Submission of information on
TEMPLATE
for third party submission of information on alternatives for
Applications for Authorisation
NON-CONFIDENTIAL
Legal name of submitter(s):
Health Care Without Harm Europe
[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture
or description of the alternative technology] [insert date of submission]
SUBMISSION OF INFORMATION ON ALTERNATIVES (NON-CONFIDENTIAL)
TABLE OF CONTENTS
1. ALTERNATIVE ID AND PROPERTIES ......................................................................... 3
2. TECHNICAL FEASIBILITY ........................................................................................ 3
3. ECONOMIC FEASIBILITY ......................................................................................... 3
4. HAZARDS AND RISKS OF THE ALTERNATIVE............................................................. 3
5. AVAILABILITY ....................................................................................................... 3
6. CONCLUSION ON SUITABILITY AND AVAILABILITY OF THE ALTERNATIVE .................... 3
7. OTHER COMMENTS ................................................................................................ 3
REFERENCES ............................................................................................................ 5
APPENDIXES ............................................................................................................. 5
[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture
or description of the alternative technology] [insert date of submission]
2
SUBMISSION OF INFORMATION ON ALTERNATIVES (NON-CONFIDENTIAL)
1. ALTERNATIVE ID AND PROPERTIES
[Insert text here]
2. TECHNICAL FEASIBILITY
[Insert text here]
3. ECONOMIC FEASIBILITY
[Insert text here]
4. HAZARDS AND RISKS OF THE ALTERNATIVE
[Insert text here]
5. AVAILABILITY
[Insert text here]
6. CONCLUSION ON SUITABILITY AND AVAILABILITY OF THE ALTERNATIVE
[Insert text here]
7. OTHER COMMENTS
Insufficient information
The information provided for stakeholders to comment is not sufficiently detailed to understand the uses
of DEHP for which an authorization was required. Moreover, the data provided by the manufacturer is not
use specific, which prevents a serious analysis of the suitability of the alternatives. Data on environmental
and human exposure and health and socio-economic costs are only very generally described or are missing.
Recent scientific or technological developments are not described. For example the value of DEHP in the
manufacture of blood bags is mentioned, but nothing is said about the new advancements in the
development of a PVC-free blood bag prototype (http://www.pvcfreebloodbag.eu).
Exposure
The applicant notes that DEHP is used in medical devices because of a lack of current evidence of
unacceptable adverse consequence in patients. Nonetheless, it is well established that patients are heavily
[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture
or description of the alternative technology] [insert date of submission]
3
SUBMISSION OF INFORMATION ON ALTERNATIVES (NON-CONFIDENTIAL)
exposed to DEHP through medical devices. Unborn children and infants are especially vulnerable to DEHP
exposure as they are not able to process chemical substances as adults. A recent review summarized
evidence of exposure through PVC medical devices such as blood bags and tubings in infants undergoing
intensive care and in dialysis patients and blood donors1. In another study, levels of DEHP metabolites in
urine were related with the number of DEHP-containing medical devices2. While neonates receiving lipidbase infusates through a PVC infusion line, received a DEHP dose exceeding the lower limit of the total daily
intake (TDI) within 6 hours3. Premature infants undergoing intensive therapeutic medical interventions had
mean urinary concentrations of DEHP one order of magnitude higher than the general population4.
Current scientific studies that have focused on evaluating the effects of mixtures and the potential
cumulative effect of exposure to DEHP and other phthalates or endocrine disruptors should not be
disregarded.
Alternatives
The applicant only considers alternatives to the substance as plasticiser and does not consider alternative
materials that eliminate the need of using a plasticiser. Alternative materials currently being used in PVCfree medical devices include among others: latex, polychlorpropene, ethylene-vynil acetate,
polyisopropene, silicone, glass, polyurethane, polyethylene.
Substitution
Hospitals across Europe are phasing out PVC medical devices in order to protect patients from DEHP and
other alternative plasticisers5.
Austria
To avoid unnecessary health burdens for premature babies, the Vienna Hospitals Association (18 hospitals)
adopted a PVC-free policy in their Neonatal Intensive Care Units. A product catalogue listing approximately
630 alternative PVC-free products is available to the hospitals and geriatric centres associated with the
Vienna Hospital Association. The listing covers invasive consumables and products that come into contact
with the skin of babies. In the Neonatology Unit of the Glanzing Children’s Hospital, the phase-out of PVC
started in 2000 and the PVC content of invasive medical products was halved by 2010, with an estimated
increase in prices of less than 15%6. The neonatal and paediatric departments in the following facilities:
Preyer Pediatric Hospital
, Vienna General Hospital Neonatology Clinic 1 & 2, Danube Hospital Neonatology
Clinic
, Hospital Rudolfstiftung, Empress Elisabeth Hospital, Hospital Hietzing are using almost all the
same PVC/DEHP-free devices as Glanzing and are in the process of substituting the rest.
Denmark
The Sønderborg Hospital Neonatal Department uses several medical devices that are DEHP-free including
IV Catheters
, IV administration sets, IV Tubing
, Guedel Airways.
Sweden
32 neonatology units and hospitals in Sweden use feeding tubes for long-term treatment of babies that are
PVC-free.
The Stockholm County Council decided to phase out PVC and phthalates from its hospitals as early as 1997.
In 2004, a collective purchasing arrangement to buy phthalate-free gloves was introduced, eliminating the
environmental impact of 100 tonnes of phthalates per year7. To date, the neonatal unit of the Karolinska
University Hospital is completely PVC-free. And, in the entire hospital several other products are also DEHP
or PVC-free including blood transfusion sets, IV bafs and IV sets, urinary bags, feeding tubes and catheters.
[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture
or description of the alternative technology] [insert date of submission]
4
SUBMISSION OF INFORMATION ON ALTERNATIVES (NON-CONFIDENTIAL)
In the Skane Region hospitals, all syringes, enteral nutrition tubing infusion sets and bandages are PVC free.
Gloves are all DEHP-free.
Czech Republic
At Na Homolce Hospital, the nephrology department switched to DEHP-free haemodialysis sets made with
PVC. This measure, combined with substituting IV bags for PVC-free alternatives, reduced haemodialysis
patient exposure to DEHP to zero.
The Neonatal Intensive Care Unit at Olomouc Faculty Hospital contacted manufacturers directly, to obtain
further information about the products and existence of alternatives. One of the manufacturers, agreed to
deliver an entirely PVC-free set for infusion therapy, including the exchange transfusion set. By 2005, 95%
of medical devices in close and regular contact with newborns at Olomouc NICU were replaced with safer
alternatives. Alternatives were unavailable for only 5% of the equipment.
The Faculty Hospital of Olomouc succeeded in replacing about 95% of medical devices that are in direct
contact with neonates. These are mainly intravenous and transfusion devices – the entire circuit into the
patient’s body.
The St. Elizabeth Hospital, Louny conducted a PVC audit in 2007. In the first stage they substituted 2 groups
of products for the entire hospital (anaesthesia masks and syringes)
Ceske Budejovice Hospital substituted 90 % of special-use medical devices in intensive care and
resuscitation. Devices which have been substituted include: Venous catheters
, Umbilical catheters,
Invasive monitoring devices, Respiratory tubing, IV catheters, Women’s catheters, Syringes, Reusable
transducers
, Oxygen masks
, Dialysis catheters, Bags for peritoneal dialysis
The termination of PVC products is also taking place in other countries - Slovakia, France, Italy, The
Netherlands - providing extensive evidence that a PVC phase-out is not only possible but realistic.
In December 2012, France passed a law that bans (from July 2015), for the first time, the use of tubes
containing DEHP in paediatric, neonatology and maternity wards. The Danish Health Minister has recently
supported the phasing out of phthalates in medical devices, pushing for the creation of partnerships
between industry, authorities and experts to call for a European phase-out within a reasonable time frame.
These two regulatory positions follow both the updates in the scientific knowledge about the exposure and
effects related to exposure of patients to phthalates, in particular to DEHP. But also, the developments at
the industry level in the creation of new products that do not contain these substances.
REFERENCES
1 Wittassek et al., 2011, Mol Nutr Food Res 55: 7–31
2 Hu et al., 2005, Environ Health Perspect 113: 1222-1225
3 Rose et al., 2012, Anaesthesia 67: 514-520
4 Calafat et al., 2004, Pediatrics 113: e429–e434
5 Health Care Without Harm Europe (2007): PVC/DEHP phase-out is possible anywhere in Europe: Model
hospitals show how to succeed (http://www.noharm.org/lib/downloads/pvc/PVC_DEHP_PhaseOut_Europe.pdf)
[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture
or description of the alternative technology] [insert date of submission]
5
SUBMISSION OF INFORMATION ON ALTERNATIVES (NON-CONFIDENTIAL)
6 Lischka et al., 2011, J Environ Sci Eng 5: 1162-1166
7 Vesterber et al., 2005, “An inventory of PVC and phthalates containing devices used in healthcare”,
Karolinska University Hospital, 18 pp.
APPENDIXES
[Insert text here]
[insert consultation number] [insert non-confidential generic name of the alternative substance/mixture
or description of the alternative technology] [insert date of submission]
6