STERILE SERVICES
In essence it is the product’s ‘passport’ within the EU and appears as a logo on medical devices to show they conform to the requirements in the directives. It indicates that the product may be legally placed on the market in their country. The logo shows that the device is fit for its intended purpose stated and meets legislation relating to safety. CE marking on a product permits the withdrawal of non-conforming products by EEA (European Economic Area) customs and enforcement/vigilance authorities.
If a product is just intended to be used for cleaning it will only carry a CE mark and nothing else. For example, thermosept X-tra designed for the automated cleaning of medical devices and accessories has a CE mark on the label meaning that it is compatible with and authorised for use on surgical instruments, rigid endoscopes and other instruments commonly used in the central sterile supply department. However, if a medical device is intended for use as a disinfectant the CE symbol is followed by a series of four numbers. Thermosept PAA for the automated disinfection of flexible endoscopes in AERs, is a class 2b medical device and the label carries the CE mark followed by the four digits - 0297.
Any cleaner or disinfectant which does not carry a CE mark should not be used in a
When developing a product to conform to the MDR, a risk assessment is conducted by the manufacturer to evaluate the intended purpose, the risk to the patient, the risk to the user and to third parties.
healthcare setting such as a hospital. When developing a product to conform to
the MDR, a risk assessment is conducted by the manufacturer to evaluate the intended purpose, the risk to the patient, the risk to the user and to third parties. This must be undertaken before a declaration of conformity to the MDR can be received for the product. There is a set of agreed standards which must be followed to bring an MD for cleaning and disinfection to the market. ISO 13485 is an international standard that defines quality management system (QMS) requirements for manufacturers of medical devices. The primary objective of the standard is to facilitate harmonised QMS requirements for regulatory purposes within the medical device sector. It is applicable to all manufacturers of medical devices who have a duty to ensure that devices consistently meet customer requirements and meet all applicable regulatory requirements.
In addition, a company manufacturing a medical device must have established risk management processes that comply with ISO 14971:2007. This standard ‘specifies a process for a manufacturer to identify the hazards associated with medical devices…
..to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.’ The requirements of ISO 14971 are applicable to all stages of the life-cycle of a medical device. The MDR, ISO 13485 and ISO 14971 are the key building blocks underpinning product quality. All need to be in place to ensure the highest quality disinfectant or cleaner.
Biocidal Products Regulation
Products developed for disinfection may also come within the remit of the biocides regulations as well as the medical device regulations, depending on their intended purpose, composition and the claims made for the products concerned. There are considerable differences between a medical device and a biocide. The MHRA states that biocides are ‘intended as general purpose disinfectants for rooms, hard surfaces etc’ and ‘are not considered to be medical devices’. [MHRA, 2016] A biocide is approved based on its active substance, so it is only the active ingredient which is approved, not the final complete product, whereas an MD refers to the complete product. The EU Biocides Regulation 528/2012 covers a diverse range of products which control harmful or unwanted organisms through chemical or biological means. These include disinfectants. The difference between MDR and BPR is that BPR applies to the disinfection of non-critical areas which do not come into contact with patients like floors and work tops. Whereas MDR covers products which are used to clean or disinfectant anything which comes into direct contact with a patient. For critical healthcare areas a CE mark is required and for non-critical areas where disinfection is claimed, BPR registration is needed. In practice this means that a disinfectant used in the healthcare environment may need a dual registration and need to be registered according to both the BPR and MDR. For example, the mikrozid range of
surface cleaners has a dual registration as they have a biocidal formulation for the disinfection and cleaning of hard surfaces as
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WWW.CLINICALSERVICESJOURNAL.COM AUGUST 2019
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