Manufacturers, please!

Dr de Lint: In hospitals, medical practices and particularly operating theatres (OT), many sterile packaged goods and appliances are needed and often must be unpacked without delay for immediate use. The article – a scalpel, stitch, implant – is typically recognised at a glance, based on shape and colour of packaging and other physical features.
However, where package and shape are not unique for their content, the label has to be read to make the right choice. Evidently, an appropriate and prompt recognition of contents is mandatory for safe, quick delivery to the instrument table. One would therefore expect that contents recognition from the label has high priority in the manufacturing process. However, there are many examples of the opposite.
Food, hazardous substances, pesticides, shoes and baby clothing have better standardisation of labeling than medical devices and disposables! Medical firms are eager to have their brand, logo or company name prominently on the package. Often this comes at the expense of space and readability of the contents description. Type, diameter, size and material are often poorly recognized on the label and only found by cumbersome searching of the label between barcodes, re-ordering numbers and company details. It is of paramount importance that the contents of a packed item are immediately recognised from the label. In terms of font, size and relationship to other information on the label, the text should be immediately eye-catching and legible at a distance. When appropriate, a sketch or pictogram of the contents is very helpful, in addition to this text, and will enhance the recognition. Another aspect of labelling is content recognition in a stacked situation.
Products are often packaged in an outer box or tray and it should not be necessary that the entire contents of a tray has to be spread on the floor to find a certain type or size. In short, there is often no focus at all on the practical display of product information on labels. The ultimate goal should therefore be an international standard in labeling for medical goods. The European hospital community could take the leadership in this.
Is such clarity so difficult to achieve?
Rainer Hill: ‘First we have to clarify which packaging level we are talking about: Is this the primary wrap that directly protects the product and keeps it sterile, or are we talking about the secondary packaging that has to show the necessary information, or the tertiary, meaning transport packaging. ‘The debate about labelling of medical products most frequently concerns the secondary packaging. Larger units, such as those sold to hospitals, for example 1,000 hypodermic needles, do not include instructions for use – IFU – for every single needle. It’s the hospital that has to ensure that the safetyrelevant information provided with the entire unit is always accessible when needed by the staff. Thus, this is an issue that concerns not only the manufacturer but also the hospital.’
The legal framework
‘In the EU, labelling of medical products is unambiguously regulated.The information to be provided by the manufacturer encompasses labelling as well as instructions for use. Annex I of the Council Directive 93/42/EEC states statutory product requirements which are rather general but which are clarified by harmonised European standards that were commissioned by the European Commission. ‘As far as labelling of medical devices is concerned, there are EN 980 on symbols for use in the labeling of medical devices and EN 1041 on information supplied by the manufacturer of medical devices. EN 980 allows the manufacturers to replace multilingual text by unified symbols that are used throughout Europe.
The role of CE marking
‘The statutory requirements regarding CE marking, which certifies conformity to EU legislation, of medical devices are inter alia defined in the section ‘Essential Requirements’ of Annex I of Council Directive 93/42/EEC and encompass labelling. ‘In Germany EU legislation is in force via reference in section 7 of the Medical Devices Act, the Medizinproduktegesetz MPG. Additionally, section 11, paragraph 2, sentence 3 MPG requires all safety-relevant information to be provided in German or in the language of the user. That means an exception to the mandatory use of German is possible if a hospital and manufacturer agree on a different language for the product information, for example, English. If such an exception is intended, the parties to the agreement must ensure that the entire staff – from medical director down to junior nurse – are sufficiently versed in English, to avoid misunderstandings and errors in the product’s use. If this is not the case, non-German product information can be considered a defect for which the manufacturer is liable.’
Control mechanisms
‘Conformity with labelling requirements on the product itself and/or the sales packaging is checked by different bodies, depending on the product risk class. They ensure that information and content are in accordance. In the past, certain German regulatory authorities intervened only after a dangerous event had occurred. Preventive control of samples is not a standard operating procedure in all countries. New administrative regulations, coming into effect in early 2012 in Germany, intend to harmonise market control and control by the regulatory authorities. ‘To facilitate labelling even further, an EU regulation on electronic labelling of medical devices is expected to be enforced in early 2012.
‘This regulation would allow electronic instructions for use to be provided in addition to, or as a replacement of, print IFU – for example via the internet rather than with each single item. However, the e-labelling option is initially limited to certain product groups, such as implants, or large equipment such as CT and MRI systems. For other medical devices e-labelling is far from imminent. Product information that is primarily intended for the industry can be provided as bar codes or data matrix codes.’

Suggestions for requirements:
A recognisable label
• colour – contrasting with package colour
• size – minimum size, e.g. 5 x 7cm.
• font – legible at a distance; i.e. minimum font size

Indication of contents
• dimensions
• properties of the product
• quantity of items
• use before: … / sterile until: …

Information for all stakeholders
(user, buyer, purchasing, inventory, retailer)
• user information (OT) has primacy
• lot number
• reference number
• barcodes
• company logo

Label still legible
• in a box, rack or display
• after opening the package
 

18.11.2011

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