Ni Ti 전동파일 이슈, 1회용인가 재사용인가?

최근 치과계의 이슈중 하나가 근관치료시 사용하는 전동파일의 재사용입니다.

전동파일은 감염으로 괴사된 치수조직을 제거하는데 사용하는 도구로 인체에 접촉하므로 철저한 멸균관리가 필요합니다.

최근 유럽이나 미국에서는 아래의 여러가지 이유로 전동파일을 1회만 사용할 것을 권장하고 있습니다.

국내에서는  전동파일이 1회용 의료기기로 규정된 바 없으므로  재사용이 불법은 아닙니다. 단 철저히 멸균관리를 하고 수시로 파일을 체크하여 사용횟수를 최소화 할 필요가 있습니다.

또한 건강보험심사원의 청구기준은 치아당 전동파일을 1회 산정한다고 되어 있으므로 재사용을 통한 이중청구가 되지 않도록 하는것이 좋습니다.

미국및 유럽의 제조사들도 이런 추세에 맞게 1회용 전동파일을 생산하여 판매하고 있으며 국내에도 판매 되고 있습니다.

제조사 기준으로 1회용 개념으로 생산하여 판매하는 제품은...

덴츠플라이사의 WaveOne gold, Protaper next, Proglider가 있으며 오스템에서 수입 판매하는 Reciproc Blue가 있습니다.

■1회용 의료기기의 사용 시 주의사항
✔ (허가‧인증) 1회용 의료기기의 사용방법 또는 사용 시 주의사항에
‘일회용 의료기기’및 ‘재사용 금지’ 내용을 포함
✔ (표시기재) 1회용 의료기기의 외장(용기)에 ‘일회용’이라는 표시와
‘재사용 금지’라는 표시가 필수 기재사항임
✔ (첨부문서) 의료기기와 같이 제공되는 첨부문서(사용설명서 등) 또
는 제품의 외장(용기)에 사용방법 및 사용시 주의사항이 기재되어 있음
나. 또한, 내시경과 같이 멸균‧소독하여 재사용 가능한 의료기기는 의
료기관에서 허가(인증‧신고)사항의 사용방법 및 사용 시 주의사항에 따
라 멸균‧소독 후 사용하여야 함.

아래는 전세계 전동파일 시장점유율 1위인 덴츠플라이에서 홍보용으로 만들어 배포하는 자료를 정리한 것입니다.

첫번째 이슈는 안전성입니다.

Maintaining rigorous safety methods is vital for the dental profession. That’s exactly
why it’s so important to be clear on this point: no matter how well an instrument is
sterilized, research shows that bacteria and tissue remnants remain on the instrument.
Any additional use of these instruments, therefore, greatly increases the potential for
cross-infection to every subsequent patient.
There is substantial research and support concerning these safety and health issues,
all of which build a strong case for “single-use” of endodontic files:
• Every patient is a potential carrier of infection.

감염병의 전이문제
Virox Technologies Inc., an antimicrobial technology company based in ontario,
Canada, offers an Infection Control Protocol for dentistry and provides online
continuing education for U.S. Air Force dental personnel. As in other areas of
the healthcare industry where the philosophy already exists, Virox encourages
dental practitioners to institute a “Standard Precautions” procedure that
considers all patients to be infected with pathogenic organisms. For that reason,
certain basic infection control procedures must be used during the care of all
patients. According to the protocol, “the only safe approach is to assume that
every patient is a carrier.”
• Decontamination methods for sterilizing instruments do not remove the risk of
cross-infection to other patients.

 멸균과정에서 교차감염을 완전히 차단할 수 없다.
The HIV Dental Education Association, in the May 2001 edition of its Infectol
newsletter, states that instruments such as reamers, files and certain burs are
difficult to clean and cross-infection is a risk.
• Decontamination techniques used routinely in general dental practice cannot
activate the infective protein responsible for transmitting such diseases as Variant
Creutzfeldt-Jakob Disease.

치과에서사용하는 멸균테크닉은 Creutzfeldt-Jakob병과 같은 감염성 단백질의 활성화를 차단할 수 없다.
In her July 2002 Primary Dental Care article, “Variant Creutzfeldt-Jakob Disease
– A Problem for General Dental Practitioners?” Christine L. Whitworth wrote
there have been more than 100 deaths recorded from variant Creutzfeldt-Jakob
disease (vCJD). The incubation period for CJD may be up to 40 years and the
number of asymptomatic carriers in the population could be as many as 100,000.

access and clean with detergent.
encephalopathies raises the possibility of cross-infection from apparently healthy
persons who are incubating vCJD.
According to Whitworth, decontamination techniques routinely used in general
dental practice are incapable of inactivating the infective protein responsible for
transmitting the disease.
“The presence of PrP in circulating B-lymphocytes in patients with confirmed
vCJD should be of concern to dentists undertaking surgical treatments, or even
placing a matrix band subgingivally,” states the article. “Any instrument
contaminated with the blood of such a patient may carry the risk of iatrogenic
transmission. Those practitioners who carry out endodontic treatment,
periodontal or implant surgery have the additional concern that PrP may be
present in the dental pulp and gingival tissues of patients with vCJD.”
• Sterilization against some infectious agents is not 100 percent effective.
Moreover, only a small percentage of dental practitioners even possess the
equipment needed to sterilize endodontic files for possible re-use.

증기멸균이 100프로 효과적인것은 아니다. 게다가 대부분의 치과는 재사용목적으로 근관치료용 파일을 멸균한 충분한 장비를 갖추고 있을 뿐이다.

The decontamination technique recommended for inactivation of PrP-infected
instruments by the Spongiform Encephalopathy Advisory Committee (SEAC) is
18 minutes or six consecutive three-minute cycles at 134 degrees in a vacuum
autoclave – with the caveat that this method does not completely inactivate
the infective agent. A study of decontamination methods used in general
dental practice found that only three percent of dentists surveyed possessed a
vacuum autoclave.
• Endodontic files and restorative matrix bands can harbor proteinaceous material
in crevices that are impossible to access.

전동파일이나 메트릭스밴드는 접근이 불가능한 미세한 틈들을 가지고 있다.
Dr. Andrew Smith, at the University of Glasgow Dental School, further
highlighted the importance of not reusing single- use metal items. Endodontic
files and matrix bands, he said, could harbor proteinaceous material due to the
micro and macro crevices on the surface. These crevices are impossible to
access and clean with detergent.

• Some abnormal prion proteins responsible for diseases are resistant to
sterilization efforts. Furthermore, autoclaving the instruments can actually
stabilize the proteins on the metal.

특정 질병과 관련된 단백질들은 멸균을 무력화 시킨다. 나아가 기구의 증기멸균은 실제로 금속에 단백질들을 안정화시킨다.
A symposium on Transmissible Spongiform Encephalopathies (TSEs) and their
implication for dental practice generated lively debate at the September 2002
Pan European Festival of Oral Science, an inaugural meeting of the Pan
European Federation of the International Dental Association.
Professor Collinge, of the Prion Disease Group at UCL/Middlesex Hospital, told
the audience that the abnormal prions causing vCJD and TSEs are an insoluble,
detergent and protease resistant form of a normal protein that occurs naturally
in the body. He described experiments designed to simulate transmission on
surgical instruments. In five to 30 minutes of contact time with a mouse brain,
vCJD prion-contaminated stainless-steel wires, which had been washed and
sterilized, could transmit vCJD as efficiently as an injection of a vCJD infected
brain homogenate.
Adherent prion proteins that have not been removed from the wire by cleaning
and sterilizing, act as a template to stimulate further prion protein propagation.
In the stainless-steel experiments, autoclaving actually stabilized the prion
protein to the metal.

두번째 이슈는 재사용으로 인한 절삭력의 감소입니다.

Further research has shown that using endodontic files in multiple cases actually
reduced their cutting efficiency. Ultimately, this reduces operating efficiencies in a
dental practice and affects patient satisfaction and your practice’s bottom line.
These operational issues involve:
• With each use of a file, cutting efficiency is reduced.

재사용시 절삭력이 줄어듭니다.
A study that appeared in the September 1995 Journal of Endodontics (JOE)
evaluated the performance of seven different brands and types of files on
human dentin. All files evaluated rapidly deteriorated during the machining of
dentin. This decline in efficiency was significant but different within, as well as
among, brands. The authors suggested that the endodontic files be disposable.

• All stainless steel files are prone to dulling when machining dentin.

모든 전동파일은 상아질에 무뎌진다는 사실이 검증되었습니다.
In an article titled “Stainless Steel Endodontic Files Should be Disposable,”
published in Practical Endodontics in August 1995, the authors stated that “all
files wear with use.” The study tested ten of the following files and brands: K-File
(Maillefer), K-File (Sjodings), H-File (Maillefer), H-File (Sjodings), S-File (Sjodings),
Flex-R (Union Broach), and K-Flex (Kerr). All evaluated files deteriorated rapidly
when machining dentin.
• Repeated sterilization of rotary nickel-titanium files decreases cutting efficiency.

반복적인 멸균시 절삭력이 줄어듭니다.
A 1999 study published in Oral Surgery, Oral Medicine and Oral Pathology
investigated the cutting ability of 36 ProFile® rotary nickel-titanium instruments.
The results showed that repeated sterilizations of these endodontic files showed
a decrease in cutting efficiency and caused an alteration of the instruments’
superficial structure.
• Use of sharp instruments is more cost effective, increases patient comfort and
reduces operator fatigue.

날카로운 기구를 사용하는것이 비용효과적이며 환자도 편하고 술자의 피로도를 낮출 수 있습니다.
Authors of a study in 1995 that appeared in Practical Endodontics proposed
that from a cost-effective point of view, all endodontic files should be considered
disposable after one use because it is nearly impossible to institute a positive
system in a dental office to ensure that files are optimally efficient if reused. In
addition, the study proposed “sharp instruments should always be used for root
canal preparation to optimize cost effectiveness, increase patient comfort, and
reduce operator fatigue.”
• Repeated reprocessing of some endodontic files can lead to breakage during
patient treatment.

전동파일의 반복적인 사용은 치료중 파절을 유발할 수 있다.
According to the U.S. Air Force Dental Investigation Service: “Due to the
physical construction of some devices…cleaning tooth and tissue debris from
the device safely and efficiently may also be difficult...after repeated
reprocessing cycles, alteration of some types of endodontic files occurs,
potentially leading to breakage during patient treatment. If you aren’t already
using single-use products, the above factors – coupled with the knowledge that
burs and endodontic instruments exhibit signs of wear during normal use – may
make the decision to consider them single-use more practical.”

유연성, 강도, 가격 모두 믿을 수 있는 엣지엔도 전동파일!