Patient Safety

Patient Safety

What Does Safe Patient Care Look Like?

Where do the differences in quality control in plastic surgery come from? Our patients recognize that not all surgeons created equal but, what else contributes to differences plastic surgery centers?

We Buy Injectables & New Medical Supplies Direct

All of our medical supplies such as sutures, medical tubing, sterile supplies, dermal fillers, BOTOX® and all medications, are purchased in USA and directly from our manufacturer’s and/or their approved suppliers.

We don’t shop on ebay, Craig’s List, flash web sites, or from discounted medical supply stores. We don’t buy anything from  independent sales representatives or from discount medical supply companies.

We also do not buy pre-owned products including injectables from other physicians, hospitals, or surgery centers that try to resell their stagnate or “going out business” inventory. We don’t buy used equipment or “gently used” supplies.

The internet has made it possible for physicians to purchase BOTOX®, facial fillers, and plastic surgery supplies from resellers and unlicensed suppliers. We are routinely contacted by companies claiming to have purchased bulk BOTOX® as well as other medical supplies. They explain how they can import drugs from Canada and other foreign countries to us cheaply. They try to resell it to us a significant discount. [quote style=”3″] While some physicians may find it tantalizing to save money, we simply do not trust the quality or integrity of 3rd party resellers. We never have and never will purchase BOTOX® or any medical supply from unlicensed or 3rd party resellers- that’s our promise to you.[/quote]While some physicians may find it tantalizing to save money, we simply do not trust the quality or integrity of 3rd party resellers. We never have and never will purchase BOTOX® or any medical supply from unlicensed or 3rd party resellers- that’s our promise to you. One reason that we purchase direct form reputable medical supply companies is because they are required to follow the US Pharmacopia’s rules for storage and shipping of medical supplies and pharmaceuticals from their warehouses, manufacturing plants, and during transport to our office.

The FDA safe storage guidelines come direct form the US Pharmacopia, which mandates proper storage and handling of supplies of every US Medical supply company.  But, not all countries follow the FDA and US Pharmacopia guidelines.

Poor storage conditions can impact the sterility, safety, and efficacy of medical supplies such  as BOTOX®. We are not able to confirm the storage conditions of unlicensed resellers and other companies that do not fall under the guide of the FDA and US Pharmacopia. In those situations, we are not able to know whether they store their pharmaceuticals in temperature controlled environments and whether their warehouses are free from insects, rodents, airborne pathogens, or other environmental hazards that could jeopardize the safety of medical products.

We purchase products from a reputable medical supply companies such as Mentor Inc. In contrast to an unlicensed or 3rd party reseller, Mentor Inc., welcomes us to tours of their R&D facilities. Mentor Inc. manufactures their implants in Texas and are subject to State and Federal storage and shipping guidelines as directed by the FDA and US Pharmacopia (USP).

We Never Buy Injectables from the Black-Market.

We never buy ANYTHING from the Black-Market. Cheap BOTOX® and other inejctables are readily available from what is known as the Black-Market.  Black-Markets sales are prevalent in Florida. When physicians purchase from these sources, there is no telling what they are actually purchasing. Furthermore, people who are not physicians can also buy off the black market.

The FDA has investigated illegal injections of fake Botox in over 1,000 patients across the country and have arrested 31 people. The FDA website describes how scammers advertise Botox Cosmetic, display certificates of training, and have patients sign consent for Botox® injections. Despite the FDA’s warning, illegal cosmetic procedures are on the rise in Florida.

The black market is not just limited to illegal and cheap BOTOX® sales. Deaths from butt injections using industrial silicone have also been reported in Florida and other US states. The American Society for Aesthetic Plastic Surgery (ASAPS) also has issued a warning to consumers about physicians illegally buying cheap BOTOX® and dermal fillers from the Black Market and having their patients suffer from devastating consequences.

We always buy cosmetic injectables direct from manufacturers. For example, we only buy Botox® direct from Allergan, Inc., which puts holograms on their BOTOX® bottles to help consumers distinguish between real vs. fake BOTOX®. The serial number on the bottle of BOTOX® should also match the serial number on the box. But, the FDA warns that scammers have become very sophisticated and counterfeit drugs are difficult to identify. Physicians, they warn, should only buy direct from manufacturers and not from middlemen or resellers of discounted products. Last year, the FDA created the office of Drug Security, Integrity and Recalls to warn physicians against buying drugs including dermal fillers and injectables used for from unlicensed suppliers.

 

We only buy FDA approved medications and we only buy them directly from approved US medical suppliers, to ensure the highest possible standards for safety, storage, packaging, and durability. We do not buy medication, including BOTOX®, from overseas or through unapproved 3rd party distributors who claim to purchase medication in bulk and resell to physicians at a discount. Such unapproved suppliers make no guarantee that their warehouses and storage facilities, are temperature controlled for heat or humidity, each of which are factors that impact the durability and safety of inectables (BOTOX®, Juvederm®, etc), pharmaceutical products, and surgical supplies. We also do not purchase existing injectable inventory from other physicians because we are not able to confirm whether they maintained proper storage conditions.

We Only Buy NEW Medical Devices

As with our injectables and medical supplies, we always purchase NEW medical devices—never refurbished, used, or preowned. This means that we are not buying instruments on the internet, ebay, Craig’s List or companies where doctors can buy used medical equipment at discounted pricing. We always buy our medical devices and medical lasers direct from manufacturer’s and their approved US suppliers. Thus, our medical devices come with lengthy and comprehensive service, training, and warranty programs, which adds cost to the purchase price.  Used medical devices may or may not have a limited warranty. Others come with minimal warranties for 30 days. We take this to mean that the company selling the used device has little to no confidence in its proper functioning and that seems unsafe to us. So, we always purchase new medical devices with guaranteed service and warranties.

We believe our patients rely on us to deliver the safest possible procedure by using medical devices that are reliable and predictable. When we buy new medical devices such as lasers, the manufacturers are able to provide us with service agreements and warranties. They also provide us with their professionally trained Medical Device Engineers to service our equipment. We feel that there is no one better qualified to service a medical device than the person who created the device. All replacement parts are new and warrantied– we never buy refurbished replacement parts.

We believe it’s important to ensure the the medical device companies that we purchase from are willing to stand by their workmanship with a guaranteed warranty. When doctors purchase used or preowned medical devices such as lasers, the original manufacturer of the device does not stand by the medical device and is released from all liability for any faulty parts. Used lasers and medical devices only come with very limited warranties from the broker who is otherwise released of any liability for patient injuries or from malfunctioning devices.

Our Track Record for Safety

At Ocean Drive Plastic Surgery, we have an impeccable track record for patient safety. We are proud of our patient care process, and we are especially prideful of our patient safety success record.   Our practice has never had any adverse events that resulted in patient injury or death.  We have never had a patient transferred from our operating room to another facility for medical issues.  In short, we have had a flawless safety record since our inception, and we intend to maintain it.

We get Best Manufacturing Practices

All of our medications are purchased direct from manufacturers and are shipped to us in the best possible shipping standards for maintaining drug stability. Florida is hot and humid and both of which are environmental hazards to drug stability. That’s why its important that we purchase injectables direct from manufacturers who uphold “Good Manufacturing Practices” called, GMPs. GMPs are guidelines that reputable manufacturers follow for quality assurance. The GMP guidelines include the proper distribution of drugs, such as BOTOX and dermal fillers, to minimize any risk to their quality during storage and transport to physicians.

We also limit our shipping times of your medications and medical supplies by purchasing from within the US. This means our suppliers are closer to us as compared to China and other far-away countries. When we do need to buy from long distances such as California, we expect our supplier to provide us with expedited shipping and specialized packaging including dry ice. We, for example, some medical products should not be freight shipped or travel long distances from overseas where storage conditions on ships, trains, and trucks can exceed the recommended temperatures guidelines established by the FDA. Our expectation for best product shipping and packing better ensures that our injectables and other medications delivered to us are still stable and have not begun to decompose or inactivate.

All deliveries to our office are made M-F during regular business hours and are immediately unpacked and stored in our temperature controlled containers. When shipments arrive to our office, we inspect the product packaging for damage, melted ice, and for other signs of improper handling such as bottles that feel warm to the touch when they should be cold. When we do question the quality of shipping standards, we immediately return any questionable products back to the supplier for a fresh shipment.

Recall Systems are in Place

Manufacturers are known to make products recalls. For example, a food distributer may make a recall on specific food products that have been delivered to a grocery store. Similar product and drug recalls also occur in healthcare. Because we buy direct from licensed medical suppliers, our suppliers maintain a system for recalling any batch of drug or medical product from sale or supply. So, we are immediately notified, often in advance, of any voluntary recalls that a medical company issues. All of our injectables and medical products are delivered to us with lot numbers and serial numbers to help manufacturers know precisley where all of their shipments are delivered to. It is unknown to us how physicians who purchase from unlicensed or 3rd party middlemen manage their product recalls.  This also means that in the unlikely event that we do receive feedback from our patients regarding unexpected side effects or questions about the quality of medical products received, we are able to initiate an investigation with our suppliers who will have systems in place to help them track down the exact source where our product was produced from to help resolve any unanswered questions. This will be important to you, our patient, because we will be able to help you get answers to your questions.

This is true, for example, with our breast implants. If a breast implant malfunctions such as a rupture, we are able to execute a full investigation with the implant company to help them identify why the problem occurred.  If your physician is purchasing from unlicensed or 3rd party suppliers, such recall systems may not be in place.

We Mix Injectables Fresh for You- Every Visit

It’s not enough to ask your physician if the product they are injecting into you is expired. A better question to ask is, “will you be opening a new bottle for my procedure or am I getting an injection from a previously mixed solution?”.

When neuromuscular modulators such as BOTOX® and Xeomin® are delivered to our office, the manufacture ships them in their most stable form, which is usually a crystalized or lyophilized form. That means the substance looks like a powdered tablet. It’s up to the physician to solubilize the tablet into an injectable solution. Once solubilized and mixed, the product becomes less stable and as with all chemicals, it will begin to degrade over time. The rate of degradation can be slowed by keeping the mixture properly refrigerated but, it still degrades.

Compare this to buying milk. If you buy powdered milk, it can sit on your shelf for months without going sour. Once you mix the powdered milk, it will soon sour if not refrigerated. But, even refrigerated milk sours over time.  Injectables are no different except that they don’t smell sour when they degrade and so, neither you nor your doctor will know whether it is still in an active form. That’s why we always open new bottles and mix fresh daily.

Our injectables such as BOTOX® and Xeomin® are mixed fresh daily for you—it does not get premixed and stored in bottles or syringes. We also do not store leftover BOTOX®, Xeomin®, or dermal fillers in the refrigerator overnight, over the weekend, for the holidays, or ever.  We don’t store partial syringes of any dermal filler for your next vista. This means that if Dr. Durkin doesn’t use all of a premixed product fully on you, we discard the unused product. If you return for a touch-up, you receive another new freshly prepared injectable, not a premixed or prestored syringe.

We never use expired product on our patients. We always discard products that has been left out or have not been stored properly while in our possession. We also purchase BOTOX® and Xeomin® in reasonable quantities frequently throughout the year. This minimizes the time that products sit on our shelf because we maintain a high turnover of fresh product.

We Monitor Electrical Safety

In addition to the service and warranty programs on our our medical devices, we also have a Certified Biomedical Engineer routinely inspect all of our office equipment and electrical instruments for any signs of wear, electrical damage, and overall safety on a scheduled basis.

Every device in our office that has a plug is certified for electrical safety. Any instruments showing signs of wear and tear are removed from shelving and are not used until a certified electrical engineer comes to our office, inspects the device, replaces any questionable parts, and clears it for safe usage.

We believe that this is important for our patient’s safety because it helps prevent equipment from malfunctioning during usage. It helps protect patients from power surges and reduces the chance of sparks or short fuses blowing.

We Have Separate Clean and Dirty Rooms

All of our instruments are cleaned and sterilized by our Nursing Director who follows State regulations, CDC, and OSHA protocols. Our OR facility is physically separated from both our “dirty room” and from our “clean room”. This means clean instruments are stored separately from dirty instruments. Some facilities are too small to be able to separate dirty instruments from clean instruments and thus, they are placed next to each other. Failing to separate dirty supplies from clean supplies results in a higher risk for cross-contaminating clean supplies with germs and infectious diseases. Separation also minimizes cross contamination in other parts of our facility such as our MedSpa. Our MedSpa supplies including spa wraps are always kept separate from OR towels and other supplies.

[quote style=”1″]Creating separate cleaning rooms was as an invaluable investment on our part in preventing infections, says Dr. Durkin.[/quote]

 

Creating separate cleaning rooms was as an invaluable investment on our part in avoiding infection. Instruments that have been used during surgery are maintained only to clean instruments and cleaned immediately following and this is done in our dirty room. Once complete, the instruments are taken to our on-site autoclave where they are sterilized according to OSHA guidelines. They are sterilely wrapped on premises trained nursing staff and stored in our clean hold room which is an infection free zone.  All of our linens are cleaned according to OSHA and CDC regulations.

Dedicated Air Conditioning and Ventilation System

We also have a separate air conditioning and ventilation system that maintains our OR for optimal temperature and humidity. When we give people a tour of our surgery center they are often surprised at how dry and cold our OR is even when temperatures outside exceed 100 degree in the summertime. That’s because we never turn off our OR air conditioning just to save money. Even in the middle of our Florida summers, our OR air conditioner runs around the clock and is working hard to maintain temperature and humidity.

Why does this matter? Bacteria and mold love warm humid areas to grow. By maintaining our OR for temperature and humidity, we are able to minimize the chance that bacteria colonize in our OR because our OR is never warm or humid. Furthermore, all of our surgical devices including our anesthesia machine, are stored in the same temperature controlled environment and thus, we prevent moisture from collecting on anything in the OR, which could otherwise make a machine malfunction. That’s a risk that we are unwilling to take.

We use Intravenous Antibiotic Therapy

All of our patients receive intravenous antibiotic during surgery. As well, patients are commonly given oral antibiotics after surgery to minimize infection. Our operating room is comprehensively cleaned with Hospital Grade disinfectants after every patient, a process that is called, “terminal cleaning”. A terminal cleaning  means that we scrub the ceilings, floors, and all devices in the OR. Our full-time Nurse Risk Manager also performs routine quality control inspections of our OR with microbial swab tests to assure cleanliness.

Our Surgery Center is Spacious, Designed for Safety

Our privately owned surgery center was designed  with the highest standards for prevention of infections in mind. Our Operating Room is state-of-the-art and it is the same size as any or in any hospital in Florida. The spacious size of our OR minimizes chances of our medical staff breaking sterility by bumping into objects during your surgery. During surgery, people and objects are not supposed to touch each other or drag across your body as the physical act of touching can result in cross-contamination. Since operating rooms become crowded during surgery having small operating rooms are at higher risk for cross-contamination.

Our Operating Room allows everyone to comfortably position themselves during your surgery while keeping all medical devices such as anesthesia equipment, medical tubing, medical supplies, and lasers a safe distance from touching each other. Many other medical facilities will have the smallest operating room possible to minimize their overhead. We believe that’s cutting corners on your safety.

Our Operating Room is Specialized for Cosmetic Plastic Surgery ONLY

Our privately owned surgery center is specific for cosmetic plastic surgery and thus, provides our patients with added benefits including better privacy and quality assurance. Not only do other outpatient surgery centers feel impersonable but, they treat  a broad range of patients undergoing all kinds of surgical procedures including ones involving infections diseases such as MRSA, HIV and Hepatitis. In comparison, we do no accept insurance based surgery in our operating room at Ocean Drive Plastic Surgery. This means that we are specialized in cosmetic plastic surgery and our patients tend to be in good overall health.

Unlike other surgical centers, patients with infections are not candidates for surgery at Ocean Drive. Patients who are identified with infections are treated at community hospitals to minimize contamination of our operating room and to provide those patients with the additional medical support from Infectious Disease and Hospital Specialists who can provide them with specialized attention. We believe that this process minimizes your risk of becoming exposed to infectious agents from other patients unnecessarily. For example, we have never had an incidence of MRSA at Ocean Drive Plastic Surgery.

At other surgery centers, surgeons routinely have to share OR space with a broad range of medical specialities. The surgery centers have to try to equip the OR for every kind of procedure but, since their space is limited, they have to make decisions to limit their available supplies and equipment. That means, each specialty earns just enough space to accommodate minimal requirements. An orthopedic surgeon, for example, will require large amount of space for leg braces and implants, which will need to share space with a plastic surgeon who will require their own medical supplies. When space is shared at a hospital, it is the hospital’s decision, not the surgeon’s decision, on how much space each specialty can have for their supplies.

Our privately owned surgery center, on the other hand, is maintained only for cosmetic plastic surgery procedures that Dr. Durkin performs. All of our medical supplies and equipment is specifically designed and available to accommodate all of our plastic surgery procedures. This allows Dr. Durkin to have a broad range of sutures, specialized surgical instruments, and other medical supplies at his disposal for every patient every day. At our surgery center, Dr. Durkin personally selects all medical supplies including the brands of products himself for all of his patients.

We Maintain 200+ Implants Onsite

Many patients are thrilled to see Dr. Durkins onsite supply of over 200 breast implants. Why does our large inventory of breast implants important to your quality of care? There are two key reasons.

First, it better assures you receive your desired aesthetic result. Not only are you able to try on a variety of shapes and sizes prior to surgery, but having so many breast implants in-house allows Dr. Durkin to sit you up during surgery and examine how you look in the implants. If he feels you will be unhappy with the chosen implant, he can immediately exchange for a different size or shape implant during your surgery.  In comparison, other surgeons have predict which implant will look best and order individual implants to be delivered to there office prior to your surgery. But, you get what they order and there can not be any exchanges without a secondary surgery.

Secondly, it is important that your surgeon have breast implant redundancy or “back-ups” in the event that there is an unplanned drop or break in sterility with one of your implants when removing it from its sterile container. Have you ever wondered what would happen if an implant slips from the hands and falls on the floor? Or is accidentally torn or damaged? At Ocean Drive Plastic Surgery, if this happens, we are able to select another new breast implant from our shelf. Furthermore, Dr. Durkin inspects every implant for any flaws in design such as a small wrinkle or anything that makes him question the quality of production. When this happens, he chooses another new implant from our inventory and returns the questionable implant back to the manufacturer. So, you can take comfort in knowing that every commercially available implant is available onsite during your surgery in multiple quantities. Having limited supply of implants would otherwise result in the risk of having to abort your surgery. But at Ocean Drive Plastic Surgery, we have more than enough breast implants onsite to readily backup any faulty implants or accidental drops during your surgery. We simply, open a new box. That’s quality control that we believe is important.

We Believe in Continuity of Care

We do not use recruiting agencies or temp agencies. Every nurse, physician, and employee of Ocean Drive undergoes screening, credentialing, and background check and they are permanent members of our practice. For you, this means that the nurse that you meet on your per-operative appointment will be the same nurse that takes care of you on your surgery day. When someone in our office as to miss a day of work, we have enough staff to cover each other. All of our staff have been cross-trained in appropriate areas of work. Thus, we do not use staffing or temp agencies to send in a temporary person to “get us through the day”. Therefore, our employees will be there for you everyday by your side and you will get to know all of us as if we were family. We call this “continuity of care” and it is discussed further by clicking here.

In-house Pre-Operative Lab Work

When you elect to have cosmetic plastic surgery with Dr. Durkin, you will be provided with an appointment for preoperative lab work. We do not send you to point of care reference labs such as LabCorp or Quest Diagnoistcs that can be crowded and in impersonable. Instead you will have the convenience and privacy of our office. The only exception to this  process is if Dr. Durkin orders sub specialized testing such as a cardiac clearance or a mammogram prior to your surgery. Otherwise, for all of your other standard pre-op lab work, our pre-op nurse (RN) will meet with you and review your medical history as well as go over all medical consents and surgical information together with you. This also gives you extra time to ask questions about your surgery and postoperative recovery. She will also obtain any necessary lab work that Dr. Durkin requests to clear you for surgery.  For instance, your bloodwork and EKGs will be done by our nurse in our office.

We choose to perform your lab work through our surgery center so that we can control the quality of the tests being performed. Dr. Durkin and our Anesthesiologist will review all of your results before clearing you for surgery.

Certified by the American Board of Plastic Surgery

It’s not enough to ask your physician if they are Board Certified. The better question to ask is “what Board Certification do you have and who certified you?”.  When medical students graduate from Medical School, they immediately earn a Medical Degree (MD) and may apply for a medical license in the State that they wish to see patients. Any physician with a medical license is capable and legally able to treat patients and do surgery. Doctors need not be Board Certified. Board Certification in any field, however, is an important quality to have when choosing a physician because it is a testament to their quality of training and experience in a specific medical specialty.

Once a physician becomes Board Certified in their field, however, they are free to change the scope of their practice. Many doctors decide to change specialties or begin doing procedures that are different than the ones that they became Board Certified in. For example, an eye doctor may initially become Board Certified in Ophthalmology but, he/she may start doing facelifts. They can advertise simply that they are “Board Certified” without ever telling you that they are not Board Certified in Plastic Surgery. There is nothing illegal about this and they may have done a fine job in teaching themselves how to do a facelift or cosmetic eyelid surgery but, we firmly believe its misguiding their patients.

Furthermore, cosmetic surgeons are not equivalent to plastic surgeons and the terms are not interchangeable. What does this mean? Some physicians in mixed specialties (family physicians, eye doctors, OB/GYN doctors, etc) will claim to be certified by the American Board of Cosmetic Surgery. However, the American Board of Medical Specialties does NOT recognize Cosmetic Surgery as a valid board certification. Why? For one reason, there is no formal medical training or residency program available for “cosmetic surgery”. There is only plastic surgery residency and training, which leads to Board Certification in Plastic Surgery. So, physicians in the American Board of Cosmetic Surgery have either not completed any formal plastic surgery residency and/or were not able to achieve Board Certification in Plastic Surgery. Physicians accepted into the American Board of Cosmetic Surgery are required to meet specific criteria however, it is not the same qualifications met by Board Certified Plastic Surgeons. Physicians that are certified by the American Board of Cosmetic Surgery are required by Florida Law to tell patients that their Board Certification is not recognized. However, the statement may be placed in the very fine print.

Dr. Durkin is certified by the American Board of Plastic Surgery. Board Certification in Plastic Surgery is the Gold Standard of care and it is recognized by the American Board of Medical Specialties. Plastic Surgeons that obtain Board Certification in Plastic Surgery must meet years of rigorous training in a medical residency program specific for plastic and reconstructive surgery. Dr. Durkin is required to stay up to date with new plastic surgery guidelines, meet many credentialing requirements, and continuing education requirement to sustain his Board Certification.

Dr. Durkin is a Member of the American Society of Plastic Surgeons (ASPS)

Board Certified Plastic Surgeons may become members of additional professional organization such as the American Board of Plastic Surgeons (ASPS). Dr. Durkin is a member of the American Board of Plastic Surgeons (ASPS). Only Board Certified Plastic Surgeons are eligible for membership in the ASPS. Each of these organizations require that board certified plastic surgeons demonstrate additional levels of expertise to become members of their respective organizations.  The ASPS physician members are required to uphold stringent advertising guidelines that prevents them from misleading patients or offering free or discounted surgery. These same advertising guidelines are not required by non-member physicians or physicians that are not board certified in Plastic Surgery.

Quality of Anesthesia at Ocean Drive Plastic Surgery

The quality and safety of anesthesia is one of the most frequently asked questions that our patients talk to us about. Quality control in anesthesia pertains to the types of drugs used for anesthesia, how the drugs are administered during surgery, the qualifications of the person administering your anesthesia, pre-operative preparations for anesthesia, post-operative care immediately following your surgery, and additional quality assurance procedures that support safe and effective anesthesia. To address quality differences in anesthesia in greater detail, we have dedicated a page on our website that focuses the quality of anesthesia at Ocean Drive Plastic Surgery.

We are Certified by the State of Florida

Our operating room is licensed by the State of Florida and is subject to both scheduled and random site visits by State Inspectors.  Our medical staff is highly trained and continuously meets and exceeds state healthcare requirements. Furthermore, you are also welcome to come in for a tour of our surgery center anytime provided that we do not have surgery in progress. We are open M-F and love to show off our beautiful state-of-the art plastic surgery center and MedSpa.

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