Chemicals in Medical Devices
The European Union (EU) has taken the lead in limiting the use of hazardous substances in the marketplace.
The EU regulation for the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and the EU directive for the Reduction of Hazardous Substances (RoHS) are both soon to affect manufacturers of medical devices.
RoHS 2 Directive
Directive 2011/65/EU (RoHS 2) represents a recast of original Directive 202/95/EC and broadens the scope of RoHS to include electrical and electronic medical devices. RoHS 2 restricts the use of certain hazardous substances. The list of restricted substances includes four heavy metals (lead, mercury, cadmium and hexavalent chromium) and two brominated flame retardants (polybrominated biphenyls and polybrominated diphenyl ethers).
From 22 July, 2014, electrical and electronic medical devices, when placed on the EU market, shall comply with the RoHS 2 provisions. In-vitro-diagnostic devices (IVD) that contain the restricted substances will no longer be allowed on the European market after 22 July 2016. According to the directive products must not contain more than 0.1% of the listed substances by weight of homogeneous material (except for cadmium, where the limit is 0.01%).
RoHS 2 is a CE Marking Directive, which means manufacturers must take into account the RoHS requirements in technical documentation and EC Declaration of Conformity when they are affixing the ‘CE’ mark to their product.
The required technical documentation shall align with module A of Annex II to decision 768/2008/EC and/or harmonised standard EN 50581 and include:
- Conformity assessment
- Use of standards
- Supplier declaration of compliance
- Materials declarations
- Results of supplier audits
- Possible testing results
The conformity assessment of the equipment includes a process to demonstrate that the medical device does not contain any of the restricted substances.
There can be exemptions to RoHS 2 for implantable devices.
Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) imposes EU requirements on both manufacturers and importers of chemicals and products containing chemicals. REACH requires producers of medical devices to examine and disclose the characteristics of the substances they use. Dangerous substances will face an outright ban.
REACH imposes different requirements to medical products depending on whether the product is a ‘preparation’ or ‘article’, and whether the product is manufactured in, or imported into, the EU. The definitions of preparation and article are as follows:
- Preparations: mixtures of solutions of two or more substances, for example dental filling material or iodine solution used as a disinfectant
- Articles: objects that during production are given a special shape, surface or design that determines their function to a greater degree than does their chemical composition, for example cardiac pace makers, catheters, corrective glasses, surgical gloves and defibrillators
Preparations that are defined as medical devices have an exemption from REACH.
Medical devices classified as articles are not exempt under REACH. REACH requires producers of medical devices, and their component suppliers, to examine their products and identify any ‘substance of very high concern’ (SVHC). The definition of SVHC is a substance that meets one or more of the following criteria:
- Category 1 or 2 carcinogenic, mutagenic or toxic to reproductions (CMR)
- Persistent, bioaccumulative and toxic (PBT)
- Very persistent and very bioaccumulative (vPvB)
- Raising ‘an equivalent level of concern’
When an article is placed on the market, presence of SVHC exceeding 0.1% by weight must be immediately disclosed to downstream purchasers. The manufacturer or the importer is required to provide the name of the SVHC substance(s) and information on safe use. Additionally, a customer may request the same information and the manufacturer is obliged to respond within 45 days.
It is expected that most world markets will follow the EU model for banned and registered substances
Since 2007, China has operated RoHS legislation, however, under a different scope and requirements compared to the EU RoHS legislation. All items in the scope shipped to China have to be properly labeled to show whether they contain hazardous substances or not. The six banned substances are the same as the original EU banned substances (lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls and polybrominated diphenyl ethers).
Statewide legislation exists in the US, which bans some substances. Additionally, the Securities and Exchange Commission (SEC) is controlling the use of conflict minerals. Starting from May 31, 2014, companies need to report their use of conflict minerals annually for the previous calendar year.
It is not just dangerous substances that need to be controlled in medical devices. All devices must meet the applicable essential requirements (ER) of 93/42/EEC, including ER 7 (chemical, physical and biological properties). The basic standard for medical electrical equipment, IEC 60601-1 also requires that all parts or accessories that are intended to come into contact with biological tissues, cells or body fluids shall be assessed and documented according to the guidance and principles given in the ISO 10993 series of standards. This means that materials should be carefully selected to ensure they are appropriately biocompatible for their intended clinical use.
However, it is not enough just to select a well-known and safe material. The manufacturer of the equipment must collect documented evidence of the biocompatibility of the materials used, and by exploiting the risk management process, draw up conclusions according to ISO 10993-1. This ensures the medical device in its finished format meets biocompatibility requirements. Typically a supplier of the material may be able to provide the necessary information to address biocompatibility of a material. If that is not possible, third-party testing laboratories can perform the appropriate testing required to ensure the product is biocompatible for its intended use (e.g. cytotoxicity and irritation and sensitisation potential tests on the materials, according to the relevant parts of ISO 10993).
In addition, according to ISO 10993, animal tests should be avoided whenever an alternative method exists to verify the biological safety of materials. For example, if any pre-existing toxicological data, history of clinical use or human exposure data are available, all of this data can be used as a powerful tool to demonstrate the product is appropriately biocompatible without the need for additional animal testing.
European and international legislation places obligations on manufacturers and importers of medical equipment to manage materials and chemicals used during manufacturing or included in the final product. The aim of the legislation is to improve protection of human health and the environment. In a global market, expect these requirements to be reflected worldwide.
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