Becton Dickinson Reports Progress on Substitution

US-based global medical equipment producer Becton Dickinson (BD) has revealed its progress towards cutting use of materials of concern in its products.

The company's 2016 sustainability report outlines actions towards its 2020 goals to eliminate:

> phthalates and PVC from devices;

> phthalates, brominated flame retardants (BFRs) and heavy metals from instruments; and

> polystyrene and PVC from packaging

BD senior director of global sustainability, Ellen Kondracki, told Chemical Watch, that the company's customers had identified these substances as a priority and "also happened to be included Regulations."

Last year, BD launched a catheter in China containing extension tubing made from polyurethane instead of DEHP-plasticised PVC. It was designed specifically for clinical practices within the local market and was not intended to be launched more widely.

Ms Kondracki said there was no 'one fits all solution' and the company would continue to evaluate the best material fit for each product.

"Through dedicated research efforts and integration of sustainability considerations into our product development efforts, we will continue introducing non-PVC infusion products into the market," she said.

NGOs, such as Health Care Without Harm (HCWH), have raised concerns that phthalates commonly used as softeners in PVC-based medical devices are endocrine disrupting chemicals (EDCs).

He added that the EU medical devices Regulation (MDR), which comes into force in May 2020, will provide a legal framework where "such substitution is hopefully encouraged".

The MDR includes a 0.1% concentration limit for category 1A and 1B carcinogenic, mutagenic, and reprotoxic (CMR) substances, and for endocrine disrupting chemicals, in devices that are invasive and come into direct contact with the body. Devices would only be permitted to contain these substances at a level above this limit if a justification is provided to the notified body overseen by the national competent authority.

Chemical Footprint

In 2016, BD took part in the Chemical Footprint Project (CFP) survey, run by the NGO Clean Production Action (CPA). This tracks companies' progress towards safer chemicals, by measuring the total mass of substances of concern in their products.

Ms Kondracki said BD joined the CFP because it understood that material transparency in products was a priority for its customers and the project "offered a good roadmap of how to improve our performance in this area."

She also said that it was helping the company define a methodology for compiling quantitative measures of performance across its different businesses.

"We will be fully transparent in future sustainability reports about the progress we are making toward the 2020 goals," she added.

In 2016, BD also completed product changes to bring in vitro diagnostic devices (IVDs) into compliance with the EU RoHS Directive. On 22 July 2016 IVDs came within scope of the Directive. This bans from the European market any electrical and electronic equipment that contains more than the permitted level of six hazardous substances – the heavy metals lead, mercury, cadmium and hexavalent chromium, plus two types of brominated flame retardants, PBBs and PBDEs.