Evaluation of Plasticisers for PVC for Medical Devices
9 Proposal for further work
According to the original proposal for this project (ref. 41), which is shown in the project flow diagram on the next page, the manufacturing of Medical tubes and bags and further physical and chemical characterisation of those articles should succeed this project. The need for more data and experience has not decreased during recent years.
The Swedish National Board of Health and Welfare have expressed their concern for the risk of the patients safety associated with (uncritical - authors remark) replacement of phthalates in PVC Medical Devices (ref. 37).
The Public Health Notification by FDA's Department of health & human services by July 12, 2002 recommends as follows (ref. 38), which is based on the FDA CDRH assessment of DEHP from September 2001 (ref. 39 and 40):
"Most important, you should not avoid the procedures cited above (a number of procedures that have been identified as posing the highest risk of exposure to DEHP in the patient treatment - authors remark) simply because of the possibility of health risks associated with DEHP exposure. The risk of not doing a needed procedure is far greater than the risk associated with exposure to DEHP.
For some of the above procedures, PVC Devices that do not contain DEHP can be substituted, or Devices made of other materials (such as ethylene vinyl acetate (EVAC), silicone, polyethylene or polyurethane) can be used, if available. If PVC Devices containing DEHP must be used, you may be able to minimise exposure to DEHP by, for example, using the freshest possible blood products stored at the lowest possible temperature, or by using heparin-coated ECMO circuits.
We recommend considering such alternatives when these high-risk procedures are to be performed on male neonates, pregnant women who are carrying male fetuses and peripubertal males…
For other patient groups, who are presumably at lower risk, the decision to use DEHP alternatives must take into account the Medical advantages and drawbacks of the substitute materials and their availability."
A wide agreement appears on the necessary cautiousness to be shown in this question.
It is still the recommendation and the intention of the project group to proceed with the investigation of DEHP alternatives according to the original proposal mentioned above.
