I believe it is absolutely mandatory

"I believe it is absolutely mandatory...and not just a recommendation"


I play a double role in the hospital being Chief of the Department of Maxillofacial Surgery in the San Filippo Neri hospital in Rome and collaborating with the international organization Operation Smile to treat children born with facial deformities, like cleft lip and palate all over the world. 

In Italy Operation Smile has developed a program called Smile House: a network of cleft centers (Rome, Milan, Vicenza, Ancona, Cagliari and Taranto) where children affected by clefts and other facial deformities are treated in
partnership with the Regional Health Care System since the diagnosis (prenatal or neonatal) to the end of growth. I’m also the Director of Smile House Roma, located inside the San Filippo Neri hospital where I work. 


Together with my team we perform surgery two times per OR and per week, which comes down to approximately 700 surgeries per year and at minimum 70 surgeries per month. 


COVID-19 has had a double impact in Italy, with the first wave hitting the country between February and June causing a true emergency and the second wave continuing in January 2021. Even if the hospital was not directly involved in the first wave, attending only the 2nd row of emergency, and having received no more than 20-25 COVID cases, the hospital wasn´t impacted as heavily. However, we were still obliged to stop elective surgeries. Last October 2020, the hospital stopped performing elective surgeries and continued to operate only for emergencies which meant performing surgery only in case of trauma and worst-case tumors.  


With the COVID emergency, we needed to fully redesign the pathway to access ambulatory as well as OR. Especially during the 1st wave, all patients were considered a risk and had to be tested ensuring maximumm protection for everyone in the hospital. The remaining challenge is how to cover patients, parents and medical staff for the full pathway starting in the ambulatory, continuing in operating room, and even out in the world. As a collaborator of the international organization Operation Smile, I was heavily involved in the search for solutions aimed to restart surgeries.


At the time, the worldwide community was severely impacted and not only in Italy, but in 70 more countries we were obliged to stop elective surgeries. 


The main impact is based on the key question 'How do we protect the entire community involved in treating patients with facial deformities and any other patient in need of maxillofacial surgery'. 


In what ways has Covid-19 impacted the amount of surgeries you perform? 

The hospital was very well prepared to face the second wave of emergency, which is why we continue to operate elective surgeries since the end of October. By the beginning of the second wave, the hospital was completely converted into a COVID hospital focusing especially on finding different solutions to continue to operate elective surgeries. 

Most surgeries were moved to private clinics with a commitment to the public health system allowing me and my team to receive patients within a safe pathway ensuring the same quality and the same kind of treatment. In essence, it became a matter of organizing separate sessions of surgery outside of the hospital in a private clinic.

In my opinion, in the next 6 to 12 months, the main challenge will be the way to restart surgery and how to organize the spaces in the OR and clinics. Unfortunately, in our hospital the waiting list has grown significantly between the 1st and the 2nd wave. We have found a temporary solution moving patients from the hospitals to private clinics for those surgeries required to be treated on time and as primary treatment of facial deformities, trauma or tumors. 

We have not stopped clinical services and consultations and will continue to receive patients from other hospitals and areas. This means that the waiting list is growing vastly with a significant strain on the ability to review the list and control all the patients. 


What does the hospital recommend regarding the use of personal protection equipment due to COVID-19?


We are following the same rules in place for all hospitals. Nonetheless, even before the COVID 19 pandemic, we were used to wearing PPE for patient's parents as well as medical staff. The risk of infection, especially when treating children, is extremely high. Protection is key and considered of utter importance, not only by the organization Operations Smile, but also by the Maxillofacial Department of the hospital.

Even before COVID-19 it was already a general rule within the hospital to ensure general conditions of health were regularly checked and all staff must wear a mask, especially when in touch with any of the children. It was not yet mandatory to wear a mask when only visiting a patient for a couple of seconds. 

Today, all operators present in the hospital must wear an FFP2 mask at all the times. Surgeons and nurses that come into the hospital need to be checked and protected, just as all patients. The hospital is very strict and has implemented a great number of procedures and processes to reduce the risk of infection in addition to the mandatory use of PPE.

Obviously, a maxillofacial surgeon still needs to be able to check the face for which the patient´s mask needs to be removed. As a result, ever since the outbreak of the pandemic, focus on protection for the operator has increased enormously needing to be able to take care of the operator even more than before. It is very difficult to establish the actual risk of any new patient coming in from the outside. Did the patient come by train, by subway, how old is the mask that the patient is wearing? When patients come into a hospital through ambulatory, these types of questions become both simple and hard to respond. In those cases, in which patients come in directly through OR, it is mandatory that they are tested with a regular, molecular COVID-19 test. When a patient comes in through ambulatory, a mere test of body temperature is the only reference. If a patient comes in asymptomatic, it is simply not possible knowing the actual risk of infection. 

On my recommendation, the hospital will implement an additional regulation applicable to any kind of activity organized dedicated to the children in any of the private clinics we are currently collaborating with. Each person involved, meaning parents, children, and any kind of operator, must be tested before accessing the hospital. This is mandatory and includes anyone that needs to access the hospital, even if it is merely to deliver something from the outside. For this purpose, the availability of the new rapid test has proven to be very responsive and a great indicative of the risk that we must take.

The regular, molecular COVID-19 test will remain mandatory for patients. Especially in case of children, the risk of anesthesiology is very high if tested positive. A rapid test is not enough for my patients. In any case, the OR will procure means of protection as if all patients were tested positive, implementing a maximum level of protection.

In trauma cases, patients are tested with a relative molecular COVID-19 test which is done as they arrive for emergency. In any case, it is my strong recommendation that all operators consider all
patients as if they were tested positive and to wear PPE following recommendation. Even if helmet-based PPE is not a respiratory device, we recommend wearing this in addition.

In general, even if I already have had COVID vaccination and I may consider myself more or less protected against the infection for the next six months, with all my colleagues we have to consider that not only for  COVID but also for any future kind of infections.
Something has changed and this needs to change our perception of risks. I strongly insist that we need to change our conduct for the future if we want to prevent COVID or any other type of infection becoming a problem for patients or for operators. In consideration of the arisen COVID infection, a change of mind for all has been imposed and it has become an absolute necessity.

This is even more important if you consider the humanitarian activity that we carry out around the world. A regular mission such as those that Operation Smile has organized in the past in which we were able to attend 2.000 people in a same small area, performing screening of the patients and risk of infection has become simply impossible to organize today. At the same time, it is impossible to think of stopping surgery.

We are working on finding a solution that increases the possibility of establishing a safe pathway for all those patients. The pathway needs to change drastically, not only thinking of the use of PPE, but also the entire pathway as such which needs to be redesigned completely. This is particularly important considering that for Operation Smile activities surgeons from different parts of the world are gathered. If you're not well protected, there is a huge risk that you spread the infections all over the world. Due to this, ever since last March, Operation Smile International had to stop the activity in over 70 countries. Unfortunately, this means losing around 10,000 children in 2020. 10,000 Children that we could not treat and assist. You can only imagine what it means to have 10,000 children that are not able to receive the proper care on time.

This is extremely sad for our patients.

Since March 2020, we started to organize meetings with other colleagues. Together, we created a work group and a manual of standard of care post COVID. We are spreading our experience of what we did here in Italy and share this with many different countries. All my colleagues are adopting the same rules and standards that we are following here to protect the patients, parents, and operators. In some countries they are restarting procedures applying additional standards which include suggestions from us such as not only wearing a mask in a specific situation, but also to adopt the helmet-based equipment and additional types of protection for the operator.

In the specialty of maxillofacial surgery, we usually use specific instruments that produce the vehicle that leads to the major risk of infection, the aerosol. Aerosols are produced using drills, electro cautery and other methods. We generally use a drill not only in OR but also in ambulatory. Therefore, in ambulatory, it is now mandatory to use a specific protection to avoid the operator getting in touch with the aerosol directly. The risk is very high. Even for the anesthesiologist it is truly important to protect themselves, because
the time of intubation comes with maximum proximity of the operator to the mouth of the patients, who are breathing without control. The anesthesiologists have an increased risk of infection especially in emergency cases with the patients.


Are you aware of any guidelines inthe maxillofacial community regarding the use of personal protection equipment before COVID-19? How have these changed due to COVID-19?

No specific guidelines exist in the maxillofacial community. However, we did write a manual for any kind of operator involved in surgical activity with the organization of Operation Smile. This manual is basically a complete list of all regulations to follow for any kind of operator. Any kind of activity for children and other patients that undergo surgery with our organization are only allowed in case all these regulations are met.

We are very strict in following these regulations. Our scientific community in Operation Smile drafts and updates these every two years to ensure that everyone follows the same regulations, have the same objectives, and uses the same conduct during this kind of surgery.

I am also part of the European Association of Maxillofacial Surgeons and a member of the Italian Board of Maxillofacial Surgeons. There are no existing specific regulations established within these associations. There are several groups that do make suggestions on how to follow new arrangements post-pandemic, but no specific regulations are shared with the entire community.

When did you become familiar with helmet-based personal protection equipment?

I experienced the helmet-based personal protection equipment myself in my own OR as I share this with a couple of our Orthopedic Surgeons. I was under the impression initially that helmet-based personal protection equipment could protect from aerosols even when I now know that it doesn´t since it´s not a respiratory device.

How has your opinion on helmet-based personal protection equipment systems changed since you have started to use this? 

I find the helmet-based personal protection equipment extremely useful since it offers a wide screen and it is extremely comfortable. It even feels as if I am not actually wearing any helmet. It is so comfortable and very easy to adopt to my specific needs. I truly believe that helmet-based equipment is a great personal protection option. 

How often are you using helmet-based personal protection equipment, and for which type of procedures?

We are currently using helmet-based equipment for all orthognathicsurgeries, all the traumas and all craniofacial deformities. Each time that Iuse a drill or believe it is necessary to use electro cautery, both for a longer or shorter time, for small or large surgery, I will use helmet-based personal protection equipment. In total, we use helmet-based personal protection equipment in an 80% of our cases. Using helmet-based personal protection equipment has become mandatory for us in our hospital.

Do you use helmet-based personal protection equipment in combination with other types of personal protection equipment? For instance, FFP2- FFP3 masks. Conscious that it is a general rule at the hospital to wear FFP2 face masks, not only in the operating room. Is there anything else? Any other requirements?

When I wear helmet-based personal protection equipment, I normally use a surgical mask underneath. Whether we wear helmet-based PPE or not, it is still mandatory to use FFP2. FFP2 is a two-way protection system, which ensures we protect while being ourselves protected as well. 

What kind of protection do you expect from helmet-based personal protection equipment?

When I think of helmet-based equipment, I expect maximum liquid barrier protection. I truly believe that the helmet-based personal protection equipment should be the standard for the future. 

What was your first impression when you started using helmet-based personal protection equipment and did this perception change over time? How do you feel today when using Helmet-based personal protection equipment?

When we had started to wear helmet-based personal protection equipment we were worried about wearing something on our heads, although we are usually comfortable in wearing head-lights, glasses with lights and other equipment.

The wide screen is very clear and very, very bright. I have never experienced fog in or outside the helmet to build up, which is fantastic.

Another aspect I worried, was about the breath and the temperature inside the helmet. Sometimes in the OR, we sweat even without wearing a helmet. But honestly, I feel that it is actually much more comfortable to wear the helmet-based personal protection equipment. It offers continuous ventilation and temperature regulation inside.

I feel extremely good wearing helmet-based personal protection equipment.

In my opinion and that of my hospital, wearing helmet-based personal protection equipment is not a recommendation... in my department it is mandatory!

In the hospital, it is mandatory to wear helmet-based personal protection equipment. Without it is not allowed to perform maxillofacial surgery. Even if it is in the ambulatory for a tooth extraction, wearing helmet-based personal protection equipment is mandatory not only for the surgeons, but also for the nurses. If they don´t wear it, I will not authorize the operation. 

What are your expectations about the use of personal protection equipment after the COVID-19 pandemic?

As mentioned before, I think wearing personal protection equipment should be mandatory because you never know what infection you might be dealing with. We must learn from our experience with the COVID-19 pandemic. It is not a matter only of how we protect ourselves from COVID, it is protecting ourselves from any kind of infection risk. Nothing changes for a surgeon in wearing or not wearing helmet- based protection equipment. I feel comfortable and it only takes a couple of minutes to put your equipment on and to be ready to use it. Any resistance is similar when to wear a belt in the car years ago became mandatory, or another type of helmet when riding a motor bike for instance. Nobody wanted to adopt this then, nobody wanted to put it on, but today… it is not only
mandatory, we could not imagine going without using it.

If we think back 20 years ago, when people didn´t even wear the surgical masks in the OR or they would put their noses outside the mask. These standards and our habits in that aspect have changed as well. It is all a matter of changing habits. If we don´t change our habits, the situation will remain the same and the risk will never disappear!

What are your expectations about the use of personal protection equipment in the maxillofacial your surgical community after COVID-19 now, will surgeon´s habits change?

The challenge with the community is to ensure that the change is perceived as positive. For instance, I can control the network involving Smile House because Smile House is a project that we are developing here in Italy. It is all about making a commitment between the hospital, a public hospital, and Operation Smile. Within the network we have the capability of sharing and implementing common regulations which enables us to protect the entire pathway. In the future these will be the standards of the global Operation Smile community.

Do patients usually ask for the use of personal protection equipment by the surgical team creating a barrier that can also protect patients?

It is not something that patients have regularly asked for. In the OR the patients don’t see me before the surgery because they are under anesthesia. On the contrary, the patients see me and the other operators in the ambulatory services where, after an initially bit surprise, they are very happy to know we are adopting so important protection measures.  

In ambulatory, if this is not asked by the patients, this is definitely something that you can address yourself as the reactions are always positive.

Do you usually inform your patients about the personal protection equipment that you and your surgical team use during their surgeries?

In private practice it is common to share the list of personal protection equipment that we use as well as to address the general rules we adopt regarding the prevention of infection risks. The patients really appreciate this. It makes them more comfortable and secure.

All patients, my older friends, and all other people that have seen images of me wearing helmet-based personal protection equipment were very surprised initially. They are all very well
aware of the fact that we always look to adopt the best protection for the patients and the operator, but it was still strange for them to see at first. However, reactions have been extremely positive. It makes them very happy to see that we are always investigating how to use specific protection because. In case you follow only the general regulations, it may feel as if you are just respecting law. However, if you do something additional while looking out for your personal protection and that of your patients, it is something that is truly appreciated.

For me and my team there is no sense in performing our activities if we do not take care of our patients. 


Dr. Domenico Scopelliti - Direttore dell’Unità Organizzativa di Chirurgia Maxillo – Facciale



If you do something additional while looking out for your personal protection and that of your patients, it is something that is truly appreciated. 


- Dr. Scopelliti - 

Direttore dell’Unità Organizzativa di Chirurgia Maxillo –

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1) The Flyte PPE products are not cleared as respiratory protective products. European Centre for Disease Prevention and Control guidance for respiratory protection directs the use of an FFP3 respirator mask for medical staff performing Aerosol Generating Procedures.

2) Dr. Scopelliti is a paid consultant of Stryker. The opinions expressed herein are the opinions of Dr. Scopelliti and not necessarily those of Stryker. Individual experiences may vary.

3) This information is intended solely for the use of healthcare professionals.A healthcare professional must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that healthcare professionals be trained in the use of any particular product before using it in surgery. The information presented is intended to demonstrate the breadth of Stryker product offerings. A healthcare professional must always refer to the package insert, product label and/or instructions for use before using any Stryker product.

All opinions expressed in this article are solely and exclusively from Dr. Scopelliti and do not represent Stryker's.