From compliance to excellence.
EXAMPLE OF THE MOST COMMON OFF-LABEL USE- SINGLE-USE DEVICES AND THEIR REPROCESSING (when on IFU- Instruction for use – the manufacturer indicates SINGLE-USE but the end user REUSE it)
Single-use devices are not designed to be reused, for example, a syringe. A company that re-sterilizes a single-use device effectively becomes the manufacturer of the device and is responsible for getting it CE marked. If the device is not CE marked for its new intended purpose, it would be considered off-label use if you re-use it and it would be at your own risk.
Regulation (EU) 2017/745 – Medical Devices – Article 17
Any natural or legal person who reprocesses a single-use device to make it suitable for further use within the Union shall be considered to be the manufacturer of the reprocessed device and shall assume the obligations incumbent on manufacturers laid down in this Regulation, which include obligations relating to the traceability of the reprocessed device in accordance with Chapter III of this Regulation. The reprocessor of the device shall be considered to be a producer for the purpose of Article 3(1) of Directive 85/374/EEC. (The single-use devices that are reprocessed by an external reprocessor at the request of a health institution, provided that the reprocessed device in its entirety is returned to that health institution and the external reprocessor complies with the applicable requirements).
The name and address of the manufacturer of the original single-use device shall no longer appear on the label, but shall be mentioned in the instructions for use of the reprocessed device.
[Responsibility goes directly from the original manufacturere to the natural or legal person who reconditions a single-use device as the new manufacturer.]
Member States shall encourage, and may require, health institutions to provide information to patients on the use of reprocessed devices within the health institution and, where appropriate, any other relevant information on the reprocessed devices that patients are treated with.
Use off-label – in clinical procedures
You should use medical devices as described by the manufacturer in the instructions. If you use the device in any other way, it’s considered ‘off-label’ use. Without the manufacturer’s approval this will be at your own risk and you or your employer could become liable for civil claims for damages from injured patients or their families if something goes wrong with the device.
Off-label use of a device could lead to dangers.
Devices without CE marking (OFF-LABEL use) can only be used in two cases:
– in clinical investigations;
– for compassionate use (exceptional use) (rare, non-repetitive or systematic situations for which therapeutic alternatives do not exist in the opinion of medical practitioners)
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is no legitimate alternative available. This is called an exceptional use of a non-CE marked medical device. The same provision may be made for custom-made devices that have not complied with the standard conformity assessment procedure.
No option but to use a device off-label
It is possible that there is no medical device available for a procedure. In this case you should decide whether to use an existing medical device for a different purpose, modify a medical device for a new purpose or use a product for a medical purpose that is not CE marked as a medical device.
You must balance the risks and benefits to the patient taking into account recommendations which include:
- carrying out a risk assessment and documenting it
- considering the ethical and legal implications
- implementing suitable precautions to minimise the risk
- reviewing the risk assessment at suitable periods
- getting approval from Ministry of Health for compassionate use (exceptional use) of non-complying devices
In Italy you have to complete the application:
You must inform the patient during the consent procedure and make a note on their records that you will be using a medical device off-label.
But economic operators who (consciously) sell a dm for non-certified use that they have obligations?
We talk of the distributors who are subject to specific obligations and have a key role to play in the context of market surveillance. Along with manufacturers and importers, distributors are the third category of economic operators who are subject to specific obligations. The distributor is a natural or a legal person in the supply chain, other than the manufacturer or the importer, who makes a product available on the market.
Retailers, wholesalers and other distributors in the supply chain are not required to have a preferential relationship with the manufacturer like the authorised representative. A distributor acquires products for further distribution either from a manufacturer, from an importer, or from another distributor.
Distributor must act with due care* in relation to the applicable requirements*. They have to know, for instance, which products must bear the CE marking, what information is to accompany the product (for example the EU declaration of conformity), what are the language requirements for labelling, user instructions or other accompanying documents, and what is a clear indication of the product being non-compliant. Distributors have an obligation to demonstrate to the national market surveillance authority that they have acted with due care and ensure that the manufacturer, or his authorised representative, or the person who provided him with the product has taken the measures required by the applicable Union harmonisation legislation as listed in the obligations for distributors.
Conformity assessment, drawing up and keeping the EU declaration of conformity and the technical documentation remain the responsibility of the manufacturer and/or importer in the case of products from third countries. It is not part of the distributor’s obligations to check whether a product already placed on the market is still in conformity with the legal obligations that are currently applicable in case these have changed. The obligations of the distributor refer to the legislation applicable when the product was placed on the market by the manufacturer or the importer unless specific legislation provides otherwise.
The distributor must be able to identify the manufacturer, his authorised representative, the importer or the person who has provided him with the product in order to assist the market surveillance authority in its efforts to obtain the EU declaration of conformity and the necessary parts of the technical documentation. Market surveillance authorities have the possibility to address their request for the technical documentation directly to the distributor. The latter is however not expected to be in possession of the relevant documentation.
Before making a product available on the market, the distributor must verify the following formal requirements:
— that the product bears the required conformity marking(s) CE marking), — that the product is accompanied by the relevant documents (EU declaration of conformity) and by instructions and safety information in a language which can be easily understood by consumers and other end- users if required by the applicable legislation,
— that the manufacturer and importer have indicated their
(2) registered trade name or trademark and
(3) the address at which they can be contacted on the product or when not possible because of the size or physical characteristics of the products, on its packaging and/or on the accompanying documentation, and that the product bears a type, batch or serial number or other element allowing the identification of the product.
Distributors must not supply products that they know or should have assumed, on the basis of information in their possession and as a professional, not to be in compliance with the legislation. Further, they must cooperate with the competent authority in actions taken to avoid or minimise these risks, inform the manufacturer or the importer as well as the competent national authorities.
Similar obligations bind distributors once a product is made available. If they have reasonable grounds to believe that a product is not in conformity, they have to make sure that corrective measures to bring the product into conformity are taken by the manufacturer or the importer and inform the competent national authorities. Distributors have to contact the importer or manufacturer to clarify any doubt about the conformity of the product.
In addition to controlling the conformity of the product with the formal requirements, the distributor must:
- initiate corrective measures where there is suspicion of a non-conformity;
- assist market surveillance authorities in identifying the manufacturer or importer responsible for the product;
- upon a reasoned request from a competent authority, cooperate with that authority and provide it with all the information and documentation necessary to demonstrate the conformity of a product;
- on request by market surveillance authorities, identify any economic operator who has supplied them and to whom they have supplied the product. They must be able to present this information for a period of 10 years after they have been supplied with the product and for a period of 10 years after they have supplied the product.
The distribution conditions (for example transport or storage) may have an impact on maintaining the compliance with the provisions of the applicable Union harmonisation legislation. Thus, the person in charge of the distribution conditions must take the necessary measures to protect the compliance of the product. This is to ensure that the product complies with the essential or other legal requirements at the moment of first use within the Union.
All economic operators have a role and obligations in market surveillance.
End User – Consumer (Professional or Patient)
Contrary to economic operators, end-users are not defined in Union harmonisation legislation and are not subject to obligations. Many medical devices covered by Union product harmonisation legislation are used at work and thus also subject to Union safety at work legislation.
Union harmonisation legislation does not create obligations for the end-users of the products in their scope. This is the case even when there are no responsible economic operators present within the EU (for example, in the context of products sold online). Consequently, the term is not defined in that legislation. It is certain however that the term covers both professional users and consumers. The concept of ‘end use’ by a professional or a consumer is intrinsically related to the concept of ‘intended use’
1° Case:End-User (Patient) ==> No obligations for the end-users of OFF- LABEL MDs and IVDs.
THE LEGISLATION ON PRODUCT LIABILITY provides the clarification: The fact that a product is not fit for the use expected (Use OFF LABEL) is not enough to claim damages. The Directive only applies if a product lacks safety. The Directive only applies if a product lacks safety. The fact that a better product is made afterwards does not render older models defective.
2°Case: Professional ==> Read back ==> Use off-label – in clinical procedures
3°Case: Worker (when a professional user has employees, for example nurses who using the MDs OFF LABEL) ==> Must report the use of OFF LABEL to its direct manager
End User – Worker
Health and safety related legislation is also applicable to employers providing any equipment including devices for use in the workplace that the health and safety executive provide advice and guidance upon.
Many medical devices covered by Union harmonisation legislation are used at work. According to legislation based on Article 153 TFEU, employers have obligations as regards the use of work equipment by workers at the workplace. An employer is considered to be any natural or legal person who has an employment relationship with a worker (that is any person employed by an employer), and has responsibility for the undertaking or establishment.
According to the Directive concerning the minimum safety and health requirements for the use of work equipment by workers at work (2009/104/EC), the employer must take all measures necessary to ensure that the work equipment (for example machinery and apparatus) made available to the workers is suitable for the work carried out, and may be used by workers without impairment to their safety or health. The employer may only obtain or use work equipment that complies with the provisions of the applicable legislation at the time of its first use, or, if no other legislation is applicable or is only partially applicable, the minimum requirements laid down in Annex I to Directive 2009/104/EC. The employer must also take the necessary measures to ensure that work equipment is kept at such a level. Further, the employer has an obligation to provide information and training for workers as regards the use of work equipment.
According to the Directive concerning the minimum health and safety requirements for the use of personal protective equipment by workers at the workplace (89/656/EEC), such equipment must comply with the relevant Union provisions on design and manufacture with respect to safety and health (that is the Union harmonisation act relating to personal protective equipment). Further, the equipment must be appropriate for the risk involved, correspond to existing conditions at the workplace, take into account ergonomic requirements and the worker’s state of health, fit the wearer correctly, and be compatible where more than one pieces of equipment must be used simultaneously. The employer is required, before choosing the personal protective equipment, to assess that it satisfies the requirements.
Directives lay down minimum requirements. Therefore, Member States are allowed to adopt or retain more stringent provisions, as long as they are compatible with the TFEU. The provisions of Union harmonisation legislation must be respected and, thus, additional national provisions may neither request a modification of a product within the scope of a Union harmonisation act, nor influence the conditions of the making available on the market of such products..
Examples of problems with off-label use:
|Medical device and use||Problems caused|
|IV cannula / catheter used as arterial catheter||On removal, a section of the catheter was left in the patient.|
|A modular head and stem for a total hip replacement (not an approved combination)||Failure earlier than expected.|
|Single-use insulin needles were used more than once contrary to the manufacturer’s instructions||Blockage and incorrect dosage reaching the patient.|
|A contact lens solution used during surgery rather than after surgery as stated in the instructions||Central toxic keratopathy.|
|A disposable temperature probe used via the nose rather than rectally / orally as stated in the instructions||Significant nose bleed.|
|A wheelchair modified to fit a docking system in a car||Damage to the wheelchair.|
|A defibrillator was unable to deliver a shock in manual or AED mode due to patient impedance being outside the specified range||Third-party electrodes used were not compatible with the defibrillator.|
|A user attempted to re-configure a Bain’s breathing system||Breathing system did not work properly due to wrong size oxygen connector being put back into the system.|
|An IVD test was used for a sample type other than that recommended by the manufacturer||You should not perform IVD tests on samples other than those recommended by the manufacturer. If there is no alternative the laboratory performing the test will be responsible for these tests. They should have strong data to support the test on non-approved sample types.|
|An IVD test used with incorrect software||Incorrect results generated or delay to treatment and/or diagnosis.|
- Def: Due care refers to the effort made by an ordinarily prudent or reasonable party to avoid harm to another, taking the circumstances into account. It refers to the level of judgment, care, prudence, determination, and activity that a person would reasonably be expected to do under particular circumstances.
- Article R5(1) of Annex I to Decision No 768/2008/EC.
- Regulation (EU) 2017/745 – Medical Devices
- European Commission
- DIRECTIVE 2009/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 September 2009 concerning the minimum safety and health requirements for the use of work equipment by workers at work (second individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC)
- Web Site of the Italian Ministry of Health
- Guidance Off-label use of a medical device Published 18 December 2014 (GOV.UK)
- Experience 😉