BS EN ISO 14971: Risk Analysis and Risk Management Report

Transcription

1 BLACKHORSE ROAD, LETCHWORTH, HERTS, SG6 1HB, ENGLAND Tel: + 44 (0) Fax: + 44 (0) BS EN ISO 14971: Risk Analysis and Risk Management Report Product: Maxflex Pop On Disc Classification: Class 2a Medical Device Risk Management Report 1. PRODUCTS Product: Maxflex pop on discs Description: Stoddard Maxflex pop on discs are a Synthetic moulded disc abrasive loaded attached to a central brass ring. They are two component products. 2. RISK MANAGEMENT PLAN The risk management plan is designed to identify and analyse the risks associated with the devices detailed above during their intended usage life cycle. The process verifies as far as is possible the risks and control solutions cited and establishes criteria for risk acceptability. The process includes review of risk management at appropriate stages and as a result of post market surveillance. Risk assessment has been conducted retrospectively on established products but is also conducted as an essential part of the design and development of new or revised products or product types. The process is conducted to comply with the guidance in BS EN ISO Risk management is conducted by the quality management team with guidance as necessary from other departments within the company. 3. RISK ANALYSIS 3.1. INTENDED USES The Dental surgeon or Hygienist uses Stoddard Maxflex pop on discs for the Prophy cleaning or polishing of natural teeth and filled surfaces in the mouth. Rotary power is provided by a handpiece which can be air or electrically driven CONSTRUCTION These rotary instruments are a Synthetic moulded disc, abrasive loaded attached to a central brass ring. They are two component products. Please refer to Maxflex Pop On Disc product specification and data sheet. Issue 2 03/2014 Page 1 of 6

2 3.3. HAZARD IDENTIFICATION 1. The materials used in construction of these devices are inert in the context of their method of use and therefore present no hazards. 2. Improper use of the rotary instrument by the action of the operator. 3. If the instrument became detached from the handpiece during use injury to the tooth or gums or other parts of the buccal cavity or ingestion or inhalation of the instrument could result 3.4. ESTIMATION OF RISK 1. Synthetic Polymer: - While estimating any toxicological risks, the nature of the raw material and its possible prior use, source, processing and biological safety test data is considered. 2. Under normal conditions of use the hazard presented by rotary instruments are limited by the action of the operator. For the purpose of this risk assessment these are presumed to be adequately controlled through the education, experience and skill of the operator. The inevitable trauma of dental treatment using rotary instruments is reduced by the use of torque limiting features on dental handpieces, and the use of anaesthetic and analgesic agents. 3. If the instrument became detached from the handpiece during use injury to the tooth or gums or other parts of the buccal cavity or ingestion or inhalation of the instrument could result. There have been no reported incidents of these instruments becoming detached from the handpiece as a result of a defect in the instrument. Such incidents are generally caused by failure of the handpiece collet. The level of risk is considered acceptable. 4. RISK EVALUATION 1. Synthetic Polymer is a man made product and is for single-use (transient) only. There is no evidence of allergic reaction to these products and no allergic reaction to these products has been reported to the company in the last 20 years. 2. The risks presented by these products in normal conditions are considered to be well controlled by proper use or under the supervision of a suitably qualified dental surgeon or hygienist. 3. In view of the very low risk associated with the instrument becoming detached from the handpiece, the level of risk is considered acceptable. 5. RISK REDUCTION After evaluation the level of risk is considered acceptable and therefore under these circumstances risk reduction is not considered necessary OPTION ANALYSIS RISK REDUCTION BY DESIGN PROTECTION AGAINST RISK The quality control measures in place during and following the manufacture of Maxflex Pop On Discs are designed to control the incidence of failure, breakage or bending of the product. These have been detailed in the relevant parts of the QA system manuals INFORMATION The directions for use for these products specify conditions of use (intended uses, application speeds etc), which are considered adequate to allow safe and effective use of the devices. Issue 2 03/2014 Page 2 of 6

3 5.2. RISK CONTROL MEASURES No further risk control measures other than those described above are considered necessary RESIDUAL RISK Under proper professional use in accordance with the directions for use it is believed that, apart from those controlled risks cited above, there are no significant residual risks with these products RISK/BENEFIT ANALYSIS None considered necessary 5.5. COLLATERAL HAZARDS There are collateral hazards associated with reprocessing. These are well documented and have been the subject of extensive research in recent years in response to the challenges of hepatitis, HIV and CJD. These instruments are for single-use and should be sterilised before first single-use, the directions for use relating to these products are based on validated reprocessing (sterilisation) methods designed to control the risk from contaminated instruments. 6. RISK EVALUATION SUMMARY These instruments are generally low risk products with no uncontrollable residual risks in proper use. No further risk analysis or control is considered necessary unless there is a significant change in knowledge or legislation that may highlight unbeknown or undocumented hazards. 7. POST PRODUCTION ANALYSIS A procedure is established and maintained to review information gained about the medical device or similar devices in the postproduction phase. The Quality Management Team evaluates this information. Analysis of customer complaints indicates that there have been few incidents or defects with these products that could have harmed the patient or end-user or resulted in any clinical problem. The details of the complaints history are contained in the relevant technical file. Risk Analysis Question Answer C.2.1 What is the intended use and how is the medical device to be used? For oral prophylaxis tooth polishing. For use by or under the supervision of a qualified dental surgeon or hygienist. C.2.2 Is the Medical device intended to be implanted? The device is not intended to be implanted C.2.3 Is the medical device intended to be in contact with the patient Yes. It is used in the patient s mouth. or other persons? C.2.4 What materials or components are utilised in the medical device or are used with, or are in contact with the medical device? Refer to Product specification and Safety Data sheet. C.2.5 Is energy delivered to or extracted from the patient? No. C.2.6 Are substances delivered to or extracted from the patient? No. C.2.7 Are Biological materials processed by the medical device for No. subsequent re-use, transfusion or transplantation? C.2.8 Is the medical device supplied sterile or intended to be sterilised No by the user, or are any other microbiological controls applicable? C.2.9 Is the medical device intended to be routinely cleaned and disinfected by the user? No. They are single use Issue 2 03/2014 Page 3 of 6

4 C.2.10 Is the medical device intended to modify the patient No. environment? C.2.11 Are measurements taken? No. C.2.12 Is the medical device interpretative? No. C.2.13 Is the medical device intended for use in conjunction with other medical devices, medicines or other medical technologies? This Instrument is used with Dental Handpieces and Mandrels. C.2.14 Are there unwanted outputs of energy or substances? No. C.2.15 Is the medical device susceptible to environmental influences? Yes They should be stored at room temperature, away from light. C.2.16 Does the medical device influence the environment? No. C.2.17 Are there essential consumables or accessories associated with the medical device? No. C.2.18 Is maintenance or calibration necessary? No. C.2.19 Does the medical device contain software? No. C.2.20 Does the medical device have a restricted shelf life? Yes - 5 years. C.2.21 Are there any delayed or long-term use effects? No. C.2.22 To what mechanical forces will the medical device be Rotary Action. subjected? C.2.23 What determines the lifetime of the medical device? They are single use. C.2.24 Is the medical device single use? Yes. C.2.25 Is safe decommissioning or disposal of the medical device necessary? Yes it is recommended for single use only and suitable disposal is required after use. C.2.26 Does installation or use of the medical device require special training or special skills? Yes - For use by or under the supervision of a qualified dental surgeon or hygienist. C.2.27 How will information for safe use be provided? Refer to Instructions for use. C.2.28 Will new manufacturing processes need to be established or No. introduced? C.2.29 Is the successful application of medical device critically Yes. dependent on human factors such as the user interface? C.2.30 Does the medical device use an alarm system? No. C.2.31 In what way(s) might the medical device be deliberately Use by unqualified personnel. misused? C.2.32 Does the medical device hold data critical to patient care? No. C.2.33 Is the medical device intended to be mobile or portable? No. C.2.34 Does the use of the medical device depend on essential performance? Yes. Issue 2 03/2014 Page 4 of 6

5 Risk Evaluation Hazard Type Energy Environmental Incorrect use Functional failure Contributing Factors Rotary Power see incorrect use Metallic component parts Improper use of the rotary instrument by the action of the operator. Instrument becomes detached from the handpiece Possible effect Severity Probability Score Risk control mechanism Injury to the tooth or gums or other parts of the oral cavity due to excessive pressure. Inappropriate waste disposal Injury to the tooth or gums or other parts of the oral cavity Injury to the tooth or gums or other parts of the oral cavity or ingestion or inhalation of the instrument could result. S2 S1 3 Instruments are only for use by or under the supervision of a suitably qualified person. Single Use Device Incineration and recycling is recommended. S2 S1 3 Misuse of rotary instruments is limited by the action of the operator. Presumed to be adequately controlled through the education, experience and skill of the operator. S2 S1 3 In view of the very low risk associated with the instrument becoming detached from the handpiece, the level of risk is considered acceptable. Connection to the hand piece is made or supervised by a suitably qualified person. Severity after applying control Probability after applying control Score after applying control Issue 2 03/2014 Page 5 of 6

6 Explanation of calculation of Risk Evaluation of Products: For the calculation of Risk evaluation the level of acceptable risk has been set by the Company at a score of 10. The Risk Score is calculated by multiplying the score factors from the Severity and Probability, tables listed below: - Risk of Harm Table (Severity level) Common Term Description Rating Score Significant Death or loss of function or structure S3 5 Moderate Reversible or minor injury S2 3 Negligible Will not cause injury or will injure slightly S1 1 Risk of Harm Table (Probability) Common Term Description Rating Score High Likely to happen, often, frequent S3 5 Medium Can happen, but not frequently S2 3 Low Unlikely to happen, rare, remote S1 1 Example: - A product, which is deemed to be a significant risk of harm, but is unlikely to occur would be given a score of 5 X 1 = 5, which is taken from the tables above. i.e. Significant severity resulting in death or loss of function or structure (Score 5) but its probability is low, unlikely to happen, rare, remote (Score 1) Conclusion of Risk Evaluation. From the calculation of risk shown above and with the severity of potential injury assessed after the application of the risk control mechanism the score is reduced from 10 points to 4 points, which is deemed perfectly acceptable and is well within the target acceptable risk of 10 points. Issue 2 03/2014 Page 6 of 6