Edited by Lawyer Pietro Pettenati
Below, we present the official communication by Lawyer Pietro Pettenati on the subject of responsibility for stretcher maintenance. Many considerations have recently emerged on this topic, but we wanted to consult an expert in order to provide clarity.
Stretchers are Class I medical devices. The legislation to refer to is therefore, first and foremost, Directive 93/42/EEC, implemented in Italy by Legislative Decree 46/97, concerning the safety of medical devices.
The Directive requires CE marking for all devices placed on the market after June 1998. This marking is applied to the device only when it complies with the safety requirements set out in Annex I of the Directive.
The obligation to ensure the safety of the device therefore falls primarily on the manufacturer. However, obligations are also placed on the purchaser/user, since the objective of the Directive is to guarantee product safety not only at the time it is placed on the market, but also afterwards. In particular, Article 2 of Directive 93/42/EEC, corresponding to Article 3 of Legislative Decree 46/97, provides that the device must be subject to adequate maintenance in order not to compromise the safety and health of patients, users and, where applicable, third parties.
Stretchers are Class I medical devices. The legislation to refer to is therefore, first and foremost, Directive 93/42/EEC, implemented in Italy by Legislative Decree 46/97, concerning the safety of medical devices.
The Directive requires CE marking for all devices placed on the market after June 1998. This marking is applied to the device only when it complies with the safety requirements set out in Annex I of the Directive.
The obligation to ensure the safety of the device therefore falls primarily on the manufacturer. However, obligations are also placed on the purchaser/user, since the objective of the Directive is to guarantee product safety not only at the time it is placed on the market, but also afterwards. In particular, Article 2 of Directive 93/42/EEC, corresponding to Article 3 of Legislative Decree 46/97, provides that the device must be subject to adequate maintenance in order not to compromise the safety and health of patients, users and, where applicable, third parties.
Anyone purchasing a stretcher is therefore responsible for carrying out periodic maintenance operations according to the deadlines indicated in the instructions for use supplied with the product.
It can therefore be stated that maintenance is a fundamental step in ensuring the preservation of the safety requirements set out in Annex I of the Directive. But not only that.
Carrying out periodic maintenance also means keeping the responsibility for maintaining the essential requirements laid down by the Directive with the manufacturer; otherwise, this responsibility would be transferred to the user.
Another regulation to refer to is certainly Legislative Decree 81/2008 on workplace health and safety. Article 71, paragraph 4 of Legislative Decree 81/2008 provides, among the obligations of the employer and/or the person in charge, the duty to adopt the necessary measures so that work equipment is:
It can therefore be stated that maintenance is a fundamental step in ensuring the preservation of the safety requirements set out in Annex I of the Directive. But not only that.
Carrying out periodic maintenance also means keeping the responsibility for maintaining the essential requirements laid down by the Directive with the manufacturer; otherwise, this responsibility would be transferred to the user.
Another regulation to refer to is certainly Legislative Decree 81/2008 on workplace health and safety. Article 71, paragraph 4 of Legislative Decree 81/2008 provides, among the obligations of the employer and/or the person in charge, the duty to adopt the necessary measures so that work equipment is:
- installed and used in accordance with the manufacturer’s instructions for use;
- subject to suitable maintenance in order to ensure that safety requirements are preserved over time.
Except for periodic checks, which are the responsibility of the user, it is advisable to have routine maintenance operations — generally carried out annually — performed directly by the manufacturer or by technical personnel authorized by the manufacturer.
N.B. Relying on technical personnel not authorized by the manufacturer may have significant repercussions on the validity of the warranty and on liability for damage to third parties in the event of accidents. Click here to read our monthly issue.