Should Risk of Death Always be Part of the Surgical Consent?

Ever since reports of alleged medical negligence came up in the case of 13 years old Jahi McMath who suffered cardiac arrest and subsequent brain death after a "routine" tonsillectomy that occurred Dec 9, 2013, the question has come up whether risk of death should become part of every single surgical procedure's informed consent no matter how rare that risk might be.

It also brings up the question whether patients would want to hear every single possible conceivable risk that may occur (which could ALWAYS include some infinitesimal risk of death) with even simple surgical procedure like ear tube placement for chronic ear infections.

[Disclaimer... I am not a lawyer and this is not legal advice.]

From the physician's perspective, Duke surgeons have thought about this quandary and here were their suggestions of what is considered "reasonable" when it comes to risk of death and the consent process:

• When the risk of death is so low as to be unexpected and highly improbable, including it as part of the consent may actually be misleading (may cause a patient not to pursue a needed surgical procedure due to unreasonable concern for a remote risk of death)
• When the risk of death is felt to be “high enough” to disclose, then this adverse outcome should be discussed among the risks, and the patient must be informed.
• How high should the risk of death be before one would want to include it as part of the consent process? This risk could be any chance at all to about 0.1% risk as a reasonable threshold.

From the patient's perspective, when it at least comes to anesthesia risks with children (which also has a remote risk of death), researchers were able to provide some numbers when it comes to consent:

• 87% of parents wanted to know the risk of death as a result of anesthesia. 13% did not.
• 68% of parents knew that risk of death was "extremely rare." 19% believed that risk of death occurs "once in a while," and 13% thought there was "no chance."
• 74% of parents wanted to know "all possible risks," 24% wanted to know only "those that are likely to occur," and 2% wanted to know only about those that would "result in significant injury."
• Mothers were more likely to want to hear all possible risks, whereas fathers were more likely to want to know only about those that are likely to occur.

Although media reports stated that Jahi underwent a "routine" tonsillectomy, that was actually not true. She underwent a UPPP surgery which is much more aggressive throat surgery than tonsillectomy alone. The reported risk of death with UPPP is around 0.2%. As such, disclosure of possible low risk of death would have been not unreasonable.

The risk of death for routine tonsillectomy is somewhere between 0.003% to 0.01%.

Just for comparison, the risk of dying from driving a car for over 50 years is 1.1% and annual risk of death from smoking 10 cigarettes per day is 0.5%. [Link] Note that these "mundane" risks of driving and smoking are higher than the risk of death associated with tonsillectomy or UPPP.

In the end, there is no set policy about when risk of death should be discussed. This disclosure has been left up to individual surgeons who use their professional judgement when that risk becomes large enough to merit discussion as part of the informed consent.

What do you think?


References:
Parental knowledge and attitudes toward discussing the risk of death from anesthesia. Anesth Analg. 1993 Aug;77(2):256-60.

Surgery and the D-Word: Approaching the Topic of Death and Dying with Surgical Patients. J Palliative Care Med 2:108. doi:10.4172/2165-7386.1000108

Risk perception and communication: recent developments and implications for anaesthesia. Anaesthesia 2001;56:745-55.

Risk language and dialects. BMJ 1997;315:939-42.

Safety of Adult Tonsillectomy: A Population-Level Analysis of 5968 Patients. JAMA Otolaryngol Head Neck Surg. 2014 Jan 30. doi: 10.1001/jamaoto.2013.6215.

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Sinus Surgery Lawsuit Ruled Against ENT

A patient who had undergone endoscopic sinus surgery suffered detachment of the extraocular muscle resulting in double vision that required further surgical intervention.

A jury found against the ENT and ambulatory surgery center rewarding $2.5 million dollars to not only the patient, but also the wife "for loss of consortium".

Damage to the eye and vision is part of the normal consent process for endoscopic sinus surgery when considering the geographic proximity of the eye and sinus cavities.

Eye muscle injury as in this case is particularly relevant when surgery is performed on the ethmoid sinus cavity which is located between the eyes (purple in illustration). Risk of injury is even higher when powered instruments are used like a diego sinus shaver.

Although informed consent appears to have been present, the jury still found for the patient:

- $1.5 million to Mr. Dias for pain and suffering
- $0.5 million for loss of service
- $0.5 million to his wife for loss of consortium.

This case appears to suggest that informed consent does not really provide any legal protection. A bad outcome regardless of consent implies sufficient cause for lawsuit... and winning.

This case also suggests that any bad outcome can affect a patient's ability to have intimate relations with a spouse which is sufficient cause for lawsuit and winning.

I wonder if I now have to add to the informed consent (which may not afford me any legal protection) the possibility of "loss of consortium" with a spouse.

Source:
Patient Awarded $2.5 Million After Suffering Endoscopic Sinus Errors. Outpatient Surgery Magazine 9/5/12

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Surgical Time-Out, circa Year 2050

In the year 2050, surgical time-outs have reached a new level of safety to ensure the utmost care and risk reduction for patients.

Unlike the primitive time-outs performed in the the first decade of the 21st century (2000-2012) which involved one designated individual to confirm prior to incision (Basic9), the patient name, surgical site, performing surgeon, allergies, antibiotic administration, positioning, x-ray name confirmation, fire hazards, and fall risk, significant additional safety checklists have been implemented to create a new state-of-the-art culture of safety both in and out of the operating room.

In 2015, surgical time-outs extended to also include electrical and air quality checks (Environ2) along with separate mandatory time-outs of the Basic9 before, during, and at conclusion of surgery.  To ensure minimal air contaminants as well as maintain the highest performance of all electrical equipment in the operating room, the Environ2 requires a separate electrical and environmental engineer to certify all equipment and confirm air quality at a level of no more than one contaminant part per trillion to the 10th power in 35 separate locations within the operating theater. The Environ2 checks are double-confirmed by the circulating nurse who has been granted broad powers to cancel surgery for any reason without consequence if there are any concerns with the operating room environment that may increase infection risk for the patient as well as sub-optimal performance of any and all equipment used to perform the surgery.

In 2020, the Total5 was added to Basic9 and Environ2 which truly heralded the onset of state-of-the-art surgical time-outs. Total5, developed jointly by the Harvard School of Public Health and National Institute of Medicine, involves a comprehensive time-out of any and all individuals entering into the operating room in the knowledge that surgical outcomes are affected by personnel movement into and out of the operating room whether from contaminants on the skin or clothing of staff to infections that they may or may not be harboring. In rare cases, given the recent terrorist attacks both biological as well as chemical, the Total5 would additionally eliminate such threats.

As such, Total5 involves for each and every staff member that enters the operating room to undergo "individual time-outs":

1) Geiger counter check

2) Body pat-down by TSA (whose duties have tremendously expanded from initial airport security)

3) Metal detector check

4) Chemical check (specifically looking for arsenic, mercury, formaldehyde, etc as well as drug screen)

5) Biohazard check (routine organisms include MRSA, VRSA, C dif, HIV, hepatitis, etc as well as more exotic organisms like Ebola, Swine Flu, Anthrax, etc).

A separate consent must be in the chart for each and every individual who is present for the patient's surgery with their Total5 report.

The Basic9, Environ2, and Total5 surgical time-outs collectively have ensured a 360 degree safety net for the patient.

But... it is not until now in the year 2050 that the surgical time-out has reached a penultimate state with the expansion of the Total5 to Total10. In addition to the original Total5 for surgical staff, 5 additional time-out checks of surgical staff is now required. Continuing with #6...

6) Retina scan (to confirm staff identity)

7) Fingerprint scan (to double-check staff identity)

8) Malpractice insurance check (if positive, consent must be in chart to ensure patient was aware of any malpractice committed by any surgical personnel doctor or nurse)

9) EKG to ensure peak cardiac health of staff member

10) EEG to ensure a rested mind at peak performance of staff member

As with the Total5, Total10 report for each staff member must be included in the patient consent in the patient's chart.

There was some confusion whether each staff member can undergo just one Total10 per day, but with new regulation acknowledging possibility of patient infection contaminating personnel as well as staff member fatigue that may progress throughout the day, a Total10 MUST be performed before each and every surgical case.

For any further questions on surgical time-outs, please contact your local hospital JCAHO executive liaison.

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