This document compares the Managing Medical Devices 2014 guidelines from the UK MHRA to the AAMI EQ56:2013 standards from the USA. It outlines the roles of different regulatory bodies in each country for medical devices. It identifies several areas where the UK standards could be strengthened based on aspects covered in the AAMI EQ56 such as staff training requirements, emergency planning, benchmarking, and use of computer systems for tracking maintenance effectiveness. Implementing recommendations from the AAMI EQ56 could help bolster the UK's Managing Medical Devices 2014 guidelines.

1. Excellent care with compassion
Looking across the Pond…
How does Managing Medical
Devices 2014 compare to
AAMI EQ56:2013?
Paul A Blackett
January 2015

2. Excellent care with compassion
• Why look across the Pond?
• Who does what in the USA
• Our own MHRA
• Leading the pack
• What we can learn from EQ56
• Bolt-ons for MMD2014

3. Excellent care with compassion
Why across the Pond?
• USA has 14 out of the top 20 Manufacturers [1]
• Market value of $110+ billion in 2012 [2]
• 6,500 medical device companies [2]
• 5,723 registered hospitals in 2012 [3]

4. Excellent care with compassion
Why across the Pond?
• Worldwide market value of $300 billion [4]
• UK has manufacturer No 21, S&N [1]
• 250 medical device companies [5]
• 2,300 registered hospitals in UK [6]

5. Excellent care with compassion
Who does what in the USA
The FDA is responsible
for protecting the
public health by
assuring the safety,
efficacy and security
of human and
veterinary drugs,
biological products,
medical devices, our
nation’s food supply,
cosmetics, and
products that emit
radiation. [7]
Mostly aimed at Manufacturers
Regulatory issues : pre-market,
branding, vigilance etc [9]
Some specific guidance on “radiation emitting
products” with wide application
FDA: Center for Devices and
Radiological Health (CDRH) [10]

6. Excellent care with compassion
Who does what in the USA
– AAMI, the Association for
the Advancement of
Medical Instrumentation
– A nonprofit organization
founded in 1967.
– Community of nearly
7,000 healthcare
technology professionals
– Supporting the
healthcare community in
the development,
management, and use of
safe and effective
medical technology.
Many approved by the American
National Standards Institute (ANSI)
Publishes technical documentation
AAMI is the primary resource for
the industry, the professions, and
government for national and
international standards. [11]
Certifies Biomedical Equipment Technicians (BMET)

7. Excellent care with compassion
Who does what in the USA
– An independent, not-for-
profit organization, 1951
– Accredits and certifies
more than 20,500 health
care organizations and
programs in the US.
– Accreditation and
certification is recognized
nationwide as a symbol
of quality that reflects an
organization’s
commitment to meeting
certain performance
standards.
– Voluntary
Refers to AAMI EQ56:2013
Established a “Risk Based inventory” in
1989. Optional inclusion [13]
Equivalent to the CQC (but
not compulsory!) [12]
Inventory, Procedures, Scheduling, Monitoring

8. Excellent care with compassion
The UK
The MHRA is responsible for regulating all medicines and
medical devices in the UK by ensuring they work and
are acceptably safe. Underpinning all our work lies
robust and fact-based judgements to ensure that the
benefits justify any risks. [8]

9. Excellent care with compassion
AAMI EQ56 vs MHRA MMD2014
• What’s it like?
34 pages (inc annex) vs 60
Requirement section
followed by explanatory
notes and rationale.
4 Annexes
Databases
Benchmarking
Statistical models for
inventory accuracy
‘Crosswalk’: where the
requirements have come from

10. Excellent care with compassion
MHRA MMD2014
Leading the pack...
• Decommissioning
• Data erasure to HMG IS5
• Safety
• Disposal
• Sale and re-use
• Liabilities
• Quality Systems
• ISO accreditation of contractors
• Routine Maintenance by Users
• Use of non-approved devices
• Risk Assessment
• Electrical Safety

11. Excellent care with compassion
AAMI EQ56
What can we learn?
4.2.1 Communications with staff
There should be communication with staff about the following:
• Changes in service operations and
• Changes in health care organization operations
• Need not be the entire
staff, but communication
encouraged with all
• Monthly staff meeting
considered a minimum

12. Excellent care with compassion
AAMI EQ56
What can we learn?
4.2.2 Ongoing and timely information
Conditions that indicate a need for
user training
• problems due to improper use
of equipment
• User errors
Alert users and relevant committee
of any issues.
Journal of Clinical Engineering:
Measuring Maintenance Effectiveness
with Failure Codes.[14]

13. Excellent care with compassion
AAMI EQ56
What can we learn?
4.2.2 continued
With Staff
Work assignments
Targets
Productivity
Expectations
Policy Changes
Employment
benefits
With Customers
Eq issues inc,
Training
Recalls
Status of PMs
Status of repairs
Availability
Procedures
With Senior
Management
Standards
Productivity
Budget adherence
Major issues
Data for strategic pl

14. Excellent care with compassion
AAMI EQ56
What can we learn?
4.5 Emergency Management & Resilience
Equipment is often a key component during disasters and emergencies”“
• Active participation in major incident exercises
• Identify battery operated devices
• Identify alternative solutions
• Location of alternative equipment

15. Excellent care with compassion
AAMI EQ56
What can we learn?
8.3 Backups
Determine the type and quantity of back up
equipment required, for safe and effective
patient care in the event of equipment failure.
The availability of back up equipment
should be known…
“
”

16. Excellent care with compassion
AAMI EQ56
What can we learn?
9.1 Staff
• Organisation to review staff plan to ensure sufficient staff
Internally and with outside service providers
• Each person to be appropriately;
Educated, trained, experienced, licensed/certified
• Minimum of 72 hours of formal training every 3 years covering:
• Inspection procedures
• safety training
• career advancement
• certification achievement
• New staff should receive a minimum of
36 hours training in the first year.

17. Excellent care with compassion
AAMI EQ56
What can we learn?
9.2 Finance
Costs of the service need to be identified and
communicated to the organisation
The Organisation shall establish a budget of
sufficient funding to meet anticipated costs

18. Excellent care with compassion
AAMI EQ56
What can we learn?
9.3 Premises
Space is required for
work areas,
equipment waiting attention,
storage and documentation
120 sq ft per biomed
Plus management, admin, clerical
Physical sequestration of equipment

19. Excellent care with compassion
AAMI EQ56
What can we learn?
Annex A: Computer systems
• User / operator training needs can be identified
• Repeat repairs by the same technician = Training
• Schedule PM, based upon risk to the patient of equipment failure
• Issues found during PM = effectiveness
• Department metrics eg $/hr
References AAMI further documentation [15]

20. Excellent care with compassion
AAMI EQ56
What can we learn?
Annex B: Benchmarking
• Performance Improvement
• Best Practices
• Benchmarking itself • Financial, technical, compliance
• Ongoing
• Literature
• Professional experience (OEMs, indivdls)
• Professional associations and networks
• Any aspect of performance compared
• Identify opportunities for improvement (OFI)
Differences in performance ~ Different Practices = OFI

21. Excellent care with compassion
Bolt-ons for MMD2014
& Backups
Premises
Emergency
Management
Staff &
Communications
with others
Computer
systems
Finance
MMD 2014
Benchmarking

22. Excellent care with compassion
References…
Thankyou!
[1] http://www.mddionline.com/article/top-40-medical-device-companies
[2] http://selectusa.commerce.gov/industry-snapshots/medical-device-industry-united-states
[3] http://www.aha.org/research/rc/stat-studies/fast-facts.shtml
[4] http://www.abhi.org.uk/press/press-releases/press-2014.aspx
[5] http://www.abhi.org.uk/
[6] http://www.nhsconfed.org/resources/key-statistics-on-the-nhs
[7] http://www.fda.gov/AboutFDA/WhatWeDo/default.htm
[8] http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm
[9] http://www.fda.gov/MedicalDevices/ResourcesforYou/HealthCareProviders/default.htm
[10]http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/ucm300
639.htm
[11] http://www.aami.org/standards/index.html
[12] http://www.uktreatment.com/why-the-uk/hospital-accreditation/
[13] Dyro, Joseph, Clinical Engineering Handbook 2004, Elsevier.
[14] Wang B. et al. 2010 Evidence Based Maintenance pt 1 Journal of Clinical Engineering Vol 35, No.
3 July/Sep
[15] http://www.aami.org/publications/books/cmms.html