HCS medical devices, reporting systems and governance (FOI)

Request

May I have the information upon the following requests:

A

Where does the Health and Community Services department (HSC) take guidance for medical devices such as and likened to class two implants that include devices such as dental implants surgical mesh and similar?

B

Within the past 10 years has there been any reported failures of any medical devices made by HSC department? 

C

Within the past 10 year period has any device been reported as being faulty or otherwise by any healthcare official within Jersey, or indeed if applicable within the Bailiwick as a whole?

D

Is there a system here within Jersey or again if applicable the Bailiwick as a whole that members of the public or healthcare officials can use to report possible medical device failures?

E

Who controls where surgical implants / devices are bought from? 

F

Are there any statistics available here at a local level in regards to surgical operational outcomes? Meaning does anyone correlate data for any surgical procedure here within Jersey or is it left to the surgeon to report?

G

What percentage of work is allowable to be private and public to any given surgeon within the island?  Who sets this standard or agreement? 

H

Is there any system in place that GP's must use when a patient states that they feel a medical device has harmed them? If so what protocols and is there a guide to them?

I

Who is responsible for reporting surgical device failures, the surgeon or patient? If so is there guidance upon that system?

J

Is there a separate medical complaints system that is similar to or equivalent to an Ombudsman where HSC are not part of the complaints process?

K

Are there any reported cases of medical devices failure at all?

L

What is the protocol for GP's dentists and surgeons locally for them to report failure of any surgical device or medications?
 
M

Who is tasked with keeping records at a local level of outcomes of medicine failures device failures here within the Bailiwick?
 
N

Is there a prescribed medicines cost sheet that is publicly available?

O

What is the average cost of a bed per day within Jersey ITU unit?

P

Is there a unit cost available for medical devices such as surgical mesh implants?

Q

Are there any known reported cases by either HSC or a surgeon or person or persons within the last 10 years of surgical device failure here in Jersey?

R 

Who is responsible for underpinning the collection of data for surgical outcomes?

S 

Are surgeons obliged to provide information of any funding from industry such as medical manufacturers of medicines and devices made to them personally?

T 

Are surgeons obliged to provide information of any monetisation gifts or otherwise that could impede or influence decision making processes?

U

How are surgeons governed here within the Bailiwick?

V

HSC states that it has its own medical rules and regulations that is different to the NHS. If this is correct is there a local office that mandates all curriculum training and specialist training that is Jersey based?

W 

If the HSC department is free of NHS guidelines, why then does it use NHS guidelines and data?

X

If the HSC department is free of the NHS then who regulates the HSC authorities? Who checks that the HSC department is in fact doing its job properly?

Y

If the HSC department is free of NHS then who underwrites controls and makes sure that HSC are free from industry bias or control?

Z

If the HSC department is free from NHS control then who monitors and regulates all medicines, medical devices and items of that similar nature?

Response

A

Predominantly the (National Institute for Health and Care Excellence) NICE guidelines are referred to for guidance for acceptable implants.  However individual specialities will have their own specific guidance for good practice.

B

HCS does not maintain a central register of device failures.  These are reported to a National register. The National register do not report on individual hospital records.

C

This information is not held. Article 3 of the Freedom of Information (Jersey) Law 2011 has been applied.

D 

Any member of the public or healthcare official can report concerns to the Medicines and Healthcare products Regulatory Authority (MHRA) via the Yellow Card programme.

Yellow Card programme

E

The procurement of devices will be negotiated via the Government of Jersey's Commercial Services team (often via NHS Supply chain).  The actual 'device' will be selected by the appropriate clinical team using the most up to date evidence or where necessary to meet the needs of individual patients.

F

Certain surgical procedures are recorded with outcomes within specific specialties.  The clinical audit department coordinate collection for subscribed National outcome databases.  It is not standard practice in Jersey or the UK for each and every type of procedure to be attributed an outcome measure.

G

Consultants employed by HCS are contracted to perform an agreed number of sessions, delivering direct patient care each week.  This is negotiated between consultants and the needs of their particular service.  Therefore, it is not possible to provide a definitive percentage split between public and private care delivery.

H

Information is not held by the Government of Jersey.  Article 3 of the Freedom of Information (Jersey) Law 2011 has been applied. However, it is likely that any concerns would be directed to the Yellow Card programme.

Yellow Card programme

If the GP feels it appropriate, they may also for completeness, write to any other professionals for which the information maybe pertinent.

I

The person that recognises the failure is responsible reporting it.

J

Whilst there is no formal on-island Ombudsman, any complaint that is received is dealt with transparently and openly. If there are concerns with patient care delivery at times an external report will be commissioned by an independent provider.

K

This information is not held. Article 3 of the Freedom of Information (Jersey) Law 2011 has been applied.

L

All professionals will be aware to alert any device failures or concerns to the MHRA via the Yellow Card programme.

Yellow Card programme

M 

This information is not held. Article 3 of the Freedom of Information (Jersey) Law 2011 has been applied. However, given the nature of medical device failure, for the information to be of use it needs to be collected in volume.  This is why it is reported centrally to the MHRA.  The action taken following a suspected or confirmed device failure would be dependent on the 'device' in question.

N

The information requested is considered commercially sensitive therefore Article 33(b) of the Freedom of Information (Jersey) Law 2011 has been applied.

O

Information is publicly available on www.gov.je in response to a previous Freedom of Information request.  Article 23 of the Freedom of Information (Jersey) Law 2011 has therefore been applied. 

Cost of hospital bed occupancy (FOI)

P

The information requested is considered commercially sensitive therefore Article 33(b) of the Freedom of Information (Jersey) Law 2011 has been applied.

Q

Please see response to (B) above.

R

This is coordinated by the Clinical Audit Department.  The clinic lead for each speciality is responsible for highlighting any specific National or minimum outcome collection requirements.

S

Yes.

T 

Yes.

U 

Surgeons are registered with the Royal Court to practice in Jersey.  They are each under the reporting line of a 'Responsible Officer' as is the requirement of the General Medical Council (GMC). The GMC are the governing body for doctors working within the Bailiwick.

V

For the purpose of this response, it has been assumed this relates to doctors. The training is provided in association with and on the instruction of the Wessex Deanery. Our junior doctors have the same training expectations as those placed within the NHS.

W

The NHS is an excellent model in principle and allows HCS to deliver care that is coordinated across specialities and services. The care delivered within the NHS is evidence based and up to date.  Jersey does not have enough scope or volume to be able to produce all of its own bespoke guidance.  It would be unsafe to mix guidance from many countries as the underlying fundamental principles may conflict.

X

HCS is scrutinised by Government. This, along with individual professional responsibility to deliver safe care and report concerns of unsafe care, is the responsibility of everyone.

Y

There are Government, HCS internal and professional standards to ensure industry bias/ control does not occur.

Financial and commercial arrangements and conflicts of interest

Z

All devices will have been subjected to rigorous industry testing before being licensed for use.  The Government of Jersey's Commercial services will only purchase equipment from reputable suppliers i.e. NHS supply chain for which only licensed devices will be available.

Articles applied

Article 3 - Meaning of "information held by a public authority"

For the purposes of this Law, information is held by a public authority if –

(a) it is held by the authority, otherwise than on behalf of another person; or

(b) it is held by another person on behalf of the authority.

Article 23 - Information accessible to applicant by other means

Information is absolutely exempt information if it is reasonably available to the applicant, otherwise than under this Law, whether or not free of charge.

A scheduled public authority that refuses an application for information on this ground must make reasonable efforts to inform the applicant where the applicant may obtain the information.

Article 33 – Commercial Interests

Information is qualified exempt information if –

(a) it constitutes a trade secret; or

(b) its disclosure would, or would be likely to, prejudice the commercial interests of a person (including the scheduled public authority holding the information).

Public Interest Test

Whilst we accept that the public may have an interest in the value of Government of Jersey contracts, we believe the exact contract values are commercially sensitive and that the release of this data could affect the negotiation of future contract values.