36 min reading time

The Association for the Advancement of Medical Instrumentation (AAMI) has a seven-point plan to improve patient safety in reprocessing reusable medical devices. The action items are:
1. Gain consensus on “how clean is clean” and on adequate cleaning validation protocols for reprocessing reusable medical devices.
2. Create standardized, clear instructions and repeatable steps for reprocessing whenever possible.
3. Pay early, iterative, and comprehensive attention to reprocessing requirements throughout the device design process.
4. Make human factors and work environment factors priorities when developing reprocessing requirements.
5. Improve information collection and sharing to broaden the use of best practices in reprocessing.
6. Improve reprocessing competencies by strengthening training, education, and certification.
7. Create a greater sense of urgency and understanding throughout the healthcare community about the consequences of inadequate reprocessing.

It’s an ambitious plan given the obstacles. What advice can you share about these challenges?

> How can manufacturers agree on what “clean” means for a spectrum ranging from endoscopes to catheter trays to wheelchairs?

> Nurses complain, “There are thousands of reprocessing protocols. How can we practically follow unique instructions from each manufacturer?”

> Manufacturers of materially identical devices may publish different protocols. Is there an incentive to compete on “easier to clean?”

> Perhaps a verboten question: As important as patient safety is, are manufacturers really motivated to address this issue or is their participation (and inevitable changes to labeling) another expense with no revenue upside?

++++++++++

If you need medical device distribution, take a look at http://medgroup.biz/hida .

Our friends at the Health Industry Distributors Association are gathering distributors from all over the world (September 24-26) in Washington D.C.

See http://medgroup.biz/hida for details of the special offer they made for Medical Devices Group members.

++++++++++

Discussions You May Have Missed

Best way to find strategic partners to introduce medical devices?
http://linkd.in/str-ptnrs
Average distributor markup on medical consumables?
http://linkd.in/dtr-markup

A Harder-To-Get CE Mark
http://linkd.in/playing-hard-to-get

++++++++++

Make it a great week.

Joe Hage
Medical Devices Group Leader

---

Mark Schnapf
Senior Project Engineer at Medtronic
I worked in Quality, R and D, and Regulatory Departments of one of the largest third party reprocessors of medical devices in the U.S. I worked there for more than 10 years and was hired during the Medical Device Harmonization Act around 2000. It was then that the reprocessing industry underwent some needed changes focusing on Quality Systems, GMP, GLP, and validation of the cleaning and sterilization processes. Every type of device had to be characterized as if the 3rd party reprocessor was the manufacturer of the device because as soon as the cleaning process would begin the device surfaces were modified. We conducted studies and published manuscripts with the AOAC proving the safety of reprocessing and sterilizing cardio imaging catheters to be greater than that of a new one.(this occurs because of the amount of leechable substances or volatile and non-volatiles from a new catheter is greater). This industry was under constant scrutiny and attack from the large device manufacturers using endless dollars to lobby in Washington in the US Senate and conduct studies attempting to disqualify our research studies. When I eventually moved on from the reprocessing industry to advance my career, we were bought by Ethicon (a division of J and J, one of the biggest device manufacturers’ in the world). Our competitors’….. well, they were bought by Stryker. “If ya can’t beat them.. join them”, Or.. buy them! Seems to be an appropriate for what occurred. Anyway, using an internationally, harmonized set of scientifically validated standard processes that are focused on quality can have a significant positive impact on an industry. Continual process improvement by the companies and transparency regarding FDA and ISO device approvals are works in progress. But the safety of the industry as a whole I believe is better than it was 13 years ago.

on the brighter side,
Mark Schnapf

Thomas Dr. Fengler
Owner at CMP Cleanical Medical Processes
Cleanliness remains an important issue for a good performance in any kind of surgery. Joshua, we all know that it is impossible to provide the surgeon exclusively with disposables. There are at least four reasons:
1. From the point of environmental concern
2. Availability of the specific medical device
3. Costs
4. “Remanents” – a huge pack of disposable garbage
Let us go back to the consideration of cleanliness and how to measure it.
Which parameters do we have, what kind of remanents are important and how to standardize standard operation procedures (SOP)? We need decontamination sciences in university.

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Dear Paul
You bring up an important strategic aspect into this discussion regarding cleanliness in the medical devices sector. Your statement “everyone has a different interpretation of just what is clean and sterile depending on his or her knowledge or device sector”. I fully agree with you. However some people look at this issue beyond the industry tunnel vision. I dare to say that the closer one gets to a patient the more defined the interpretation what is clean. Her some view points:

As patient I want a perfectly clean implant, endoscope etc. I simply don’t want any risks.

As surgeon I would know that achieving 100% purity is almost impossible to achieve but I would not procrastinate and to undertake anything to get close to the 100 % – because any problem with nosocomial infection would damage my reputation and income.

As factory worker in a large medtech company I would do my job according to job description and if the management doesn’t provide the appropriate tools than this is their problem.

As Manager I am getting paid on how profitable I run the company. The Regulators define what has to be done. I need total control over my workforce to adhere to the regulatory requirements , to maximise output and to reduce cost.

As owner of a going company I do everything that the regulator demands and I watch costs to assure physical growth of my company.

As Owner of company that creates new-to-the-world products/technologies to addresse real & big issues such as reducing nosocomial infections and reducing cost in Hospitals. We conduct research for many years to understand how dramatic the “clean problem” is in the market. We also assess if there is a readiness for testing new “problem solvers”. Often we observe that some target client only want to shift the responsibility for solving the problem to another level with all kinds of rational reasoning. To solve a particular problem we have to evaluate new technologies that may solve all or part of the problem. Everybody in such a business knows that the path to a tangible solution is long and cumbersome. To go this path is realistic only through serious fundamental and applied research followed by prototyping. During this time one is surrounded and followed I call it the “1 in 10’000 ratio”. Entrepreneurs normally commence a project with few very trustworthy, hardworking and innovative partners. Gradually they become known and attract thousands of hangers-on who want to participate in their success. Hangers-on range from straight thieves who attempt to steal something from you to consultants who try to sell you’re their wisdom. As entrepreneur you have invested incredible amount of your own venture capital and thousands of unpaid working hours. What you need now is to reduce ballast and to reduce the ratio to say 1 to 10 that is you associate with people that offer you real capital, passion and trust so that you with your team will be able to achieve your goal of improving the world. The entrepreneur is totally possessed with a will to undertake everything to reach his goal.
As regards our project we now have the fundamentals in place and gearing up to find 10 to 20 trustworthy partners. After that we test through our new equipment the hypothesis that only 100% clean devices will lead to reduction in nosocomial infections.
Regards Willi

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Dear Kanwal
Not as simple as you think. You are mixing up some terms.
Selectivity has different definition on industry sector. In chromatography selectivity is “relative retention rate”. Bond strength of biomass is not only dependent on surface chemistry (Pi-Pi interaction, Hydrophobicity, Dipole-Dipol, Hydrogen bonding, Ion exchange, Ion Pairing etc.) but also on the surface mechanical structure.
Cleaning does mean transporting biomass away. Unfortunately it is impossible to carrying all bio-organics particles and molecules away. Hence one has to sterilise the item either thermally, chemically or by various forms of radiation. All these processes modify the residual bio-organics more or less,(Is dependent on particle or molecular structure. E.g. ethoxylation, oxidation etc.) Some molecules/particle are often more stabile than the under laying materials e.g Prions or LPS.

Plasma is an activated gas (very small gas particles). They are located on the surface, inside some bacteria or in or surrounding large prion molecule. We can now activate the gas with various types of energies to produce radicals, electrons etc. As indicated in our website we have studied very many plasma parameters and their interaction with bioorganic and organic molecules/particles. Thus we know which parameters to engage to break molecular bonds effectively. With 9.4I eV we break C triple bond N and with 8.41 eV C=O. and how we do this is of course our knowledge. Important for the user is the process result.
As soon as we take the energy away the activated particles return to a stabile form of small molecules e.g. CO2 .
We don’t want to bore people in this forum with complex plasma physics and chemistry. My aim is to show that we have done very serious research and development and arrived at a most advanced process that can do what the other sterilisation processes do but our process can do much more. We understand what we are doing and because of that we have rational process control. We are specialist and will use this special knowledge to make the world a safer place, to reduce nosocomial infections and growing cost in hospitals. Thus we search now for serious equity investors that realise that we can create a new products, job opportunities and industries by solving unsolved problems.

You mentioned food industry. In the food sector we don’t talk about sterilisation, we use the term disinfection. In this sector one faces very heterogeneous materials which vary from provenience to provenience. That requires totally different plasmas and another 5 to 10 years fundamental research. We have successfully eliminated various pathogens on Herbs and spices, Strawberries (shelf life extension) and Carrots. We also designed a process to clean pre-packed salads. The problem with the food sector is that it consists of about 90 % micro enterprises who operate with very small profit margins. They don’t have the funds to invest in new technologies. It is cheaper to compost contaminated food than to treat it.
Regards Willi

Paul M. Stein
Chief Scientist, Inventor, and Entrepreneur – Dedicated to the Treatment of Critical Unmet Medical Needs
Way up above, Willi brought up the issue of prions, something Medtronic got into trouble for in the past week regarding device re-use. Obviously, everyone has a different interpretation of just what is clean and sterile depending on his or her knowledge or device sector. But, we all must be aware of ALL of the issues of safety, and if a device cannot be made perfectly safe by all scientific accounts, it should not be re-used.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
Thank you for sharing.

I have read the information on your website, as also on the food discussion forum.
Obviously there are several aspects that come to mind.

One key aspect is the selectivity of the plasma interaction with the microbe/virus, fungi as against the base material being cleaned. Selectivity is a function of bond strengths of the microbe/virus etc on surface of the substrate that is being cleaned vs. that of the material that is being cleaned.

Second, if the plasma is to reduce the microbes/ virus etc to the element level to escape as gases, then very high reactivity is to be ensured. This would raise the above issues to a more significant level, in my understanding.

I am sure youwould have looked at this aspect. Hence seeking information.

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Nosocomial infections, a horrendous problem for devices manufacturer, users and patients!
Unfortunately, known sterilization processes are insufficient for today’s requirement. Many devices carry residual bio burden that interact with our immune system. To solve the problem requires removal and not only inactivation of all bio-organic residues on surfaces without changing the under-laying materials
For group members interested in sterilization technology, give [http://www.koldsteril.com%7Cleo//plh/http%3A*3*3www.koldsteril.com/j6iL?_t=tracking_disc]] a look and share your feedback. We are trying to find direct investors that have a direct interest in reducing nosocomial infections, producing sterile endoscopes, implants and other medical devices
Regards Willi

Willi Glettig
Owner of LCC Engineering & Trading GmbH
I agree with Kanwal Jit Singh – cleanliness has in every sector a different interpretation.
Cleanliness is one of the many contributors to HAI. I tend to look as patient at the HAI issue. I watched the emergence of Singe Use Devices in hospitals – The tremendous growth of the SUD industry is due to our incompetence to properly clean, sterilise and recycle devices.(It has of course created tremendeous wealth and job generation opportunities for the plastic sector) In the meantime however SUDs have become the second largest account in the P&L of Hospitals. Now the cost pressure has become so large that some hospitals have started to buy recycled devices. Nevertheless, we are still incompetent to create perfectly clean devices because we have ignored to evolve high quality cleaning, sterilisation and recycling technologies.
In recent years many book were written on the growing amount of failures and disasters in all kind of sectors (Why we make mistakes, Joseph T Hallan, Why most things fail, Paul Ormerod etc etc). We have created many experts – who have forgotten to improve existing technologies. The experts rather focus on creating their own technologies. Venture Capitalist finance only sexy technologies – nobody is interested or has the stamina in advancing existing processes with novel technologies. What matter is a quick return and certainly not “a benefit of humanity”. The 12% of unemployed in Europe (30% youth unemployed in Spain, Greece ) have started to create unrest in society (Unrests in the Maghreb countries, farmers in China, textile workers in Indi and Bangladesh are part of the unrest) . The all scream loud “ Do not forget our basic problems and needs, we are finally the financier and user of new technologies).
Since almost a decade I am collecting reports and information about cleanliness in a number of fields and I don’t see much progress to the better. The medtech sector is also showing concerning signs of slow down. We are now in a world where patients consult first the Internet on possibilities and risks. The often know very well to what risk they are exposed too when replacing a kneecap or doing an endoscopic procedure. For many patients it is easier to trust Google more than the “biased strange person in the white coat.” I believe we have to go back to improve technologies that have not been advanced during the past one or two decades and to show patients that there is progress. I just hope to be able to show soon (in say 12 to 24 month) that we are “changers” and not philosophers.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
Cleanliness in medical devices, pharmaceuticals, food etc. is significantly different issues from HAI.

In medical devices, cleanliness requirements in devices sold by the manufacturer is significantly different from the cleanliness requirements for reprocessing devices – whether single use or others.

Hence the focus has to be clear.

I find Willi’s comment rather interesting.

The world is always moving forward, and the newer generations will improve on the existing aspects – that is a given. Quantum leaps are experienced when the change is at a conceptual level.

Willi Glettig
Owner of LCC Engineering & Trading GmbH
This thread is interesting because it poses an open-ended question to many stakeholders in the Medtech industry. Everybody is invited to democratically answer the questions as he perceives the issue of cleanliness.
From my own investigation the Medtech market have many different stakeholders with different perspectives and needs. This Linked-in thread focusses on professional groups and not on patients. As entrepreneurs we know that in every market there are the “seekers”, the “preservers” of the status quo, the “changers” and the “couldn’t care less”.
The “seekers” know through rationally collected data or through observations that something is wrong e.g. with regards to cleanliness. They are looking around for new and better methods, new strategies etc. Some do it because they want to improve their personal security, some for wealth generation and some want to investigate and become experts in a particular field etc.
Any existing process/method/industry provides jobs, incomes and careers to many kinds of people. The “preservers” are convinced that what they are doing is of high quality and good for themselves and society. The last things they want are people that questions or criticize what they are doing.
“Changers” is a very small group of people. They have technical concepts and clear strategies to solve a particular problem. Most of them are possessed with a determination to improve the world with better solutions. They get the ball rolling by investing their own risk capital. “Changers” constitute a real threat to the “preservers” since they challenge their status quo with potentially better solutions. “Preservers” undertake anything to slow down or eliminate “changers”.
The last group of people, the “couldn’t care less” are fairly apathetic about progress in our world – they are hardly the decision makers or people with strong opinions.
My observation is that about 15 to 30 % of an industrial segment population are “seekers”, 15 to 30% are “preservers”, may be 0.1 to 1% “changers” and the rest are “couldn’t care less”.
Reading through the responses I sense that about halve were written by “seekers” and the rest by “preservers”. All comments indicate that cleanliness in medicinal technology is a real issue of concern. Everybody knows about the real existence and problem of nosocomial infections. The problem today is that we don’t have many people that commit them-selves to solve such a problem or people that are ready to finance such people.
Medtech is a paradise for creating new problem solutions and for creating new job opportunities and industries. Unfortunately, regulation authorities don’t have viable strategies and commitment to exploit such opportunities. Ultimately it will be “changers” (entrepreneurs and not managers) that invest their own risk capital and energy to advance a particular industry – lets hope the western societies is rediscovering and supporting such enfant terribles.
Dear Shawn if we seriously aim to eliminate HAI than we have to move into an extreme, to zero bioburden (we all measure different different things and we realy dont know which type of molecule/metabolites may initiate an infection, cancer or toxic shock etc.) We then have to take the challenge to come-up with viable technologies that eliminate and measure residual bioburden competitively.

Shawn Huelsman AAS-ST, BSHM
Assistant Chief, Sterile Processing Service, VA Northeast Ohio Health Care System
Here is a question to throw out there. My current bioburden percentages are around o.oo4% given the amount of instrumentation we process. I do not feel that this is not good enough. We run protein tests in my washers daily, I run biologicals during every sterilization cycle, and when we Ruhoff endoscopes, I don’t settle for the passing score of 45′ I look for passing scores of 0-5. I also know that bioburden episodes that we have had were discovered by peri operative staff prior to contact with any patient. So how do we reduce this percentage? Any suggestions, because our customers do not see 1 in a million in instruments proceeded, but see one or two that month or that week.

Thomas Dr. Fengler
Owner at CMP Cleanical Medical Processes
Apropos “good ´cleanical´ practices”:
I would like to add the link to our clinical study we performed once in 6 hospitals, with 6 different instrument designs, 6 samples each, and 4 different analyzing methods after elution of the surface (and before the thermal disinfection: [http://www.cleanical.de/media/pdf/FreeProt.pdf|leo://plh/http%3A*3*3www%2Ecleanical%2Ede*3media*3pdf*3FreeProt%2Epdf/hKVa?_t=tracking_disc]

WahTong Lee
Chairman & Co-Founder of Soniclean Pty Ltd
Joe, I commend on your 7-prong attack on what is industry outstanding unresolved issues, to Willi looking at the solutions as a business case, particularly at the basis of enterpreneurship perspective which is about galvanising innovation with business processes. Or the profits that comes from a job well done. Then Thomas provided a simple straightforward requirement from the quoted Standards.

Ultimately, the industry must drive the quality of outcome for patient safety. The practitioners working with the innovators, and if necessary the manufacturers.

The standards committee members will likely benefit from our discussions arising, providing their input during the next standards review.

At the break-neck speed science and technology is developing, surely there must be ‘101’ ways of addressing these outstanding industry issues and problems?

Perry Mykleby
Customer Activation, Engagement & Retention
Intriguing thread, Joe.

Chuck Fishelson
Vice president at alfa medical
Hello All great discussion,
if anyone has questions specific to sterilization of instruments, please let me know

Stephen M Kovach
Director of Education at Healthmark Industries
DR.Fengler, I agree with you, someday we will get there,calculable/controllable, and when we do we will still have that human factor,but I hope we can get there.
Great comments on a subject everybody who is taking part wants to solve and provide better patient care.

Thomas Dr. Fengler
Owner at CMP Cleanical Medical Processes
What is wrong about Steve´s comment? In fact, we are undergoing actually the difficult discussion in which way a stardardization of “allowed” remanents will take place. Look at 15664 part 5 where we find the description of typically used test soils and so on. We need experts to make sure that we do meet the clininal necessary needs. Maximum contents on a sample or on a surface? What is tolerable for small and big instruments? Do we regard remanents of blood or also of other matter? The solution in fact is not trivial and decontamination is considered as calculable/controlable.

Shawn Huelsman AAS-ST, BSHM
Assistant Chief, Sterile Processing Service, VA Northeast Ohio Health Care System
Steve cannot agree with you more. I have been in surgery for 16 years doing everything from scrubbing, circulating, first assisting, endoscopy, transplant, QAPI, and now sterile processing. All of those yeas I have always used surgical conciousness in order to ensure the quality of care given to the patients I served. Complex IFUs make it harder for us to complete our mission. Manufacturers and front line staff need to come together in product development in order to ensure cleanliness of instrumentation in order to prevent the potential of surgical site infections. It also needs to be realized that SPS or SPD is the department that initiate infection control practices. Attention has been diverted to prophylaxis antibiotics. This is great for some patients, but big concencentration should be on proper disassembly, visualization, decontamination of bio burden from objects, and the proper sterilization methods of these items.

Stephen M Kovach
Director of Education at Healthmark Industries
All I can say is I have enjoyed this link. Where have you all been the past 25 plus years ? When this topic was being addressed in the CSSD and people thought many of us crazy for taking about cleaning verification for a user, not cleaning validation for a manufacture. That is different.
How many of you can really say you have worked 8 hours in a hot hospital decontamination department and cleaned items that have been dried in blood for 4 hours and be told they need it now.
R&D and real world are two different arenas.
People have to have the time,space and the correct tools along with the IFU to get a medical device clean according to the original manufacture of that device.
Keep this going, I am learning a lot.
thank you all.

April Gibson
Science Teacher at Kingsmead School
Product development- Everyone knows as previously commented on that bacteria, viruses, pathogens, all the things that we can’t see are the problem. We all appreciate the pressure of attempting to keep devices clean and we all know that as soon as you have cleaned an item, within (lets be generous) an hour it is contaminated again from airborne bacteria. Aside from this we are the carriers of these microscopic hitch hikers and approximately 80% are transferred by our hands causing copious amounts of cross contamination and infection.

Manufacturers, why not create surfaces with antimicrobial PROTECTION which kills all microbes by up to 99.99% and if you use BioCote a minimum of 95%. Everyone thinks it is a great idea, the government just need to put their plans into place for PREVENTION not CURE. Everything is cost driven and accepted but why not spend the money on the prevention rather than the cure-in the long run the benefits of cost effectiveness are obvious.

Costas Chantzis
When You Need Pharma/MedDev RFT Solution$, We Deliver EVERY Time: Phone Consultation By Appt
Dear Willi,
I am very sorry if my post got you upset. I had intension neither to upset you with my alleged “pessimism” nor solicit your business. I am very blessed by GOD to be extremely busy and fairly well compensated for my services. Please check me out to see who I am … if you like. Now, to the facts and your points:

I wrote that only about 0.4% of new product ideas become new product winners in the market place. Well, that statement is based on facts, it is NOT fiction. Please see various references at the below link:
[http://www.technobusiness-solutions.com/intellectual-property-new-product-commercialization-success-rate.html|leo://plh/http%3A*3*3www%2Etechnobusiness-solutions%2Ecom*3intellectual-property-new-product-commercialization-success-rate%2Ehtml/IiS9?_t=tracking_disc]
Obviously, you and anyone else may choose to ignore the facts/history and believe whatever they wish for their own reasons.

I agree in principle about the traits of an entrepreneur. Incidentally, I have two inventions as well and have helped to develop/commercialize numerous products since 1980. So, I have been there and have done that.

Finally, I made my previous points to highlight my concerns about product development efforts in this area given the highly complex and rather turbulent environment that I believe exists based on my 32+ years of experience in thsi business inclusive of the “reprocessing busienss.” I will be among the first people to congratulate you and your team whenever your new IP becomes a successful product winner. I just hope for your sake, this event happens over the next 20 years because I doubt that I will around much longer :-)! Peace !

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Dear Costas Cantzis
I appreciate your concern and comments! As entrepreneur one is permanently surrounded by thousands of people that offer to coach, to advise or to sell their services. I am also vividly aware that the global markets are in disarray and some economies suffer very high levels of unemployment, have low GDPs , have risk averse buyers, politically biased registration authorities. The world is a dangerous place – and always was! What is changing over time is the density of the “disencouragement fraternity”, that is people that like to sell recipes for better times.
Your stipulated success rate of 0.4% I consider pessimistic. I don’t know any real entrepreneur that would pursue a business opportunity with such a low level of success. The success rate for raising raising Venture Capital is also below 1%. So anybody who wastes his time talking to VC cant be taken as serious entrepreneur. Such outcome statistics don’t mean anything, or they tell us how crazy and incompetent we are. Instead of worrying about statics we should look at the business process itself. And here again as entrepreneurs we know that most if not all business processes in the real world are conducted by people and thus random, uncertain and not reproducible. (One could also say not learnable ) Furthermore looking down the time path we also know that everything in front of us is risk, uncertainty and chaos. We know the decision we make today determines our wealth and success of the future. Consequently, with all the negative statistics in the air we have to have skills and knowledge as to how to make successful decisions. What is taught in Business schools is fundamental knowledge and not enough to make you a successful entrepreneur. If you build and turn-around companies during most part of your life you accumulate a large rucksack of special skills that enable you to choose from and cope in a chaotic world.
To become a high-tech entrepreneur you need to be curious person (this would apply to me because I respond to constructive comments) you need lots of empathy and you have to be risk averse. Making money is very important but it should never be the main reason for becoming entrepreneur. You have to have a solid family background, be ready to work long hours and you must have tremendous tenacity and an iron will not to exploit others or become come exploited by others. In a nutshell you have to be skilled to read human behaviour.
I am very optimistic about our future success. We have studied many target market including the dynamics in the various segments. We never do technology push, technology pull is common sense. You survive only with highly innovative business models that cant be emulated easily. Our accessible market is about USD 4 billion/a, cost conscientious and asleep. I speculate that we can get about USD 40 Million/a in revenue within six years of business building – many of my business friends consider this as realistic. If we fell that our target market is hard to access we can swing around and to targe other markets. As they say “Entrepreneurs are doers, it is just a question where?”

Costas Chantzis
When You Need Pharma/MedDev RFT Solution$, We Deliver EVERY Time: Phone Consultation By Appt
Willi,
Good luck with successful commercialization of your proprietary technology, etc. I am sure you are aware that ONLY 0.4% of every new product idea ever becomes a market winner. Sometimes, it has nothing to do with the basics, ex. labeling claims, price, regulations, etc. It is just NOT the right time for it. This area has been in turbulence for many years and I predict that it will continue to be so until both the user, regulatory bodies, international trends/politics (?) and environment in general are “ripe” for a transformational change. The best way to have a product succeed in the market is to use the “pull” rather than the “push” marketing approach. Which one are you using? How successful you have been with your approach? Have you gotten “lead market opinion leaders” onboard with your new product? What are your core assumptions about your product’s successful commercialization, the competition and barriers to entry in general? These are some of the questions that came to me upon reading your posts.
Costas

Jack Parr
President at Mobile Diagnostics fo Indiana
Jack E. Parr, PhD
ASTM Int’l Committee F04 has activity on standards for cleaning and testing cleanliness
of medical devices and implants, including reusing of disposables, such as endoscopes and catheters.

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Dear Kanwal Jit Singh Thanks for your deep empathy. Due to IPR reason it is at the moment impossible to divulge any details about our process. What I may add is that we take a process not only from a lab into commercialization but we started at fundamental science moved into applied science than process development and now large scale production and market development. As soon as we hit the market in whatever country we will release detailed process description.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
Thank you, WIlli for sharing your perception.

I can understand and appreciate your thoughts. It is not a new phenomenon in our world – Galileo would not have been charged as a traitor and terminated for challenging the popular perception at that time – that the earth was the center of the universe.

It is also true that the world moves from the laboratory (from the esoteric) to the real world ( a commercially viable product). It takes time and money and more than everything foresight. Coke, Xerox (to illustrate) would not have come into the real world, if the original inventors had not sold their rights to the current owners of the technology.

Your product is also moving from the lab to the commercial world – and is also following the same route. You are having the foresight and conviction that the lab results can be commercialized, and therefore putting money and time behind it. It requires something to do that – Bravo!!!

For medical devices, post sterilization, I find it difficult to imagine another process
to remove the endorphins. I am keen on learning about your technology as and when you are ready to share it, even if it begins with the concept.

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Dear Kanwal Jit Singh
As repeat entrepreneur I have built and turned around a number of new tech companies. Since twenty years I am also in Life sciences.
I believe we have three big problems in life sciences
1. Complexity – Very few theories that enable us to design new products
2. No free enterprise mentality in post-industrial societies
3. Too much money to play with. – no pressure on real value generation
Complex fields offer researchers huge possibilities to create new “prove of concepts” as paid employees and to advance their professional career. The finance people move-in with their own theories “to control burning of capital”. They think the answer is limiting and reporting. Reports don’t result in products. Finance people don’t care because they work with OPM (Other People Money) and not their own money. They get paid for their services. The amount of services and cost are gradually expanded and the product output is declining. (That is reality in the pharmaceutical companies). Prove of concept are assertions, they belong into the virtual world.
I am interested in anything that constitutes value. People that bring value have to be rewarded fairly and equitably. A theory is valuable if she is reproducible and of value to other people in various parts of the real world. Everything we do in business are random events – MBAs have very few theories reproducible. We need to go back to simplicity and patron driven medium sized enterprises as we experience them in Brazil, China and India. If somebody presents a new theory or application I ask to explain where in the real world reproducibility and value generation has been proven

I read your linked article from Falk about LPS. Immediately I knew that the real world is far more complex and the article is a product from the virtual world. If the researchers would have invested their own money to prove that their assertion is reproducible in various parts and circumstances around the globe than their article would have to be taken serious. Some high net-wealth individual (Not Venture Capitalists, Banks or other OPMs) would then have to team together with the researcher and to finance exploitation.
There are very many research articles on LPS but very few are taken further in the commercial domain. If we want to create new sustainable jobs for highly educated we have to invest less in “prove of concept research” and more in “product development” and stop exploiting the value supplier. (VC finance start-up companies with the overt intention to take them apart!) As long as governments accept such a status quo we don’t have progress in our industry. Do I make sense?

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
Willi, Thank you for the elaboration – interesting work that you do.

I may add that the lipopolysaccaride called progeny are emanating essentially for gram negative bacteria.

There is a research that I came across that provides for a possible alternate solution to yours – Lipopolysaccharide-Trap-Fc. Some information is available at
[http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2708546/|leo://plh/http%3A*3*3www%2Encbi%2Enlm%2Enih%2Egov*3pmc*3articles*3PMC2708546*3/COvo?_t=tracking_disc]
I wish to have your views on this route. Thank you.

Shawn Huelsman AAS-ST, BSHM
Assistant Chief, Sterile Processing Service, VA Northeast Ohio Health Care System
The V A has strict guidelines regarding the reprocessing of all RME. The first thing is that we have to have a manufacturer instructions for each and every product that we reprocess and sterilize. This instructions have to be very detailed and validated by the company or we can not use the product. I had one company who’s instructions were to reprocess per hospital protocols. In this day of age, hospitals are more and more dependent on there manufacturers IFU. Additionally, we consider that in order to be “clean”, the item has to be free of all biological and non biological substances prior to sterilization. This is all dependent on how well the technician inspects the instrumentation prior to sterilization. I feel the true definition is after cleaning an item, do you feel comfortable that the object is used on a patient.

Here is the problems encountered on the SPS/ SPD side of the house.
1). Some IFU are out dated and have not been tested with new technologies (I.e. sterrad), and are not consistently updated. If they are updated, the SPS/SPD is not notified.
2. Some IFU are too detailed wher it starts commenting on handling procedures instead of concentrating on the cleaning procedures
3) Some IFUs are not specific enough
4). Since there are so many IFUs, it is very hard to review each one prior to decontamination each time…..therefore we are dependent on yearly competency.
5). Loaner trays and instruments: very hard to get very specific IFUs for each instrument in set, let alone just getting IFUs when the are dropped off at the facility.

Willi Glettig
Owner of LCC Engineering & Trading GmbH
Following this thread is interesting because we have different regulations, different terms and different perceptions of what applies when. The problem is the problem of epidemiologist, regulatory authorities etc. it is simply not our problem until we get personally affected. As long as we have this condition there is no reason to believe that we ever make serious progress.
Under current legislation sterilization is “inactivation of pathogen”. Everybody knows that if we heat pathogen and large molecules with hot steam we break down these molecules and produce unknown peptides that may be bio-active and may cause problems. With lipopolysaccaride called progeny we know that they produce toxic shock and we know that they need more than 20 minutes of 320°C to be broken in smaller units.Only in the Pharmaceutical industry is this an issue. Bacteria never sit on a surface as mono-disperse layers. They grow on top of each other and build a glycogen. Most glycogen have carboxylic groups and have a huge affinity to metallic surfaces. Treating them with UV light should inactivate bacteria by breaking down some DNA strange. UV light coming from a light source is a wave that hits the top layer of the bacteria clusters. Those below dont get affected and they grow further. Most bio-chromatography know that most protein including prions have a tremendous affinity to metals and metal ions. etc etc.
So if we really want to address and solve the “cleanliness problem” without confusion we have to convert all organic particles and molecules residing on surfaces into low molecular weight gases that evaporate without affecting the underlying materials. Such a technology is what we have been developing in the past twelve years. A big hurdle is to finish of with a product that has low capital investment and running cost and is much faster than existing technologies. Our technology is 10 times faster and the cost hurdle we solve in the next 18 Month. So I am excited that in about 20 month we present to the world a new way to perfect clean surfaces.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
Wit UV light, bacteria and fungi etc can be killed, but they cannot be removed, is my understanding.

David Branscum
National Sales And Marketing Director at Cleanint, LLC
So I will leave it up to the epidemiologists, but we design products that sanitize commonly shared objects. Our goal is to develop a solution that requires little to no change in procedures. Step one: surface cleaning, 99 log 5. Step two: killing spores (Norovirus, C-Diff, etc), Step three: Airborne. We classify our solutions them in these three categories.

This of course applies to the devices themselves, and makes sure they are clean between uses. But, once the wrong person gets near or touches them, they are left to the mercy of the cleanliness of the personnel.

Re: Kanwal Jit Singh comment above: “Cleaning for organic contaminants cannot never be achieved, since after sterilization the residue of bacteria, fungi, spores, etc post sterilization would continue to exist on the device. The essential requirement is to render them non-viable.”

I believe this can be achieved with the proper use of ultraviolet light, and Healthcare Worker precautions. Unless you meant we can never remove the HCW from the environment, which can be argued.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
ISO 13485:2003 mandates the manufacturer to define the cleaning process for its equipment – Clause 7.5.1.2.1

david siong
International sales at Fuzhou Yumei Commodity Co., Ltd
I think There are different prevention and sterile protocols for different kind of contagious bionts,but it rarely has that protocols designated for medical equipment.
to discern how cleaning of the product is,in my opinion, only applying to some normal contact machine,for blood-contact or risk-disease-contact equipment, whoever want to take that risk or cleaning procedure to convince people using it again after recycle.
the reality maybe the recycle of the used equipment material and how they control the bacteria-stained and used equipment not affect the livings.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
There are two types of contaminants broadly speaking. They are organic and inorganic.

Cleaning requirements of inorganic requirements would be required to the extent that they do not pose a hazard (ISO 14971 definition) to the body.

Cleaning for organic contaminants cannot never be achieved, since after sterilization the residue of bacteria, fungi, spores, etc post sterilization would continue to exist on the device. The essential requirement is to render them non-viable.

Theo Ritmeijer
Owner, Trusc bv
Its great that finally the problems caused by not clean instruments have the attention. On the quote ” How clean is Clean” have I a simply answer, in the medical area of the CSSD clean is just how the glasses and the eyes of the personal are focused. Personal on the work floor of the CSSD can only interfere if they see a kind of rest dirt on the instrument after this is cleaning in the washer disinfection. But the dirt that is hidden or not visible is missed and remains on the surface of the instruments and will end finally, after sterilization, by or in the patient on the operating table. A lot of people will say that the instrument is sterile and treated properly. But the result after sterilization is ” Sterile dirt” what is still dirt that you not want to have in a patient! Back to “How clean is Clean” An instrument will never be cleaner than the air of the CSSD ward were the instrument is treated. And because these area’s are no clean rooms the instruments will never reached a higher level as the the air inside the rooms. But if we could succeed this result with the existing washer disinfection it would be nice. Unfortunately are the washing disinfection developed in the sixties and got over the years a lot of technical innovations, but the main part that must carry out the cleaning is still a rotating washing arm that has a huge flushing shadow. So cleaning in this kind of machines will never achieve an result as expected. For optimum cleaning the instruments must be treated as the industry treated there products. There is it possible to clean on a very high level with an on forehand settled end result. There is the allowed rest dirt documented and measured at the end of the process. If the washing machine is placed in a clean room class 2, then the result will never be better than this class. But its really clean. So if changes must be started, begin by the beginning. Start by replacing the old fashioned washer disinfection with washing techniques developed in the sixties by industrial washing machines that gives an 100% clean and reproducible instrument. And if this level is not high enough, make the CSSD area a clean room with the lowest class, then we can talk about cleaning.

I hope I brought some useful arguments in this discussion.

Theo Ritmeijer
The Netherlands

Jean Bigoney, PhD, RAC, CQE
Regulatory Affairs Specialist.
Joe, excellent idea for a discussion. I have enjoyed each and every one of the comments so far.
My opinion is that you can stop with the very first requirement, namely gaining consensus on “how clean is clean.” Take a look at single use devices, which can be processed in a controlled manufacturing environment. There is no consensus there, no guidelines, so how can we expect reprocessed devices, which are cleaned in an environment which does not routinely monitor cleanliness? I realize this came directly from AAMI and I think it is a noble goal, but in view of the lack of consensus for single use devices, I wonder how it will be possible to gain consensus for multiple-use devices.

A good starting point for understanding the overall requirements on cleanliness is here:
[http://www.fda.gov/downloads/MedicalDevices/NewsEvents/WorkshopsConferences/UCM268707.pdf|leo://plh/http%3A*3*3www%2Efda%2Egov*3downloads*3MedicalDevices*3NewsEvents*3WorkshopsConferences*3UCM268707%2Epdf/W_oA?_t=tracking_disc]

The first hurdle is to establish acceptable limits. It isn’t possible to remove each and every foreign molecule from the surface. So how much contamination can be tolerated? FDA has already said they are staying out of this discussion and leaving it to manufacturers ([http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm074922.htm|leo://plh/http%3A*3*3www%2Efda%2Egov*3ICECI*3Inspections*3InspectionGuides*3ucm074922%2Ehtm/cjIG?_t=tracking_disc]). Once an acceptable limit has been established, can this be verified? Meaning, how do you know for certain that a given impurity will not cause harm in the amount that you claim? Once an allowable limit is established, it only makes sense if cleaning procedures are monitored. This means a huge number of tests to check for organic, inorganic residues and particulates.

We have sterilization indicators that go along for the ride in a sterilizer and give immediate feedback as to the effectiveness of a steri-cycle. Maybe what we need are “cleanliness indicators” or “dummy devices” that get cleaned along with the real items, tucked into pouches and then get sent out to labs for the battery of tests in ASTM F2847. I’m sure that would cause a howl of protest as it would mean additional cost
for anyone cleaning in hospitals or dentistry. Perhaps inspectors could come in with their dummy items, ask hospital staff to clean them and then whisk them away for the battery of tests. Fail one of the tests, have your operation shut down.

Costas Chantzis
When You Need Pharma/MedDev RFT Solution$, We Deliver EVERY Time: Phone Consultation By Appt
I agree with Lucy Morris that it will be practically impossible to come-up with a harmonized Cleaning and Disinfection protocol for all reusable medical devices given there is no universally established definition of what is “clean” and/or “disinfected.” Yet, there is a definition for “sterile or sterilized” medical device.
Plausible solutions to this problem don’t exist in part because there are competing business interests and reprocessing of reusable medical devices for reuse takes place very frequently either under improper cleaning and sterilizing conditions and/or by unqualified/invalidated equipment/personnel, see Chet Halbel’s comment above about third party reprocessing companies. Technology alone can’t solve this problem.
It appears the FDA has concluded that it has no resources [expertise?] to regulate the healthcare community and/or the “fly-by-night” third party re processors of reusable medical devices.
So, the number one killer in hospitals will continue to be secondary infections as Brian Steller wrote above until this problem becomes systemic and uncontrollable. Then the various regulatory bodies and the public will be forced to take proper action.

Ken Kasper
Adviser – Quality and Regulatory Affairs at ARK Diagnostics, Inc.
New antibiotics are in development. FDA has a special initiative to encourage this. Also, I draw your attention to what the CDC is recommending regarding hospital acquired infections. There are reports from hospitals that improvements in reducing HAIs have been made. However, the global effectiveness of such measures impacts the relevance of this topic for globally distributed devices.
[http://www.cdc.gov/HAI/organisms/cre/index.html|leo://plh/http%3A*3*3www%2Ecdc%2Egov*3HAI*3organisms*3cre*3index%2Ehtml/f2LN?_t=tracking_disc]

Brian Stelter
Head of R&D and process eng.@ Okeller Tool
I actually have a process that I have been considering getting a patent on that cleans at
the molecular level and is cheap to use and safe… any manufacturers want to talk, after
signing a disclosure, call me. I have made a lot of money from previous patents or from
the purchase of patents and their use. This idea is revolutionary, way outside the box yet simple… hard to believe, I know. Call me.

Thomas Dr. Fengler
Owner at CMP Cleanical Medical Processes
We have been performing a multi center study 10 years ago in 6 hospitals, with 6 different instrument designs and eluting eluable contamination from the instruments (trocars, scissors inlets, specula etc.). 6 samples each (eluted after cleaning and before the thermal disinfection step in the washer disinfect or). Result: One to two out of three showed eluable pertinacious detritus (3 different detection methods used on the elate). This gives scientific evidence to the need of sterilization.
What we still do not know is – how is the patient affected? Is there any evidence? It is difficult to investigate this subject because of the impossibility of follow up studies under clinical conditions.
I only know this recent study of Spach et al (1988 ?). They were tracing back e.g. tuberculosis infection caused by flexible endoscopes to certain endoscopes thus connecting cases and ineffective reprocessing. If there is only one item/one cause it might be possible to investigate clinical evidence. And “cleanical” evidence. You find the publication on our homepage
www.cleanical.de

Adrian Zahra
Director, Quality & Compliance (International) / QP at Kyowa Kirin International plc.
Globally, there are different practices on cleaning of instruments (in some cases the manufacturer cleans the instruments before servicing them and sends them back to the hospital for re-cleaning and sterilization, in other cases the hospital does the whole process itself whilst in others the manufacturer completes the whole process and provides re-sterilized equipment to the hospital).

I find it difficult to understand, given the high variability in quality of hospital or clinic labor worldwide, how they can assimilate different cleaning IFUs from different manufacturers into their daily work.

The only viable solutions, as I see them are:
a) the manufacturer develops a detailed cleaning and sanitation procedure designed to prepare the instruments to achieve the desired SAL in a standard hospital CSSD sterilization cycle. The cleaning and sanitation to be based on a validated system of work (verifying procedures using swabs and rinses and linking them to visually-clean level). Approved disinfecting/sanitizing agents to be specified in detail. A detailed cleaning IFU to be created. The process of cleaning and sanitation to be covered by the manufacturer’s / re-processor’s ISO 13485 certification AND/OR
b) the AAMI to develop standard limits and method criteria for cleaning / sanitizing materials that will act as minimum criteria for hospitals or clinics. Training levels would have to be increased accordingly and quality systems (with external inspection) put in to provide assurance of effectiveness in implementation.

Ultimately though, this will remain a high-risk area that is currently (and for the foreseeable future) mitigated and effectively controlled only through the use of pre-/post-operative antibiotic prophylaxis.

Kanwal Jit Singh
Public Actions in Sustainability, Finance, Law etc
Cleanliness defined by the manufacturer for the equipment for the particular intended use is the cleanliness required after reprocessing.

The other question that has emerged in the discussion – on the merits and demerits of reprocessing and the regulatory aspects.

I wish to add another dimension – why should we have reprocessing of medical devices and actions required to introduce the practice in the markets.

Sustainability and Environmental Impact assessments would force the introduction of reprocessing of medical devices where the safety and effectiveness of the reprocessed medical device can be ensured.

Once this objective is enshrined in our vision, technological progress will ensure movement in that direction.

This will lead to reduction in costs, a very clear requirement considering the increasing costs of healthcare. Existing manufacturers need to

1. Accept reprocessing as an alternative to their product – cater for this in their business plans. This is similar to another competitor emerging in the market.
2. Regulators need to define the appropriate rules for enabling reprocessing. There is enough evidence of the subject engaging the attention of regulators globally.
3. The new regulations should add the responsibility on the manufacturer to include the reprocessing options that are safe for their medical devices as part of the technical documentation that will be provided to the regulators and to the users.
4. Re-processors would be treated as manufacturers and need to comply with the appropriate regulations including filing of technical documentation with the regulator and be subject to inspection, as any other medical device manufacturer.
5. Re-processors may have the option of choosing an alternative way of reprocessing than that indicated by the original manufacturer (see point 3 above), subject to obtaining appropriate regulatory approvals, as proposed. Illustratively, manufacturers use sterilization methods that are appropriate for the packaging besides the medical device, whereas simple moist heat or dry heat may be suitable for a particular device, where the gap between reprocessing and use are reduced significantly or alternate packaging can be available, as the transit environmental risks are reduced significantly.

Eric Medeiros
Professional Services Consultant at BD
These are some of the reasons that an endoscope system with a disposable barrier makes sense. It solves/eliminates most of the issues involved in reprocessing.

However, for some reason, it seems this technology is relatively unheard of in the field. Does anyone have any thoughts about this? Anyone familiar with this technology?

I work in manufacturing engineering for the disposables division, so I have little interaction with customers, so I don’t hear much from the field.

Lucy Morris
Managing Director at Tristel Asia Ltd
I would like to clarify that reprocessing of medical devices involves a three step process and cleaning is just one step;
* cleaning – is the removal of organic matter from the device (bodily fluids)
* disinfection/sterilization – complete or significant reduction in organisms (depending on the regulatory body/country requirements)
* rinsing
Furthermore other stake holders should be consulted as medical device manufacturers may not have insights into all aspects of a protocol;

– Hospital Procurement – is the protocol feasible? (i.e. purchase of a fully automated machine)
– Nurses/Doctors – is the protocol practical? (i.e. waiting 40 plus minutes to reprocess an instrument)
– Health and Safety- aspect of the protocol (is it safe for healthcare workers to be working with the chemicals for extended period?)
– Medical Device Manufacturers – instrument damage due to incompatibility with heat, chemicals or rigorous mechanical action of automated machines.
– Infection Control – are the chemicals/systems within the protocol adequate for the types of instruments involved?
– Cleaning, disinfection and sterilization product manufacturers

Each will have their own agenda and requirements.

Medical Devices are vast and varying so this can be quite a complex task when trying to develop a uniform approach to a cleaning and disinfection protocol. Good luck to the AAMI to come up with a protocol all stakeholders are happy with.

Flavien Delrieu
Président de 4 Pear
The difficulties are That there are not clear requirements. Each countries ask different things. Yes it is great subject.

Myra Donnelley
Vice President of Resource Development at Eniware, LLC
Joe – This is a dream discussion for us. Thank you for starting it.

Lubos Zilka
—
What is clean instruments?

Stephen M Kovach
Director of Education at Healthmark Industries
WOW , back, my point is visual is the first step, not the only step. Just as an FYI, I have been promoting cleaning verification beyond visual inspection for years.In fact I have written many article supporting testing beyond visual inspection.
The issue is manufactures according to the standards do not supply the end users tests that they can afford and use quickly.

And again, if the manufacture has had a product cleared by the FDA( that means the cleaning IFU has been also cleared), and the user follows all of the steps correctly, it should be clean. The manufacture has a responsibility to give the users ways to verify there process.
My experience is manufactures do not do this .

My question to all of you now is how many take part in finding solutions within the the various groups like AAMI and ST 79.

Working on trying to make the standards better for the patient and the user when it comes to cleaning verification .

So again, the first is visually clean.

Great discussion.

Brian Stelter
Head of R&D and process eng.@ Okeller Tool
To Mr. Kovach, all I can say as an engineer and research scientist of 43 years is
WOW, how scary is it when anybody who cleans medical devices for a living
may believe that any kind of visual inspection might suffice. It might be interesting for you to use a bacterial die after you have done what you believe to be a good job that visually also looks great. You may be surprised as to how much is remaining on
your devices..(I actually hope I am wrong).

Nicholas Conte
Electrical Engineering Manager at Insulet Corporation
I don’t mean to just drop a bomb – but endoscope cleaning has been done well. Check out Langford IC Systems, there is a decent amount of information on their website (<2ug/cm^2 of protein, disinfect to >10^-6 no surviving CFUs). I’m not certain where they’re at currently with the production of the device, but I worked on an earlier version and they had 510(k) clearance in 2011. Sounds like AAMI should be talking to them about this.

Eric Medeiros
Professional Services Consultant at BD
Speaking specifically about endoscopes, these devices are difficult, timely, and costly to clean. Even if after reprocessing they are clean from bacteria and other bio burden, they are cleaned with harsh chemicals. This is not ideal for the patient. I do believe that disposables are the way to go. However, the entire device does not need to be disposable. As far as endoscopes go, the company I work for manufactures endoscopes to be used with a disposable barrier, complete with working channel. This means a clean scope for the patient every time without the need for a lengthy reprocessing procedure with harsh chemicals. The difficulty with a completely disposable scope is the ability to have high-quality and low cost.
Are any of you familiar with what my company offers? What are your thoughts on it?

Merrilee Zigarelli
Medical Marketing Consultant
It seems to me that there has to be a delineation between product categories: those being used internally (i.e. surgical instruments) and those being used externally (i.e. DME). Clearly my idea of ‘clean’ would differ between these two groups. And, I believe it would be easier to create universal cleaning parameters that would satisfy the manufacturers and the users with this distinction in place.

Stephen M Kovach
Director of Education at Health mark Industries
WOW !!! is all I can say. I have cleaned thousand of medical devices. The standard is first and for most is it visually clean.
When an IFU is followed correctly, you should not have an issue. it is very simple.

Brian Stelter
Head of R&D and process eng.@ Okeller Tool
Even before we get to cleaning or the staff, we have to design for ease of cleaning
or reprocessing. Here is the problem with this and many other industries and I will take a beating for pointing it out… If as a manufacturer you see a better way to make a part
that has already been approved after sometimes years in the approval stages you can forget any help from the customer or commissioned based sales rep. The system is
designed to fail in this area, and I don’t blame someone who is commissioned based for not taking a bullet to make changes that should have or could have been done earlier.
Fact is that getting product approval takes time, and sometimes the best products
do not get to market because at some point you have to sell something to make
enough money to do research for the next product. All that said, as a man who ran
a medical manufacturing facility I can tell you we do not do a great job in the industry
from an engineering point of view when it comes to cleaning products and making sure
the designs are easy to clean or have no voids to hold bacteria and viruses.
Before I get bombarded with all of you telling me how great a job you do in this area,
I would remind everyone that the number one killer in most hospitals is secondary infection.

Stephan Holm
Export Manager at KEN A/S
ISO 15883 says a lot about cleaning and disinfection recommendations and how to verify this. In the end it is the training of the staff which is decisive for the outcome. All the instructions in the world simple or comprehensive has no meaning of the staff does noit recognize the importance. This must be the starting point.

Joshua Patton, MBA
E-Commerce and Digital Marketing Management
No matter how clean a device is, it’s still expensive to clean and time consuming… depending I guess on the method and rotation of the items. I am a big fan of disposables myself, they are generally cheaper and come pre-sealed and packaged so that you can just open another never been touched by human hands outside of a clean room kind of medical device. I know for sure from a liability perspective that many doctors and organizations are leaning towards the disposable market as the level of quality is homogeneous. You are always going to get that device exactly how it was the last time.

From your questions I think that “clean” has some fairly clean definitions in regards to FDA and ISO regulations. Manufacturers that have the certs to produce these kinds of products are very responsible in general and have multiple tiers of quality assurance to ensure the cleanliness of the product, I know we do. As far as nurses, disposables are the perfect solution. No training required, just toss the old device and open a brand new quality assured disposable. There is definitely a competition on making devices that are easy to clean but in my book it’s still the best method to just toss them. There are only a few exceptions in regards to very costly electronic and metal parts that would be more efficient to clean.. unfortunately though the closest that we will get anytime soon for a standard will be straight from the certifications and audits for production. Manufactures are most definitely motivated to address these issues, the fact they they could be liable for hurting someone is the ultimate moral responsibility, not to mention the fact that such an incident could cost the organization a certification and halt production all together. I really think though that the transition is into disposables. There are new better materials that are being created all the time that are just as effective or better than the existing reusable and they have the value added aspect of no cleaning and assured quality from device to device. This is definitely incentive for manufactures as they can make use of economies of scale and depending on the level of integration in the value chain add retain more earnings!

What are your thoughts on the disposable market?

Do you think it’s better to leave the cleanliness to the clean rooms and manufacturers with stringent manufacturing processes?