When a bone graft falls on the floor

What is your protocol for when an indispensible instrument or 'bone graft' falls onto non sterile area?

An interesting discussion...TE

https://www.researchgate.net/post/What_is_your_protocol_for_when_an_indispensible_instrument_or_bone_graft_falls_onto_non_sterile_area



Akilesh Ramasamy

Dental Speciality Clinic

Instruments can be resterilized. A flash sterilization cycle can get the instrument ready to you in about 20 minutes or so. We send the instrument for reprocessing immediately if the instrument is that indispensable, else if we can [get] away with an alternative instrument we proceed. For example, at times we have used a chisel as a screw driver alternative when our screw driver fell to the floor while fixing a fracture. But if the screw holder itself falls, we send it for processing [and] sterilization.

Grafts are another thing... you have a few options:

1. Use another graft (possible when you are using allograft sources)

2. 30-min soak in 4% chlorhexidine followed by a 30-min soak in triple antibiotic solution (gentamicin, clindamycin, polymixin), followed by sterile saline wash was 100% effective according to a study.

3. Grafts can be autoclaved as well (the technique of autoclaving and using the bone is a technique used in jaw bones in some pathologies. After resection of the mandible, the pathology is removed from within the bone the bone autoclaved and then used as a non vascularized bone scaffold to hold particulate bone grafts!)

4. Postpone the procedure and complete the procedure using graft from another site at another time after getting appropriate informed consent again.

Any such occurrence must be fully disclosed to the patient. The best choice will depend on the critical nature of the procedure and the wound bed/graft site, the graft volume and type among a few.

If you are using chlorhexidine, saline wash is mandatory and important as chlorhexidine induced chondrolysis has been reported. So if you are using cartilaginous structures after chlorhexidine wash, there can be chondrolysis.

The disadvantage is that the graft will lose all viable cells during the process of autoclaving or when using chlorhexidine.

Povidone iodine applied and dried has also been found to be effective with better cell viability.

Taking measures to avoid dropping the graft and instruments is THE only best solution. The surgeon must take full responsibility and ensure that all members of the team are aware and handle the grafts carefully during harvest, after harvest and during the time of fixation. At each point of transition of the graft, there must be good communication and co - ordination to avoid such incidents.

Regarding instruments,the same apply.

Breach in sterility would mean surgical site infection and loss of graft anyway ... So using just a saline wash and placing the graft or using an instrument with just after a saline wash can be disastrous.

Using a spirit wipe after washing before reprocessing for re-sterilization has been used by us a few times when the instrument fell into visibly soiled areas.

Dr. Akilesh. R

Chennai, India

Update:

Bone - low pulse irrigation with > 1 L of triple antibiotic solution is preferred. Cancellous bone is better re-harvested, cortico cancellous bone may be decontaminated.

Soft tissue: Low pulse irrigation with > 1 L of 4% chlorhexidine is preferred.

Interestingly a study found that PVP-I was the most commonly used decontaminant than chlorhexidine which was found to be more effective. But saline wash is mandatory in each case especially with chlorhexidine wash as it is known to cause chondrolysis if not washed off.

Low Pulse Pressure vs Washing vs Soaking

Soaking or washing is not adequate. Low pulse irrigation is preferred for thorough decontamination. The 5 second rule or the 15 second rule may not be applicable. OR floors though are cleaned they are not part of the sterile field and even the area just around the Operating table is walked repeatedly by the surgical team. Moreover, the bacteria may not necessarily fly away, they may just be bombarded into some of the crevices / folds of the harvested graft.

Culture of the graft

Routine culturing of the dropped graft before decontamination is helpful. If an infection develops we know the sensitivity and appropriate antibiotics to use.

An interesting publication in this regard is attached which formed the source of my update:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2344133/
survey covering 156 incidents of graft contamination.
"Nearly two thirds of the contaminated grafts related to craniofacial procedures. Ninety-four percent of grafts were managed with decontamination and completion of the operation...Only 3 surgeons (1.9%) said a clinical infection developed following decontaminated graft use."
"Patients were not informed in 60% of graft contamination incidents."

Jayaprakash Gadagi

Coorg Institute of Dental Sciences

UV light sterilization may help to sterilize the bone graft.

Lukasz Zadrozny
Medical University of Warsaw

With bone graft You will be in trouble, in my opinion there is no method which allows you to sterilize the bone graft especially during the surgery. And with instruments you can always use similar one instead or even try 5 minutes autoclave program to sterilize it.

Syed Wali Peeran
Sebha University

Always start with backup instruments and material. In dental operatory with autogenous bone graft we can be in real trouble especially if source was intra-oral and the patient is on the chair.  ...

Robert Betz
U.S. Food and Drug Administration

This is PERSONAL OPINION and not an FDA opinion:

I believe that the 5 second rule came from frustrated parents who stated that if a piece of food was on the floor for less than 5 seconds, it was safe to eat.  This rule has been disproven in at least one study as a sterility-safe procedure, but I do not have a study reference.

Product labeling for many bone grafting materials state that the material is not to be resterilized.  There may be good reasons for this, and not just the desire to sell more product.  From a conjectural perspective; one could surmise that bone graft products that are labeled "Do Not Resterilize" may be degrated in some manner, making them less effective in producing favorable grafting results.

I personally would recommend the Boy Scout addage - "Be Prepared", and use other sterile instruments and bone grafts wherever possible, and cancel the procedure if not able to proceed in a sterile manner.  The "Better Safe than Sorry" addage seems to apply here.

Again; this is a PERSONAL OPINION and not an official FDA opinion.

Dan Holtzclaw

Walter Reed National Military Medical Center

I am approaching this question from the viewpoint of a private practicing dental surgeon in the USA.  My country (the US) is a very litigious society.  If I were to drop an allograft or autograft onto the floor, "resterilize" it, and use the product anyway, that would be grounds for a huge lawsuit.  Even if there was literature to support doing this, the rule of thumb in US courts of litigation is "what would a reasonable person amongst you peers do in the same exact situation?"  I can tell you that no one is going to go on record saying that they would re-use something that fell on the floor.  That is bad for business and bad for your reputation.

In such a situation, if it is an instrument that fell on the floor, you should have a back-up in your office.  In my office, we have AT LEAST 1 back up for all of our instruments.  In most cases, we have multiple copies of the same instrument.  About the only thing for which we do not have a duplicate is our CBCT machine.

As for allografts, if one falls on the floor, you trash it and get another.  You eat the cost and consider a normal cost of doing business.  Again, hopefully you have backups in the office.  In my office, we have backups for all of our materials.  We do not "order as needed" because circumstances can change mid-surgery and if you are not prepared, you cannot finish the surgery.

There is just too much legal risk in re-using anything that fell on the floor.  Even if there was plenty of literature to support doing so, I would not do it.

Nicholas Malden (original post writer)
The University of Edinburgh

... thank you for all your responses which I found interesting, informative and sometimes surprising.

I was particularly interested to read the manuscript linked for us by Dr Akilesh Ramasamy, 'Management of contaminated autologous bone grafts'.

In the UK the Health Service is reinforcing the concept of our 'Duty of candour'. Driven by the public's desire for more openness/transparency within the NHS it basically puts almost a legal responsibility on clinicians to inform patients of any periprocedural operative divergence or mishap that might materially compromise the outcome of that treatment, whether or not a complication has resulted or not.

Most interesting in the survey by Robert Centeno et al,'Patients were not informed in 60% of graft contamination incidents'. 

Dan Holtzclaw has provided us with a more dogmatic protocol and although it might not protect against a charge of negligence, it might protect against the greater charge of gross professional misconduct, should a 'hidden' error result in serious complications.

Thinking about the risk vs benefit to patients, on one hand if I was a recipient heart transplant patient and my donor heart was dropped I would say "please still put it in" but in the case of a small autologous bone graft where a less optimal but sterile alternative is available in a bottle, the risk vs benefit swings away from benefit to risk.

Risk cannot be eliminated, risk can only be minimised and managed.

So in summary I have determined the following: -

A 10 (or 5) second rule has no application when applied to contamination accidents in surgery.

Every effort should be taken to minimise the risk during the 'handling phase' of a graft passing between donor and recipient sites.

A viable plan B, in the event of  graft loss, should be discussed with the patient at the consenting stage.

On the subject of minimising risk I do still use and teach the technique described in my paper 'Reducing the risk of failure during intra-oral bone grafting'. Implant Dentistry 07/2005; 14(2):154-6.

 I would consider it a useful and inexpensive technique and could be utilised when applied to larger grafts such as rib or calvarian when a plan B is not so viable.
- njm