Clinical Product Management Policy
The Trust strives to ensure equality of opportunity for all, both as a major employer and as a provider of health care services. This Clinical Product Management policy has therefore been equality impact assessed by the [insert authorising committee name] to ensure fairness and consistency for all those covered by it, regardless of their individual differences, and the results are shown in Appendix A.
Policy Number: / [Click here and type]Version: / 2.0
Authorisation Committee: / Policy Approval Group
Date of Authorisation: / [Format dd-mmm-yyyyy]
Name and Job Title of author: / Fiona Burton, Head of Clinical Products
Name of responsible committee or individual: / a)Patient Safety Committee
Executive Director Sponsor / Steve Bolam
Key individuals and/or Committees consulted during drafting: / Clinical Management Board
And Chairs of:
Medical Devices Management Committee
New and Novel Procedures and Policy Committee
Date issued: / [Format dd-mmm-yyyyy]
Review date: / [Format dd-mmm-yyyyy]
Target audience: / All Trust Staff
Equality Impact Assessments completed: / 5th September 2013
Policy Checklist completed:
Number of pages: / 19
Document History:
Version / Date / Review date / Comments
1. / 04/03/2010
2. / 5 September 2013 / September 2016 / Changes to terms of reference updated,
New Products approval included
Clinical Product Management Committee Page 1of 21 Terms of Reference v.2 Sep 2013
Contents
1.Policy Statement......
2.Definitions......
3.Scope
4.Aims and Outcomes
5.Purpose
6.Related Trust Policies
7.Monitoring effectiveness and compliance...... 7
8.References...... 7
Appendix A:...... 9
Appendix B:...... 11
Appendix C:...... 14
Appendix D:...... 15
Appendix E:...... 18
Appendix F:………………………………………….………………………………………………….....……….19
Executive Summary
St Georges Healthcare NHS Trust Clinical Product Management (CPM) endeavours to provide leadership to the procurement process through practical application and critical thinking derived from an extensive background of clinical experience. Utilisation of CPM processes encourages a balance of optimal clinical outcomes and supply governance while striving to deliver objective evidenced based clinical analysis through research, multidisciplinary collaboration and data which includes function, cost, utilisation, impact on infection control, and patient outcomes.
CPM will be achieved through the appropriate distribution of governance roles which will ensure the oversight of clinical product choice, product evaluation and quality control. This will include the management of Trust relationships with suppliers to ensure the most favourable strategic alliances with vendors and the oversight of the introduction of new products.
The structure of St Georges NHS Trusts CPM organisation will include a Clinical Product Management Committee that is accountable to the Trusts Patient Safety Committee. The CPMC will oversee three product review teams to include: a) Medicine, cardiac & Cardio-thoracic; b) Surgery, Theatres and, c) Anaesthetics; Children & Women, Clinical Imaging, Therapies and Diagnostics. These product review teams will include multidisciplinary staff and consultant end-users to evaluate and make recommendations on products. Business cases presented to the CPMC for authorisation will include a review of clinical evidence based research, patient safety cost/ benefit analysis and product evaluation and trials as appropriate. The CPMC will have an integrated relationship with the Medical Devices Management Committee and Procurement Sourcing and Contracting.
1.Policy Statement
To achieve its vision, the Trusts Clinical Product Management organisation will:
1Serve as gatekeepers of new products for each facility and system-wide in collaboration with Procurement leadership as needed.
2Drive contract compliance by identifying non-contract products and determining clinically equivalent contract supplies.
3Review product substitutions and conversions to determine clinical equivalency and the ability to meet clinical needs.
4Develop cross department review groups to standardise like products across services when products have applications throughout the organisation.
5Determine product quality concerns/issues are valid clinical concerns or product defects.
6Provide Senior Leadership with Procurement focused clinical support required to optimize and reduce the cost of providing optimal patient care.
7Provide clinical expertise regarding product safety, efficacy, and use.
8Evaluate product related safety concerns and collaborate actively with clinical teams, Risk department and Consultant Leadership to identify supply related issues.
9Provide a point of contact for suppliers wishing to build business between themselves and St Georges Healthcare NHS Trust.
The Clinical Product Management Structure will include a Clinical Product Management Committee (CPMC) with oversight of three Product Review Groups.
1.1The CPMC
Membership
Core members:
- Medical Director (Chair)
- Procurement Manager
- Head of Clinical Products
- Assistance director of finance
- Senior Nurse: DDN
- Senior Finance representative
- Senior Medical Physics Representative.
- Senior Education Representative
- Infection Control
Co opted members / Sub groups (as required)
Any key personnel the group feels should be invited
Roles & Responsibilities
- Review and approve new product (as defined by policy) requests and determine whether trials and/or evaluations are required.
- Review new product requests.
- Review and approve product conversions.
- Review results of all trials followed by selection of the most cost effective, clinically sound product.
- Serve as sole authority to evaluate and make recommendations for clinical supplies and products.
- Establish investigation and where feasible, standardise when two or more products are used to perform the same function promoting selection of the most cost effective product alternative.
- Review product usage so its economic impact can be identified.
- Validate that benchmarking and/or literature reviews are completed prior to product selection and reviews performed using evidenced based practice.
- Utilise established Product Review Teams to assist in the evaluation of products and the building of business cases.
- Identify current practice and policies and procedures impacted by the potential change.
- Recommend education and communication to support product implementation.
- Consider impact to revenue and expenses.
- Provide that the Clinical Product Management process is maintained.
- Can not delegate responsibilities.
In the event that decisions are challenged the proposer will be given the opportunity to present the alternative case at the next meeting of the CPMC. The committee’s decision after this will be final.
Full terms of reference are provided in Appendix B
1.2 Divisional Product Review Teams
The divisional product review teams will be responsible for driving forward product related review or change projects where initiated by CPMC.
Team Leadership and Standing Members
Teams will be co-lead and facilitated by a Clinical Procurement Manager, Procurement Sourcing and Contract Manager and a representative from the service line represented (i.e. a consultant or Head of Nursing).
Teams
Product Review Team
Medicine and cardiac
- Divisional Chair (Chair)
- Clinical Product Specialist
- Care Group Leads or Consultant resource
- Heads of Nursing
- Business Manager – This may be deputised by a GM
- Divisional Procurement Manager
- Ancillary Department Managers, as required
- Ad hoc subject matter experts and end users
Product Review Team
Surgery, Theatre & Anaesthetics and neurology
- Divisional Chair (Chair)
- Clinical Product Specialist
- Care Group Leads or Consultant resource
- Heads of Nursing
- Business Manager – This may be deputised by a GM
- Divisional Procurement Manager
- Ancillary Department Managers, as required
- Ad hoc subject matter experts and end users
Product Review Team Clinical Imaging, Therapies and Diagnostics
- Divisional Chair (Chair)
- Clinical Product Specialist
- Care Group Leads or Consultant resource
- Heads of Nursing
- Business Manager – This may be deputised by a GM
- Divisional Procurement Manager
- Ancillary Department Managers, as required
- Ad hoc subject matter experts and end users
Full terms of reference can be found in Appendix C
2.Definitions
2.1Medical Device:
'medical device' means any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used for human beings for the purpose of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease,
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- Investigation, replacement or modification of the anatomy or of a physiological process,
- Control of conception,
- and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. (European Union, 1993)
2.2Medical Consumable:
A ‘Medical Consumable’ is any medical device that has an in use life-span of less than 6 months.
2.3Single Use Consumable
A ‘Single Use Consumable’ is a consumable manufactured to be disposed after one use with one patient. (MHRA, 2006)
2.4Single Patient Use
This indicates that a medical consumable can only be used with one patient; however this can be on more than one occasion. (MHRA, 2006)
2.5 Systemness
Systemness takes into consideration whether the product or device has applications throughout the organisation.
Examples: Can this product be used within all Trust divisions & specialties? Does it support a need at multiple sites?
2.6 Quality
Quality is a composite criterion emphasising performance, which includes the item's durability, reliability, integrity, and maintains or enhances care delivery.
Example: How durable is a pair of gloves during normal use? How often do the gloves tear? Does the product impact the quality of care?
2.7Effectiveness
Effectiveness describes how well an item meets its intended purpose or required need.
Examples: Do the gloves meet their intended function? How well do the gloves protect your hands? Do the gloves allow for sufficient tactile response (feeling)? Does the product meet the needed capacity?
2.8Cost
Cost includes the actual direct cost of the product, the cost relative to improved clinical outcomes and the financial impact of the acquisition on revenue in alignment with product utilisation and includes frequency of use and appropriateness of the device/ product to level of care needed.
Examples: Is the product reimbursable or revenue generating and what is the impact on the overall cost per case?
2.9Standardisation
Standardisation is the ability to compress products into a standard or pre-determined set to minimise variety, reduce variability and increase interchange ability.
Examples: Can we use these gloves throughout the system? Can this item fill multiple needs or replace multiple different products?
2.10Utilisation
Utilisation includes evaluating the current trends and the manner and frequency for which a product will be used as well as the capacity of the product to meet the need.
Examples: How is it used? How often will this product be used? Does it fill the intended need?
2.11Research
Consider the impact of using the product, system compatibility, and best practice outcomes integrating clinical expertise with the best available external evidence. Conduct data analysis, case study and literature research to assess impact for system as a whole.
Examples: Can the product be used with existing equipment? Does it support clinical practice? What are the national/regional trends?
2.12Education/Training
Consider education and training requirements. Consider impact on current Policies and Procedures and/or order sets.
Examples: Does the item require any special training for use? Does this item require training for compliance with regulatory requirements? Who will be responsible for providing training? Does the use of this item require special credentialing?
2.13Safety / Infection Control / Waste Management
The item will comply with all hospital MHRA, NPSA and any other governmental regulations/requirements as well as consider CQC indicators, and NICE recommendations.
Examples: Is there an increased risk of injury. (i.e., sharps injury or back injury)? If the item is disposable, does it have any special disposal requirements? If the item is reusable, does it require any special reprocessing? Is the product invasive? Does the product come into contact with non-intact skin or mucous membrane?
2.14Clinical impact / Risk
Assess the impact of a new or substituted product on the provision of safe patient care including any factors that may affect the risk of error or adverse or unplanned events.
Examples: How will this affect patient care? What is the risk of use to the patient and staff? Does this need to be referred to the MHRA or NPSA?
2.15Packaging and Space
Optimal packaging will have minimal waste, an ease of opening, and ease of storage.
Examples: Is the item packaged as desired? Does the item require any special tools or methods for storage or opening its packaging? Does packaging and storage impact utilisation? Is there unnecessary waste with the packaging?
3.Scope
This policy will apply to all staff within St Georges Healthcare NHS Trust. The policy applies to all medical devices and their manufacturer and suppliers. This policy will be compliant with the Procurement Policy within St Georges Healthcare NHS Trust. This policy will apply to all procurement of clinical products to be used within St Georges Healthcare NHS Trust. This includes items that are funded via charitable organisations.
For clarification this includes products for Laboratories such as reagents, nutrition & medical equipment. The CPMC will not oversee the procurement of items Furniture such as chairs and other non clinical items that will be managed by the non-clinical procurement team.
4.Aims and Outcomes
The aims and objectives of this policy are to provide a structure to support effective governance of Clinical Product selection and use. This will embed within the organisation a culture of clinical oversight and engagement with end users. The increased engagement and oversight is structured to ensure that consideration is given to systemness, quality, effectiveness, cost, standardisation, utilisation, clinical risk, education, infection control, waste management and, packaging and space.
5.Purpose
Ensuring high quality clinical and financial governance to all procurement activity within St Georges NHS Trust is a necessary element to ensure the highest quality of treatment and care to our service users.
St Georges Healthcare NHS Trust recognises that good governance regarding the choice of clinical products we procure, and the availability of unsolicited or unselected products impact on our patients’ outcome and experience.
6.Related Trust Policies
Medical Devices - Management and Use of
Medical Devices - Training policy
Infection Control Policy
Decontamination Policy
Glove Policy for Clinical Use
Safe use and disposal of Sharps, Sharps Injury and Splash
Medicines Management Policy
Analysing and Learning Policy
Central Alerting System (CAS) Alerts Policy
Governance and Risk Management Strategy and Framework
Serious Untoward Incident Policy
Health and Safety Policy
Control of Substances Hazardous to Health Policy
Latex Policy
Lifting Operations and Lifting Equipment
Personal Protective Equipment (PPE)
Workplace (Health, Safety and Welfare) Policy
Standing Orders, Standing Financial Instructions and Scheme of Delegation
Procurement Procedures
7.Monitoring effectiveness and compliance
7.1Process for Monitoring Compliance and Effectiveness
The Procurement Nurse will produce a monthly report of KPI’s to be presented at the CPMC, this will be communicated as an attachment to the minutes of each months first CPMC meeting.
7.2Standards/Key Performance Indicators
Benchmark for Medical devices/consumable related incident reports
CPMC to review all S.U.I.’s that involve medical devices/consumables.
A standard for product / supplier variance
A standard for % of supplies (both cost and lines) received through NHS Supply Chain.
A measure of audit of clinical satisfaction / maybe an audit schedule (qualitative)
8.References
European Union (1993), Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Official Journal L 169 , 12/07/1993 P. 0001 – 0043
MHRA (2006), Device Bulletin Single-use Medical Devices: Implications and consequences of Reuse DB2006(04)
Appendix A:
EQUALITY AND IMPACT ASSESSMENT TEMPLATE
Policy or Service Name: / Clinical Product Management PolicyLead or EIA and contact details: / Fiona Burton ext 0768
Date completed: / 5th September 2013
STEPS/ACTIONS / OUTCOMES/KEY FINDINGS
Step 1
Briefly describe the key objectives and outcomes of Policy / The Clinical Management Policy sets the organisational strategy and structure for effective oversight of Clinical Product introduction or change.
This document has been approved by the Procurement Transformation Programme board and is being presented to CMB for approval as a working Draft.
Step 2
Screening the policy or service for relevance to diversity
- age
- gender
- disability
- race
- language
- religion or belief
- sexuality
- human rights
-A clause within the product review groups TOR states that consideration must be given if a product choice unequally affects a section of our client base.
-Where a product range is used for one section of our client population a rationale will need to be made within any business case for change. For example, should a hip replacement joint be chosen on the basis of price, consideration must be given regarding the life expectancy of that joint to ensure younger clients are not disadvantaged.
Step 3
Assessing the impact that a proposed policy or service is likely to have on diversity. / - The nature of this policy will make decisions more transparent than is currently the case.
Step 4
Consulting with groups who are likely to be affected and identifying remedial action (state which groups were consulted) / -Procurement Transformation Steering Committee
-Procurement Transformation Programme Board
-Clinical Management Board
Step 5
Proposed changes, improvements to make to the policy or service in order for it to promote equality and diversity
Step 6
Resource Implications
Step 7
Monitoring Arrangements
This is not optional. All decisions must include monitoring arrangement to ensure that the policy or service is executed appropriately and has the desired results when implemented / -KPI indicators include
- Benchmark for Medical devices/consumable related incident reports
- CPMC to review all S.U.I.’s that involve medical devices/consumables.
- A standard for product / supplier variance
- A standard for % of supplies (both cost and lines) received through NHS Supply Chain.
- A measure of audit of clinical satisfaction / maybe an audit schedule (qualitative)