Jurisprudence concerning hygiene and asepsis : medico-legal recommendations

The Code of ethics of dental surgeons specifies that the dentist must make « all appropriate arrangements to avoid the transmission of any pathology that there may be » (art. 3-1) and that, « at all times the quality of the care, the confidentiality and the safety of patients must be assured. Appropriate equipment must be installed [...] to meet the requirements of the regulations that are in force concerning hygiene » (art. 62).

Generally, before the legislation of 2002, the obligations borne by health professionals were essentially praetorian (by, for example, judicial precedence). One recalls the need for taking responsibility for one's actions, such as those related to the duty of care (the case of Mercier, Court of Appeal, 1936), in order to ensure safety, especially as related to operative procedures, and of the obligations for a safe outcome, such as those related to the harmlessness of products that are administered or to nosocomial infections.

Definition of nosocomial infection

The concept of nosocomial infection proves to be especially difficult to define with precision.

A circular of October 13, 1998 from the Ministry of the Health (relating to the organization of the means of surveillance and the prevention of nosocomial infections) initially defined nosocomial infection as being an illness caused by micro-organisms, contracted by patients in an establishment of care after their admission, either as an in-patient or as an out-patient, and that the symptoms appear during the stay in the hospital or afterwards and that the infection is recognisable on the basis of clinical or microbiological information, including serological data.

This circular appeared even though the law of the 1^st July 1998 (relating to the enforcement of health surveillance, and the control of the safety of health products destined for use on humans, and a following one which would come into force by the decree of 6 December 1999 which had foreseen that the fight against the nosocomial infections would be led, in every establishment, by a committee established for that purpose) had placed responsibility for organising the fight against nosocomial infections on health establishments.

In response to this law, a circular of the Ministry of the Employment and Solidarity, dated 9 December 2000, replaced the circular of 1998 and defined nosocomial infection more simply as being the one that is contracted in an establishment of care.

In the absence of a more precise definition, an even wider interpretation has been chosen by judges. « Today, nosocomial infection is considered to be that shown in a patient between 48 hours and 1 year after picking it up, not only in a public or private establishment of care but also in an independent practitioner's surgery, irrespective as to whether the micro-organisms are of endogenous or exogenous origin. »

What was the regime for nosocomial infection before the law of 4 March 2002 ?

The rules concerning nosocomial infection had also been built up by judges before being reframed by the legislation.

To begin with, an obligation to provide the means for the prevention of nosocomial infections was borne by establishments of care. It was incumbent on the patient to provide proof that the material used had been defective from an aseptic point of view.

The Court of Appeal then instituted a presumption of blame by private health care establishments in cases where a patient contracted an infection in the operating room. The establishments could clear themselves of responsibility by proving an absence of error on their part, i.e. in concreto, while providing proof that aseptic procedures had been undertaken correctly (Civ. 1^st, 21 May 1996. D. 1997. som 287).

This obligation has been taken to the bitter end by being progressively reinforced by judges as a result of case law, leading to a responsibility for a « safe outcome ». It was by three resounding judgements of 29 June 1999 (referred to as the « staphylococcus aureus judgements ») that the Court of Appeal redefined nosocomial infection, both with regard to establishments of health care as well as those of independent practitioners.

It first of all placed on private health care establishments an obligation to take responsibility for a « safe outcome » in the case of nosocomial infections contracted by a patient whilst being hospitalised. Only the proof of some external cause could exonerate the establishment from their responsibility. (« The contract of hospitalisation and care concluded between a patient and a health care establishment places on the latter, in matters concerning nosocomial infection, an obligation of safe outcome which can only relieved by returning proof of external cause. »)

One can well imagine that, under these conditions, the absence of an error is no longer sufficient.

It is relevant, therefore, to consider the definition of « external cause ». Three situations could be envisioned ; force majeure, an action by a third party or an action by the victim.

- force majeure, of by virtue of its exceptional nature, including « unpredictability, irresistibility and exteriority », all at the same time, is a defence that can only rarely be used ;

- action of a third party. The health care establishment could bring proof that the infection was due to a break in the chain of asepsis attributable to the practitioner (hand washing, bringing in and the use of a surgical kit, or material, from outside the operative unit) ;

- of the victim. This could be a failure to apply elementary rules of hygiene by the patient himself, or non-compliance with the practitioner's prescriptions.

In addition, through case decisions, establishments are no longer the only ones affected by the obligation of « safe-outcome ». Henceforth, general practitioners are subject to the same regime whether they practise in a health care establishment or in independent practice (« With regard to his patient, the physician has a duty concerning nosocomial infection which carries an obligation for a safe-outcome from which he cannot free himself except by returning a proof of an external cause »).

These arrangements have created an almost inextricable situation for independent practitioners :

- for those that practise in a clinic, where the establishment fails by action or inaction to execute procedures concerning asepsis and sterilisation with skill ;

- for those that practise in their own surgery, proof of an external cause is usually extremely difficult to produce a posteriori and from a distance. (For example, would it also be necessary, in order to protect one-self, to institute a systematic biological check-up before every treatment, with all the difficulties and additional expenditure that would generate in private practice ?)

In view of the difficulties caused by these arrangements, the legislator intervened in 2002 in order to reframe the law relating to nosocomial infection.

Contribution of the laws of 4 March 2002 and of 30 December 2002

With regard to the obligation for safe-outcome of health care establishments, whether they are public or private, previous judgements are unaffected. The victim does not, therefore, always have to prove contamination in the care establishment. There is an immediate presumption of responsibility and the burden of proof lays with the establishment to prove, for example, an external cause, in order to be exonerated.

One can consider that the legislator in 2002 was more lenient than the judges had been towards independent practitioners practising from private surgeries. Indeed, the latter would be able to appreciate their committed responsibility only on the assumption that the victim would bring proof of the nosocomial character of the infection, that is to say proof that it had been contracted in the practitioner's surgery.

Besides, the legislator anticipated that « national unity » would take on responsibility (the law of 4 March 2002 created the national office for the compensation for medical accidents, iatrogenic conditions and nosocomial infections [ONIAM]), for the largest compensations, i.e. those following damage caused by nosocomial infections that have led to a level of permanent partial incapacity greater than 25 % or death of the victim (law n° 2202-1577 of 30 December 2002 relating to medical civil responsibility).

However, independent practitioners practising in their own surgeries are not as well protected.

First of all, it is necessary to remember that the new legislative arrangements of 2002 only apply to damage following acts of prevention, diagnosis or treatment undertaken after 4 September 2001. Given this fact, a practitioner could see himself subject to two regimes, the consequences of which are fundamentally different, according to whether the care that is subject to the litigation was undertaken before or after that date :

- thus, the « staphylococcus aureus judgements » will be applied for all acts of prevention, diagnosis or treatment undertaken before 5 September 2001. This will impose on the independent practitioner the legal responsibility of « safe-outcome » : he could only be exonerated by bringing proof of an external cause. The victim, on his or her part, would not have to produce evidence other than having been under care in the practitioner's surgery ;

- in contrast, for the same procedures, undertaken by the same practitioner and under the same conditions but after 4 September 2001, it will be up to the victim to bring the proof of the nosocomial nature of his or her infection. That is to say, proof that it really was contracted within the surgery in which he or she received care.

On a practical level and as a consequence of our ethical obligations that were briefly outlined at the beginning of this article, it is appropriate to recall that ONIAM has at its disposal a right of subrogation against the health professional under Article L. 1142-14 of the Public Health Code if it is established, among other things, that there has been a blatant failure to comply with regulations concerning the fight against the nosocomial infections.

One understands, therefore, the importance that every practitioner takes on board, of the « line of action », combining a rigour and vigilance for mastery of the chain of asepsis, as well as the usefulness of keeping an up-to-date sterilisation register, as recommended in previous articles, in order to satisfy the present ethical and medico-legal requirements in periodontal and implant surgery.

This concept is even more fundamental in our daily practice than it is for the victim who, from now on, can delay seeking recompense for harm caused as a result of a medical accident, an iatrogenic condition or a nosocomial infection, for 10 years after having his or her health restored.