators in NZ, you can reference” education” via the website for WFHSS for useful educational material.

There was a huge amount to learn at this conference.

Personally for me, this was a lifelong experience to attend such a prestigious world class event.

On a personal note, The Nederlands is a very beautiful country and the people are very friendly. My trip ended on a very high note with having taken time off work to travel through some of the beautiful cities around Europe.

I thank the NZSSA for this opportunity given to me. I also, appreciate the support given to me by my manager, Shelagh Thomas, and the CSSD team.

Shenal Senanayake Sterile Technician, CSSD, HVDHB

In the same line, some of the speakers were emphasising on “quality management” as well as stressing the need to take IFUs in re-processing very seriously. Also, there is a lot of work being undertaken in designing single use Endoscope tips which will shall be introduced soon.

One speaker emphasised on negative effects on modifying instruments.

Then there was a talk on instrument corrosion. To minimise corrosion the following methods were suggested for use in practice.

Correct reprocessing practices, oiling of instruments when possible, proper water/steam quality, thorough inspection of instruments and instruments to be repaired by qualified personal. There were lengthy discussions on the importance of visual inspection and the use of visualisation scopes for lumened instruments.

Two speakers from the Nederland’s were explaining about the impact on CO2 emission from hospital waste.

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The Risk of Infection via Surfaces and the new Coronavirus Many of our customers are concerned over the risks of transmission arising from people who may have contracted the new Coronavirus (COVID 2019).

Their concerns focus on hand hygiene and risks via a contaminated surface? Many viruses cannot live for long outside the human or animal host, whereas other viruses can and do survive for prolonged periods on contaminated surfaces. From all reports, COVID 2019 sits somewhere in the middle of the risk zone. Coronaviruses can survive on a contaminated surface for several days, and needs to be removed from the surface, and not just killed in-situ.

Whilst the case fatality rate for this COVID 2019 appears to lower than for say the SARS Virus (another Coronavirus), the infectivity appears to be higher with far more people confirmed as infected. There does appear to be some evidence that spread of the COVID 2019 virus does include contaminated surfaces in addition to the risks of inhaled aerosolised droplets.

Whiteley Corporation has conducted a huge number of disinfectant tests against a wide array of infectious viruses over the past thirty years. There are some important things to note about Coronaviruses with respect to disinfectants, and also with respect to cleaning and surface hygiene.

Firstly, the Coronaviruses are enveloped viruses, and typically these viruses are not terribly difficult to kill on a surface. There is a tendency, amidst widespread concern with the possibility of a new pandemic, to go for the strongest disinfectant conceivable for the purpose of surface disinfection. With a hard to kill virus, or with a micro-organism with greater morbidity and mortality, this is probably warranted, but for this particular virus (COVID 2019) that may be an inappropriate overreaction that introduces other risks such as toxicity and materials incompatibility.

Of course, if you want a stronger disinfectant, with full VIRUCIDAL claims, then we have several available for surface disinfection. SURFEX® [ARTG No: 257360] is our ‘go-to’ top of the line Hospital Grade Disinfectant

product, and is proven to be Viricidal, Bactericidal, Fungicidal, and Sporicidal.

However, in the normal course of events, where surface contamination is a concern, but not a confirmed risk, then normal Transmission Precautions (see the NHMRC 2019 Guidelines), using a compatible Hospital Grade Disinfectant and wipe should be sufficient to ensure a clean and disinfected surface. Getting the context right includes not to destroying surfaces or staff with unnecessarily strong disinfectants such as highly concentrated chlorine solutions where a commonly available and safe to use alternative would be acceptable.

We recommend using a Hospital Grade Disinfectant with TGA registration and a compatible wiping system for most Transmission Precautions requirements.

VIRACLEAN® [AUST L: 69000] and V-Wipes [AUST L: 160901] are a suitable, proven and ready to use option for normal use with most Transmission Precautions situations. Published evidence has demonstrated that Viraclean® is preferred to chlorinated disinfectants and through better use provides a superior cleaning and disinfecting outcome within healthcare settings1.

Work funded by Whiteley Corporation has shown that once on surfaces, microorganisms can be transmitted to many other surfaces via contaminated hands and fingers. It is therefore essential, that appropriate Hand Hygiene compliance is maintained. Typically, the best option is to use a TGA registered alcohol-based hand rub (ABHR), which should be used in compliance with the 5 Moments of Hand Hygiene, or after touching any potentially contaminated surface. We recommend BACTOL® Alcohol Gel [AUST R 155397].

So, the simple conclusion for concerns over surfaces that could be contaminated with Coronavirus, is to clean and disinfect with a TGA approved Hospital Grade Disinfectant, and then remove the residue with a compatible disinfectant wipe. You should always use appropriate PPE and cleanse your hands regularly with a TGA approved alcohol-based hand rub. Following these simple guidelines will keep your surfaces clean and safe, and your hands free from nasty infectious germs such as bacteria, and the Coronavirus.

Dr Greg S Whiteley Executive Chairman PhD, M Safety Sc, B App Sc, Dip AICD FEHA, MASM, FSHEA 1: Friedman et al., ‘The effectiveness of a single-stage versus traditional three-staged protocol of hospital disinfection at eradicating vancomycin-resistant Enterococci from frequently touched surfaces.’ Am J Infect Control: 2013:41:227-231

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TOI-OHOMAI

Institute of Technology

Enrolments Open For Trimester 2 Upgrade your CV, knowledge and skills Prepare to be a leader in the industry Enrol in the NZ Diploma in Sterilising Technology

You could be eligible for fees free study.

Visit feesfreegovt.nz to find out more.

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And People Stayed Home This poem has been shared on social media as purportedly penned by Kathleen O’Mara in 1869 and then rereleased in 1919 and again now. The poem is actually penned by Kitty O’Meara of Wisconsin, a former teacher and chaplin last month. (Women You Should Know, 2020) I felt it was worth including in this edition as it captures our time and offers a moment of reflection.

If interested this link takes you to more information. https://womenyoushouldknow.net/fact-people-stayed-home-viral-poem-kitty-omeara-2020/

AND PEOPLE STAYED HOME by Kitty O’Meara, 2020 And the people stayed home.

And read books, and listened, and rested, and exercised, and made art, and played games, and learned new ways of being, and were still.

And listened more deeply.

Some meditated, some prayed, some danced.

Some met their shadows.

And the people began to think differently.

And the people healed.

And, in the absence of people living in ignorant, dangerous, mindless, and heartless ways, the earth began to heal.

And when the danger passed, and the people joined together again, they grieved their losses, and made new choices, and dreamed new images, and created new ways to live and heal the earth fully, as they had been healed.

NZSSA Sponsored Education Sessions 2020 Due to COVID-19 the NZSSA has suspended all education meetings until further notice. The Executive will look at other avenues for providing education. This will be dependant on how the current situation evolves and the capacity of the Executive members to organise and facilitate alternative education options. Please bear with us during this difficult time.

NZSSA ANNUAL CONFERENCE 2020 - CANCELLED

BUT WAIT NZSSA ANNUAL CONFERENCE 2021 planning is underway!

22 - 24 SEPTEMBER 2021, Christchurch Print off the Save a Date in this edition and start planning!

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The NZSSA library Librarian: Sue Woods, Manager, Burwood Hospital, Email: sue.woods@cdhb.health.nz

The NZSSA library has a range of videos, DVDs, books, guidelines and standards available to members of the Association. Some items can be borrowed others such as standards cannot be lent but the information is available.

AVAILABLE FOR BORROWING:

VIDEOS

• Sterilization – A view for insiders • Old Dogs & New Tricks – Royal Australasian College of Surgeons

DVDs

• Sterilization – A view for insiders • Old Dogs & New Tricks - Royal Australasian College of Surgeons • Manual Handling

BOOKS

• Introduction to sterilization & disinfection – Joan F Gardner & Margaret M Peel.

Publisher: Churchill Livingstone 1986

• The Becton, Dickinson Lectures on sterilization – The curriculum in Bacteriology at Seton Hall College of Medicine & Dentistry. Presented during the academic years 1957 – 1959

• EO Training manual – Mermed Australia Pty Ltd 1992

STANDARDS AND GUIDELINES Not available for borrowing but Librarian can provide information In addition to AS/NZS 4187:2014 +A1 & A2 – Reprocessing of reusable medical devices in health service organisations the NZSSA library has the full suite of normative reference standards as listed in AS/NZS 4187, Section 1, Clause 1.3 Normative References.

While the document is not able to be lent due to copyright, the librarian is very happy to provide information contained in the standards to answer any question you have.

Just email Sue and ask for assistance!

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NZSSA Sponsored Scholarships The New Zealand Sterile Sciences Association (NZSSA) is committed to providing education opportunities to its members in as many formats as possible to grow knowledge and skills in the field of sterile sciences in New Zealand. This is with the aspiration of growing our leaders of the future.

Scholarships available in 2020: Tertiary Education: close 30 May for Trimester 2

This education scholarship is being provided to enable up to two members per calendar year to develop knowledge associated directly with reprocessing of reusable medical devices and the environment this is carried out in.

Visit the website for applications and details: https://nzssa.org/scholarship/

Conferences: Due to the COVID-19 situation the scholarships for conferences are dependent on how the situation evolves. The NZSSA Annual Conference scholarship has been deferred to 2021. For the WFHSS congress please visit the website for details: https://nzssa.org/scholarship/

Research: Research enables our people to be involved in the future scape of sterilising technology. If you have a research topic the NZSSA is interested in seeing what support can be provided.

If you wish to know more contact Shelagh Thomas.

Online learning for your registration and ongoing education

Here are two links to online learning opportunities to keep your knowledge growing. Do you have some you want to share? Contact Alison Stewart: nzsterilescienceassoc@gmail.com Healthmark education: https://www.hmark.com/education.php Infection Control Today: https://www.infectioncontroltoday.com/

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ED-S8 - Endoscope drying cabinet The Getinge EDS8 drying and storage cabinet ensures up to eight disinfected flexible endoscopes are always available for immediate use.

Scan your phone here to see your new department Contact Getinge for a complimentary assessment and plans for your department.

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Next generation pass through design

Standards News Here is some standards news to bring you up to date with happenings in our region.

AS 2773:2019 Ultrasonic cleaners for health service organisations Publishing date: 20 December 2019 This standard was formerly AS 2773 parts 1 and 2. These two standards addressed the different types of ultrasonic cleaners separately, part 1 built in, part 2 benchtop. These two standards have been melded into a single standard which specifies the requirements for ultrasonic cleaners intended to clean reusable medical devices. This standard also includes details on the information to be provided by the manufacturer to the purchaser.

AS 5330:2019 Drying cabinets for reusable medical devices Publishing date: 20 December 2019 This standard is a new standard created from AS 2514 Drying cabinets for medical equipment and AS 2774 Drying cabinets for respiratory apparatus. These two standards addressed two different drying cabinet types which no longer reflected the equipment being produced in the 21st century. The new standard specifies requirements for drying cabinets intended for use in hospitals and other facilities for drying reusable medical devices.

This does not include requirements for thermolabile flexible endoscope drying cabinets. These requirements are in standard - EN 16442 Controlled environment storage cabinet for processed thermolabile endoscopes.

AS/NZS 4187:2014 +2 Reprocessing of reusable medical devices in health service organisations AS/NZS 4815:2006 Office based health care facilities - Reprocessing of reusable medical and surgical instruments and equipment, and maintenance of the associated environment There is a project underway to review AS/NZS 4187 to ensure that it is appropriate for all environments where reprocessing of reusable medical devices is undertaken.

When the project is complete there will be a single standard presenting best practice requirements for reprocessing of reusable medical devices . The draft will be presented for public comment in the coming months.

Notification when it is open for comment will be made on the NZSSA website.

While this project is underway AS/NZS 4187 and AS/ NZS 4815 in their current versions stated above are the

current standards. There are no other versions. It is also not appropriate to use draft documents as a reference as the content may change and therefore is not reliable. If you are in the process of tendering for new equipment or doing a business case for change only reference the current published standards and their normative references.

Membership Update Due to workload the processing of memberships has been sporadic over the last few months for which I apologise. I am pleased to announce that things are back on track and really looking up for the coming year.

Membership Fee - $60.00 from 1 January 2020 The increase in the membership fee was approved at the AGM 2019. Please when making payments ensure it is at the new rate.

Printing membership cards: Cards for renewals and

new members will be ordered in the first week of the new month for memberships processed in the previous month, eg. February cards ordered by 5 March, 1 week to print, in the post to members by the end of the second week. Capturing a whole calendar month enables a streamlining of process.

Receipts for membership payment: Commencing

1 April 2020 electronic receipts will be emailed to members within a week of the payment. Memberships are processed on the weekends so the receipt will come out on a Saturday or Sunday.

Member Only section on website: Creation of this

new section is almost ready. The main piece of work has been to transfer membership with individual emails and the membership section of the website will go live by 30 March. Any member who has not provided an email address will be sent a letter advising how to set up their membership online. Members who are fully loaded onto the website membership page will receive temporary login details to activate their access.

the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

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Porous Loads and Hollow Instrument Load (Porous, Hollow, Cannula, or Trapped Lumen)

“What is the difference?”

Background: In 1963 Doctors J Bowie and J Dick worked out a method to show the centre of a porous pack was sterile based on 29 to 36 towels, each folded and stacked to a height of 10 – 11 inches, with a piece of paper with steam indicator tape in a pattern placed in the centre of the stack. If the steam indicator tape in the centre changed colour evenly, then the steriliser was working, and the air had been replaced by steam. This was said to represent a 7kg pack and has been the benchmark daily test since. This test was able to work on both downward displacement sterilisers (if the timer was set to a long enough time) and work on pre vacuum machines also.

They made this test up to check for an air leak in the chamber, or inadequate air removal and steam penetration in the performance of the steriliser.

Prior to the 1970’s in New Zealand most of the sterilisers in use in hospitals were downward displacement sterilisers. During the 1980’s we saw many hospitals in New Zealand start to change over to pre vacuum or forced air removal sterilisers. At this time all the loads were wrapped in linen and there were absolutely no metal containers with filters and sealed bottoms and sides (rigid containers).

There were 3 main reasons for this change in sterilisers: 1 The new technology was a much better process and could save time in the cycle 2 The new technology could dry the loads after sterilisation 3 The instruments were becoming very complicated with many parts with recesses and places to trap air.

Without forced air removal some instruments would never be sterilised.

During this time hospitals were sterilising their own linen and instruments were wrapped in linen so this method was very relevant to the practices of the day. Sterilisers often had timers set to 10, 15 and 20 minutes for sterilising to allow the steam to penetrate the packs and to provide what the standards detail as a safety margin for the process.

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In the 1980’s due to many substitute materials being used in many different type packs the first standard was written by AAMI in which they gave boundaries on what a pack should contain and how long the sterilising timer should be for this test to accurately show correct functionality (3.5 minutes). The original American standard specified a 4kg pack but in New Zealand and Australia the 7kg test was chosen.

WHAT DOES POROUS MEAN? Porous: - having minute interstices through which liquid or air may pass An item that is porus means that it doesn’t prevent a barrier to steam. Eventually steam will penetrate the surface and work its way through the item. If we go back to the old displacement steriliser this means that the steam enters the top of the wrapped load and eventually works all the air in the load out by pushing it downwards and leaves the bottom of the pack. It might take 20 minutes or more but steam will always push the air out if given enough time. Also even in a steriliser with forced air removal if the air removal wasn’t fully effective, given enough steriliser time the centre of a porus pack will have the air pushed out by the steam and still become sterile.

WHAT DOES HOLLOW, CANNULA OR LUMEN MEAN? Hollow: - having a hole or empty space inside. “a hollow metal tube” Cannula: - a thin tube inserted into a vein or body cavity to administer medication, drain off fluid, or insert a surgical instrument.

Lumen: - The inner open space or cavity In practical and hospital specific terms these are instruments, implants, devices that are hollow or have cavities or crevices which contain air that is trapped when put into a steriliser. Because typically these devices are metal and other non porus materials no amount of time in the presence of steam will push this air out from the top of the item out the bottom of the item. If the hollow device is lying horizontally steam cannot penetrate to S U P P LY L I N E – D E C E M B E R 2 0 1 9

remove the air. If the hollow item has one sealed end then again the air cannot be removed by steam alone.

Without effective air removal by mechanical means these items will never be sterile.

and the recognition that metal instruments with lumens cannot be demonstrated as sterile by the use of a Bowie Dick type system that only represents porous items. This standard was first written in 2001.

The Present

Future Surgical Improvements

As the instruments have become more complicated since the 1980’s and have more delicate and confined spaces where air is trapped they now present a much more difficult challenge than is represented by the 7kg test pack we call the Bowie Dick.

It has been well recognized for many years now that to achieve parametric release of the loads, means were needed to show process efficacy. It started out with biologicals but they required many days to be incubated and up to 1 week before the load should have been released. However, the placement of the biological didn’t represent the hardest location of trapped air in a complicated instrument. Experts in the industry at GKE developed devices from the mid 1990’s that could exceed the requirements of the Bowie Dick test and test for air removal, steam penetration and non-condensable gases. It is also far better to have and use a testing product that can pick up a cycle failure at the time of failure and on the cycle that failed rather than a day later when those instruments may have already been used on a patient.

The Bowie Dick Type test while it is a daily requirement and shows the steriliser does function to a level set in the 1980’s it only represents a porous pack. The original 7kg towelling test pack that started this whole testing process was changed to the current paper and cardboard test’s many manufacturers use but these still only represent porous loads. However today the porous load only represents a fraction of the loads put through a steriliser and doesn’t represent the complicated instruments and implants used in and on patients. In practical terms this means that just because a Bowie Dick type test passes it can’t be used as a guarantee that all the non-porous sets will be sterilised.

Therefore, the best Bowie Dick type test is one that has been designed to represent the porous load and also the non-porous hollow load. One that has also been designed to check for air removal and steam penetration in metal instruments with trapped air in complex situations and also checks for non-condensable gases. To restrict the Bowie Dick type test to one that only represents porous loads is to limit the diagnostic efficiencies used in conjunction with the sterilisers controlling system.

EN 867-5 is a standard that was developed for Nonbiological systems for use in sterilizers - Part 5: Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S. This standard was introduced due to the many surgical instruments that contained lumens

PCD’s or process challenge devices have been made since 2014 that now far exceed the requirements for a 7 kg test and have also exceeded the requirements of EN 867-5 and can replicate higher challenges to the sterilisation process than the most complicated instruments in use in hospitals worldwide. These are utilized on every cycle and can advise the CSSD staff at the time of load removal. Now these loads can be released for use once they are cooled as the class 5 or class 6 indicator inside the PCD if it has fully changed colour can give a level of sterility assurance that exceeds the worst-case instrument throughout the load.

Should you have any questions regarding the content of this article send them through to us we would be pleased to provide any additional information and information you require.

Email info@surgicalsystems.co.nz

the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

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NZSSA Membership Application Form Form NZSSA Membership Application Please print clearly when completing this form

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For further details contact : www.device.co.nz - sales@device.co.nz - 0508 338 423

the journal of NEW ZEALAND STERILE SCIENCES ASSOCIATION

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NZSSA Executive 2018 – 2021 President:

Secretary:

Shelagh Thomas

June Isted

CSSD

Sterile Services Unit

Hutt Hospital

Hawkes Bay Hospital

Private Bag 31907

Omahu Road

Lower Hutt 5040

Hastings 4120

Phone: 04 566 6999 ext 2745

Phone: 06 8788109 ext. 6597

Mobile: 027 589 6473

Mobile: 027 727 3048

Email: shelagh.thomas@huttvalleydhb.org.nz

Email: june.isted@hawkesbaydhb.govt.nz

Treasurer:

Sue Woods (Librarian)

Alison Stewart

TSU

NZSSA Treasurer

Burwood Hospital

28 Brighton Street

Private Bag 4708

Island Bay

Christchurch 8140

Wellington 6023

Phone: 03 383 6836 ext. 99990

Mobile: 021 209 8127

Mobile: 027 711 1444

Email: nzsterilescienceassoc@gmail.com

Email: sue.woods@cdhb.health.nz

Kerry Nicholls

Martin Bird

CSD

Sterile Services

Wakefield Hospital

Dunedin Hospital

Private Bag 7909

Private Bag 1921

Wellington 6242

Dunedin 9054

Phone: 04 381 8100 ext. 5927

Phone: 03 470 9639

Mobile: 027 275 3603

Mobile: 027 812 6064

Email: Kerry.nicholls@wakefield.co.nz

Email: martin.bird@southerndhb.govt.nz

Kevin Green

Tracey Kereopa

Sterile Services Unit

Sterile Services

Whangarei Hospital

Wairarapa DHB

Maunu Road

Mobile: 0275 829 541

Whangarei

Email: Tracey.Kereopa@wairarapa.dhb.org.nz

Email: Kevin.Green@northlanddhb.org.nz Joel Enoka

Maureen Scott

Sterile Services

Sterile Services

Nelson Hospital

Waikato Hospital

Tipahi Street

Pembroke Street

Nelson

Hamilton

Email: Joel.Enoka@nmdhb.govt.nz

Email: Maureen.Scott@waikatodhb.health.nz