Supplyline Online Magazine November 2021

ISSN 2744-6824

SEPTEMBER 2021

SUPPLYLINE

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NZSSA New Zealand Sterile Sciences Association

www.nzssa.org Find out the latest on our own website!

Business Card Directory A QUICK AND HANDY DIRECTORY OF OUR STERILE SERVICES SUPPLIERS

Neil Maclennan

Garry Gorham

Medical Products Manager

Business and Operations Manager

P: +64 9 276 3271 M: +64 21 499 101 E: nmaclennan @ crknz.co.nz

M: +64 21 554 789 P: +64 9 276 3271 E: ggorham@crknz.co.nz

3 Hotunui Drive Mount Wellington, Auckland P: +64 9 276 3271 F: +64 9 276 9645 www.crkennedy.co.nz

Annette Moffatt

3 Hotunui Drive Mount Wellington, Auckland P: +64 9 276 3271 www.crkennedy.co.nz

DESIGN PROOF DESIGN PROOF

Account Manager 021 587 031 annette.moffatt@opritech.co.nz

SIGN-OFF REQUIRED SIGN-OFF REQUIRED

Customer Care 0800 32 40 32 Follow us:

opritech.co.nz

Attention: Attention: Richard Murray buscard.indd 2

Damian Draper / Jason Hopper Damian Draper / Jason Hopper Surgical & Medical Systems Surgical & Medical Systems 5/11/18 3:07 pm

Date: 29 September 2015 Date: 29 September 2015 From: Andrea Rickerby From: Andrea Rickerby Proof:1 1 Proof: Page:1 of 1 of Page: 22

Tim Messenger

mitch varnam

Please: Please:

product specialist, infection prevention

Sale and Service Specialist – South Island

mvarnam@device.co.nz M +64 21 521 981 | P +64 9 215 0974 47 arrenway dr, albany, Auckland, New zealand

tmessenger@device.co.nz m +64 21 197 2472 | P +64 3 925 8567 47 ARRENWAY DR, ALBANY, AUCKLAND, NEW ZEALAND

TICK box below below Please supply third device TICK relevant relevant box technology business JAMEScard.

HENDERSON SIGN happyto toproceed proceed SIGN ifif you are happy FAX aa signed signed copy FAX copy back backto tous us 027 543 2266 | jhenderson@nzvalidation.co.nz 615 Peacockes Road, RD 2, Tamahere, Hamilton nzvalidation.co.nz

device.co.nz

device.co.nz

Damian DamianDraper Draper Operations Manager

INTERMED MEDICAL LIMITED

Operations Manager

+64 274 972 445 +64 274 972 445 damian@surgicalsystems.co.nz

Leonie Jack NZSSA Member/Graduate Product Specialist - CSSD

damian@surgicalsystems.co.nz

021 246 4444

P

71 Apollo Drive, Albany 0632 , PO Box 33268 , Takapuna 0740 , Auckland New Zealand T 09 415 4800 F 09 415 9045 E leonie@intermed.co.nz FREE 0800 333 444 W www.intermed.co.nz

F

+64 3 376 4046

A PO Box 1336, Christchurch 8140, New Zealand www.surgicalsystems.co.nz www.surgicalsystems.co.nz

Dustin Habeck Richard Steingold

Dustin Habeck

NZ RegioNal MaNageR MANAGER BUSINESS DEVELOPMENT PLEASE FAX TO: 03 366 3017 DEADLINE: AS SOON AS dustin.habeck@ecolab.com richard.steingold@ecolab.com PLEASE FAX TO: 03 366 3017 DEADLINE: AS SOON

NZ RegioNal MaNageR dustin.habeck@ecolab.com T 0800 425 529 M +64 21 280 6869 W ecolab.com

0508 SURMED (0508 787 633)

F +64 AP PO 0508 (0508 787 8140, 633) New 3 376 4046 BoxSURMED 1336, Christchurch Zealand

7a Pacific Rise Mt WelliNgtoN aucklaNd 1060

please tick the box 3 please tick the box 3OK TT 0800 0800425 425529 529 MM+64 +642121280 08166869 2290 WWecolab.com ecolab.com

7a 7APacific PACIFICRise RISE Mt MTWelliNgtoN WELLINGTONaucklaNd AUCKLAND1060 1060

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Editor’s Note Ehara tāku toa i te toa takitahi, engari he toa takitini My strenth is not as an individual, but as a collective Kia ora koutou, ngā mihi nui ki a koutou, ngahau te kaupapa I tēnei panui.

I hope you all enjoy this edition of Supplyline. Coming up to Christmas and the warmer weather (hopefully) we here in the Wairarapa will be starting to think about humidity in our department. I found Terry McAuley’s article on specifications for temperature and humidity in sterile storage environments very interesting.

Thank you very much Antony, for your article on team culture. I found it very interesting reading as we here in the Wairarapa have been doing some work collaboratively with periop around designing a charter specifically for us, also the new values for Wairarapa DHB have been rolled out and Manaakitanga (Respect) is first and foremost.

I welcome this. It’s just a pity I could not include Anthony Valvoi’s gymnastics routine in print! (Have a look on our facebook page, if you have not already seen it).

Finally, with all of the uncertainty around levels and exactly what to expect moving forward around the entire country at the moment, remember there are always people you can talk to, your managers can point you in the right direction, or we as Executive can as well. I hope you all stay safe and well in the months ahead.

Ngā manaakitanga, Tracey Kereopa

If you come across any articles you find interesting or just want to send me some pictures for inclusion in Supplyline

MANAAKITANGA - Respect

KOTAHITANGA - Relationships

We care for each other, showing kindness and empathy in all that we do.

Our diversity is our strength, we back each other and work together in partnership.

AUAHA - Innovation We are committed to finding future focused solutions and take personal responsibility to be better every day.

EKE TAUMATA - Equity We are committed to doing the right thing by ensuring equity and hauora are at the heart of everything we do.

President’s Message Hi Everyone By now we should all be reminiscing about out time at the conference which would have been held in September. We would be talking with our colleagues about the topics we had listened to, the new ideas coming out from our trade partners and of course all telling them about the new or old friends that we had caught up with. I personally was looking forward to going to Christchurch. This was my opportunity to farewell some of our executive members, who have been wonderful ambassadors and supporters of our professional body.

Sue Woods from Burwood Hospital and Kerry Nichols from Wakefield Hospital has been members of the executive as long as I have. Sue has been the keeper of the association library including the ISO standards.

She has also been the one who has been a major organiser for the conference dinners and venues.

Kerry has done a wonderful job with the registration portfolios that members submit. She has ensured that all portfolios have met the requirements to be accepted.

Her expertise in this area shall be missed. The conferences would not have succeeded without the input of Kevin

Green from Whangarei Hospital who for the past 3 years has been very active in taking the lead of conference organiser. I thank all three of you and wish you the best in your future endeavours. Conference AGM is also the time when I would introduce new and returning executive members to you all. Unfortunately, they had their introduction via Zoom meeting, which is the way we are conducting business at present under Covid restrictions. I would like to welcome back to the NZSSA executive Jenny Carston from Tauranga Hospital and Aileen Derby from Middlemore Hospital. I would also like to welcome our new executive members, Sharon Moss from Southern Cross Hospital Christchurch, Karen McCormick from Wellington Hospital and Paul Moody from F&P Healthcare.

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I shall shortly put onto the website the roles, that all of the executive shall be undertaking.

For 2022 we shall once again be offering a variety of scholarships to members. Please regularly check the website for availability.

A request from me to all of you who completed LV4 cert in sterilising technology and the L5 Diploma this year, would you kindly send me via email your contact address in order for me to send out your NZSSA badges to you.

I began by lamenting the fact that we did not attend conference this year, but there is good news and a light at the end of the tunnel. The conference has been rescheduled for March 2020 at the same venue in Christchurch. If you are transferring your registration

and travel to March, please do this ASAP. I have heard that Christchurch will be very popular in March with the women’s International Cricket tournament also being held there at the same time. Accommodation will be hard to find if you do not get in early.

We have all been working during unprecedented times and situations. I spent 7 days in early September working as a Covid vaccinator during a mass drive through vaccine campaign and will spend another four days doing the same from the 15th October.

Please ensure that you keep yourself and your families safe. Remember wash your hands, sign in with the covid tracker and wear a mask.

Shelagh Thomas President NZSSA

Happy Retirement Jill Parker - Timaru Hospital October 2021 brings the end of a long career in sterilising for Jill. She first started here in June 1985 as a sterilising assistant. She and another colleague decided to undertake the sterilising technician qualification, this was new to the profession and not required at that time. She passed with flying colours in 1990. This was the start of what is now recognised as an integral piece of education often required to work in the profession.

June 1994 Jill became the “boss” which has given her many titles over the years, supervisor, manager and as she is now known Clinical Leader. She has been a fantastic boss, always put her staff first, and if there was a problem, she would seek a way to solve it via a process rather than blame the staff member.

She has made incredible contributions to the unit over the years, refurbishment of the department twice, implementation of up to date equipment to work with, ensuring all standards were met and followed, just to name a few.

Another huge task she undertook was the introduction of a computerized tracking system called L.Trace.

Once in place, Jill entered all the theatre instruments into the system, which was a massive undertaking and so began a 15 year challenge which is still in process to this day.

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She was also actively involved in the NZSSA Executive Body for many years representing the South Island chapter. She was a major contributor in the setting up of the documentation and processes for sterilising personnel to gain registration under the Health Assurance Competency Act (HPCA). Jill worked through the complexities of the act which was not an easy task.

During her time as an executive member she also organised and hosted an annual sterilising conference in Timaru.

Jill is a senior member of the sterilising fraternity here in N.Z. She has a huge amount of knowledge and combined with many years of experience, has been a positive source of information and support for others throughout the country.

We wish her a fond farewell and a happy, healthy retirement.

She will be sadly missed.

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Harness the power of UV-C

Opritech can help you harness the power of UV-C light to eliminate pathogens.

We supply a range of innovative infection prevention solutions including air purifiers, upper air systems, disinfection chambers and disinfection robots.

UV-C light is a well-recognised, widely used method of eliminating pathogens and has been used for over 40 years. It provides a fast, efficient and chemical free way of eliminating pathogens in a range of settings.

Contact us for more information on 0800 32 40 32, email sales@opritech.co.nz or visit opritech.co.nz

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ProReveal

Fluorescence Protein Detection Test

For checking the efficiency of Surgical Instrument Washing.

The ProReveal Fluorescence Protein Detection System has been developed in response to the need to find a more sensitive and accurate method of checking for residual proteins that can sometimes remain on surgical instruments after the washer disinfection process.

Using the ProReveal in Sterile Services Process Optimisation – Cleaning Process

ProReveal - Key Features Highly sensitive test Detects down to only 50 ng of residual protein User designed level A user designed level of residual protein can be set to meet the requirements of AS/NZS 4187 (Sec 8 – Routine Monitoring & Control) Whole instrument can be measured.

Assurance that the whole instrument has been tested Quantitative result Peace of mind - no need to worry about interpretation of results Instant result Test performed on site in less than 4 minutes with a PASS/ FAIL

Manual Wash

Ultrasonic

Washer/Disinfector

The ProReveal will allow the SSD to establish the best cleaning protocol for an individual instrument. Complex instruments may require all of the identified cleaning steps. Where more basic instruments will require less steps.

Spot readout on measurement

Report generation Full traceability for quality control - reports can be generated for all images saved and are downloadable to usb stick or network.

3D visual display as to the location and quantity of the proteins Pin points difficult areas to clean Stored Measurement All stored data can be analysed using the monitor history graph.

On the Measurement Details dialogue, you can touch spots of contamination on the displayed image to show a localised readout of mass detected for that spot.

address: 3 Hotunui Drive, Mt Wellington, Auckland

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email: nzmedical@crknz.co.nz

phone: 09 276 3271

web: crkennedy.co.nz/medical

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The Importance of Compliance! - AS / NZS 4187:2014 Garry Gorham, Business & Operation Manager, CRK NZ

Background - What is a QMS? For years the compliance to standards for Sterile Sciences Departments (SSD’s) in New Zealand has been quite relaxed, however, operational failures have highlighted the need for urgent change. The NZSSA has discussed compliance in the past with the MoH on more than one occasion, highlighting that the current approach is a danger to ongoing patient safety for anyone having medical or surgical intervention requiring Reusable Medical Devices (RMD’s) in the healthcare environment.

standardising the process, and identifying and removing risks. In addition, looking at opportunities for improvements.

Implementing a QMS can help your SSD to achieve greater consistency in the activities involved in providing products or services. In turn reduce expensive mistakes and increase efficiency by improving the use of time and resources.

SSD’s in both New Zealand and Australia have worked

Question?

As an outcome of previous failures within our profession the MoH have recommended 2 immediate outcomes.

1. For all CSSD in NZ to have a computerised tracking system. 2. For all CSSD in NZ to audit against the standards. Does this address the future risk?

closely with Standards Australia & New Zealand to develop AS/NZS 4187:2014. This standard exists to identify the systems and processes required to monitor and control the environments in which RMD’s are reprocessed, washed, packed, and sterilised.

The AS/NZS 4187:2014 standard has numerous elements for compliance. Tracking & Traceability only satisfies one of the requirements.

AS/NZS 4187:2014 Section 2 identifies a requirement to have a Quality Management System (QMS) developed and implemented to meet the elements of the standard.

Such requirements are supported and encouraged by the New Zealand Sterile Sciences Association (NZSSA).

Addressing this recommendation only satisfies a small percentage of the standard. This is very much a reactive approach, in that what this does provide, is it makes it easier to recall after an error, rather than being proactive by recommending full compliance to the standard.

However, standards should not drive change. The responsibility to ensure things are being done correctly, risks are being identified, control measures are in place to address the risks and systems are being reviewed at regular intervals, lies with the management of the department, and as per the standards, with the full support of senior management.

Regarding auditing - Auditing is about assessing a departments compliance through their documented QMS, which meets the requirements of the standard in a working environment. It is not about picking up a copy of the standard and saying Yes or No on meeting each element, evidence must be made available to prove compliance, therefore supports the need for a QMS to be in place.

“Standards that are not policed or audited, are merely a bit of paper with recommendations!”

In the health sector we all have a responsibility to ensure that we do the best for the patient and ensure that good patient outcomes are our top priority.

The standard has been available to us all since 2014, 7 years, so the time to act is now. The decision to implement a QMS is not based on the failings of others, in fact, quite the opposite, they are there to identify risks, and reduce the opportunity to fail in the first instance.

What is a QMS? A QMS is a collection of documented procedures focused on consistently meeting customer requirements,

What can I do to make a difference?

Implement a QMS! Discuss the importance of this with your senior management. Make them fully aware of the consequences of failure. This may be daunting for some and does require dedication, time, and resources to allow for the development and maintenance of such a system.

This can be simplified, by eliminating the development phase, and purchasing an “off the shelf” fully compliant QMS, which are available in the current market, to meet the requirements of external audit bodies

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LASER MARKING + TRACEABILITY

A Comprehensive laser instrument marking + Asset tracking system ‘Increase Accuracy’ ‘Boost Productivity’ ‘Improve Patient Safety’

Laser Marking is a high-speed identification process that creates a permanent mark of the highest quality onto a wide variety of different materials including, metals, alloys, polymers, ceramics and a wide variety of other materials.

Nothing needs to be added to the surface being laser marked.

The resultant high contrast inscription can consistently be achieved and does not create a crevice in the part, where dirt or debris could collect.

Laser marking has for some time been the technology of choice for surgical instrument and medical device manufacturers, as well as for hospitals looking to introduce a fast and effective instrument tracking and traceability system.

Key features of Laser Marking Marking instruments is a quick and simple process.

The equipment requires minimal housekeeping.

No on-going requirement for consumables.

The ability to mark exceptionally small detail and to mark the GS1 machine-readable codes means that laser marking can create small and very small DataMatrix code sizes, to fit onto almost all surgical instruments. No fixturing or clamping is required and the typical marking time of just a few seconds means that marking large numbers of instruments can be a rapid and easy process to undertake.

Permanent marking is essential in medical devices as it provides traceability.

The laser mark is a permanent mark on the surface of the instrument and does not affect the protective “passive” layer.

With many years of expertise in code reading technology, CRK can supply customers with both the laser marking system and the hand-held or benchtop reading technology, to form a complete hardware package for ‘track and trace’, with technologies that are developed to work together.

CRK can supply laser marking systems in a number of different system configurations, including compact energy-efficient desktop systems, or floorstanding workstations. This technology is easy and safe to use, running from a standard electrical supply and requires no scheduled maintenance.

For an on-site demonstration or a free sample marking service -please contact CRK for more info.

address: 3 Hotunui Drive, Mt Wellington, Auckland

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email: nzmedical@crknz.co.nz

phone: 09 276 3271

web: crkennedy.co.nz/medical

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Team Culture Drive Forbes magazine recently wrote “There are very few factors that contribute more to success than culture”. Culture has many facets including goals, focus, symbols, norms, identities, beliefs, and values. Simply put, organizational culture can be defined as the patterns of thinking and behaving that are recognized mainly and adopted. However, at the heart of culture is the issue of core values. We at CDHB conducted a Sterile Services culture drive to explore our core values and wanted to reach out and find the voice of the team, we did this by promoting an anonymous team survey and to put this out to the department.

Understanding your results How Strongly Agree to Strongly Disagree Likert scale questions are scored

Don’t know

Each score contributes:

Strongly Disagree

Disagree

Somewhat Disagree

Somewhat Agree

Agree

Strongly Agree

40%

60%

80%

100%

No Score 0%

Don't know responses are excluded in calculating the score. The number of people that do not know may indicate an issue. Is it a lack of awareness that needs to be addressed?

20% Red is an area that needs focus.

What can you and your team do to improve this? Do you need help from others to solve it?

Orange shows potential concerns and identifies where you could act. What could you build on?

Yellow is good. But are there key areas important to your organisation that should be Green is excellent! This is worth improved? celebrating. How could you make this even better? What best practice can you share with other teams and leaders?

Each response on this scale contributes a score as outlined below. The responses are then averaged to give your overall question score as a %. For example, if 5 people selected ‘Strongly Agree’ and 5 people selected ‘Strongly Disagree’ the score would be 50% 5 x Strongly Agree responses at 100% = 500% | 5 x Strongly Disagree responses x 0% = 0% Score = 500% / 10 responses = 50%

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Making it Better in Sterile Services

Recent department views had been due to both legacy and current issues causing staff concern. The legacy issues were attributed to a previous not-fit-for purpose working environment coupled with failing, end of life reprocessing equipment. Funny enough the current concerns were attributed to a brand-new department with brand new reprocessing equipment, and a migration into the new department was rushed (beyond our control).

Our department was losing staff at an alarming rate including a high level of leave, this elevated department stress levels which in turn created department unrest.

We ran an ‘Ask My team Survey” AskYourTeam which had a brief template of organisation questions with the ability to have customised questions added, this company was able to run detailed reports (20 page presentation) and provide areas of feedback for ‘quick wins’ and ‘long-term goals’. As the survey was confidential we were able to obtain true and accurate views of the department and target these areas quickly. Once the responses were collated we ran a series of workshops with various vocal and non-vocal team members for their input and culture buy-in. From these workshops we were able to create a theme to target 3 main areas of concerns, these were communication, collaboration and bullying. These three areas provided focus in creating baseline department behaviour expectations, solidified the need for effective constant communication across both the leadership team and floor staff, and a need to develop a team culture.

I cannot state strongly enough ‘Few things impact workplace culture, productivity, and morale more than communication’ and we have tried to develop multiple channels for this to occur. There were 9 common types of communication in our workplace and all of which needed to be addressed professionally and documented within the four points of communication - Verbal, non-verbal, written, and visual.

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1. ‘Leadership Communication’ 2. ‘Upward Communication’ from the team members 3. Updates ‘on various platforms i.e. handover book, emails, note pads 4. Presentations/In-services 5. Meetings 6. Customer communications e.g. “you lost my instrument” ㈚ and our response (always polite), priority requests etc.

By no means has the above been easy nor do we have 100% on board 100% of the time but what we do have is a high level of engagement, lower levels of sick leave and a stronger level of staff retention.

Cultures do not arrive ready-made. They are the outcome of choices made about people, goals and behaviours over a period of years. They are especially a reflection of the leadership of the hospital: what and who those people most value. We have just begun our journey and it is a long, long road ahead.

7. Notifications 8. Informal interactions i.e. issues with stock, instrument tracking etc.

9. Training and educational.

In addition to communication we focused in dealing with inappropriate behaviour in a timely manner before it manifested and was pleased to gain support from our HR team.

We are now also identifying what success in our department looks like and promoting our team results on a monthly basis i.e. how many sets were processed, number of theatre cases, number of incidents, health and safety etc. We are also concentrating on an identity piece which consists of our new logo plus highlighting team members on a photo board. A poster campaign with words drawn from the team during our workshops is under wraps and these have been shared with the NZSSA Sterile Services Leaders my personal favourite is:

KEEP CALM

Smile

I am fortunate that our Sterile Services team here at CDHB is so supportive and hardworking, I am privileged to be able to work with them and in supporting our hospital and Canterbury Health sector! They are an amazing and diverse bunch.

Be an encourager.

The world has plenty of critics already.

DaveWillis.org

AND

We’re trained Sterile Services Technicians!

Best Sterile Services department in New Zealand

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Good luck to you all.

Tony Hampton Clinical Technologies Manager Canterbury District Health Board (CDHB)

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The art of perfecting infection control

Getinge has extensive experience in supplying infection control and supply management solutions to hospitals.

Our sterile reprocessing and traceability solutions provide the ability to improve patient safety and quality of care. Giving you peace of mind to focus on the task at hand.

For more information visit email sales.nz@getinge.com or call 0800 143 8464 www.getinge.com/anz

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MEDITRAX® Getinge’s manual instrument tracking system that allows you to record every step in the sterile supply workflow.

• Easy-to-use system to help comply with AS/NZS 4187:2014 Standards • Record and track data on single instruments and instrument trays • Components available to track the entire sterile supply flow • Entry level alternative to electronic traceability solutions

For more information visit email sales.nz@getinge.com or call 0800 143 8464

www.getinge.com/anz

Toi Ohomai Institute of Technology Ltd NZ Certificate in Sterilising Technology Level 4 Jemelette Aquino Arnold Aromonia Sandra Baker Monique Ethier Terito Ine Richard Jewson Jinu John George Sunija Jose Heyiyantuduwage (Chandani) Karunathilake Rejeeshkumar Vasu Matthew Lettman

Michael Mananghaya Sangeeth Mathew Narissa Nuezca Elizebeth Paul Pino Paul Sneh Prasad Luke Rabjohn Lerma Sana Ana Santos Ballesteros Xiuling (Linda) Zhang

Toi Ohomai Institute of Technology Ltd NZ Diploma in Sterilising Technology Level 5 Kathryn O’Connor Therese Godfree Kelsey Smith

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Specifications for temperature and humidity in sterile storage environments – Where’s the evidence?

Terry McAuley MSc (Medical Device Decontamination) (current), Grad Dip Education and Training STEAM Consulting, Melbourne, Victoria, PO Box 100, Endeavour Hills, Vic. 3802, Australia.

Email: terry@steamconsulting.com.au

Abstract The concept of event-related sterility for storage of medical devices is widely applied in Australian healthcare facilities. This paper reviews available literature, international standards and guidance documents with respect to the concept of event-related sterility in order to determine: (i) why commercially produced sterile medical devices may withstand adverse temperature and humidity conditions better than items produced in a Sterile Services Department; (ii) what effects temperature and humidity have on maintenance of sterility; and (iii) whether temperature and humidity conditions specified in AS/NZS4187:2003 are evidence-based and whether changes to these could be made in any future revisions. The literature review revealed that manufacturers of commercially available sterile medical devices are subject to stringent medical device regulations that require them to ensure that the devices remain both fit for purpose and sterile until use. This necessitates that manufacturers conduct accelerated ageing and environmental challenge tests to establish and justify the expiry dates given on the package label. The review also found a variety of specifications for temperature and humidity and the guidance documents gave no indication of evidence used as a basis for these requirements. In addition, it was apparent that many published studies on event-related sterility did not include consideration of the effect of temperature and humidity on the duration of sterility. After examination of a range of published material, it was concluded that the specifications in any future edition of AS/NZS4187 could be expanded to a temperature range of 16–25‡C and a relative humidity range of 30–75%.

Introduction In Australia, reprocessing of reusable medical devices takes place in accordance with the Australian and New Zealand Standard Cleaning, disinfecting and sterilising reusable medical and surgical instruments and equipment and maintenance of the associated environment in healthcare facilities [AS/NZS4187:2003].

This Standard recognises the concept of eventrelated sterility and includes specifications for storage environments for sterile medical devices [SMD] irrespective of whether these are produced by a Sterile Services Department [SSD] or a commercial manufacturer. Conditions for SMD storage require temperatures between 18–22‡C and relative humidity [RH] between 35–68%.1 Extreme weather conditions experienced in Australia over the past several years, in conjunction with ageing air-handling systems in many healthcare facilities, has highlighted issues regarding the ability to maintain these conditions. Thus SSD managers are questioning the temperature and humidity specifications in AS/ NZS4187:2003, as commercially manufactured SMD are often labelled with acceptable storage conditions outside those written in the Standard.

The questions asked include: • Are commercially manufactured SMD able to withst and adverse temperature and humidity conditions

more readily than those SMD produced by SSD and if so why?

• What are the effects of elevated temperature and/ or humidity in terms of sterility maintenance?

• Is there any safe duration of exposure to these conditions and are there any simple method(s) to ensure sterility maintenance under adverse conditions?

• What are recommended temperature and humidity ranges for storage of SMD in other published standards and guidance documents?

• What evidence has been the basis for these conditions?

• In light of the above, what changes should be considered during future revisions of AS/NZS4187?

A literature review was conducted to locate published studies on event-related sterility to determine if these included consideration of the effects of temperature and humidity on sterility maintenance In addition, published guidance from a variety of sources was examined to identify temperature and humidity specifications for storage of SMD and compare these with AS/ NZS4187:2003.

The anticipated outcomes of the literature review were: • Finding answers to the SSD manager’s

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questions, and Identification of evidence-based recommendations for temperature and humidity ranges for sterile storage environments which could, if necessary, be used in a future revision of AS/ NZS4187:2003.

pertaining to the areas of sterilisation, packaging and sterile barrier systems. In addition, ProQuest, PubMed, Google and Google Scholar search engines were used to identify and locate peer-reviewed and non-peer reviewed literature available on the internet.

This paper will discuss the findings, using the questions posed by SSD managers as subject headings.

The search terms included event-related sterility, shelf-life, humidity, storage, packaging, sterile barrier systems and surgical instruments. Key words were also typed into the search engines as separate items to identify other possible sources of material.

Background Although temperature and humidity monitoring in sterile storage environments is currently not required

by AS/NZS4187:2003, several Australian SSD managers implemented monitoring systems during extreme weather conditions experienced over the past several years.

Monitoring revealed that deviations from specified conditions occur at various intervals and for varying lengths of time, raising concerns for patient safety, as increased humidity should be considered an adverse event.2,3 The usual practice upon identification of deviations from acceptable temperature and/or humidity is to reprocess SSD produced items. However, some commercially produced SMD have specified limits for temperature and humidity on the packaging which allow exposure to conditions outside those specified

by AS/NZS4187:2003. As long as these conditions have not been exceeded, these items can be retained.

However, all commercially producedSMDwith no specified storage conditions, or those showing signs of moisture, should be discarded.

In some hospitals, problems with humidity pre-existed and/or persisted even after extreme weather conditions passed. Costs to fix or replace air-conditioning systems are prohibitive and with some facilities planned for refurbishment over the next 5–10 years, there is a reluctance to invest significant capital in solving these problems.

In situations where ongoing exposure to adverse conditions has been experienced, SSD managers are resorting to sealing SMD in impervious plastic dust covers in order to mitigate the exposure to increased humidity and minimise the cost and impact of reprocessing or discarding SMD. However, these practices also incur costs in both time and resources.

Clearly, evidence-based guidance is required to inform practice and to ensure patient safety is maintained.

Literature review Due to a limited timeframe for conduct of the literature review, research was limited to sources readily available through the internet or already on hand in the author’s personal library.

The author had on file several older articles on eventrelated sterility in addition to copies of various international standards and guidance documents

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Search results were scanned to eliminate: • duplications, • items that were facility-specific guidelines or policies, • patent applications, • product-specific literature with limited exceptions, • articles which cited no references, and • book results.

Book results were not included due to lack of ready access.

Materials were considered for inclusion based on their content and contribution to developing an understanding of event-related sterility and the possible basis for temperature and humidity specifications in sterile storage environments.

Reference lists were examined to identify further relevant literature and where possible, were accessed online. However, difficulties were experienced in locating some articles due to their age, changes in publishers or discontinuation of the journals. In addition, the author did not pursue the purchase of several expensive resources, such as testing standards for ageing of SMD and related guidance that may have assisted in developing a broader appreciation of the medical device industry context for specifying storage conditions. Both of these factors are recognised limitations of this review.

After conclusion of the search, over 45 documents had been selected for further examination in order to determine whether relevant information pertaining to the effect of temperature and humidity on maintenance or duration of sterility was presented.

Discussion Are commercially manufactured SMD able to withstand adverse temperature and humidity conditions more readily than those SMDproduced by SSD and if so, why? Very simply, the answer is frequently yes, because the methods of sterilisation employed by SMD manufacturers allow more robust packaging systems to be used in comparison to those available for use in SSD.4 Annex 1 of the Medical Devices Directive [MDD] 93/42 EEC requires medical devices be designed and

S U P P LY L I N E – S E P T E M B E R 2 0 2 1

manufactured so sterility will be maintained during storage or transport, providing manufacturer’s specified storage and handling instructions are followed.5 While the MDD is not directly applicable in Australia, Australian medical device legislation is very similar. In addition, many products compliant with the European MDD are used in Australia.

In the author’s opinion, testing of packaging systems under assumed ‘worst-case’ conditions currently used by commercial manufacturers of SMD could be applied to manufacturers of packaging products for use in SSD. This would provide SSD managers with guidance as to acceptable storage conditions to ensure effective maintenance of sterility for SSD-produced SMD.

ISO11607–1 requires manufacturers of packaging systems to ensure the products are able to perform as a microbial barrier and ‘maintain sterility until the point of use or until the expiry date’ and should provide information on ‘known restrictions on handling and use’ which presumably includes ‘any shelf-life limitations. . .for post-sterilisation storage’ and recognises that ‘loss of sterility is regarded as event-related’, therefore accelerated and real-time ageing studies, stability and biocompatibility tests are required.6

What are the effects of elevated temperature and humidity in terms of sterility maintenance?

Dunkelberg and Rohmann12 state: ‘Studies of the sterile integrity of sterilised packages, conducted under hospital conditions and various different environmental conditions (e.g., level of cleanliness, humidity, and temperature), have been hampered by technical and statistical difficulties.’ This is also true for commercially produced SMD, for example SMPC8 indicates that the effect of temperature on ageing of SMD is well understood, although the effect of humidity requires further study.

Consequently significant progress has been made in improving packaging systems and developing procedures for accelerated ageing and environmental challenge studies that include consideration of the effects of temperature and humidity, allowing more precise labelling of acceptable storage conditions.

7,8 Nonetheless, it should be noted that the Sterilisation Packaging Manufacturers Council (SPMC) advocates shelf-life testing should be distinct from ‘the environmental impact of temperature and humidity’ and there is still no universally agreed method for performance of microbial barrier testing.9,10 Rutala and Weber11 advise that when selecting a sterilisation wrap, SSD managers should ask the manufacturer for evidence of independent laboratory testing on the time and event-related performance of their product as a microbial barrier.

The author contacted several manufacturers of sterile barrier systems sold for use in SSD applications to identify if their product literature contained any specifications for storage conditions to maintain sterility of items until use. At the time of writing, limited responses had been received from two manufacturers, indicating this information was not currently available, but may be in the future.

It is therefore feasible to expect manufacturers of packaging materials for use in SSD to undertake poststerilisation validation studies of the performance of their products under extreme temperature and humidity conditions, utilising the testing protocols used by SMD manufacturers and thus provide recommendations for storage conditions suitable for event-related sterility programs.

Such testing programs would be advantageous because, to date, the published studies on eventrelated sterility all use vastly different approaches in experimental design, making comparison of the results challenging.

SomeSMDmanufacturers indicate higher temperatures adversely affect the stability of some products.13 Phillips13 also states that minor variation of 1–2‡C should have little effect on the product, while temperatures in excess of 5–6‡C higher could significantly reduce shelf life, although no mention is made if this is loss of sterility.

During email correspondence between the author, Dr F. McGain and Professor Tallentire, Tallentire 14 wrote:

‘Mycolleague and I are not aware of any evidence to suggest a storage temperature of 27 degrees poses any greater risk to loss of sterility compared with a temperature of 20 degrees.’

However, the Sterile Processing University15 state that microbes prefer warmer temperatures; therefore, controlling temperatures below the range preferred by microorganisms is a method to reduce environmental bioburden.

Several studies on event-related sterility mention temperature and humidity were monitored or controlled during experiments; although few indicate what the ranges were. One exception is the study by Widmer, Houston, Bollinger and Wenzel16 who stated temperatures were in the range of 20–22‡C and RH fluctuated between 30–80% during the experiment; however the impact of this on study results were not discussed.

Other studies indicated temperature and/or humidity were not controlled or monitored during storage periods and results of sterility testing did not indicate higher levels of contamination.17,18 Webster et al.19 attempted to examine the effect of a variety of controlled and uncontrolled storage conditions in their study over a 2-year period. One interesting finding was from testing articles stored in a box in the rear of a car for 9 years. Although these devices were subjected

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to extremes of temperature and humidity in a subtropical climate, no contamination was found. There is wide recognition microbes require ‘vehicles’ for transportation such as lint, dust and air currents and moisture allows microorganisms to penetrate through packaging materials.20 Only one article on eventrelated sterility indicated high humidity promotes fungal growth.21 The Canadian Standards Association3 advises exposure to high humidity and moisture could allow ‘wicking’ of microbes through packaging and facilitate microbial proliferation, therefore this must be considered an event. Clearly, high humidity has an effect on sterility maintenance.

Several recent studies led by Dunkelberg demonstrate that the number of atmospheric pressure changes, increasing microbial load with consideration of humidity, resulted in increased levels of contamination of sterile packages.12,22,23 While studies by Rutala17 and Webster et al. 19 provide some assurance most packaging materials in use in healthcare facilities can withstand the rigours of storage and handling in uncontrolled environments while maintaining an effective microbial barrier, there is no clear evidence in the available literature that definitively demonstrates the impact of known levels of elevated temperature and humidity on sterility maintenance and links these to specified conditions for storage environments.

Is there any safe duration of exposure to these conditions and are there any simple method(s) to ensure sterility maintenance under adverse conditions?

AS/NZS4187:2003 makes no recommendations for monitoring temperature and humidity in sterile storage environments, nor does guidance available from the United Kingdom. However, ANSI/AAMI ST79:200624 and CSA3 recommend that temperature and humidity in storage areas be monitored and recorded daily.

However, ANSI/AAMI24 gives no indication what action is required if limits are exceeded.

In many cases, commercially prepared SMD have specifications for storage conditions on package labels, thereby making judgement of whether sterility of the device has been compromised more straightforward.

However, there is much less certainty in the case of SMD produced within SSDs. A consensus statement developed by an ad hoc committee of sterilisation experts regarding high relative humidity advises that humidity in excess of 70% is considered an event, although no evidence is provided to support the selection of this critical variable.3 CSA recommends that where humidity >70% is detected, packs should be assessed and if no moisture or other effects are noted the packs may still be used. In addition, they recommend that corrective action be taken to rectify the problem, and items be

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transferred to an alternative location while humidity exceeds specification.3 If the humidity reading is still high 24 h later, any packs remaining in the storage area should be inspected again and a risk assessment conducted. Packs showing wetness, moisture or other adverse effects must be discarded; however, items packaged in impervious materials, such as plastic may still be able to be used.

However, it should be noted that no evidence is cited for these recommendations.3 The USA Food and Drug Administration stated in an advisory notice that a strategy to protect sterile items from high humidity is to ‘enclose them in plastic containers to keep them dry’.25 This approach was first advocated by Mayworm.20 Therefore the strategies being practiced by SSD managers in Australian healthcare facilities are in keeping with those recommended elsewhere.

What are the specified temperature and humidity ranges in other guidance documents?

Review of guidance documents and standards revealed specifications for temperature and humidity were similar in range, although inexplicably different as seen in Table 1.

What evidence has been the basis for these conditions?

None of the published guidance cited evidence-based sources for specified temperature and humidity conditions. Where a source was indicated, tracing back to the original references showed brief mention of temperature and humidity being a factor influencing sterility maintenance, without any scientific evidence for this or indication of actual limits determined through an experimental process. ANSI/AAMI24 indicated the specified ranges have been adapted from the American Institute of Architects and not from published literature or studies on sterility maintenance.

Phillips13 indicates that commonly accepted definition for room temperature in various pharmacopoeias is 15– 25‡C and this definition is often used by medical device manufacturers. The adoption of room temperature conditions for storage of SMD by default was confirmed in email correspondence between the author, Dr F. McGain and Professor Tallentire.14 Therefore, it appears that specified conditions for temperature and humidity in sterile storage environments may have been derived from pharmacopoeias and guides to ‘good manufacturing practice’ rather than actual evidence of the effect of temperature and humidity on sterility maintenance, or at least this has been true in the past.13 What changes should be considered during future revisions of AS/NZS4187?

Based on information in Table 1, it appears published guidance S U P P LY L I N E – S E P T E M B E R 2 0 2 1

Table 1. Temperature and humidity ranges in published guidance.

Country

Document

Temperature range (*C)

Relative humidity (%)

Australia

AS/NZS4187:20031

18–22

35–68

Australasian Health Facility Guidelines26

<27 for storage areas

Not specified

PIDAC2

18–20

30–60

CSA3

18–20

30–70

HBN 1327

16–21

30–60

Steering Committee for Decontamination of Reusable Invasive Medical Devices

18–21

35–60

HTM2010 Part 529

18–22

35–75

Centers for Disease Control30

Avoid extremes

Avoid extremes

Association for peri-Operative Registered Nurses31

<24

<70

ANSI/AAMI24

<24

<70

Canada

UK

US

supports storage conditions with upper and lower limits for temperature and humidity being between 16–27‡C and RH 30–75%, respectively. However, the article written by Phillips13 indicated many SMD manufacturers specify <25‡C for storage of their SMD and labelling indicates items should be stored in ‘a dry place’. Some SMD manufacturers specify exact storage conditions for their products. For example Vallelylab32 indicates that RH >75% can affect the water-based adhesive on Tyvek packaged products, while Cook33 indicates products can withstand RH up to 90% and temperatures <40‡C.

Therefore, at face-value, it appears a storage temperature of 16–25‡C and RH between 30% and 70– 75% should be suitable for most SMD whether produced in an SSD or by a commercial manufacturer, unless the manufacturer specifies alternative conditions.

Providing these conditions are appropriate for those sterile barrier systems used in SSD applications, and subject to further confirmation, the author recommends that specified ranges for temperature and humidity in sterile storage environments according to AS/NZS4187 be changed to 16–25‡C and RH 30–75%.

Conclusion This paper has explored the effect of increased temperature and humidity in sterile storage environments and the possible impact on duration of sterility through examination of published literature and guidance. No scientific studies were identified that definitively examined this issue. Further, existing guidance documents are not consistent in specifying temperature and humidity conditions for storage of SMD and no indication is given as to evidence upon which conditions were based.

However, the literature review, while somewhat limited in scope, clearly demonstrates that requirements of theMDDand ISO11607 have led to developments in testing the performance of packaging systems used for commercially producedSMDand these concepts for package testing could possibly be applied to validation of packaging materials used in SSD. Such testing would improve understanding of the temperature and humidity conditions able to be tolerated by packaging systems used in SSD and allow evidence-based specifications to be included in published guidance documents in the future.

Recommendations • Manufacturers of packaging systems used in SSD applications should consider validating the post sterilisation performance of their products utilising accelerated ageing and environmental challenge testing protocols, in order to provide evidence

based instructions for acceptable temperature and humidity ranges in sterile storage environments.

• The specified temperature and humidity conditions in AS/NZS4187 should be changed to a temperature range of 16–25‡C and a RH of 30–75% during the

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next revision process, and make reference to following manufacturer’s instructions.

• A requirement for daily monitoring of temperature and humidity in sterile storage areas should be included in the next edition of AS/NZS4187 along with recommendations for preventative and corrective action when conditions deviate from specified limits or those documented in manufacturer’s instructions.

Conflict of Interest No conflict of interest has occurred in the development of this paper.

Acknowledgement With thanks and in recognition of the Sul Stuart Fraser Scholarship awarded me by the College of Nursing, facilitating my participation in the Master of Science Medical Device Decontamination program offered by the University of Highlands and Islands, Scotland.

References 1. Standards Australia. Cleaning, disinfecting and sterilizing reusable medical and surgical instruments and equipment and maintenance of the associated environment in healthcare facilities. AS/NZS4187:2003 Homebush; SAI Global.

2. Provincial Infectious Diseases Advisory Committee [PIDAC] Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings. 2006 [online] Available from http://www.health.gov.on.ca/ english/ providers/program/infectious/diseases/ic_cds.html last accessed 16 April 2009 3. Canadian Standards Association [CSA] Consensus Statement re: High Relative Humidity in Sterile Storage Areas. 2007 [online] Available from http://www.csao. net/files/pdfs/High%20Humidity %20in% 20Sterile%20 Storage%20CSA%2 July%202007.pdf last accessed 17 April 2009 4. Belkin NL. Wrapping for event-related shelf-life.

Healthcare Purchasing News March 2004 [online] Available from http://www.hpnonline.com last accessed 4 May 2009 5. Medical Devices Regulations (2002) SI 2002/3017 [online] Available from http://www.opsi.gov.uk/si/si1994/ Uksi_19943017_en_1.htm last accessed 20th December 2007 6. International Organisation for Standardisation.

Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems and packaging systems. ISO11607–1:2006. Geneva: International Organisation for Standardisation.

7. Sterilization Packaging Manufacturers Council [SPMC] Sterile Packaging: The facts of Shelf Life. 2006 [online] Available from http://www.medicaldevicenetwork.com/features/feature245/ last accessed 27 April 2009

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8. Sterilization Packaging Manufacturers Council. The role of humidity on the accelerated ageing of sterilizable medical packaging. 2007 [online] Available from http:// faq.sterilizationpackaging.org/category/28 last accessed 27 April 2009 9. Herman P, Larsen C. ‘Measuring Porous Microbial Barriers Part 1.’ Medical Devices and Diagnostic Industry 2008 [online] Available from http://www.devicelink.com/ mddi/categories/Packaging.html last accessed May 2009 10. Herman P, Larsen C. ‘Measuring Porous Microbial Barriers Part 2.’ Medical Devices and Diagnostic Industry 2008 [online] Available from http://www.devicelink.com/ mddi/categories/Packaging.html last accessed 5 May 2009 11. Rutala W, Weber D. Choosing a Sterilization Wrap for Surgical Packs. 2000 [online] Available at http://www. infectioncontroltoday.com/last accessed 16 April 2009 12. Dunkelberg H, Rohmann S. Test to Determine Sterile Integrity of Wrapped Medical Products at a Probability of Recontamination of 1 : 1,000,000. Infect Control Hosp Epidemiol 2006; 27(4): 367–71. doi:10.1086/503345 13. Phillips P. Storage of Medical Disposables and Dressings. 1998 [online] Available from http://www.smtl. co.uk/MDRC/Storage/ last accessed 27 April 2009 14. Tallentire A. Effect of temperature and humidity on sterility maintenance. 2007 [Email] to McGain F. [18th July 2007] 15. Sterile Processing University. Event-related sterility – What’s it all about anyway? 2007 [online] Available from http://www.spdceus.com/ event_related. htm last accessed 16 April 2009 16. Widmer AF, Houston A, Bollinger E, Wenzel RP. A new standard for sterility testing of autoclaved surgical trays. J Hosp Infect 1992; 21: 253–60. doi:10.1016/01956701(92)90136-A 17. Rutala W. Effects of long-termstorage on sterility of medical supplies. Am J Infect Control 2006; 34(4): 248. doi:10.1016/j.ajic.2005.09.008 18. Webster J, Radke E, George N, Faoagali J, Harris M. Barrier properties and cost implications of a single versus double wrap for storing sterile instrument packs.

Am J Infect Control 2005; 33(6): 348–52. doi:10.1016/ j.ajic.2004.11.010 19. Webster J, Lloyd W, Ho P, Burridge C, George N. Rethinking Sterilization Practices: Evidence for EventRelated outdating. Infect Control Hosp Epidemiol 2003; 24: 622–4. doi:10.1086/502264 20. Mayworm D. Sterile Shelf Life and Expiration Dating. J Hosp Supply Process Distrib 1984; 2(6): 32–5.

21. IAHCSMM. Sterility Maintenance: Sterile Storage and Transport Standards. Lesson Number 102. 2008 [online] Available from https://www.continuinged.purdue. edu/lessons/pdf/Lesson102.pdf last accessed 16 April 2009 S U P P LY L I N E – S E P T E M B E R 2 0 2 1

22. Dunkelberg H, Fleitmann-Glende F. ‘Measurement of the microbial barrier effectiveness of sterilization containers in terms of the log reduction value for prevention of nosocomial infections.’ Am J Infect Control 2006; 34: 285–9. doi:10.1016/j.ajic.2005.09.012 23. Dunkelberg H, Schmelz U. Determination of the Efficacy of Sterile Barrier Systems Against Microbial Challenges During Transport and Storage.

Infect Control Hosp Epidemiol 2009; 30(2): 179–83. doi:10.1086/593208 24. American National Standards Institute [ANSI] & Association for Advancement of Medical Instrumentation [AAMI] Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 Arlington; Association for Advancement of Medical Instrumentation.

25. US Food and Drug Administration. FDA offers tips about medical devices and hurricane disasters.

2008 [online] Available from http:// www.fda.gov/cdrh/ emergency/hurricane.html last accessed 26 April 2009 26. Australasian Health Infrastructure Alliance.

Australasian Health Facility Guidelines. 2007 [online] Available from http://www. healthfacilityguidelines.com. au/ last accessed 8 May 2009 27. Department of Health. Health Building Note 13.

Sterile Services Department. 2004 London; The Stationary Office.

28. Steering Committee for Decontamination of Reusable Invasive Medical Devices [SCDRIMD] Health Service Executive Code of Practice for Decontamination of Reusable Invasive Medical Devices. Part 3: Recommended Practices for Central Decontamination Units. 2007 [online] Available from http://www.hse.ie last accessed 16 April 2009 29. National Health Service Scotland. Health Technical Memorandum 2010. Part 5 of 6. Good practice guide.

Sterilization. 2001.m Healthcare Infection T. McAuley 136 30. Centers for Disease Control [CDC] Guideline for Disinfection and Sterilization in Healthcare Facilities.

2008 [online] Available from http://www.health.gov.on.ca/ english/providers/program/infect ious/diseases/ic_cds. html last accessed 16 April 2009 31. Association of peri-Operating Registered Nurses [AORN]. ‘Recommended Practices for Selection and Use of Packaging Systems for Sterilization.’ AORN J 2007; 85(4): 801–12. doi:10.1016/ S0001-2092(07)60155-0 32. Valleylab SP. Labeling and Use Guidelines. 2005 [online] Available from http://www.valleylab.com/ education/hotline/pdfs/hotline_0512. pdf last accessed 17 April 2009

The conference was postponed not cancelled!

Make sure you are registered to attend in March.

Click on this link to find out more information and register your attendance: https://nzssa.org/conferences/ The executive is pleased to advise that scholarships to attend conference are available. Check out the scholarships page on the website: https://nzssa.org/scholarship/ Leaders Meetings Next meeting: January 2022 There have been two meetings by zoom in 2021. The next one is in January, also by zoom. It was decided by those present that these meetings will be every two months by zoom to enable networking and keeping up with what is happening.

The meetings are for people in leadership roles (Managers, Team Leaders, Educators, Quality Facilitators …) at an operational and strategic level. If you wish to participate in these meetings make sure you are on the leaders list. To be added to the list email: nzsterilescienceassoc@gmail.com Midland CSSD Regional Seminar Saturday 4 December 2021, Tauranga Hospital Education Centre This is a popular meeting which has had to be delayed due to CoVID. All going to plan it will be going ahead in December!

Watch the or changes.

NZSSA

website

for

any

updates

33. Cook Medical. Sterilization of Reusable Products.

2009 [online] Available from http:// www.cookmedical. com/help.do?id=456 last accessed 26 April 2009

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IQ, OQ, PQ- The Impact on the CSSD department The terms installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) are bandied around very frequently since mentioned first in our national standards when they came out in 2003. Prior to this we used to refer to validation of the equipment and processes. The term validation has many different meanings to many different groups but initially it was a wide-ranging term that encompassed the operation of the equipment and its ability to interact with the loads as presented to achieve a task.

Validations carried out before 2003 on equipment had multiple areas covered in one document that showed a combination of factors without mentioning each detail specifically. The old validation reports were generally carried out by the use of independent certified test equipment and observation with greatly experienced trained technicians provided by the service company or sub-contractors.

In our AS/NZS 4187-2014 we find the three terms that now cover what a validation report prior to 2003 used to accomplish.

• Clause 7.2 Installation Qualification • Clause 7.3 Operational Qualification • Clause 7.4 Performance Qualification Let’s start looking at these one at a time and without going into too much technical detail to begin to understand what each term refers too and what group or groups will be responsible.

Installation Qualification: This doesn’t cover the equipment with regards to what the equipment does but covers the services to the equipment in relation to the services being appropriate for what the machine is required to do.

The first part of installation qualification is that the services meet the requirements of the manufacturer of the equipment. It is no good having water pressure of 2 Bar if the machine needs over 3 Bar to work reliably.

This also includes items that are often forgotten such as airconditioning, plant room extract air, humidity, placement of temperature controllers and lighting.

This shows that installation qualification of services is specific to only your equipment. This testing and

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

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signing off process is done when the equipment is first installed. If the quality of the services drops often that will be discovered straight away when the equipment stops working and not picked up during the next performance qualification period. Examples of this might be the drains get blocked and the floor floods. The fault is repaired quickly. Wet loads in steam sterilisers would see the steam reticulation system checked in between its regular service routine. Important services such as steam that have many working parts will have planned preventative maintenance work as well.

The second part of installation qualification is the quality of 2 specific services. Water and Steam. These two are mentioned specifically because they have a potential impact on the process for washer disinfectors and for dedicated steam generators, steam sterilisers and endoscope reprocessors. They are repeated as often as required in standards and they need to meet clear criteria set out in many tables in AS/NZS 4187-2014.

Tables 7.2 for washer disinfectors, 7.3 for thermolabile endoscope reprocessors, 7.4 for dedicated steam generators.

Table 8.1 for testing frequencies of the above equipment. For steam testing requirements refer to 7.2.3.2 All services included as part of the installation will need to meet New Zealand Electrical and Plumbing regulations and steam sterilisers will also need to comply with pressure vessel regulations in relationship to seismic restraints, and certification. The responsibility for these requirements is covered by two groups.

1.

For services such as electrical, plumbing, steam and ventilation the contractors

installing the services will independently supply

certificates and a PS4 certificate showing

compliance and correct installation.

2. The installer of the equipment and an outside body such as SGS inspect the installation of steam sterilisers to sign off on seismic restraint and New Zealand certified pressure safety relief valves.

Operational Qualification: This is all about the equipment. It covers the safety features of the equipment, the performance of the equipment to carry out repeatable operations or cycles in the correct temperature range. This is before any loads have been presented to the equipment. This is done when the equipment is first installed, and any good maintenance routine will check these functions every service so in effect it is carried out multiple S U P P LY L I N E – S E P T E M B E R 2 0 2 1

times in a year. It is also done again if the equipment is moved or relocated or had any major repair. It is all about the machine working safely and correctly as per manufacturer’s specifications. Also, full compliance with all New Zealand health and safety codes of practice and regulations. For example, correct working of emergency ‘stop’ buttons positioned in the correct locations for each type of equipment that requires these devices.

Performance Qualification: This is all about the load that the department presents to the equipment and the machines ability to process that load to the standards of the day. Up to this point we have proven that the services to the equipment are satisfactory and that the machine is functioning as it was designed and there is no reason for a mechanical failure during the performance qualification process.

Now at this point it is taken for granted that the PQ process will pass but that is not strictly factual. There are many factors relevant to washer disinfectors, steam sterilisers, low temperature sterilisers and ultrasonic machines. Some examples of these variables are the manufacturer’s loading patterns and parameters, chemistries, types of materials the instruments are made from, packaging (wraps, flexible packaging), load presentation, service supply fluctuations, air conditioning and many other variables.

What a good performance qualification does is establish the most successful parameters of the process that should bring about the greatest reliability of consistency in the process. It is not about creating an impossibly difficult load that doesn’t exist in the normal work routine and which may be outside the scope of the equipment manufacturer’s maximum loading. Qualifying such a load is pointless as it isn’t a representation of the department’s normal processing requirements and does not add value.

If performance qualification is about the load and the process interacting with the equipment and not about the equipment alone what potential does this give us when someone thinks a change needs to be performance requalified or as many still refer to it as, validated. There are several considerations that will determine the correct action.

In standard AS/NZS4187:2014 section 10 and appendix A clause A10.5, assessment of change for maintaining process effectiveness provides important guidance on the steps required for any change minor to major.

Looking at section 7 of AS/NZS 4187-2014, the clause 7.1.2 note also gives us an important clue.

“In the case where process cycles using the same load configuration only differ by the length of different phases, the cycles being tested could be the shortest cycle proposed for validation and the longer cycles can be validated by extrapolation”

Let’s look at this in context of the type of change that occurs naturally in the reprocessing department.

1. Minor Changes

a) What this means in practical terms is that if you change for example a washing phase from 5 minutes to 8 minutes

b) Increasing drying time on a steriliser from 30 to 35 minutes or sterilising from 4 minutes to 5 minutes

c) Or increased the chemical from 3mls/litre to 5 mls/litre These minor changes do not need performance requalification however the change does need to be documented and reason for change expressed so there is a rationale for the change and proof of the desired outcome being achieved. However, if you decrease the time or chemical dosing it would need to be performance requalified.

2) Larger Changes

a) Change chemicals used in a washer disinfector, like for like or similar chemistries

b) Change wrap material in a steam steriliser

c) The water supply or steam supply was changed These changes and other similar changes need to be further evaluated. All evaluations should be documented so you have a trail that shows your logic and the process you have done to make sure there are no adverse effects. For a water supply change you can get water testing done to show that the water is of the same or similar quality as when validated. For steam the same testing can show no adverse effects.

It becomes harder when we look at chemicals and wrap changes however there are steps to check for change in outcomes or results. You can use your testing consumables inside wash loads to show that the chemical is still removing the indicators in addition to visual inspection, or inside wraps air is still being removed and steam is still penetrating by using type 5i steam indicators inside the packs with biologicals next to each indicator. Doing these tests 3 times with documentation can show repeatability and performance levels are been met. Dryness of a steam steriliser load with a new wrap is a visual test done after the load has finished drying and cooled down to atmospheric room temperature.

These steps mentioned are actually performance qualification tests that can be done in house, documented and they don’t need the use of independent certified test equipment inside the equipment loads because the machine itself hasn’t been changed and based on previous history you know that the temperature hasn’t changed or that the timer hasn’t become less reliable.

The only time for these changes you may consider using the independent certified test equipment is if the last

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years report was due to expire in the next month or two and then you can combine processes to minimize costs.

3) New Processes

a) new sets never before used, new product family

b) new temperature range not used before 121ºC instead of 134ºC

c) faster cycles with shorter phases These changes require the new process to be completely revalidated (performance qualification (PQ)) from handling through to the machine process. Performance qualification using independent certified test equipment as well as testing consumables should be completed after the sterile service has verified the process will achieve the specifications. The purpose of completing the performance requalification is to learn if there are any adverse effects such as incomplete cleaning, dryness issues, instrument damage or wrap damage. You don’t revalidate all loads just the new process.

Don’t bring in your experts for testing until you have confidence the process will pass. What does this mean.

Ideally unless there are specific time constraints such as the need to switch to a new product due to supply issues you will take the time before bringing in the validation company to have run your own test loads/ sets and have used testing consumables and visual inspection to verify the process is fit for purpose. This way you will have confidence that the performance qualification will pass first time and not involve having to repeat any loads due to unexpected failures.

The reason is to limit pressures such as time required for completing performance requalification and cost involved with bringing in contractors and the potential for the process to be repeated if further improvement is required.

Your process would look similar to this • Document the new process and the logic behind your choices. Instructions for use would be referenced • Set up any new cycle in the machine required or if you can use an existing cycle add it to the documentation • Run the new load in the machine with the correct testing consumables • Visual inspection of the load and the testing consumables to check for inconsistent results • Repeat above three times and document results • Call in the validation company to carry out the performance requalification.

Conclusions In summary I would start by saying “if in doubt check it out” with manufacturer’s instructions for use, standards, peers, industry experts, . Prove, Test, Prove, is an apt process when patient and staff safety is in question. Changes to services and machines require IQ and OQ. Changes to your loads and processes require documentation, testing, and proof of no adverse effects but it doesn’t always require a full machine performance qualification. It may be external testing with consumable testing products, or it may be 1 load repeated 3 times with test equipment.

It is important to understand, what was changed, why was it changed, what effects could be possible, is the outcome still the same?

Why? We all need to become experts and to understand how the national standards and the equipment and the loads interact. Healthy discussion and examination of changes and repairs will provide the best outcome with the correct cost and ensure patient safety. This maintains a high-quality management system. We don’t want potential problems to slip through the cracks and we also don’t need to overcomplicate, overspend and create issues that aren’t there. They will cause unnecessary delays and time constraints and put pressure on departments.

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Vear Surgical is a New Zealand based company specialising in repairs and servicing of high quality surgical instruments and accessories. Vear Surgical can also facilitate design and development of custom instruments and prototypes to meet your unique requirements within the medical industry.

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NZSSAProcessing Membership Processing NZSSA Membership The management of memberships has been reviewed and the following process is what will be followed going forward.

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https://www.gesa.org.au/education/clinical-information/ There is also a presentation on the new edition which can be viewed if you register as a GESA Education Participant.

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InterMed Announcement

NZS 8134:2021 NZ Health & Disability Service Standards The new standard is now available via Standards NZ:

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InterMed is proud to partner with Healthmark as the exclusive New Zealand distribubtor of their Sterile Services product range

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S U P P LY L I N E – S E P T E M B E R 2 0 2 1

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For more information about Whiteley products visit www.whiteley.co.nz or call the Product Support Hotline on 0800 257 352 Trademark Whiteley Corporation Pty. Ltd. © 2021 ® tRegistered he journal of NEW ZEALAND STERILE

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NZSSA Executive 2021-2024 President: Shelagh Thomas CSSD Hutt Hospital Private Bag 31907 Lower Hutt 5040 Phone: 04 566 6999 ext 2745 Mobile: 027 589 6473

Secretary: June Isted Sterile Services Unit Hawkes Bay Hospital Omahu Road Hastings 4120 Phone: 06 8788109 ext. 6597 Mobile: 027 727 3048

Email: shelagh.thomas@huttvalleydhb.org.nz

Email: june.isted@hawkesbaydhb.govt.nz

Editor: Tracey Kereopa

Paul Moody

Sterile Services Wairarapa District Health Board Masterto Mobile: 0275 829 541

Senior Product Development Manager Fisher & Paykel Auckland

Email: Tracey.Kereopa@wairarapa.dhb.org.nz Karen McCormick CSSD Manager Capital & Coast District Health Board Wellington Email: Karen.mccormick@ccdhb.org.nz

Martin Bird Sterile Services Dunedin Hospital Private Bag 1921 Dunedin 9054 Email: martin.bird@southerndhb.govt.nz

Sharon Moss National Sterile Services Manager Southern Cross Health Christchurch

Aileen Derby CSSD Manager Counties Manukau District Health Board Manukau

Email: sharon.moss@southerncrosshospitals. co.nz

Email: Aileen.Derby@middlemore.co.nz

Maureen Scott Sterile Services Waikato Hospital Pembroke Street Hamilton

Jenny Carston CSSD Manager Bay of Plenty District Health Board Tauranga Email: Jenny.Carston@bopdhb.govt.nz

Email: Maureen.Scott@waikatodhb.health.nz Treasurer: Alison Stewart NZSSA Treasurer 28 Brighton Street Island Bay Wellington 6023 Mobile: 021 209 8127 Email: nzsterilescienceassoc@gmail.com

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