Endoscopes - The neglected workhorse of key-hole surgery

The chances are you have already had the experience of an endoscopic procedure. The most commonly reported procedure group for the private sector in 2007-2008 was procedures on the digestive system (673,000), with 87.9% of these being for fibreoptic colonoscopy, panendoscopy with excision and fibreoptic colonoscopy with excision. Other commonly reported procedures across both sectors were diagnostic gastrointestinal endoscopy (626,000 separations).

This may have happened in either a free-standing day surgery unit, an integrated (hospital based) day surgery unit or in the operating room of a public or private hospital.

There are many more endoscopic procedures carried out each year in Australia, in the fields of orthopaedics, urology, gynaecology, ENT and laparoscopy, just to name a few. There are also procedures carried out in unlikely areas of skull base surgery and removal of salivary gland stones.

Endoscopy provides economic savings for governments and hospitals. Patients have a reduced risk of infection, a quicker recovery time and return to normal activities sooner with less time off work.

What is endoscopy?
Endoscopy is the examination and inspection of the interior of the body and its structures through an endoscope. An endoscope is a device that uses a series of powerful glass rod lenses (rigid), glass fibre optics (fiberscopes) to provide lighting and visualisation of the interior of the body.i

An endoscope uses two fibre optic lines. A “light fibre” carries light into the body cavity and an “image fibre” carries the image of the body cavity back to the surgeons viewing lens. Endoscopes are used in conjunction with a camera or video recorder to document images of the inside of a joint or an endoscopic procedure. New endoscopes have digital capabilities for manipulating and enhancing the video images.

The “image fibre” leads from the ocular (eye piece) to the inserted end of the scope. The “light fibre” is below and leads from the light source to the working end of the endoscope.

Prior to the widespread use of endoscopy and diagnostic imaging, most internal conditions could only be diagnosed or treated with open surgery.

Brief history of endoscopy
460-375BC: Endoscopy was first described by Hippocrates in Greece and he was the first to make reference to a rectal speculum.

70AD: A three-bladed vaginal speculum was found in Pompeii’s ruins; this instrument was similar to the modern vaginal speculum.

1773-1809: Philipp Bozzini developed a light conductor which he called “Lichtleiter”. It directed light into the internal cavities of the body and then redirected to the eye of the observer. Bozzini’s invention founded the principles that guided the development of endoscopy.

1798-1850: John D. Fisher described an endoscope to inspect the vagina, and he modified it to examine the bladder and urethra too.

1853: Antoine Jean Desormeaux, a French surgeon, first introduced the Bozzini’s “Lichtleiter” to a patient. For many he is considered the “father of endoscopy.” This instrument had a system of mirrors and lenses, the light source was a lamp flame. The endoscope burned a mixture of alcohol and turpentine. Lichtleiter was mainly used for urologic cases, however its major complication was burns to the patient.

1848-1906: Maximilian Nitze created the first electrical light bulb as the light source. Again this was only used for urological procedures.

1883: Newman of Glasgow described using a miniaturised version of the incandescent bulb in a cystoscope.

1910-1911: H.C. Jacobaeus in Stockholm used the term “laparothorakoskopie” for the first time.

1911: Bertram M. Berheim, an assistant surgeon at John Hopkins, performed the first laparoscopy in the USA. He named the procedure “organoscopy.” The instrument was a proctoscope of a half-inch diameter, and he used ordinary light as a light source.

1929: Heinz Kalk, a German gastroenterologist, is considered the founder of the German School of laparoscopy developed a 135-degree lens system and a dual trocar approach. He used laparoscopy for the diagnosis of liver and gallbladder disease.

1934: An American internist, John C. Ruddock, described laparoscopy as a good diagnostic method, many times superior to laparotomy. He developed an instrument with a built-in forceps with electrocoagulation capacity.

1944: Raoul Palmer, Paris performed gynaecological laparoscopy. He placed the patients in the Trendelenburg position so air could fill the pelvis. He also stressed the importance of continuous intra-abdominal pressure monitoring during a laparoscopic procedure.

1960s: Kurt Semm, a German gynaecologist, created the automatic insufflator. His experience with this new device was published in 1966. He played a major role in the development of laparoscopy. He called his procedure “pelviscopy.” He performed an appendectomy during a gynecological procedure and opened a large door for a new surgery. Although Semm was not recognised in his own land, on the other side of the Atlantic, both American physicians and instrument makers valued the Semm insufflator for its simple application, clinical value, and safety. Semm made and designed many new instruments. H.M. Hasson, a gynecologist from the Grant Hospital of Chicago, Augustana Hospital and Columbus-Cuneo Medical Centre, developed a technique performing laparoscopy through a miniature laparotomy incision.

1980: In England, Patrick Steptoe started to perform laparoscopic procedures in the operating room under sterile conditions.

1982: The first solid state camera was introduced. This was the start of “video-laparoscopy.”

1987: The first laparoscopy cholecystectomy on a human led to so many other developments during the past 25 years.

Phillipe Mouret performed the first video-laparoscopic cholecystectomy in Lyons, France. Within a year, Dubois (Paris), Perissat (Bordeaux), Nathanson and Cuschieri (Scotland), McKernan and Saye (Marietta, Georgia), and Reddick and Olsen (Nashville, Tennessee), had also performed laparoscopic cholecystectomy.

Development of the endoscope
Professor Harold H. Hopkins was responsible for the two most important inventions in endoscopy: the rodlens system and fiberoptics.

Professor Hopkins (in the 1960s) used glass rods to fill the air-spaces between the ‘little lenses’, which could then be dispensed with altogether. These rods fitted exactly into the endoscope’s tube – making them self-aligning and requiring no other support. They were much easier to handle and utilised the maximum possible diameter available. As with the fibroscopes, a bundle of glass-fibers would relay the illumination from a powerful external source. With the appropriate curvature and coatings to the rod ends and optimal choices of glass-types, all calculated and specified by Hopkins, the image quality was transformed – light levels were increased by as much as eightyfold with no heat; resolution of fine detail was finally achieved; colours were now true; and diameters as small as a few millimeters were possible. With a high quality ‘telescope’ of such small diameter, the tools and illumination system could be comfortably housed within an outer tube.

The endoscope evolution – hopkins rod lens system
Professor Hopkins patented his lens system in 1959. Seeing promise in this system, Dr Karl Storz bought the patent and in 1967 began to produce endoscopic instruments with a brilliant image and superb illumination. This began a long and productive partnership between Professor Hopkins and KARL STORZ GmbH. While there are regions of the body that will always require flexible endoscopes (principally the gastrointestinal tract), the rigid rod-lens endoscopes have such exceptional performance that they are to this day the instrument of choice and in reality have been the enabling factor in modern key-hole surgery.

Modern endoscopy not only revolutionised medical diagnostics, but also paved the way for operative technology: minimally invasive surgery.

Advances in current endoscopic surgery
“Key-hole” surgery is constantly evolving with Surgeons looking to improve on the current techniques.

N.O.T.E.S.

Natural Orifice Translumenal Endoscopic Surgery, or N.O.T.E.S. eliminates the need for incisions and allows for less pain and scarring associated with traditional laparoscopic surgery along with a much faster recovery time for the patient. N.O.T.E.S. is performed by passing an endoscope through a natural orifice, or opening, then through an internal incision in the stomach, vagina, bladder or colon, thus avoiding any external incisions or scars.iv

Single port laparoscopy (SPL)
A minimally invasive surgical procedure in which the surgeon operates almost exclusively through a single entry point, typically the patient’s navel. Unlike a traditional multi-port laparoscopic approach, SPL leaves only a single small scar. SPL is accomplished through a single 20 mm incision in the navel (umbilicus or belly button), minimising the scarring and incisional pain associated with the multiple points of entry used during traditional laparoscopic surgery.

One endoscope with variable direction of views – endocaMeleon®
Until now, surgeons had to choose in advance which telescopes to use in a procedure. They were generally able to select from telescopes with 0°, 30° or 45° viewing directions, but were restricted to the selected direction throughout surgery or had to perform an intraoperative telescope change to obtain another viewing direction required for the specific procedure. KARL STORZ GmbH has developed the multidirectional telescope or the EndoCAMeleon®v

Minilaparoscopy
While laparoscopy (key-hole surgery) has been an enormous advance from open laparotomy (big incisions) recent development in microfibres and lenses have seen the creation of even smaller laparoscopes measuring two to four millimeters which are known as micro and mini laparoscopes, respectively. At the same time, small laparoscopic instruments have been produced so that the total laparoscopic procedure can be performed with incisions of two to four millimeters. Conventional laparoscopy uses a 10 mm umbilical incision for the laparoscope and 5 mm to 10 mm incisions elsewhere.vi

Robotic surgery
While it may sound futuristic, robotic surgery is an extension of minimally invasive techniques. The difference is that the surgeon is using robotic arms instead of endoscopes and other tools.

The robot has three or four arms that are inserted into the body through half-inch incisions. One arm is a camera and two act as the surgeon’s hands. The optional fourth arm moves obstructions out of the way. The surgeon looks into a viewfinder and operates the robot from a console. As the surgeon moves his or her hands, the robotic arms inside the patient’s body mimic the movements – cutting, suturing.vii

Safety or compromise – Are tight budgets compromising safety?
Patients assume the facility where they are having their procedure uses only the best equipment available on the market. They are unaware, however, that the facility is a business and the reality of funding is a constant consideration, for both public and private institutions.

The “behind the scenes” consideration that hospital managers have to juggle a budget, that may compromise the maintenance of equipment including endoscopic equipment, is a reality, but comes with some risks that need to be considered.

Endoscopes are precision medical instruments which its basic and critical function is to illuminate and return an accurate image of an interior body region to the surgeon through a combination of light fibers and complex lenses. Using an endoscope, the surgeon can see distinct structures and lesions inside the body and can also manipulate instruments for the removal or treatment of such areas.

If the surgeon's field of view is incorrect because the repaired endoscope was not returned to its original specifications because non-original parts were used or because of poor workmanship, he or she could make a mistake, injuring the patient or missing important diagnosis.

Endoscopes are precisely engineered and calibrated to assure an accurate field of vision for the surgeon who is performing difficult, delicate diagnostic and / or therapeutic procedures. The lenses are precisely positioned to provide a specified angle of view; the sightline may be straight ahead (for a urethrotomy), 30’ for a TURP or 70’ angle for a bladder inspection. Similarly the field of view is optimised for each procedure.

The optical components are also matched to provide the best possible contrast, resolution, and colour reproduction - essential characteristics for the clear image and accurate representation that the surgeon requires. Special coatings on the lenses further assure good contrast and colour reproduction. If they are altered or replaced with non-genuine parts, the risks become obvious.

What does this mean?
When the objective lens assembly of an endoscope is replaced by a company other than the original manufacturer, this may result in a significantly altered field of view. A secondary problem arises when the distal end of the shaft is shaved down to compensate for the new angle of the objective unit or as the result of damage to the shaft during the repair process. This results in the shortening of the length of the shaft rendering the endoscope incompatible with other devices. Shortening the shaft by even a millimeter can cause a resectoscope sheath to partially obstruct the surgeon's view.

Should a patient in a private or public hospital enter surgery unaware that he is to be operated on using sub-standard equipment? In the western world optimal healthcare is viewed as a right rather than a privilege.

Why are non-validated repairs cheaper than the original endoscopic manufacturer?
Non-validated repair companies repair just the damage that has been detected and then return the endoscope to the hospital. They generally repair with non-original components or salvaged components.

Generic lenses: Replacing or mixing generic lenses with original lenses alters the original prescription of the endoscope.

Generic spacers: Increases internal reflection and results in a reduction in image contrast.

Replaced eyepiece window: Eyepieces are milled in place and are mounted flush with the surface of the eyepiece. A non validated repaired eyepiece window has a noticeable ledge, thus will be less resistant to damage and prone to failure of the seal and subsequent leaking.

Visible signs of epoxy: KARL STORZ uses a proprietary epoxy. Without this the sterilization integrity may be compromised, resulting in leaking seals and a medium for harboring proteins and salts not to mention early fogging following repeated autoclave cycles.

Shaved distal tip: Shaving the distal tip will shorten the overall length of the shaft as well as shaving the illumination fibers which will likely diminish light output as well as redirecting the light outside the field of view…does your surgeon complain of poor light output even after turning the light source up?

These repair anomalies are just a few of the practices that non-validated repairers may employ.

Whose problem is it when something goes wrong?
The block assembly which has the manufacturers' name engraved is retained on the repaired scope by the non-validated repairer in all repaired scopes. This often causes confusion to the customer as to who the responsible party is in the event a problem arises.

According to an extract from an American monthly advisory on clinical and administrative practices there have been legal cases in the US where the hospital, the manufacturer and the surgeon were all sued due to a bad outcome. The scope manufacturer can be counted on to claim that it is not liable because its product was altered significantly. Equipment that had the manufacturers label on it had been repaired by someone else other than the original manufacturer. The manufacturer was dismissed from the lawsuit as not liable, leaving the surgeon and the hospital to be sued.viii

Both private and public hospitals struggle with budgets and cost cutting exercises. However, when the facility has purchased high quality endoscopic equipment to assist in the best possible patient outcomes, it makes sense to continue to maintain that equipment to the highest quality and to ensure that the equipment continues to be maintained to the original manufacturer’s specifications.

The TGA does not regulate repair companies
The TGA does not regulate repairs of endoscopes or instruments, even though repair companies are disassembling the telescope and then reassembling.

Recently the TGA placed an announcement on the website outlining the following:

22 September 2011

The TGA’s Incident Reporting and Investigation Scheme receives reports about the safety and performance of medical devices as part of its ongoing monitoring of products supplied in Australia. As part of this process the TGA has recently reviewed several reports associated with repaired endoscopes. These reports relate to the quality of the repair and the use of unsuitable parts.

“The TGA recognises that medical device repairers provide a useful service in assisting healthcare facilities to maintain good quality medical devices. However, it is important that healthcare facilities who require repairs to be made to medical devices, such as endoscopes, should satisfy themselves that the repairers have an appropriate level of training and experience to be able to competently undertake the repair work.”

To view this statement on the website, go to:

http://www.tga.gov.au/hp/iris-articles-2011-110825-scopes.htm

The TGA has acknowledged that they have received several reports relating to the quality of repairs to endoscopes and the use of unsuitable parts.

Risk management
The TGA has given the advice that “it is important that healthcare facilities that require repairs made to medical devices, such as endoscopes, should satisfy themselves that that the repairers have the appropriate level of training and experience to be able to competently carry out this work”. In other words the healthcare facility should fully understand the risks of using a non-validated repairer and carry out a “risk analysis”. Any reasonable person would conclude that the risks associated with using a company other than the original manufacturer are significantly greater. In other words, the healthcare facility needs to consider their risk management policy. Risk is often characterised by reference to potential events (2.19) and consequences (2.20), or a combination of these.ix

A neglected endoscope is a dangerous endoscope
This article endeavours to take the reader through the history, development and advances in endoscopic surgery. However, to balance the argument, it is important that healthcare facilities are made aware that this once radical approach to surgery is now usual and as such the workhorse of endoscopic surgery. The fundamental ability to accurately diagnose relies heavily on the surgeon’s ability to visualise what he or she sees through the endoscope. That endoscope that facilitates diagnostic and therapeutic procedures should not be neglected in the servicing and maintained to the highest standards as would an x-ray machine, MRI or any other piece of technologically based medical equipment.

Amanda Silverstone
Amanda Silverstone is a Senior Product Manager for KARL STORZ Endoscopy Australia Pty Ltd and has worked in the area of endoscopy for over 15 years.

References
i. www.AIHW.gov.au/publications, Australia’s Health 2010 – National Hospital Morbidity Database

ii. www.imaginis.com/endoscopy 

iii. www.alexea.org/historyofendoscopy Alexandria Endoscopy Association

iv. http://en.wikidepia.org/wiki/Harold_Hopkins 

v. NOTES 2/6/09 eurekalerts.org/pub: American Gastroenterological Association

vi. www.karlstorz.de vii. www.reproductivecentre.com

viii. www.WebMD.com/a-to-z-guides/features/understanding-endoscopic-surgery  When is minimally invasive surgery better than traditional surgery? What are the Risks? By R. Morgan Griffin

ix. Laparoscopic Surgery Update Vol 7, No. 12 Dec 1999

x. Risk Management Institute of Australia www.rmia.org.au  (Risk Management-2009)