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Biomedical Engineering > Medical Device Regulations and Regulators > Flashcards

Medical Device Regulations and Regulators Flashcards

1
Q

What are medical maggots used for, and what is the confused with how they are defined?

A

Medical maggots are used for cleaning wounds. The USA defines them as medical devices, however in Europe they are categorised as a medicine.

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2
Q

Why is there the differences in the way that medical maggots are defined?

A

The reason the USA state medical maggots as a medical device is because they argue that the maggots use their teeth to clean the wound, therefore it has a mechanical function. In Europe, they argue that the maggots release a chemical, and its the chemical reaction that cleans the wound, therefore it would be a medicine.

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3
Q

What is the definition of a medical device, as stated by the TGA?

A

The TGA states that a medical device is:
‘An instrument, apparatus, appliance, material or other article intended to be used on human beings for:
-Diagnosis, prevention, monitoring, treatment or alleviation of disease, injury or disability
-Investigation, replacement or modification of the anatomy or a physiological process
-Control of conception

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4
Q

What does IVD in diagnostics stand for?

A

In Vitro Diagnostics

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5
Q

Give an example of an IVD.

A

A glucose monitor.

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6
Q

What are the four categories for classifying medical devices, and give examples in each category?

A
  • Class I: lowest risk; gloves, wheel chair, spectacles etc
  • Class IIa: contact lenses, catheters
  • Class IIb: condoms, blood bags
  • Class III: highest risk; heart valves.
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7
Q

How does the level of regulatory control compare to the product risk class?

A

If the product risk class is high, then the level of regulatory control will be high. Vice versa.

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8
Q

How are medical implants classified?

A

They are a subset of medical devices.

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9
Q

Give some examples of medical implants?

A

Spinal implants, knee joints, bone screws, shoulder joints, heart valve, stents

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10
Q

What is the difference between a medical device and a medical implant?

A

An implant goes inside the human body.

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11
Q

Following a number of implant scandals involving metal-on-metal hips, breast implants, and mesh implants, what did the House of Commons do?

A

The House of Commons select committee held an evidence session on Regulation of Medical Implants in the EU and UK, and produced a report on this in Nov 2012.

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12
Q

What was the response from the government to the report written by the House of Commons?

A

The government responded by saying that despite there being issues with the existing system, it has still done some great things and there is no need for any change.

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13
Q

What issue did Jeremy Hunt raise with the European regulator?

A

In October 2012, Jeremy Hunt spoke out about a regulator in the EU that said it was on the side of the manufacturer, despite being a notified body.

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14
Q

Why was it concerning that the notified body sided with the manufacturer?

A

Because the notified body was suppose to remain independent when licencing, however they were trying to make a profit by helping the manufacturer.

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15
Q

What changes have happened recently with the EU legislation?

A

It has increased in volume substantially. It took a 7 year journey as all EU countries had to agree to it.

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16
Q

What is the new EU Legislation called?

A

EU MDR 2017/745

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17
Q

How long is the transition period for the new EU Legislation?

A

3 years, so it should come into affect in may 2020

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18
Q

What was the previous EU legislation called?

A

Medical Devices Directive (93/42/EEC) it was made in 1993

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19
Q

What is the scepticism with the new EU regulations?

A
  • Lack of transparency
  • The notified bodies are still commercial interests
  • No clinical investigations required if implant is substantially equivalent
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20
Q

What is the issue with the lack of transparency with the new EU regulations?

A

Members of the public cannot see the documents made by the notified bodies to decide if a company can go ahead. This is however the law because the information can be commercially sensitive, and they wouldn’t want any competitors gaining any knowledge.

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21
Q

What is substantial equivalence?

A

It is when one product is substantially equivalent to another product, so no clinical investigations are required.

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22
Q

What must be included in the post-market surveillance as stated by the new MDR?

A

It must include:

  • Information on serious incidents
  • Relevant literature on registries
  • Complaints must be recognised and dealt with
  • Information about similar medical devices
  • They must be proactive and systematic
  • Effective and appropriate methods and processes to access the collected data
  • Suitable indicators and threshold values that shall be used in the continuous reassessment of the benefit-risk analysis and of the Risk Assessment.
  • Effective tools to trace and identify devices for which corrective actions might be necessary
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23
Q

What is post-market surveillance?

A

Post Market Surveillance is the systematic
-collection
-analysis
-interpretation
-review
of product related data to ensure distributed products meet specified performance and safety requirements .

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24
Q

What are the purchasing controls on post market surveillance?

A
  • defined component and service specifications
  • defined quality requirements for suppliers
  • suppliers are qualified and monitored
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25
Q

What is another requirement stated about the people involved with customer data?

A

All personnel that may be involved in collection of customer data (complaints, adverse events etc) must be trained to ensure events are captured in the appropriate system.

26
Q

Sometimes registries exist to help with what?

A

They can sometimes help with post market surveillance.

27
Q

What is the registry for hips and knees?

A

National Joints Registry for England, Wales, N. Ireland and the Isle of Man

28
Q

What is the guidelines from NICE on revision rates? and what was the revision rate for the artificial hip joint (ceramic on polyethylene )?

A

NICE has guidelines of <5% revision rate at 10 years. If revised, it is a failure. One type of artificial hip joint has a 2.4% revision rate at 10 years.

29
Q

How can it seem unfair if a product is revised (removed) and therefore classified as a failure?

A

It can seem quite tough as even if it is removed due to an infection, and has nothing to do with the implant, it still counts as a failure.

30
Q

What tools are used in post-market surveillance?

A
  • Risk Management Plans
  • Adverse Event Reporting
  • Environmental Scanning
31
Q

What is Environment Scanning?

A

This is a tool used in post market surveillance. It is seeking confidential advice from other regulators and review of medical literature, regulatory news media and other sources.

32
Q

The FDA has an open-access data base, what is it called?

A

The FDA has an open-source data base called MAUDE

33
Q

What does MAUDE stand for, and what does it do?

A

Manufacturer and User Facility Device Experience, it is an open-source data base made by the FDA.

34
Q

Who reports 81% of adverse events?

A

Industry

35
Q

Who reports 10% of adverse events?

A

Health professionals

36
Q

Who reports 4% of adverse events?

A

Hospital supply and administrators

37
Q

Who reports 2% of adverse events?

A

Engineers and Technicians

38
Q

Who reports 1% of adverse events?

A

Consumers

39
Q

Why do industry report the most adverse events?

A

This may be because industry have mandatory reporting requirements

40
Q

What is the yellow card system, and where is it in place?

A

The UK has a ‘yellow card’ system. This is an ‘early warning system’ for identification of previously unrecognised issues. It helps to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them.

41
Q

Why is the number of consumers that report adverse events so low?

A

This may be because the ‘yellow card’ system isn’t very well known.

42
Q

What is the definition of an adverse event?

A

For both medicines and medical devices: an event that resulted in, or could have resulted in serious injury, illness or death.

43
Q

What is the definition of adverse event of a medical device?

A

It can be associated with the use (or misuse) of a medical device. This may include difficulties or malfunctions such as problems with getting the device to operate, the need for repeated repairs, difficulty of use or difficulty cleaning after use.

44
Q

Give an example of difficulties with cleaning after use of a medical device.

A

A Power Morcellator. Used in the uterus of cancer patients, inserted via a 2cm incision, it has tiny spinning blades that grind up the cancerous tissue and it is vacuumed away. It has however been found that the teeth/blades in the barrel were very hard to clean, and so the use of the power morcellator was found to be spreading cancer.

45
Q

What is MHRA?

A

This is the UK regulator, it stands for Medicines and Healthcare products Regulatory Agency.

46
Q

What does the MHRA do?

A

They cover many different areas, regulating medicines, medical devices and blood components for transfusions in the UK.

47
Q

How is the MHRA funded?

A

The MHRA is funded by the Department of Health and Social Care for the regulation of medical devices, whilst the costs of medicine regulation is met through fees from the pharmaceutical industry.

48
Q

What have many MP’s been concerned about with the MHRA?

A

Some MP’s have suggested that the MHRA is too reliant on industry, and isn’t independent enough.

49
Q

What is NICE and what does it stand for?

A

National Institute for health and Care Excellence. They look at clinically and cost effective technologies.

50
Q

Who is this talking about ‘Their medical technologies and diagnostic guidance helps to ensure that the NHS is able to adopt clinically and cost effective technologies rapidly and consistently. ‘

A

NICE

51
Q

What do NICE do in order to ensure the NHS can adopt clinically and cost effective technologies?

A
  • producing evidence-based guidance and advice for health, public health and social care practitioners
  • developing quality standards and performance metrics for those providing and commissioning health, public health and social care services.
  • providing a range of information services for commissioners, practitioners, and managers across health and social care.
52
Q

What are HTA’s?

A

Health and Technology Assessments. HTA research is undertaken where some evidence already exists to show that a technology can be effective and this needs to be compare to the current standard intervention to see what works best.

53
Q

What does FDA stand for?

A

Food and Drink Administration

54
Q

What is the CDRH?

A

It is part of the FDA, taking care of medical devices.

55
Q

What does CDRH stand for?

A

Centre for Devices and Radiological Health

56
Q

What are the different routes the FDA have to market?

A
  • 510k- substantial equivalence
  • PMA: Pre-market approval
  • HDE: Humanitarian Device Exemption
57
Q

What is HDE?

A

Humanitarian Device Exemption. This is one of the routes in the FDA to market. This may be used if the device is only going into a few hundred people, to avoid having to go through all the big regulations. You have to accept more risk, but chances are it will go to market more quickly.

58
Q

How does the FDA compare to the EU regulators?

A

The FDA is known for being stricter than EU regulators. A few years ago the FDA released a document called ‘Unsafe and Ineffective Devices Approved by the EU that were not Approved in the US’. This may have been as a result of complaints from manufacturers in the US about the stricter regulations.

59
Q

What is the TGA and what does it stand for?

A

It is an Australian Regulator, and it stands for Therapeutic Goods Administration.

60
Q

What does the TGA do?

A

It provides a national system of controls relating to the quality, safety, efficacy and timely availability of therapeutic goods used in, or exported from Australia.

61
Q

What does the TGA rely on?

A

They have some reliance on overseas regulations FDA, EU approvals.

62
Q

What is classed as therapeutic goods as stated by the TGA?

A

Therapeutic goods according to the TGA include: medicines, blood products, medical devices, and biologicals (human stem cells, tissue or cells based on products).

Biomedical Engineering (13 decks)

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