The Official Journal of the National Association of Medical Device Educators & Trainers

MEDIA INFORMATION

2019

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MDET 1MDET 1

The Offi cial Journal of the National Association

of Medical Device Educators & Trainers

The Journal of Medical Device Education & Training

GDPR and the NHSA mock coroner’s court

IV medication errors

Volume 2Issue 3October 2018

The Amalthea Trust

training in Uganda

Voices:AfPP

NHS

Improvement

MDET Vol2 Issue3.indd 1

10/10/2018 21:18

16 MDET MDET 17

VOICES

How we responded to the issues you reportedTo accompany our bi-annual production of official statistics on incidents reported to the National Reporting and Learning System (NRLS), and using information received from other sources, we produce a regular Review and Response Report outlining how we used this information to improve patient safety.

Our latest report was published 25 September 2018, covering the period October 2017 to March 2018. It describes our process for reviewing incident reports and gives examples of the actual action we took as a direct result, whether by issuing a Patient Safety Alert or working with partners.

Our primary reason for publishing the report is as a thank you to all the staff, patients and members of the public who have taken the time to report incidents. By showing the difference their efforts have made, we hope staff across the NHS find the report both informative and inspirational; and that it encourages them to continue to report all incidents so that together we can improve patient safety and protect our patients from harm.

In the six month covered by this report our clinical teams reviewed

What we reviewedOur review and response role starts with our clinicians reviewing information from a range of sources to identify new or emerging issues that may need national action.

This function is supported by registered nurses, with experience in patient safety relating to surgical, medical, community, paediatric, neonatal and mental healthcare, a midwife, pharmacists, a pharmacy technician and a physiotherapist; many of whom work on wider patient safety policy and projects as well as review and response.

Additionally, we use the skills and experience of expert patient safety advisors who combine working one day a week with us with clinical, educational or leadership roles as GPs, paramedics or in the care home, mental health or learning disability sectors.

9,991Incidents reported to the NRLS with an outcome of death or severe harm (including reviewing each update of these incident reports)

4,257Selected categories of Serious Incident reported to StEIS (new or under-recognised review)*

519NRLS incidents from areas of special focus (currently inclusing all GP eform repors of moderate harm, all anaesthetic eform reports)

236Potential and confirmed Never Events reported to StEIS*

39Incidents reported to the NRLS by patients or the public (we review all these even if not reporting harm)

22Regulation 28 letters (letters from coroners where they have identified a need for action to prevent further deaths)

Where any of these sources suggest there could be a new or under-recognised issue that requires national action we explore further. Although our process is often triggered by a single patient safety incident, from that point onwards we work to understand the patient safety issue. We do this by looking to identify a wider pattern in other similar incidents reported previously, including no harm ‘near miss’ incidents – and we focus on what could go wrong in future.

Of the incident reported, and the other sources we reviewed between October 2017 and March 2018, our clinical teams identified 85 issues to take forward for potential national action. We then worked with frontline staff, patients, professional bodies and partner organisations to decide if we need to issue advice and guidance to reduce risks, via a Patient Safety Alert, or if we can influence or support other organisations to act upon the issue.

What action did we take around medical device issuesThe Review and Response Report covers not only the alerts we issued but case studies on how we worked with other organisations during the set timeframe, as well as the issues discussed through the MDSO monthly WebEx and forum. You can read the full report on the NHS Improvement website but some examples relating to medical devices are below:

Patient Safety Alerts

Confirming removal or flushing of lines and cannulae after procedures

Issued: 9 November 2017

This alert asked providers of NHS-funded care that undertake surgical interventions or other procedures involving anaesthesia or intravenous sedation to amend the Sign Out section of the WHO Checklist, or equivalent in local use. It should include confirmation that before a patient leaves the procedural area cannulae and intravenous (IV) lines have been removed or flushed, and this action should be documented.

Risk of death and severe harm from failure to obtain and continue flow from oxygen cylinders

Issued: 9 January 2018

As previously reported in the MDET journal, this alert asked providers that use oxygen cylinders to determine if immediate local action is needed to reduce the risk of incidents involving staff being unable to obtain and continue flow from oxygen cylinders.

Issues where we advised or influenced others on action

Medication via nasogastric tube in unconscious cardiology patients

An incident identified through our regular review of Never Event reports described a patient who needed emergency treatment following a cardiac arrest. The patient had been intubated and urgently needed dual antiplatelet therapy (DAPT); a nasogastric (NG) tube was inserted to allow administration. After DAPT had been administered the NG tube was identified to be in the patient’s lung. The essential checks of NG tube placement had not been done.

Together with the British Cardiovascular Society we have developed guidance that reinforces our earlier advice on confirming NG tube placement and provides information on alternative intravenous or rectal antiplatelet medication for unconscious patients in whom NG tube placement cannot be safely confirmed.

Risk of harm from ophthalmic cannula detachment during surgery

MHRA contacted us about a small number of incidents of ophthalmic cannula detachment during ophthalmic surgery. The ophthalmic cannula is attached to a syringe and when pressure is applied to the plunger can produce significant hydraulic force. Should the cannula detach, it will do so with an intensity that can cause injury and visual impairment.

An NRLS search for a two-year period identified 23 incident reports of cannula detachment during an ophthalmic procedure. Reviews by MHRA concluded cannulae were detaching because of how they were being used rather than a design issue with the equipment concerned. MHRA issued a short safety message via the MDSO network advocating that only Luer lock syringes should be used in ophthalmic surgery and only after their secure connection has been checked. We asked the Royal College of Ophthalmologists to disseminate the information from MHRA and the NRLS through its networks.

Entrapment due to bed/bedrail/mattress incompatibility; assessing ‘hybrid’ mattresses

Our regular clinical review of Serious Incidents reported to StEIS identified an incident of entrapment involving a patient in the community and a ‘hybrid’ mattress (in a healthcare context, this is a mattress that can be switched between foam and alternating pressure modes). The mattress appeared to compress to such an extent that the patient was able to thread their legs between the mattress and the lower rail of the bedrail. This incident suggested that the need to assess hybrid mattresses twice – in both their standard mode and alternating pressure mode – might be under-recognised.

We shared this information with the MDSO’s network, MHRA, to inform any future updates of its guidance, and the National Association for Safety and Health in Care Services, which has agreed to share key learning messages with relevant forums such as the National Association of Equipment Providers.

Risk of bowel perforation when self-administering rectal irrigation

We identified an incident where a patient sustained a perforated bowel while self-administering trans-anal irrigation. Such specialist systems are used to manage chronic bowel dysfunction and patients, carers and staff need specialist training in their use.

We were concerned that the risks of harm are not always fully appreciated. We asked MHRA, who had previously published a medical devices alert on a trans-anal irrigation system, to review company training guidance manuals and instructions for use, to ensure risks were adequately described.

We also brought our concerns, and MHRA’s alert, to the attention of NICE; who plan to update its medical technologies guidance (MTG) development processes to ensure any relevant alerts are included.

Stephen Lee, MHRA Senior Regulatory Policy Manager

VOICES

The new medical device regulations (MDR) and in vitro diagnostic medical device regulations (IVDR) continue the exemption for devices that are made or modified and used within a health institution. To benefit from this exemption, health institutions will need to put in place a number of specific requirements.

Compliance is required by 26 May 2020 for medical devices and 26 May 2022 for in vitro diagnostic medical devices. During this transitional period, it is expected that organisations work towards compliance.

The NHS Confederation has produced a briefing paper, and the MHRA has also produced a simple one page outline for NHS organisations to refer to when considering how to prepare for the changes ahead.

Are you a health institution?

The new regulations define a health institution as “an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health”; NHS Trusts and Health Boards fall within that definition. Some specific collaborations may also be included.

What devices are made or modified and used in your health institution?Making or modifying a device may include:

• putting together a device from raw materials or component parts where this is not explicit in the manufacturer’s instructions

• fully refurbishing a device

• developing new software or new diagnostic devices

• assigning a new medical purpose, performance or function to an existing device

• using a device without a CE mark for a medical purpose

Devices that are manufactured on an industrial scale are not eligible for the exemption.

What will you need to do?

You will need to have in place:

• An appropriate quality management system

• A justification for applying the exemption that is based on target patients’ clinical needs that cannot be met by equivalent devices available on the market

• A public declaration of conformity

• Full technical documentation to allow understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose

• A system of reviewing clinical experience in the use of the device and taking necessary corrective actions

You will need to fulfil all the relevant general safety and performance requirements set out in Annex I of the regulations. This includes requirements for devices to be designed and manufactured to achieve their intended purpose, to be safe and effective and to not compromise the safety or clinical condition of patients, users or other persons. Risks should be acceptable when weighed against the benefits for the patient.

Next steps – scoping

Senior managers in health institutions should plan for implementation of the health institution exemption. This might begin with a scoping exercise to find out how many devices may fall within the exemption. This may include ‘home brew’ devices, modified devices, non-medical products, research or investigational use products, off-label use of devices, and custom-made devices. Some research and development projects (including clinical trials) might also need to consider the requirements of the exemption.

Next steps – implementation

It is likely that you will need to upgrade your existing quality management systems to meet the new requirements.

You should set up an implementation roadmap that clearly identifies actions and responsibilities for implementation of the changes brought by the new regulations, including gathering clinical evidence to support the use of the device now and for the lifetime of all affected products.

You should link with the medical device management committee (or equivalent) to establish defined responsibilities for action.

Senior managers should be responsible for reviewing implementation to identify any new or ongoing areas of risk.

Next steps – MHRA consultation

Prior to the final date of application of the new IVDR and MDR, the MHRA is consulting on a guidance document to advise health institutions who make or modify and use their own devices.

This can be accessed at: www.gov.uk/government/consultations/health-institution-exemption-for-ivdrmdr

The consultation poses several specific questions and also seeks general responses and feedback. Alongside the consultation, the MHRA is setting up a network of UK demonstrator sites to help inform the final guidance. Demonstrator sites are being asked to share the outputs from their scoping surveys and gap analysis to help other health institutions benefit from their experience.

Next steps – gap analysis

Once you have an indication of the numbers of products and their spread across different departments, you can start to consider the impact of the new regulations and the adequacy of your existing systems and processes. You will also need to decide what resources you will need to continue providing essential clinical services.

Medical device regulations and the health institution exemption: what you need to know

The Journ

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MDET is the official journal of NAMDET and has become one of the UK’s leading Medical Device publications. The journal focuses on views, learnings and best practice within medical device education and training, whilst sharing the work of NAMDET and how the organisation helps NHS Trusts and their staff. The journal is produced and published by Specialist Publishers Ltd. and profit from the journal helps to fund NAMDET’s work.

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