Tekni-Plex, the US-based high-barrier blister film and foil company, says it is close to developing new material for IV and nutrient bags that will reduce the medical industry’s reliance on PVC. The bags are made of a polyolefin-based compound using a specific extrusion technology that produces an autoclavable sheet film with a clear finish.
The development has been welcomed by the medical field and pharmaceutical industry, which have been working to increase the ability to visually inspect solutions used for such treatments while maintaining standards required for sterilisation.
Better still, the material is flexible enough to allow for sufficient drainage for IV bags and cost effective enough to allow for widespread use. It can handle the humidity, pressure and temperature that such bags are exposed to in sterilisation environments and maintains its seal and shape at 121°C.
Tekni-Plex director of global packaging and development Michael van en Berg said the material has been four years in the making. The company is also working with other providers which specialise in seals, tubing and bags to ensure its material will be suitable from bag to its point of injection. But in a world where medical innovation moves so fast, what will the real impact of such a development be?
At the Pharmapack conference in Paris on 21/22 January, industry expert Dr Catherine Blanchon, who works in supply chain for Nestlé, said that more innovation is required in the space of medical bags and administration tools for clinical nutrition to advance. Figures show that 40% of patients in hospital suffer some form of malnutrition. A study released by the Centre for Health and Social Care at London’s South Bank University shows that malnutrition also leads to an increase in disease, especially in at-risk groups such as the aged.
Clinical nutrition, while quite a recent addition to the care process for patients at 30 years old, can reduce the risk of complications from surgery by 35.1% and reduce the overall length of hospital stay by 14.8%, according to medical device company B Braun’s research into the area.
Today, the only way for many patients to receive the correct nutritional amounts, according to Blanchon, is through enteral administration (where supplements are fed through nasal or jejunostomy tubes) from solution bags. How such administration is applied, however, is closely related to the packaging and medical devices designed for such techniques.
"A patient can receive 2–3,000 kilos of calories a day – the make up of this can include lipids, drugs, water and micronutrients," Blanchon said. "Administering this can be quite challenging as you have patients in different clinical status. For hospital staff, administering this therefore needs to be easy for them and for the patient."
Quite often more than one bag is used with the solutions combined at the point of administration to ensure contamination and correct sterility is maintained during the process. It is vital that medical devices used for such purposes keep each solution sterile and stable and interactions between the components and the container during migration need kept at a minimum, or not at all.
Some hospitals Blanchon has spoken to, however, said that staff have taken their own measures to help improve efficiency by removing an outer nutritional bag, in place to ensure oxidisation of the solution. Other hospitals are reporting problems with sealing the bags to the tubes used for such administration, resulting in uneven amounts of formula.
One solution, according to Blanchon, would be to have a single bag that could cater to all solutions. But as yet, no one-size-fits-all solution exists.
The use of PVC films in the medical industry needs to be reduced. PVC films are not seen as ideal for the creation of medical bags as they contain low-molecular weight additives which can contaminate medical fluid held by the vessel. It is also restrictive to the type of fluid it can carry – PVC’s properties are not high barrier enough to use for pH solution bags.
Tekni-Plex’s product looks as if it can help overcome some of these issues. It also offers a more efficient ‘peel and seal’ solution.
According to Blanchon, the area will be held back by other parts of the sector. She says that better, automated techniques such as sealing controls need to be designed for administering clinical nutrition such as enteral-specific ports for connection to bags. Packaging design and strength also needs to be developed further to allow for more ambulatory purposes, bearing in mind that some patients may require such care for weeks.
While in some areas Tekni-Plex may be experiencing a breakthrough, other areas could be holding the field of clinical nutrition back.
Like one speaker representing medical device company B Braun said, we area long way off the perfect pill to fix diet for patients. It seems that clinical nutrition, and the providers that feed the industry, still have far to go before that perfect balanced meal can be cooked up.