What We Do:

Build and Manage User Manual Libraries for Hospitals. These are Manufacturer-Supplied Product-Specific:

  1. User Manuals
  2. Directions for Use
  3. Operating Instructions
  4. Quick-Start Lists
  5. Troubleshooting Guides

How Are They Accessed:

Via your hospital intranet site at the Point-of-Care – 24/7 365 – in an organised, searchable database.

Who Will Use Them:

Medical, Clinical and Nursing staff who are confronted with 10 to 30 different Makes and Models of complex medical devices every day.

How Will It Help Your Hospital

  • Improve Patient Safety
  • Reduce User Related Errors

Every single manufacturer in the world has a notice or disclaimer highlighting the fact that all equipment users should read the supplied instructions before use.

Anecdotal evidence going back to the 1990s suggests that professionals are not doing this and there is a culture of "nobody reading the User Manual".

The minimum that the hospital can offer, particularly when it comes to high profile professionals and rotating staff, is to make sure the device-specific instructions are available, 24/7 for the full working life of that device.

Our Clinical Equipment User Manual Library is the only commercial solution currently available to store and manage this data on your behalf, without incurring high costs and increasing the administrative burden on members of your clinical and management teams.

The study [by the Harvard Medical Practice] analysed more than 30,000 medical device- related injuries... 27.6% of patient's injuries were caused by pure negligence.

Journal of Clinical Engineering: July/September 2011: The Impact of Medical Devices on Patient Health: An Analysis of Patient Safety and Risk: Robert Hijazi, PhD(c), MS, MHSA, CBET

4 b) if a particular product was involved was the manufacturer's instructions available and followed? (If not why not?).

State Coroner Victoria Standard [Australia]: Coroner's "Investigation Standard": Fall-related deaths in hospital

The value of this service to Risk Managers: It makes sure the entire hospital is compliant with respect to manufacturer's instructions and their availability.

Quality and Safety Departments rely on their Biomedical Engineering Department (BME) to ensure the equipment is "technically" safe and "ready for use". Various studies point to the fact that medical equipment technical failure rates are extremely low.

The majority of adverse events and incidents are associated with users and your BME Department should be measuring and reporting the "User Error" metric (also called – "No Fault Found"). You can objectively quantify the skill levels of medical equipment users by Department and Make & Model, once you have a base measurement to work from, you are able to proactively respond to skills shortages, training and/or other interventions before a patient gets injured.

The manufacturer's instructions are the most reliable source for "correct use" and "user setup / troubleshooting" for the 7 to 10 years of a devices expected working life. Creating a culture of staff constantly referring to this documentation is the only reliable way to standardise device use in a hospital with hundreds of beds and thousands of different makes and models in use every day. Just like a handwashing program, making sure the staff do not have to jump through hoops to use the service is the first step in changing culture and attitudes.

It has been a constant surprise to the author to discover, during litigation, that many users of medical devices have never read the instruction manual. It should be a rule that before operating a medical device, the operator should be required to prove that he or she has read the manual, no matter how good the in-service training may be or no matter how obvious it is to use the device.

Medical Device Accidents and Illustrative Cases, 2nd Edition: Leslie A Geddes: Purdue University distinguished professor of biomedical engineering and recipient of the National Medal of Technology: 2002

The value of this service to Quality Managers: This is a starting point to ensure Clinicians at all levels of seniority , throughout your hospital or organisation are empowered to take control and responsibility for the devices they use on a daily basis.

Your Biomedical Engineering Departments (BME) statistics related "User Error" and "No Fault Found" allow you to measure the impact and effectiveness of medical equipment in-service training. Competent users should make fewer "User Error" mistakes. In-service training that includes details on how to use the "Manufacturers Instructions" – particularly the "User Troubleshooting Guide" are going to target tech-savvy members of staff who are interested in technology and become the Product Champions in a department or ward team.

Team work in healthcare is currently influenced by Commercial Airline Industry CRM training and within the Airline Industry even the most experienced pilots have to constantly refer to the planes instruction manuals when there is a problem.

Confidence and experience are only fully realised when staff have to work through issues – that's how we all learn. Making all the medical device user information available 24/7 supports front line staff at the point-of-care and their efforts to resolve issues when time constraints exist.

Careful analysis of more than 62,000 work orders collected showed that the failure rate for each type of equipment within a single hospital tend to converge to a stable pattern with less than 100 work orders... [In the conclusion] The outcomes ("low rate of technical" failures) suggest that improving user training on equipment usage and proper care of accessories and batteries can significantly reduce the amount of failures and thus improve patient care and safety.

Journal of Clinical Engineering: July / September 2010: Evidence-Base Maintenance Part 1: Binseng Wang, ScD, CCE ET el

The value of this service to Nurse Educators: By using the manufacturer's reference material during an in-service you standardise the minimum requirement with respect to device-specific knowledge for the duration of that device – not the duration of that device trainer.

Knowing the equipment you rely on by Make & Model is the only way to ensure you use it safely and you are interpreting the result presented from it with insight. Knowing its limitations and proprietary features ensure the outcome of what you are doing will be predictable. Manufacturer proprietary features built into devices and the associated custom algorithms used can make a significant difference when interpreting or using a device with a feature which you know and understand the principle but have yet to read the manufacturer's instructions. Many of these limitations in your understanding manifest themselves when time is limited, the patient is compromised and you need to deal with what might seem to be more pressing issues at that point in time.

Doctors Arreza and McGill acknowledged the limitations of their understanding of the ventilation machines and appropriate applications

Office of the State Coroner – Findings of Inquest (COR 1172/06(09) – Brisbane (Australia) – Death of a 2nd twin

We found out:

  • They hadn't gained proper informed consent to use the morcellator.
  • The operating surgeon had five minutes undocumented training from a surgeon who had used and seen the morcellator in action five years previously.
  • They had completed no risk assessment and had not followed correct procedure in implementing a new technique into the surgery.
NHS Risky Business – The death of Bethany Bowen

It has been a constant surprise to the author to discover, during litigation, that many users of medical devices have never read the instruction manual. It should be a rule that before operating a medical device, the operator should be required to prove that he or she has read the manual, no matter how good the in-service training may be or no matter how obvious it is to use the device.

Medical Device Accidents and Illustrative Cases, 2nd Edition: Leslie A Geddes: Purdue University distinguished professor of biomedical engineering and recipient of the National Medal of Technology: 2002

The value of this service to Medical Staff: Technology is now a part of medicine and most of the things you do or decisions you make rely on it. The Library allows you the opportunity to fine tune your make and model product knowledge – what the limitations are, what are the ranges within which it's been designed to work - these are engineering and commercial realties you need to be aware of to get the best outcome from that device and the most accurate clinical picture.

The biomedical engineering department is in the ideal position to not only assist with measuring the skills of all clinicians with respect to equipment use but to also address common user issues which can be dealt with at the point–of-care. By analysing No Fault Found and User Errors, irrespective of the department or clinician, data related to the performance of the device by Make & Model can be captured and analysed.

When issues related to captured data are addressed, patient safety, workflow and the total cost / ownership of the device are addressed. Just as importantly, it allows hospital-based engineers to teach nursing staff basic user troubleshooting skills which allows them to develop confidence. A hospital is a 24/7 organisation and there is anecdotal evidence to suggest most events and incidents occur "after hours" when access to a biomed is limited, expensive and mostly likely to be delayed (on-call).

It's unacceptable for staff to use a piece of equipment every day for 5 or 6 years and still only have a basic understanding of how it works

This does not mean that nurses will be taught to service equipment, but rather educated on the first response or troubleshooting aspects of patients care equipment failure... Teach nurses check electrical connections first, turn off and restart equipment ...And follow any other troubleshooting tips provided by the vendor or CE...

Biomedical Instrumentation & Technology: March/April 2004: The Collaboration of Clinical Engineering (CE) and Nursing: Debra McPherson; RN, BSN, MS

The value of this service to Biomedical Managers: Testing and checking equipment which Biomeds know is most likely not faulty is not only soul-destroying and a waste of time but it affects patient flows, impacts on clinicians time and can result in delayed surgery and treatment which also have negative effects on the patients and their condition.

The information held within The Clinical Equipment User Manual Library is protected by the manufacturer's copyright and trademarks. The hospital buys the right to use information contained in that User Manual when they purchase the Device and the conditions of those rights remain unchanged. The Clinical Equipment User Manual Library organise and store an electronic copy of that manual for the hospitals exclusive use. This shared database offers the various hospitals the least expensive option with respect to setting up, managing and maintaining this important information.

We do not sell User Manuals and/or any other document supplied to us for storage. The manufacturers' information supplied to us is only made available to organisations which have the necessary mechanisms in place to protect this information with respect to the manufacturers copyrights. The Library offers manufacturers more protection with respect to their copy right than does a CD sent to a individual within a organisation as it is made available to professional nursing, clinical and medical staff only. These professionals are bound by internal confidentiality rules which involve patient information, access to various subscription based libraries from around the world and those rules associated with accessing the hospitals intranet and emails etc. This system allows the hospital to monitor and manage access where as sending out information on a CD does not.

Access to the User Manuals is password protected and those passwords are made available to hospital authorised personnel who will acknowledge the terms and conditions of their subscription each and every time they access The Clinical Equipment User Manual Library.

The average functional life of a medical device is 7.5 years – many last and are used for + 15 years. During a 7.5 to 15 years period it's very unlikely that the Clinical Staff who attended the In-Service when the device was purchased will still be there so this is a practical and systematic approach to addressing this issue.

Before you request to have your user manual removed from this web server keep in mind that one day we all become patients.

Manufacturers can request not to have their manual loaded or have it removed from The Clinical Equipment User Manual Library and to do so they should send us an email with the following information to info@bioclinicalservices.com.au

  • Your Name
  • Your Position
  • Contact Phone Number
  • Contact Email Address

Incident Links

(All of these links are currently available via a Google search)

Note: The purpose of this page is to remind people who use and/or are in any way involved with medical equipment that accidents happen – they tend to be unexpected, unpredictable and happen to people with varying degrees of experience.

Most people don't come to work with the intent of injuring patients or contributing to a death. Most of those the people involved are devastated and are affected by these incidents for the rest of their lives.

WE ALL MAKES MISTAKES – EVERY SINGLE ONE OF US!

So when you read these links we ask that you do so with the intention of learning and sharing in order to prevent similar incidents from recurring again and again.