Project 2

Introduction

An adequate Risk management system for manufacturing medical devices - orthopaedic and dentistry implants is critical due to sensitive nature of these devices. The main goal of this research is to apply a risk management system based on International Organization for Standardization (ISO) 14971 to Medbone Medical Devices, an orthopaedic medical devices manufacturer. The Whole Life Cycle Risk Management model is the framework for risk analysis and management that was used to guarantee that acquired knowledge and expertise are always present in the process. The risks were classified with a top-down approach as global risks and elemental risks. The elemental risks arising from the production and usage of the product, according to ISO 14971 were identified. A Risk Matrix shows the characteristics of the risks their allocation Probability of Occurrence, Impact and Risk Severity of Harm.
The analysis showed that risks with a High level of Severity of Harm were the following

• From the responsibility of the Government
• Inflation, Will of Government and Licences and authorisation from Regulatory Agencies; from the
  responsibility of the Manufacturer
• Price variations, payment and from the doctor not Single Usage of the product and from the patient subdue the product to mechanical loads.

Afterwards, risk control measures were considered and applied to the company, As a result of the appropriate control measures some risks can be mitigated or even extinguished, including risks related to the handling/usage of the product by the patient, helping the product to achieve its main goal: to heal the patient and give them a better quality of life. Medical companies usually have a generic risk plan, but that sometimes overlooks important risks over the entire industry value chain. In addition, feedback from doctors is critical regarding the conception and production of new products.

The increased number of bone fractures as a result of accidents and degenerative bone diseases, is a stimulating factor for studying the risk factors in the life cycle of materials, for orthopaedic applications and dentistry usage henceforth referred as ‘medical devices’. These products are absorbed by the organism and offer advantages over the natural bone such as lower price, lower risk of disease transmission and preservation for five years without requiring refrigeration. ISO 14971 Medical devices – Application of risk management to medical devices states that “the manufacturer shall establish, document, and maintain throughout the lifecycle an on-going process for identifying hazards associated with a medical device, estimating and evaluating associated risks, controlling these risks and monitoring the effectiveness of controls and shall include: risk analysis, risk evaluation, risk control and production and post production information”.

Methods

Risk Analysis articulates three steps: risk identification, assessment and estimation

• Risk Identification, is the systematic process for detecting and validating all risks and/or sources of risk. It produces a comprehensive list of risks classified in Global – Those that affect the market and Elemental those that are specific of the project/company.
• Risk Estimation that calculates the probabilities of occurrence of each event and their impact.
• Risk Management establishes an appropriate framework with a specific set of goals and objectives. It recognizes selects and implements appropriate actions to control risks.

The outcome after these phases are Risk Matrixes of Global and Elemental Risks, that include their Allocation,
Probability and Impact listed as Severity of Harm, and the appropriate Control measures. The risk mitigation/control measures include the analysis of control options, their implementation, the identification of the residual risk and the check of the completeness of risk control measures.

Whole Life Cycle Risk Management of Medbone® Medical Devices – Case Study

Medbone Medical Devices Ltd started in 2008 in Portugal and its mission is to produce innovative and high quality implants by providing the medical professionals with tools to improve the living conditions of their patients. They use innovative technology and the implants made of absorbable biomaterials are used both in the national and international market, for orthopaedic and dentistry implant surgeries. They have unique properties that make them similar to natural bone, which allows a better quality of life. Medbone markets two products designed for the filling of bone voids or defects: adbone TCP and adbone BCP in the form of granules, cylinders and wedges. adbone®TCP is a porous synthetic ceramic that contains 99.9% tricalcium phosphate (TCP). Due to its macroporosity, the product has an excellent osteointegration as well as a total vascularisation of the implant due to the interconnected porosity. It is a highly bioactive product and during the healing process, new bone replaces the implant. adbone®BCP is also a porous synthetic ceramic that contains calcium phosphate. It consists of a mixture of TCP and hydroxyapatite (Hap). Since TCP is more soluble than Hap, this biphasic composition enhances the ceramic resorption, which allows an optimal resorption rate compatible with the physiology of the bone cells.

Products Life Cycle

The major phases in the life cycle of Medbone’s medical devices are:

• Conception and development – it establishes the scientific principles upon which a device is based. The
  concept and the adequacy of design, construction and testing require the scrutiny of scientific experts to
  ensure that design parameters and performance characteristics do not impose unwarranted risks as the more complex the device is, the higher the risk of user error;
• Manufacture – The production and packaging of adbone®BCP and adbone®TCP is done in a clean room
  class 6, divided into three rooms: production room, packaging room, and clothing room;
• Packaging and labelling – This process consists in placing the product in individual bags. In the case of
  granules, these are first weighed. Previously labelled, the blisters are tagged with markers for the presence of gamma rays. These markers are yellow and only after being submitted to gamma rays will change colour, to red. This identification is used to monitor the correct sterilization of the product. The blisters are boxed together with the labels of the patient's record and the product’s Informations for Use (IFU). The box is sealed with the aid of a larger label and placed a marker for the presence of gamma rays to facilitate the quality control of the sterilization process;
• Sterilization - The final package goes to the warehouse of not sterile products and from there head to the sterilization process accomplished in a UK based company. After sterilization, the package is inspected for correct sterilization and damages. Medbone® sterilizes its products in its double wrapping by gamma radiation at the minimum dose of 25 kGy;
• Distribution, Advertising and Sale - The qualified distributers buy the products from Medbone® in order to sell them to orthopaedic doctors, dentists or veterinaries;
• Usage - users of medical devices can have a deep effect on their safety and effective performance.
  Unfamiliarity with a certain technology or operating procedure, and the use of products for clinical
  indications outside the scope of those specified in the labelling, can cause device failure even in the absence of any inherent design or manufacturing defects. The re-use of disposable devices contrary to the manufacturer’s instructions, and without proper control or precautions for minimizing associated risks, can be dangerous. The lack of or inappropriate calibration and maintenance of medical devices can seriously prejudice their safety and performance;
• Disposal – disposal of certain types of devices should follow explicit and rigorous safety rules

Results

The results are attached in Table 1: Severity of harm for risk matrix.

Table 2: Global risks table

Global Risk	Main Characteristics	Specific Risk/Hazard	Allocation	Proba bility	Imp act	Risk Severity of Harm	Control Measure	Term
Economical and Financial	Inflation		Government	6	4	HIGH	Information	When needed
	Interest rate			4	4	MEDIUM	Information	When needed
	Foreign currency			3	2	LOW	Information	When needed
Human	Culture		Shared	3	4	MEDIUM	Indicator to monitor customers	Annual
	Ethics			3	3	LOW	Code of ethics of the company	Annual
	Values/Beliefs			3	3	LOW	Information about new customers	Annual
	Risk profiles			3	3	LOW	Information about new customers	Annual
Operation and Maintenance	Operation and Maintenance Costs		Manufacturer	6	3	HIGH	Stops in the production line,	Annual
	Obsolescence of technology and service performance			4	3	MEDIUM	Response time and information about	Annual
	Latent defects			2	4	LOW	Complaints by customers	Annual
Political and Regulatory	Will of government		Government	5	4	HIGH	Information	Annual
	Regulatory agencies	Licenses and authorizations		6	5	HIGH	Information and formation	Annual/Semi -annual
	Labour regulations			4	4	MEDIUM	Information	Annual
Commercial	Demand risk			4	4	MEDIUM	Sales and divulgation	When needed
	Price variations	Price variations in the market	Manufacturer	5	5	HIGH	Sales decrease	Annual
		Price variations for each client	Manufacturer	4	5	HIGH	Sales decrease	Annual
	Payment risk		Manufacturer	5	5	HIGH	Indicator of payment deadlines	Annual
Force Majeure	Wars	Power failure		2	5	MEDIUM	Emergency plan, security officer	Annual
	Natural Disasters	Floods		2	5	MEDIUM	Emergency plan, security officer	Annual

Table 3: - Elemental Risks Matrix

Eleme ntal Risks	Main Characte ristics	Specific Risk/ Hazard	Allocation	Probabil ity	Impact	Severity of Harm	ControlMeasure	Term
Product ion	Design	IFU translation	Manufacturer	2	3	LOW	Retranslation	When needed
		Labels with wrong information	Manufacturer	3	3	LOW	Complaints by customers or internal non conformity	Annual
	Production	Quality of raw material	Supplier	3	4	MEDIUM	Tests by the company	Annual
		Inadequate sterilization	Supplier	2	5	MEDIUM	Certificate by the sterilization company	Annual
		Vials unsealed	Manufacturer	3	3	LOW	Complaints by customers or internal non conformity	Annual
		Blister unsealed	Manufacturer	3	3	LOW	Complaints by customers or internal non conformity	Annual
		Raw material transportation	Transporter	3	3	LOW	Check list	When needed
Usage		End of product’s expiration date	Doctor	3	5	MEDIUM	Not to sell products with less than two years of	Annual
		Products’ transportation	Transporter	3	3	LOW	Checklist	When needed
		Incorrect application	Doctor	3	5	MEDIUM	Pre-training by the manufacturer	When needed
		Infection	Doctor	2	5	MEDIUM	Good sterilization	Annual
		Choice of product	Doctor	3	3	LOW	Information to the doctors	When needed
		Not single use	Doctor	4	5	HIGH	Information to the doctors	When needed
		Subdue the product to mechanical	Patient	4	5	HIGH	Information to the doctors	When needed
		Implant into infectious site	Doctor	2	4	LOW	Information to the doctors	When needed
		Lack of hygiene	Patient	3	4	MEDIUM	Information to the doctors and patients	When needed
Post Market		Problems with other similar products	Manufacturer	4	4	MEDIUM	Information	When needed
		Side Effects	Manufacturer	3	5	MEDIUM	Quality +Information	When needed

References

https://www.researchgate.net/figure/Elemental-Risks-Matrix-MedboneR-Medical-Devices_tbl2_282326283

https://www.researchgate.net/publication/282326283_Risk_Management_of_Orthopaedic_and_Dentistry_Medical_Devices

Braddon (2008), L.; Risk Assessment for Medical Devices, Secure BioMed Evaluations.