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04 Jun 2019

CLH Blog - MHRA Field Safety Updates For May 2019

CLH Blog - MHRA Field Safety Updates For May 2019

As always, we have researched the various field safety alerts that have been filed over the past month and have put together a roundup of the most relevant MHRA updates and recalls. These focus on recalls and updates on products and equipment that are relevant to UK care homes and other care facilities.

Please note that the updates mentioned below are all things listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers. Please also note that if you receive a field safety notice from a supplier, it is vital that you act on it immediately.

 

Last month, THIIS reported "Etac calls on dealers to inform their customers of potential risk relating to 2-point sling bar and take action".  They said as follows: 

Etac, the manufacturer of the Molift Mover 180/205 mobile hoist and Molift Air ceiling hoist, has issued a Field Safety Corrective Action (FSCA) for the two-point Sling Bars delivered as an option with the devices.

An FSCA is an action taken by a manufacturer to reduce a risk of injury, death or serious deterioration in the state of health associated with the use of a medical device that is already on the market.

Relating to all Molift two-point Sling Bars of all sizes manufactured from May 2013 to October 1st 2018, Etac says it has received several reports claiming that parts of the composite hook of the two-point Sling Bar have unintentionally broken off.

Despite no reports of patient injuries as a result from the incidents, with the device meeting its performance specifications and performing as intended, the investigation by the moving and handling equipment manufacturer revealed the device was not being used appropriately when the incidents occurred.

Although the risk is related to unintended use, Etac says it considers the risk unacceptable and, as a result, amended the user manual instructions to clarify the correct use of these ranges of hoists.

Additionally, the company has upgraded the Sling Bar design, with all new two-point Sling Bars now equipped with metal alloy hooks, replacing the previously used composite hooks and reducing the risk of product failure.

Supplied in the UK by R82 UK, the affected Molift units are not supplied with serial numbers, therefore, Etac is using its sales records to inform its dealers of the field safety notice and, in turn, is calling on dealers to contact their customers from their own sales records to find out which replacement bars are needed.

Dealers are then asked to contact and order the necessary replacement bar by emailing the invoice number, UK reference, item number and quantity required to enquiries@etac.uk.r82.com. After receiving the replacement parts, dealers are required to ship out the bars to affected customers.

The replacement of the two-point Sling Bars is intended to be carried out by dealers’ customers at their own premises, with Etac noting that the individual performing the replacement will need general product knowledge and an understanding of the replacement instruction described in the user manual.

 

Care Home Management also reported last month that "The CQC has made five recommendations to improve medicines practice in care homes."  They said as follows:

In a new report sharing the learning from risks and good practice in medicines arising from inspections, the regulator for England advises the following:

  • Follow best practice guidance, specifically NICE guidance for managing medicines in care homes (SC1) and in the community (NG67).
  • Have an attached or named pharmacist to support staff with aspects such as administering medicines covertly, ‘when required’ (PRN) medicines, and those required as part of end of life care. Train staff and assess their competency in handling and administering medicines. It should be clear who is responsible for training staff about medicines and that this training is kept up to date.
  • There should be clear clinical responsibility for, and oversight of medicines.
  • Nursing associates should be deployed safely and effectively, with the appropriate competencies and supervision when their work involves medicines.
  • Adopt NHS England initiatives such as Enhanced Health in Care Homes and Medicines Optimisation in Care Homes.

In the report the CQC highlights that as well as errors with administration and ‘when required’ medicines, incidents included intentional overdose by individuals, and errors linked to supplies from the pharmacy or doctor.

Incorrect doses are the most commonly-reported error in statutory notifications from adult social care services. This sometimes happened when members of staff did not check the medicines administration record (MAR) chart before administering the medicine, original doses not signed as being administered on the MAR chart, and missed doses, caused by changes in the timing of medicines rounds, incomplete MAR charts, staff forgetting to administer or order medicines in a timely way.

Staffing levels were also found to affect the timing of medicine administration, and distractions for administration errors. Transdermal patches are a particular area of concern, as patches can be doubled-up, missed off or changed at incorrect intervals.

Other issues include:

  • Record keeping: Handwritten MAR charts are particularly prone to errors or omissions. PRN medication (see below) record-keeping is particularly problematic.
  • ‘When required’ (PRN) medicines – such as pain relief, or asthma reliever inhalers. Staff in adult social care services did not always have enough information to administer correctly. ensure they were able to support people with PRN medicines. Records did not always show what actions were taken before using PRN medicines, which should not be used as a first line option.
  • Storage and disposal of medicines: Problems include unattended trolleys unattended and medicines being stored in accessible or unsuitable (temperature) locations.
  • Covert administration and mental capacity: Mental capacity and best interest assessments were not always carried out.
  • Staff training: lack of competency assessments or regular competency checks.
  • Policy, procedures and audit: Out of date policies and ineffective systems to monitor quality and drive improvement.
  • Self-administration of medicines: A considerable number of statutory notifications relate to intentional overdose (especially young adults with a mental health condition).
  • Transfer of care: Problems include: Missing or unexpected medicines following discharge, misinterpreted instructions, and missed actions.

 

Joerns Healthcare reported on an update to their Oxford Pro Series In-line Class III Weigh Scale

The Oxford Pro Series In‐line Weigh Scale, available on the Oxford Presence, Stature and Calibre patient lifts has been updated.

There are some inherent benefits as a result of this change which include:

  • More compact size reduces the risk of the scale interfering with the patient during transfer
  • Upgraded maximum load reading of 400kg (Previously 350kg)
  • Larger LCD screen for improved readability
  • Continued conformance to latest global regulations and standards

Fundamentally, the scale remains Class III compliant and the user instruction has not changed to any significant level, however please be aware of the subtle aesthetic differences.

 

As always, we’ll be back again next month with all of the latest MHRA field safety updates. Seen an alert we’ve missed? Tweet us at CLHGroupLtd to let us know and don’t forget to use '#CommittedToCare' in your posts.

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