Know your boundaries when undertaking new and innovative procedures

Feb 27, 2018

The exponential increase in medical knowledge and the solutions to medical problems provided by innovative technology is a challenge to any proceduralist.

Practitioners want to offer their patient the best procedure available, but they also have to manage clinical and medico-legal risks that can be associated with being an early adopter of a new procedure where there is a lack of longitudinal evidence around its efficacy and safety.

New procedures that offer the hope of reducing suffering for patients are newsworthy. However, as several high profile cases in recent years have shown, so are stories about the actual and perceived harm that some new procedures have caused. These cases have led to political, regulatory and legal action.

So how do you select treatments and procedures?

The fundamental safe practice points are:

  • use treatments that are only evidenced based
  • use drugs and prosthetics that are approved by the Therapeutic Goods Administration
  • undertake adequate training in the new treatment
  • work within your approved scope of practice
  • ensure that your institution’s facility’s resources are appropriate
  • use an adequate consent process including informing your patients that the procedure is new and may have risks that are not yet known
  • audit your outcomes
  • consider whether you should notify your medical defence organisation (MDO) before you start the new procedure.

Training

We recommend that if you are considering taking on a new procedure that involves the use of different technology, such as a new prosthesis or a different surgical route of instruments, an ideal training program would be:

  • first study the theory behind the procedure
  • observe some cases before undertaking your first case
  • engage with an experienced mentor to assist with case selection and ensure they are present for the initial procedure.

The extent of supervision/mentorship will depend on the degree of novelty and complexity of the treatment.

Some companies will have prescribed training that must be completed before their technology may be used. Access to the prosthesis may be conditional on completing the training.

Scope of practice and your institution’s resources

It is important to keep your hospital informed about your intention to start offering new treatments.

Scope of practice is variably defined in the private sector by a credentialing process.

Also consider the need for training of the nursing staff and the effect on other services such as intensive care or imaging.

It is likely that more companies will restrict prosthesis use to authorised hospitals, for example in the case of the trans-catheter aortic valve implantation device TAVI.

Consent

The High Court in its decision of Rogers v Whittaker in 1992 confirmed that patients are entitled to information regarding their treatment that they are likely to attach significance to. It is up to practitioners to ensure that the discussion with the patient has met this obligation.

In the case of a new treatment it is important to discuss with the patient the place of the new treatment among the options available.

Research has shown that surgeons have a different perception of patients’ expectations regarding the details of a new procedure. For example, 60% of patients wanted to know technical information, whereas only 20% of surgeons thought a patient would have this degree of interest. 1

Good practice is to discuss:

  • the level of evidence supporting the new treatment
  • the ‘newness’ of the treatment
  • the perceived benefits of the treatment, over the previous option or other options
  • any new potential complications
  • the practitioner’s experience and training administering the treatment or performing the procedure
  • any cost difference to the patient
  • any concerns the patient has.

It is also worthwhile to:

  • use models and diagrams to explain the proposed procedure
  • give relevant brochures and/or information sheets to the patient
  • offer a ‘cooling off’ period, followed by a second consultation.

It is essential to carefully document evidence of all these steps.

Audit

An audit of new procedures is useful because it will alert a practitioner early to any problems. It also allows benchmarking with accepted standards and may be more relevant in the event of a claim or complaint by providing supportive evidence of competency.

Your medical defence organisation

Informing your MDO of your intention to offer a new procedure or treatment will help to ensure you receive the right level of cover in the event of a problem. Your MDO may require evidence of appropriate training and experience.

Adherence to the consent process outlined above will greatly assist in making a claim defendable. Bear in mind that falling back on ‘usual practice’ introduces a significant element of additional risk in establishing that informed consent was obtained.

So, for the future

Just as the speed of introduction of new treatments is increasing, so it is important for medical practitioners to approach their adoption in a systematic manner as described here.

This article was previously published in the Australasian Gynaecological Endoscopy and Surgery (AGES) e-Newsletter, escope in February.

Reference

1 Susan Lee Char et al (2013) Informed Consent for innovative surgery: A survey of patients and surgeons. Surgery 153(4).

Share your view

We welcome your feedback on this article – email the Editor at: editor@avant.org.au