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Risk Control Options for Medical Devices: Deviation #6

This blog discusses risk control options for medical devices; the 6th deviation identified in the European National version of the Risk Management Standard.%name Risk Control Options for Medical Devices: Deviation #6

Design is not the same as design and construction. This is the interpretation of the European Commission. The sixth of the seven deviations identified in the European National (EN) version of the Risk Management Standard (i.e., EN ISO 14971:2012; http://bit.ly/ISO14971-2012changes), states that “inherent safety by design” is not precise enough. Section 2 of the Essential Requirements (i.e., Annex I of the MDD) states that the first risk control option must be selection of design and construction that eliminates or reduces risk as far as possible, while the international (ISO) risk management standard (i.e., ISO 14971:2007) only states that inherent safety by design is required.

The difference between the requirements of the ISO and the EN standard are not just semantics. If you read part II of the Essential Requirements (ERs; i.e., ER 7-13), there are many examples of how the construction of devices should be considered. The following are three examples:

  • ER 7.5 – leaking from the device
  • ER 8.2 – tissues of animal origin
  • ER 9.2 -aging of materials

Therefore, in order to comply the the intent of the Directive, you must consider far more than just the design of the device.  Construction is interpreted as both the risks associated with the materials to fabricate a device and the methods of manufacture. In the proposed EU regulations, the European Commission seeks to clarify the requirements for implementation of risk controls, but the draft legislation still seems vague.

Implementing Risk Control Options for Medical Devices

The following wording for implementation of risk control options in the new proposed second Essential Requirement is below:

“The manufacturer shall apply the following principles in the priority order listed:

a. identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;

b. eliminate risks as far as possible through inherently safe design and manufacture

c. reduce as far as possible the remaining risks by taking adequate protection measures, including alarms; and

d. provide training to users and/or inform users of any residual risks.”

In this proposed wording, the word “construction” was replaced by the word “manufacture.” However, in other parts of the new proposed Essential Requirements (http://bit.ly/NewERCGap) the materials of fabrication are specifically addressed, as well. For example:

  • ER 7.1d) was added as a new requirement…”d) the choice of materials used, reflecting, where appropriate, matters such as hardness, wear and fatigue strength.”
  • ER 7.6 was added as a new requirement to address risks associated with the size and properties of particles—especially nanomaterials.

The new proposed Essential Requirements also include numerous examples of how the manufacturing processes must ensure proper safety. Essential Requirement 10 specifically references new Commission Regulation (EU) No 722/2012 (http://bit.ly/AnimalTissueReg)–specific to devices manufactured using animal tissues or cells of animal origin.

Even though the proposed regulations are more detailed with regard to application of risk management, they do not specify if it is required to implement risk control options for both materials and methods of manufacture simultaneously, or if the manufacturer may choose between the two. The phrase “taking account of the generally acknowledged state of the art” is used in the second Essential Requirement, but “state of the art” is a moving target, and the European Commission may find existing Standards to be deficient.

For reducing the risk of infection, the Commission does not require that companies implement aseptic processing, antimicrobial materials and terminal sterilization. One of the three is sufficient. This is why we have ISO Standards for sterilization validation, and we define “sterile” as a sterility assurance level of 10-6.

If the Commission maintained the language of the ISO 14971:2007 Standard, “as low as reasonably practicable,” then manufacturers could select risk control options based upon acceptability of risk. However, the EN version of the risk management standard creates significant challenges for implementation, and we are forced to evaluate the risk control measures we implement against those used by other manufacturers during the process of risk option analysis.

If you are interested in ISO 14971 training, we are conducting a risk management training webinar on October 19, 2018.

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Contract Manufacturers Need Strong Risk Management Processes

This blog discusses why contract manufacturers need to have strong risk management process and your company needs to help your contract manufacturers.

Risk management is not our responsibility Contract Manufacturers Need Strong Risk Management Processes

Can contract manufacturers exclude risk management from the scope of their quality system?

Most contract manufacturers in the medical device industry exclude design from their Quality Management Systems. Unfortunately, most of the contract manufacturers also associate risk management with only the design process. Risk Management cannot be “not applicable” in an ISO 13485 Quality Management System. The requirement of section 7.1 is: “The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained.” The Standard also references ISO 14971 as a source of guidance on Risk Management.

Have you experienced an audit dialogue at a contract manufacturer similar to this?

The auditor asks, “How do you manage risk throughout the production process?” Then the auditee responds, “That is the responsibility of our customers. We will prepare a risk analysis if customers pay for it, but usually customers do the risk analysis.”

For a contract manufacturer, compliance with ISO 14971 is not my primary concern as an auditor. My primary concern is to verify that contract manufacturers analyze risks associated with the processes that they perform, and do their best to minimize those risks. What I don’t understand is why more companies don’t want to have strong risk management processes. Risk management is how we prevent bad things from happening. Bad things like scrap, complaints and recalls. Should we expect our suppliers to have a strong risk management process?

Duh.

Why your company needs to be involved in the risk management process?

Contract manufacturers should be doing everything they can to get better at risk management. During pre-production planning they should be asking, “What happens if…” The contract manufacturer knows best HOW things will fail in production, while the customer knows best WHAT happens when things fail in production. In order to be safe and effective, both companies need to collaborate on risk analysis.

In any risk analysis, you need to estimate the severity of potential harm and the probability of occurrence of that harm. For production defects, the contract manufacturer can estimate the probability of occurrence of defects (i.e., P1 in Annex E of ISO 14971:2007), but the probability of occurrence of harm is less. The probability of occurrence of harm is the product of multiplying P1 and P2. The probability that occurrence will result in harm is P2, and P2 is a number that is less than 100% or 1. Your company can gather pre-market clinical data and post-market clinical data to estimate P2, but prior to launching your product you can only guess at the value of P2. Your contract manufacturer, however, is not able to estimate P2 at all. It’s ok estimate risk without P2 during the design phase, because this will overestimate risks and result in more conservative decisions.

In addition to P2, your contract manufacturer is also not capable of estimating the severity of potential harm. As the designer of the medical device, you will know best how your device is used and what the likely clinical outcomes are when a device malfunctions. There may even be multiple possible clinical outcomes. The contract manufacturer knows what can go wrong during manufacturing, but you will need to define the clinical outcomes due to malfunctions.  

Why do contract manufacturers avoid doing risk analysis?

The reason contract manufacturers avoid doing risk analysis is because it’s time consuming and tedious.

Too bad, so sad.

Balancing my checkbook is time consuming and tedious too, but I balance my checkbook to prevent an overdraft charge. Not doing risk analysis can be much more painful. Scrapping out a part can cost tens or hundreds of dollars. Complaints can cost thousands of dollars. Recalls can cost millions of dollars.

If I owned a contract manufacturing company, I would ensure that everyone in the company is involved in risk management. We don’t want scrap, we can’t afford mistakes that lead to complaints and a recall could put us out of business.

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