Excellent care with compassion

Looking across the Pond… How does Managing Medical Devices 2014 compare to AAMI EQ56:2013?

Paul A BlackettJanuary 2015

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• 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

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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]

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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]

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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]

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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)

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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

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The UKThe 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]

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AAMI EQ56 vs MHRA MMD2014

• What’s it like?

34 pages (inc annex) vs 60

Requirement sectionfollowed by explanatorynotes and rationale.

4 Annexes

Databases

Benchmarking

Statistical models for inventory accuracy

‘Crosswalk’: where the requirements have come from

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MHRA MMD2014Leading 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

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AAMI EQ56What 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

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AAMI EQ56What 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 errorsAlert users and relevant committee of any issues.

Journal of Clinical Engineering: Measuring Maintenance Effectiveness with Failure Codes.[14]

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AAMI EQ56What can we learn?4.2.2 continued

With StaffWork assignmentsTargetsProductivityExpectationsPolicy ChangesEmployment benefits

With CustomersEq issues inc,TrainingRecallsStatus of PMsStatus of repairsAvailabilityProcedures

With Senior ManagementStandardsProductivityBudget adherenceMajor issuesData for strategic pl

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AAMI EQ56What 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

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AAMI EQ56What 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…

“”

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AAMI EQ56What can we learn?9.1 Staff

• Organisation to review staff plan to ensure sufficient staffInternally 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.

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AAMI EQ56What 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

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AAMI EQ56What can we learn?9.3 Premises

Space is required for work areas, equipment waiting attention,storage and documentation

120 sq ft per biomedPlus management, admin, clerical

Physical sequestration of equipment

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AAMI EQ56What 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]

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AAMI EQ56What 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

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Bolt-ons for MMD2014

& Backups

Premises

EmergencyManagement

Staff & Communications

with others

Computer systems

Finance

MMD 2014

Benchmarking

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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/ucm300639.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