May 17, 2020

Wireless Technology In The Hospital Supply Chain

Admin
4 min
Wireless Technology Implementation In Supply Chain
Follow @HealthCareG Written by Emily Couch Read This Article In The May Edition Of Healthcare Global's Digital Magazine The hospital supply chain...

Written by Emily Couch

 

Read This Article In The May Edition Of Healthcare Global's Digital Magazine

The hospital supply chain has been trying to pull alongside its counterparts in the retail and manufacturing industries when it comes to the implementation of wireless technology in their facilities.  A hospitals supply chain is one of the most complex operations within the hospital. The adoption of wireless technology as a means to manage and lower the cost of hospital supplies and streamline the management of the supply chain is becoming a hot topic at the forefront of the healthcare industry. The goal of reducing cost while providing high-quality medical care is a top strategic objective.

When trying to lower annual cost and save money, one of the first steps any healthcare facilities should take is to look at all aspects of their supply chain. On average, one-third of their budget is allocated to supplies, which is only second to labor cost. Conventionally hospitals only used logistics software to track and manage high-cost elements; in today's economy it dictates that organizations should use software tools to identify any elements that could be causing them to lose money.

Putting The Emphasis On Software

It is critically important to rely on data collection tools. In the nations unpredictable economy it is imperative for hospitals to examine every part of their supply chain for any possible areas of cost savings.  All supply chain categories, including information technology, facilities and purchased services, should be accounted for. Cost savings can come from unlikely places and that’s why relying on supply software to analyze your supply chain is more effective and less subject to human error.

When hospitals widen their search for savings in the supply chain, they need to employ different tools and networks to do so effectively. For most organizations it is not cost efficient to have multiple employees with high levels of expertise on staff. The ideal situation would be having supply chain experts on staff to help their facilities to better manage their supply chain and inventory.  Instead, healthcare providers should consider using supply chain software and wireless technology that can aid in discovering any issues or potential cost saving shortcuts.

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Inventory Management

The main purpose of introducing wireless technology into a hospitals supply chain if for cost reduction through inventory management. Electronic medication administration and reporting systemsalong with automated drug dispensing systems can help manage the amount of drugs being dispensed and to whom. Having a more precise system of tracking drugs and where they are going leaves less room for human error.

Inventory management systems can adequately track all inventory in the hospital from surgical supplies to high end machinery. In the past hospitals did not pay as much attention to lower end inventory, but it came to light that savings on the lower end inventory can save hundreds of thousands in the annual budget.

Visibility Within The Supply Chain

The savings of time is at the helm of this issue. Generally speaking an individual lacks the visibility of their entire supply chain. With the implantation of mobile devices all aspects of the supply chain are right at their fingertips while they move about the hospital. Up-to-date inventory reporting, ordering and notifications are instantaneously. The user no longer has to go back to their desk to access and update valuable information, improving their work flow.

The value of implementing wireless technology to a hospitals supply chain can cut down on wasted time, money and resources. Ensuring the right people and wireless technology is employed to manage a supply chain is just as vital as the supply chain itself. Establishing a governing supply chain council will provide direction and help align supply chain strategies with the hospitals overall strategy. This governing council should be lead by the leader of the supply chain organization as well as corporate executives, business unit managers, and other influential company leaders.

Overall, a reduction in data inaccuracy, increased cycle times and decreased supply chain cost, can be the direct benefits of employing wireless technology into a hospitals supply chain. 

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Jun 20, 2021

Medical device companies: how to prepare for Brexit

medicaldevices
supplychain
Brexit
Compliance
Ed Ball
6 min
Ed Ball, Senior Associate at RQM+ , explains how medical device companies can prepare for post-Brexit compliance

Over the last decade, medical device businesses have been no strangers to regulatory changes and new compliance requirements. Companies with devices in the EU market have been working hard to achieve conformity with the requirements of the EU Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Regulation 2017/746 (IVDR), but the UK’s exit from the EU, effective as of 1st January 2021, demands yet another change: to comply with the new UK regulatory regime.

The Medicines and Medical Devices Act passed into law on 11 February 2021 does just that; it enables the UK to build its own regulatory system, although when this new framework will be fully in place is not yet known.

The transition to the UK’s new regulatory regime officially began on the 1st of January 2021, and with it a series of deadlines and phases that medical device manufacturers exporting to GB and Northern Ireland would do well to take close notice of. During the transition period, the UK Medical Devices Regulations (UK MDR) 2002, not to be confused with the EU MDR, will continue to apply in England, Scotland and Wales, whilst CE marked medical devices will still be accepted up to 30th June 2023.

The conformity assessment processes defined in the UK MDR 2002 (as amended) will require that medical devices carry the UKCA mark for entry in the GB market or the UKNI mark for entry in Northern Ireland (where the devices are not CE marked for the EU). In Northern Ireland, where the rules for placing a device on the market differ, the EU MDR and IVDR will apply in 2021 and 2022 respectively, in line with the EU’s implementation timeline. 

This easing-in period of transition is valuable time that should be used productively by manufacturers to ensure that they get up to speed, keep up with relevant updates and prepare strategies and product portfolio for the next phase. To do this, businesses should make sure they consider the following areas as they assess their strategy for UK market access:

Potential Overlap with EU MDR and IVDR
Medical device manufacturers have been working to implement measures to ensure they comply with EU MDR and IVDR for quite some time. The experience, processes and objective evidence that they have gathered in these efforts are certain to be of use when applying for UKCA marking. 

Rigorous Planning
Product portfolios and new product pipelines should be evaluated against both overall compliance risk and commercial and strategic value. By identifying the regulatory compliance status for each product for the UK market and the efforts required to maintain that compliance, manufacturers can plan to use the grace period up to June 2023 to complete their activities. These plans should also be evaluated in consideration of the commercial importance of the individual products to help prioritise the workload. This may well result in the decision to discontinue certain products in the UK or to introduce new products on the UK market ahead of other markets.

Engage with Approved Bodies
This activity cannot take place too soon; as of the 1st of January 2021, UK organisations that were acting as EU Notified Bodies have become Approved Bodies in the UK, while EU Notified Bodies are no longer able to provide conformity assessments under the UK regulations. As there are currently only three UK Approved Bodies offering this service, there is a very real risk that latecomers will struggle to find a UK Approved Body to carry out the conformity assessment required to attain their UKCA mark in time.

Authorised Representatives
Just as EU Notified Bodies are no longer relevant to pursuing UK certifications, UK-based Authorised Representatives are no longer valid when CE marking against the MDR or IVDR. Manufacturers using UK-based EU Authorised Representatives must switch to an EU-based Authorised Representative.

For the UK market, the role of the EU Authorised Representative is also no longer applicable. Non-UK manufacturers must have a UK-based Responsible Person (UKRP), which is equivalent to the EU Authorised Representative in terms of roles and responsibilities. Only one UKRP may be appointed, unlike EU Authorised Representatives, and they must have a registered place of business in the UK in order to register with the MHRA. Approved Bodies may be able to provide details of organisations acting as UKRPs and once this role has been assigned it will be critical for manufacturers to determine exact procedures for managing documentation and that clear communication channels are established. 

Labelling and Import/Export
New UK regulations require that medical devices bear a UKCA mark in addition to the name and address of the UKRP for non-UK based manufacturers. Manufacturers who use the same products/packs for the EU and UK markets will need to consider the impact of adding more content to their labels in terms of usability for the supply chain and end-users. 

While CE marking and certificates will continue to be recognised by the UK until June 2023, import/export administration is likely to change and become more burdensome. Manufacturers using separate products for GB (UKCA) and the EU and Northern Ireland (CE marked) will need to plan for how to ensure that the CE marked product is not shipped to GB post June 2023. Ensuring that processes and resources are in place to deal with developing situations will help manufacturers hit the ground running.

Clinical Investigations
Many businesses will find that clinical investigations are carried out across multiple sites, some of which are outside the UK. In these instances, manufacturers will do well to have a plan for implementation and management of investigations, in compliance with local requirements. It is likely that the MHRA will also continue to update their requirements for clinical trials in the UK.

Data Protection and Standards
New tensions are emerging between the EU and the UK concerning UK data protection rules and the EU’s General Data Protection Regulation (GDPR), suggesting that maintaining ‘equivalency’ may involve a number of different phases.

Compliance with applicable standards also requires close attention; the list of designated standards for medical devices issued by the UK’s Department for Health and Social Care is based on the list of harmonised standards published in the Official Journal of the EU, which in turn are harmonised to the MDD, AIMDD and IVDD. More recently published standards, however, have not been harmonised to the latter European directives and are thus not in the UK’s designated list, despite being considered state of the art. It would be prudent for manufacturers to monitor the state-of-the-art standards and apply where applicable, rather than rely on superseded and outdated standards.

As the UK moves into a new regulatory regime, medical device manufacturers who have already invested time and resources to comply with EU MDR and IVDR can use this to attain their UKCA mark. However, a dynamic compliance environment combined with the new onus relating to export policies means that close attention needs to be paid on numerous fronts. Keeping pace with this changing environment will ensure that manufacturers face the future with confidence and do not lose important space on their markets.

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