As originally asked by Yash Khanna.

Last year, Kaiser Permanente announced a move away from IV medical equipment made from PVC and DEHP; the latter being a plasticizer.

I am interested in learning more about the rationale and the story.

I know DEHP has been reported to have adverse effects on human health but there are alternative FDA approved plasticizers. Similarly, PVC resin itself has issues with incineration but still it remains the 3rd most widely used plastic in the world.

Also surprisingly, Kaiser Permanente indicates a $5M annual savings from the use of PVC alternatives.

In talking to suppliers of PVC based products, it appears that the move away from PVC is not clear, yet. Moreover, the alternate/replacement products are thought to be more expensive than PVC. So, being new to the field, I am just trying to understand if PVC replacement is happening and if so, at what pace. Moreover, where does the $5M annual savings come from ? Are the replacement products cheaper ? What are the replacement products ? Any update from the EXPERTS will be helpful in understanding the story.

Len Czuba
Distinguished Honored Service Fellow at Society of Plastics Engineers
There will be some good discussion on the question of PVC or alternative materials in medical devices at our panel discussion at the Plastics in Medical Devices 2013 (www.plasticsnews.com/pmd2013) in Boston 13 – 15 May. I am hoping to get more facts on both the cost issue and safety out for discussion and consideration.

Len Czuba
Distinguished Honored Service Fellow at Society of Plastics Engineers
There seems to be 2 separate issues here. One is whether there is a need to change from the use of PVC in medical devices and the driver here are concerns with the exposure of patients to phthalate plasticizer (DEHP). As has already been mentioned and testing continues to show, there does not appear to be a need to stop using these materials from a patient health perspective. Studies continue to be done on top of the 40+ years of investigations trying to prove a negative (no adverse effect) but critics continue to raise concerns. At some point, I would hope that good science would prevail and that we could stop all this discussion about what could happen in some unique or special patient exposure situation. By far the majority of patient exposure to DEHP/PVC has resulted in safe medical treatment for that pt and the treatment gives both safe and cost effective therapy.

If a company is so inclined to find alternative materials, there are many. I have 9 patents on PVC alternative materials and several are currently being used. Others non-PVC materials have been developed, qualified as suitable replacement materials but remain on reserve in case a company were to need them. All these materials would add both material costs as well as manufacturing costs to any new medical device because from what I understand, there is nothing as cost effective as PVC nor is there any material as easily made into liquid containers or tubing sets as PVC. With added manufacturing complexities, even though reliable products can be made, there us usually added manufacturing costs.

I have long questioned the Kaiser Permanente claims of savings even though looking at the entire product use life cycle, differences in weight of PVC vs olefins favors non-PVC, cost of disposal, PVC is often more expensive to incinerate, and other savings inherant to non-PVCs I still cannot reconcile the numbers and find how there can be any savings.

At the PMD 2013 conference in Boston ([http://www.plasticsnews.com/pmd2013|leo://plh/http%3A*3*3www%2Eplasticsnews%2Ecom*3pmd2013/fbC6?_t=tracking_disc]) in 2 weeks, I will chair a panel discussion on this topic and hope that our panelists, especially Janet Brown, our friend from Healthier Hospitals Initiative can shed some light on this complicated matter.

As I tell my clients, I can give you a good product with any of a number of materials. I have no vested interest in PVC. But I will give you the facts before you make your decision.

Steve Heveron-Smith
Product management and business development consultant at Tech-athlon. Turning product ideas into vibrant businesses.
Kaiser Permanente’s savings might have been a combination of new materials and new measurement technology. We’ve put in systems that have saved customers 5% and more by being able to measure their products better. It doesn’t take long to get to $5M.

Max Sidner
President, Sidner & Associates
Excellent comments here. With regards to how aggressively are US medical device companies moving toward DEHP free resins….as an OEM contract mfg performing almost 90% injection molding and extrusion for our clients we have seen this being implemented (or attempted to implement) from our client in erratically over the past few years in asking resins for production to be changed to DEHP Free…..certainly the EU k(SVHS, Reach , ROHS) etc have companies working on this….our observation is that IF the change to DEHP free has nominal cost impact and alot or “marketing cache” for their sales effort, companies will push ahead……..cost and time of revalidation of these resins frfrom current PVC per the clients internal requirements are a significant consideration,,,,,,,along with how much pressure they might be getting from regulatory agencies, perceived necessity from their customers, any competitive advantage, etc……the “rate” of transition depends on many factors beyond just the constantly evolving regulatory environment or studies indicating possible health risks from plasticizers…….I can say this much…….overall it is increasing the cost of goods sold and the overall management of the organizations business as so much resource is put into these efforts

Ole Grøndahl Hansen
Project Manager at PVCMed Alliance
In his post Nicolas Held mentions the conclusions about the possible risks associated with the use of DEHP in medical devices formulated by EU’s scientific committee SCENIHR in 2008. The conclusions from this committee is extremely important for EU member states. I can inform you that the EU Commission have asked the SCENIHR committee to once more evaluate whether there are risks associated with the use of DEHP in medical devices. The conclusion is expected to be published in June this year. The conclusion will – among other things – be decisive for whether the EU Commission will accept the French ban on DEHP in medical devices (for vulnerable patients) that the French Parliament adopted last year.
If you are interested in developments associated with the use of PVC in medical devices PVCMed Alliance have a Twitter account that you can follow. By following us you will be sure to be updated on every development within this area.

Yash Khanna
Business Owner at Innoplast Solutions
Keynote Lecture: “State of PVC vs Competitive Materials for Tubing / Bags in Health Care Industry:”

In view of the importance of this subject and the strong discussion we had here, we are searching for an expert who can address PROS & CONS of the PVC alternate materials at our JUNE 26-28 conference in San Francisco. Any recommendations will be truly appreciated; for details visit
[http://www.MediPlastConference.com|leo://plh/http%3A*3*3www%2EMediPlastConference%2Ecom/hzRd?_t=tracking_disc]

Yash Khanna
Business Owner at Innoplast Solutions
Kaiser Permanente’s Views ? ? ?

In reviewing all the feedback, it is very clear that PVC is hard to beat in either COST or PERFORMANCE.

It would have been very informative for KAISER PERMANENTE to comment on how they save $5M a year by replacing PVC. Comments by other institution(s) who replace PVC for Performance or Cost reasons, will be TRULY WELCOME at this point.

ROBERT W. ANASTASIA
SENIOR CONSULTANT at R. W. Anastasia Consultants and R.A.Q.A. Associates, Inc.
I worked for Allied Chemical Plastics Division in 1969 and people were talking about replacing PVC then and they’ll still be talking about it when we’re all dead.

It’s hard to make a case to replace PVC in products like tubing sets when it’s used for long term storage of human blood.

Nicholas Held
Quality Engineer at Boston Scientific
It looks like you have an understanding of some of the complexities of the perceived issue. I thought I would include a paragraph of a paper I wrote about the value of DEHP as a plasticizer, and where it is headed:

The value of DEHP-PVC lies within the combination of mechanical and barrier functional properties, coupled with the ease of fabrication, and the relatively low cost [5]. Despite this there have been moves to try and replace DEHP-PVC with alternative materials that display similar, if not identical functional characteristics. However, the oxygen permeability coefficient in DEHP-PVC, which extends platelet stability in blood bags, is difficult to replicate in other polymers. Despite this, other materials including some non-DEHP plasticized PVC formulations, and other polymers including polyethylenes, silicones, and polyurethanes would be suitable for most medical applications [5]. Specifically, the primary materials sought to replace DEHP-PVC are, ethylene vinyl acetate (EVA), polyesters, polyolefin’s, silicone elastomers and certain polyurethanes. However, because of lack of mechanical properties and material processibility, some of these materials have not ‘caught on’ with medical device manufacturers. Despite this, some materials, such as silicone elastomers and polyurethane thermoplastic elastomers, have found some clinical use. Both silicone elastomers and polyurethane thermoplastic elastomers have more acceptable properties and can be used for nasogastric tubes, venous and arterial canals and other tubing.

5. Scientific Committee on Emerging and Newly-Identified Health Risks. Medical Devices Containing DEHP Plasticized PVC; Neonates and Other Groups Possibly at Risk from DEHP Toxicity. 2002. Web. <[http://ec.europa.eu/health/ph_risk/committees/04_scenihr/docs/scenihr_o_014.pdf|leo://plh/http%3A*3*3ec%2Eeuropa%2Eeu*3health*3ph_risk*3committees*304_scenihr*3docs*3scenihr_o_014%2Epdf/wLYB?_t=tracking_disc]>.

There is pressure to switch to a different plasticizer because of the negative perception. It can really only effect infants in critical care, when it comes to tubing in contact with the blood for a long period of time. However, most disposable companies are moving away from DEHP to protect current and future sales, in case a law does get passed in the next few years.

Hope this gives you some added insight.

Yash Khanna
Business Owner at Innoplast Solutions
I think, Ole wraps it up very nicely in defence of PVC. However, it is still unclear as to how Kaiser Permanente claims $5M in annual savings by switching to PVC ALTERNATES.

At our upcoming conference on Medical Polymers / Plastics,
[http://www.MediPlastConference.com|leo://plh/http%3A*3*3www%2EMediPlastConference%2Ecom/hzRd?_t=tracking_disc],
this may be a TIMELY presentation. Can someone recommend a SPEAKER / COMPANY to make a presentation “State of PVC vs Competitive Materials for Tubing / Bags in Health Care Industry:”

Ole Grøndahl Hansen
Project Manager at PVCMed Alliance
In the discussion about the use of PVC in medical devices it is often forgotten, I think, that the fact is that we use different polymers for different medical applications for a reason. It is not by chance that you use PVC for medical tubing for example. As Harold Hambrice correctly points out cost is an extremely important factor here. The combination of low cost and the high performance of PVC is essential. Think about the wide range of requirements that a medical tubing have to fulfill: clarity, colourability, flexibility, ease of use, softness, lubricity, tear resistance, burst-strenght – and the key requirement where PVC beat all other polymers: the PVC tubing does not kink, because if it did the liquid flow would be blocked. I think it is fascinating that a low cost polymer can fulfill all these requirements at the same time.

John Douglas
“If the bee disappeared off the face of our Earth, man would only have four years left to live” Albert Einstein.
My father Robert Douglas (now retired) pioneered the formulation, processing and manufacturing of PVC for use in Blood Transfusion and Donor bags in Australia some 30 years ago. PVC with the correct plasticiser enables 1. solvent joints strong enough for centriguge pressures during cell separation and 2. Red Blood Cell life of 37 days. It is not always cost that determines the appropriate material.

Harold Hambrice
Outsourcing/Offshoring Consultant and Contractor
I have 15 years of experience in the PVC rocessing of medical devices and the challenge continues to be cost as most of these products are considered commoties.There are many other polymers that are better based on safety for the consumer but customers must be willing to pay for the difference.
Europe is leading the way on this change but cost will be the issue on the short term. I welcome your comments.

Lisa Tao
Director Of Business Development at Co-Innovation Development(HK) Ltd / Medicare Test Inc
Dear all,
Great discussion here!
Will you be interested in the disposables made by Non-woven materials? I think it’s widely accepted for people range from the common and professional, such as doctor, nurse, surgeon, etc. Don’t you think so? And the most important is lower cost and fast production to consume. So I think it’s popular consumables applied in our daily life.

David Hajicek
Owner / Luthier at Hajicek Guitars
One problem is, as Gary Gillis mentions, that any change in material will require changes in processes and re-certification or validation of the product. It isn’t as simple as just buying a different polymer.

Rainer Grassinger
Director & Owner bei Cable &Tubing Solutions
On the tubing site we replaced PVC Tubing with TPE and Polyolefine. We developed a complete new range of ISO zertified and medical grade tubing range, used in medical applications and for the food and behaverage industry.

Ole Grøndahl Hansen
Project Manager at PVCMed Alliance
I would like to add a comment from a European perspective. In Europe we have just formed the PVCMed Alliance (www.pvcmed.org) with the objective to inform and discuss exactly the issues that you are writing about here Mr.Yash. The use of PVC in medical application is a complex issue and we experience a lot of misunderstandings. On behalf of The PVCMed Alliance I run an active Twitter account (@PVCmed) where we update and discuss the issue with all interested stakeholders. According to your question I can shortly say that PVC account for 40% of all plastics used for medical devices and the use is increasing all over the globe. According to the use of DEHP as plasticiser I can inform that if you want to use other plasticizers it is today possible without compromising the unique performance of PVC.

Yash Khanna
Business Owner at Innoplast Solutions
Thanks Gary…Is there is real shift / drive towards PVC replacement in Medical IV / Bags or Kaiser Permanente is just one isolated case?