치과용 임플란트에 대한 ISO 14971 기반의 리스크관리

* ** *** †
윤지훈․김영진 ․전계록 ․정창모
오스템임플란트(주) 임플란트연구소․*부경대학교 공과대학 시스템경영공학과
**
부산대학교 의학전문대학원 의공학과․***부산대학교 치의학전문대학원 보철과
(2011. 12. 7. 접수 / 2012. 3. 19. 채택)

Application of Risk Management for Dental Implants Based on ISO 14971

* ** †***
Ji Hoon Yoon․Young Jin Kim ․Gye Rok Jeon ․Chang Mo Jeong
Implant Research Center, Osstem Implant Co.
*
College of Engineering, Dept. of Systems Management and Engineering, Pukyong National University
**
Dept. of Biomedical Engineering, School of Medicine, Pusan National University
***
Dept. of Prosthodontics, School of Dentistry, Pusan National University
(Received December 7, 2011 / Accepted March 19, 2012)

Abstract : Risk management is the process that helps to identify hazards, analyze them, and then to create an action
plan to avoid and mitigate these hazards. The main objective of risk management in product development and manu-
facturing is to provide safe and efficient products without spending too many resources. Medical device manufac-
turers also face enormous risks - regulatory, legal, and financial - based on their products and processes, and the
concepts of risk management are particularly important because any single failure may result in serious damages to
body or loss of life. In this regard, a set of guidelines for the application of risk management to medical devices has been
issued by ISO and specified in the document ISO 14971 Medical devices - Application of risk management to me-
dical devices. The main objective of this study is to investigate the application of risk management to dental implant
development and manufacturing processes based on ISO 14971. A general risk management process is first
introduced, and the application of ISO 14971 to dental implants is further investigated.
Key Words : risk management, ISO 14971, medical devices, dental implants, case study

1. Introduction* appear similar to an actual tooth root and are placed

within the drilled socket of jaw bone. Dental imp-
A dental implant has widely been recognized as lants are usually made of titanium and osseointegrate
one of the most innovative and efficient ways of with the jaw bones. The term ‘Osseointegration’ refers
restoring the masticating function of missing teeth. to the adhesion of the implant surface to surrounding
Prior to the advent of dental implants, a number of bones. With the rapid aging and improved standard of
dental prostheses including bridges and dentures have living, dental implants have become a very popular
been applied. Compared with the dental implants, choice for numerous patients although relatively expen-
these prostheses are readily inexpensive but causes a sive. It has been reported, in many clinical studies,
great deal of discomfort and inconvenience to patients. that the success rate of installing dental implants
Furthermore, the jaw bone actually sinks away when ranges from 95% to 98%. Although the success of a
teeth are lost, and just wearing dentures without bone dental implant is related to various factors such as ope-
supports may accelerate this process. Thus, the resto- rator skills, quality and quantity of the bone avai-
ration of teeth roots supported by jaw bones may be lable, and the patients’ oral hygiene, any single fai-
far more beneficial in the long run. Dental implants lure attributable to the product itself will be devas-
†
tating. Thus, the responsibility of manufacturers is inc-
To whom correspondence should be addressed.
[email protected] reasingly emphasized to ensure the product quality,

92
 치과용 임플란트에 대한 ISO 14971 기반의 리스크관리

safety, and efficacy. a sequence of events or other circumstances lead to

Risk management is the process that helps to iden- a hazardous situation. At this stage the risk can be
tify hazards, analyze them, and then to create an assessed by estimating both severity and probability
action plan to avoid and mitigate these hazards. The of occurrence of harm that could result. Thus a good
main objective of risk management in development starting point for risk management is to locate the
and manufacturing is to provide safe and efficient sources of potential hazards and understand the mec-
products without spending too many resources, for hanism leading hazards to hazardous situations. In
example, for verifying and validating processes and general, risk management process consists of the fol-
equipments. Medical device manufacturers also face lowing elements: risk analysis, risk evaluation, risk
enormous risks - regulatory, legal, and financial - control, production and post-production information.
based on their products and processes, and the con- First, risk analysis activities involve the identification
cepts of risk management are particularly important of characteristics related to the safety of the medical
in relation to medical devices because of various device, identification of hazards, and estimation of the
stakeholder including medical practitioners, the organ- risk(s) for each hazardous situation. Some available
ization providing health care services, governments, techniques for the purpose of risk analysis include
industry, patients and member of the public1). In this preliminary hazard analysis (PHA), fault tree analysis
regard, a set of guidelines for the application of risk (FTA), failure mode and effect analysis (FMEA), fai-
management to medical devices has been issued by lure mode, effect, and criticality analysis (FMECA),
ISO and specified in the document ISO 14971 Med- hazard and operability study (HAZOP), and hazard
ical devices - Application of risk management to med- analysis and critical control point (HACCP). Detailed
ical devices. The specifics of applying ISO 14971 procedure and guides for the application of indivi-
may greatly differ with respect to the characteristics dual techniques can be found in the existing literature.
of medical devices under investigation in the sense For example, readers are referred to IEC 61025 ,
4)

that the types and scopes of risks are highly dep- 5) 6) 7)

IEC 60812 , IEC 61882 , Flick et al. for detailed
endent on the product. The main objective of this information on FTA, FMEA, HAZOP, and HACCP,
study is to investigate the application of risk mana- respectively. Using these techniques, the probability
gement in the development and manufacturing proce- of occurrence and severity of individual harms may
sses of dental implants and related surgical tools. be estimated quantitatively or qualitatively. Second,
Specifically, ISO 14971 is adapted to examine the the purpose of risk evaluation is to decide whether risk
applicability of relevant tools for identifying and con- reduction is required (i.e., whether a risk is accep-
trolling various risk factors. Most of existing studies table or not) for each identified hazardous situation.
on risk management of dental implants are concerned Risk acceptability may be determined by using appli-
with the surgical treatments2,3). To the best of aut- cable standards, comparing levels of risk evident from
hors’ knowledge, this study is the first to deal with medical device already in use, and/or evaluating cli-
the risk management of development and manufac- nical study data. Risk evaluation matrix is most com-
turing processes for dental implants. A generic risk monly used to indicate acceptability criteria. When
management process is briefly introduced, and the risk reduction is required, it is imperative to perform
application of risk management to dental implants risk control activities such as risk control option anal-
based on ISO 14971 is further investigated. ysis, implementation of risk control measure (s), resi-
dual risk evaluation, and risk/benefit analysis. It is
2. Generic Risk Management Process worthy of noting that ISO 14971 deals with an as-
According to ISO 14971, a risk is defined by the low-as-reasonably -practicable (ALARP) approach
‘combination of the probability of occurrence of harm when establishing the risk acceptability policy. After
and the severity of that harm’. By definition, a a particular risk control option has been exercised,
hazard itself cannot result in harm until such time as the residual risk(s) may be in between acceptable

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 윤지훈․김영진․전계록․정창모

and unacceptable regions. For these risks, the resi- 3.1. Hazard Identification
dual risk is acceptable for the option that reduces the Referring to Annexes C and E of ISO 14971, identi-
risk to the lowest practicable level. It may be conve- fication of intended use and characteristics related to
nient to use the ALARP approach for risks of which the safety of the medical device are prepared by the
probability cannot be estimated. Completing the eval- risk analysis personnel. Twenty nine potential haza-
uation of overall residual risk acceptability, a review rds have been identified as shown in Table 1. Most
of the risk management process should be carried out of the hazards are identified on the basis of clinical
prior to release for commercial distribution of the papers, ISO standards, and internal information on
medical device. Schematic representation of the risk production and maintenance.
management process is depicted in Fig. 1.
3.2. Risk Estimation and Acceptability
3. Application to Dental Implants Referring to Annexes C and E of ISO 14971, A
semi-quantitative analysis specified in D.3.4.2 of ISO
The leading company of dental implant market in
14971 has been adapted, and a 5 × 5 risk matrix is
Korea has initiated the risk management process in
cooperation with KFDA (Korea Food and Drug Admi-
Table 1. Hazard identification of dental implant
nistration) in 2008, and the process has been imple- ID Hazard Hazardous Situation
mented for development and manufacturing of dental R1 Errors of Selecting Material
implants and surgical tools. Risk management for the Design
R2 Errors in the Fixture Design
development of newly designed implant fixture is R3 Errors in Measuring a Bone Quality
Diagnosis
briefly discussed in the below. R4 Errors of Measuring an Anatomic Structure
R5 Misrepresentation of the Specification Info.
R6 Misrepresentation of Precautions
R7 Misrepresentation of Directions
R8 Surgical Use of an Expired Product
R9 Operation Over Torque
R10 Errors of the Insertion Depth
R11 Errors of Connecting Mounts
R12 Errors of Connecting Cover Screw
R13 CNC Programming Errors
R15 Defects in Cutting Tools
R16 Out of Specification
R17 Out of Tool Holder Setting Point
R18 Cleaning Machine Stoppage
R19 Post Machine Stoppage
R20 Residual Chip and Dump
R21 Product Mixed Up
Production
R22 Defects in Masking Jig
R23 Steam Cleaner Stoppage
R24 Dropping Product
R25 Defects in Alkali Recycling
R26 Double Marking
R27 Blister Unforming
R28 Label Information Errors
1)
Fig. 1. Risk management process R29 Humidity Out of Specification

94 Journal of the KOSOS, Vol. 27, No. 2, 2012

 치과용 임플란트에 대한 ISO 14971 기반의 리스크관리

used. The severity levels of individual harms are deter- ted to be acceptable as shown in Table 4. For exa-
mined on the basis of focused group interviews (FGIs) mple, a hazard in diagnosis may lead to a hazardous
with expert dentists with over 10 years of experience situation of committing errors of measuring a bone
in implant dentistry, and descriptions on each seve- quality, which may cause the harm of bone loss or
rity level are also derived from FGIs. The proba- insufficient initial stability. The severity and proba-
bility of occurrence of harms is estimated by analy- bility of the harm are evaluated to be 2 and 3, respec-
zing published FDA data and internal customer com- tively, which results in ALARP. In this case, allevia-
plaints database. Thus the severity and probability of ting severity of the harm would be costly and time
occurrence of harms are estimated for all harms consuming.
identified. Risk acceptability criteria are indicated in Thus, risk control measures to reduce the proba-
a 5 × 5 risk evaluation matrix as shown in Table 2. bility of occurrence would be more practicable. One
It is noted that an ALARP approach is adapted. No of the identified control measures to reduce the occur-
harms are evaluated to be unacceptable and six harms rence of the harm R3 is to optimize the design of
are located in ALARP regions as shown in Table 3. surgical drills which has a significant effect on the
Risks associated with individual harms are calculated bone loss and initial stability. A twist drill is mostly
by multiplying the severity and probability scores. used to secure enough space at the site for an effec-
tive and safe placement of dental implants. Drilling
3.3. Risk Control Measures: An Example causes a certain amount of heat around the alveolus
Risk control option analysis has been performed bone, which often results in the bone loss and insuf-
to determine whether risk reduction is required for ficient initial stability of implant fixtures. Thus the
harms in ALARP regions, and risk control measures amount of heat generation is clearly affected by the
have been implemented for all harms in ALARP design of surgical drills. There are many design fac-
regions. Residual risk for individual harms is evalua tors affecting the performance of drills including point
angle, helix angle, relief angle, flute geometry, and
Table 2. Risk evaluation matrix tip shape, among which angle-related design factors are
Severity*
Probability** specified based on the prior experiments. To reduce
1 2 3 4 5
the amount of heat generated when drilling, an experi-
1 ACC ACC ACC ACC ALARP
ment is conducted with two design factors: flute
2 ACC ACC ALARP ALARP IR
geometry and tip shape. Four different drills arepre-
3 ACC ALARP ALARP IR IR
pared to conduct a two-level factorial experiment as
4 ACC ALARP IR IR IR
5 ALARP IR IR IR IR
Table 4. Risk control measures
※ IR : Intolerable Region, ACC : Acceptable Region
*
Severity Score: 1 (Negligible), 2 (Minor), 3 (Serious), 4 (Critical), ID Harm Severity Probability Risk
5 (Catastrophic) Design Optimization of
**
Probability Score: 1 (Frequent), 2 (Probable), 3 (Occasional), 4 (Re- Surgical Drill
mote), 5 (Improbable) R3 2 2 4
Providing Proper Information
on Surgical Procedures
Table 3. Harms in ALARP regions Providing Surgical
R6 4 1 4
ID Harm Severity Probability Risk Information in User’s Manual
Bone Loss or Insufficient Expression of the Available
R3 2 3 6 R8 3 1 3
Initial Stability Period in User’s Manual
Inflammation Provocation & Implantation Torque Test
R6 5 1 5 R9 Providing Proper Information 2 2 4
Loss of Function by Infection
on Surgical Procedures
Inflammation Provocation &
R8 5 1 5 Packaging IOQ
Failure of Osseo-Integration
R26 Validation of Packaging 3 1 3
R9 Fracture of Alveolar Bone 2 4 8 Inspection Records
R26 Out of Specification 3 3 9 Chart Record Monitoring
R28 3 1 3
R28 Increased Bacteria 3 2 6 Bioburden Test

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 윤지훈․김영진․전계록․정창모

given in Table 5. Changes in heat cannot be mea- Table 6. Experimental results

sured directly, but they may be detected their effect Temperature Changes
Type Description
on the alveolus bone, i.e., changes in temperature. Mean ± SD(℃)

Drilling on artificial bone specimens with uniform A 3-Flute, No-Step Drill 22.72 ± 1.63
B 3-Flute, Step Drill 19.92 ± 0.82
density using the equipment shown in Fig. 2, five mea-
C 2-Flute, No-Step Drill 15.10 ± 1.02
surements of temperature are taken with respect to
D 2-Flute, Step Drill 7.16 ± 1.15
drilling depth.
Experimental results are summarized in Table 6
and Fig. 3, and a two-way analysis of variance
(ANOVA) indicates that both factors have significant
effects on changes in temperature with p-value less
than 0.01 and 96.87% of R-square. Since changes in
temperature are much smaller, 2-flute is preferable to
3-flute with respect to flute geometry. Further, conven-
tional no-step drills may be replaced by step drills to
reduce the changes in temperature. In conclusion, 2-
flute step drill design has been adapted and deployed
for further validation. Afterward, new surgical drills
have been shipped out to customers and clinical data
are currently stacked for updating risk management
profiles. In addition to the optimization of surgical
Fig. 3. Temperature changes with respect to depth.
Table 5. Factor levels
Levels Table 7. ANOVA Table
Factor
Low High Sources DF SS MS F
Flute Geometry 2-Flute 3-Flute Flute 1 559.7 559.7 392.1
Drill Tip Shape No-Step Drill Step Drill Drill Tip 1 124.0 124.0 86.9
Interaction 1 23.8 23.8 16.7
Error 16 22.8 1.5 -
Total 19 730.3 - -
※ R-square = 96.87%, R-square(adj.) = 96.29%

drill design, providing proper information on surgical

procedures in the product catalog is also identified as
a proper control measure and executing these mea-
sures is judged to reduce the occurrence level to 2.
Consequently, the risk related to the harm can be
reduced from 6 to 4 to be acceptable.

4. Conclusions

A proper management of risks associated with

medical devices is particularly important because any
single failure may result in serious damages to body
Fig. 2. Schematic diagram of experimental equipment. or even loss of life. In this regard, the concepts of

96 Journal of the KOSOS, Vol. 27, No. 2, 2012

 치과용 임플란트에 대한 ISO 14971 기반의 리스크관리

risk management have drawn an increasing attention References

from the community of medical devices including
1) ISO, ISO 14971:2007 Medical devices - Appli-
medical practitioners, organizations providing health
cation of risk management for medical devices, ISO,
care services, governments, industry, patients and mem-
2007.
bers of the public. In this study, the application of
2) N. Givol, S. Taicher, et al., “Risk Management
risk management to medical devices is first briefly Aspects of Implant Dentistry”, Int. J. Oral Maxillofac.
reviewed, and the risk management process for den- Implants, Vol. 17, pp. 258~262, 2002.
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14971, hazards associated with the design, diagnosis, Hong Kong Dent. J., Vol. 2, pp. 58~60, 2005.
surgical operation, and production of dental implants 4) IEC, IEC 61025 Fault Tree Analysis (FTA), IEC, 2006.
are identified. Risks corresponding to identified haza- 5) IEC, IEC 60812 Analysis techniques for system relia-
rds are then evaluated with respect to probability and bility - Procedures for failure mode and effect
analysis (FMEA), IEC, 2006.
severity. Risk control measures are investigated and
6) IEC, IEC 61882 Hazard and operability studies
it has been found that conventional statistical tools
(HAZOP studies) - Application guide, IEC, 2001.
such as experimental designs may be beneficial for the
7) G. Flick, J.L. Salyer, et al., Medical Device Risk
purpose of risk control and risk reduction in the course Management Training Using HACCP Principles, 2nd
of development and manufacturing of medical devices. ed., Medical HACCP Alliance, 2003.

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