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How Human Factors Lead to Medical Device Adverse Events

A Look At Human Factors

By Suzanne Rich, RN, CT, MA          FOLLOW US ON TWITTER
ADVERSE EVENTS involving medical devices or equipment can lead to serious problems, including incorrect or delayed diagnosis and treatment or patient injuries. When errors involving medical devices recur repeatedly, people typically blame the users instead of the real culprit, which is often a poorly designed interface between the medical device and the user. Human factors is the science that focuses on understanding and supporting how people interact with technology.
In health care, the objective of human factors is to improve human performance with medical products, including medical devices, and to reduce the likelihood of error or injury, thus improving patient and workplace safety.1 In this article, I’ll discuss some common problems and steps you can take to prevent them.

Design considerations

The complexity and diversity of medical devices used simultaneously contribute to human factors errors. A key objective of human factors in medical device design is to enhance the likelihood of good performance under less-than-ideal conditions. To minimize human factors problems, devices should be designed according to users’ needs, abilities, limitations, and work environments. This includes the design of the device’s user interface, which includes controls, displays, software, labels, and instructions—anything the user may need to operate and maintain a device.
Good design should include:
  • operation that’s intuitive and doesn’t require frequent reference to an instruction manual
  • easy-to-read displays
  • easy-to-use controls
  • appropriate connections of device-to-device and device-to-outlet for safe use
  • effective alarms
  • easy repair and maintenance.2
Consider three major areas when evaluating medical-device-related adverse events from a human factors perspective:
  1. user characteristics, including the person’s abilities and training and her expectations of the device
  2. device design considerations, which focus on the device-user interface, including
    instructions for use
  3. the environment in which the device
    is used, including the lighting, noise,
    distractions, and time constraints.1 , 2 
Let’s examine these elements in more detail, starting with the device user. For examples of errors in each major area, see Troubling human factors problems.

Training and expectations


Make sure everyone using a device has received training on it. Then consider a less obvious factor, the user’s expectations of how the device works. Whether a user is a health care professional or a patient, she may expect a device to work like another device that looks similar. For example, based on her experience, she may expect a device to deliver the same prescribed treatment or dose as a similar device, or expect the alarms to be in a specific sequence or pattern of sounds. Many reported I.V. fluid pump programming errors resulted when the actual device function wasn’t what the user expected.3

Looking at design


A user’s ability to interpret or understand device communication is often impaired by incomplete, confusing, or misleading labeling and instructions for use. Ambiguity about the sequence of steps required for device setup and operation can also be a factor.
Sometimes the instructions for use aren’t easily accessible, which prompts users to operate devices based on previous experience instead of on the requirements found in the labeling. An example of this problem is when the text or numeric font is difficult to find in the device’s display panel.
When similar devices are made by different manufacturers, the vocabulary in text displays may be inconsistent. For example, adverse events have involved devices that used different units of measure, such as cubic centimeters instead of milliliters. When devices display unfamiliar text abbreviations or words, this may further compound difficult or confusing navigation through menus to set up the device, leading to errors.
Make sure that when your facility chooses devices, it takes into account the following visual, auditory, and tactile features of the interface between user and device.

Visual considerations:


  • The user can see the device displays, labels, or markings.
  • Display screens are easy to see, have clear contrast, and are bright enough to be seen without glare.
  • The font is large enough to be read by all users.

Auditory considerations:


  • The user can easily hear and interpret alarms.
  • The sequence of sounds is appropriate in volume, frequency, tone, and pitch.
  • The alarm’s timing clearly defines the acuity of the warning and gives the user enough time to make adjustments and corrections.

Tactile considerations:


  • The device’s components can be connected easily.
  • The device’s components can’t be easily disconnected or connected by mistake. (Problems have been reported with some electrodes, cables, and I.V. tubing.)
  • The device’s components can be connected so that the user feels a “click” to help ensure a proper connection.
  • The user can feel the controls of knobs, buttons, switches, and keypads.
Instructions for maintaining and cleaning the device should be clear and include what compounds can and can’t be used. Some devices, such as electronic medical devices, shouldn’t be cleaned with fluids, which can leak into the device housing and cause performance problems and even fires. Some cleaning agents may degrade or otherwise affect a device’s plastic casings, impairing performance.

Consider the environment


Both user and device performance can be influenced by physical characteristics of the environment, such as adequate lighting, clear and unobstructed views of devices (especially those used for monitoring), and controls for temperature and humidity.
These workplace constraints can contribute to medical device errors or
adverse events:
  • staff with heavy workloads, such as multiple high-acuity patients
  • staff working double shifts
  • float and temporary staff who may be unfamiliar with the unit’s equipment
  • different brands or models of the same type of equipment within the same facility.
Some organizations have moved to using a single brand or model throughout their facilities.

Reporting problems


If an error or an adverse event occurs despite your best efforts, take action. Medical-device-related adverse events involving death or serious injury must be reported. Reporting near misses or events that could cause patient harm can help identify system improvements that can prevent similar adverse events in the future. Follow your facility’s policies and procedures. You can report events to MedWatch.  See the nearby link to MedWatch.
Addressing human factors in both the design and clinical use of medical devices mitigates risk, improves patient safety, and improves workplace safety.




Adverse events reported to the Food and Drug Administration involving human factors errors range from the simple to the complex. Here are examples of errors in each major area involving human factors:4
User expectations. One error involved an otoscope and transilluminator that look similar but have different light intensities. During an urgent intervention, the health care provider picked up an otoscope, thinking it was a transilluminator. When he tried to use it to locate a child’s vein for an I.V. catheter insertion, the patient experienced a second-degree burn.
Device design. Another error concerned noninvasive blood pressure (BP) tubing that was mistakenly connected to I.V. tubing. The patient, who was being monitored in the ED with a noninvasive automatic BP device, also had an I.V. catheter. The BP cuff tubing was disconnected when the patient went to the bathroom, and it was reconnected upon his return. The patient’s wife found the patient “blue from the neck up.” Despite resuscitation efforts, he died. The BP cuff tubing had been connected to the I.V. catheter and had delivered about 15 mL of air. An autopsy confirmed a fatal air embolus.5
Environment. A safety issue was reported when newly purchased ventilators were placed into service in a trauma ICU. Staff immediately noted that the ventilators had an alarm that wasn’t audible when the patient-room door was closed. Although the devices weren’t defective, they weren’t suited to the environment where they were being used.


1. FDA’s Human Factors Program: Promoting safety in medical device use. Accessed March
27, 2008.
2. Sawyer D. Do it by design: An introduction to human factors. Accessed March 27, 2008.
3. Rich S. Medical devices and patient safety: The role of human factors. Association for Vascular Access Pre-Conference, Indianapolis, Ind., September 8, 2006.
4. Food and Drug Administration. Manufacturer and User Facility Device Experience (MAUDE). Accessed March 27, 2008.
5. Eakle M, et al. Luer-lock misconnects can be deadly. Nursing2005. 35(9):73, September 2005.

Suzanne Rich is a senior project manager of the patient safety staff at the Office of Surveillance and Biometrics, Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md. (Article reprinted from June Nursing2008, Volume 38, Number 6, Pages 62-63)

 Source ~

WARNING: DEADLY Luer connections

WARNING ~ DEADLY Luer connections


Hospitals and other healthcare facilities depend on a variety of catheters, tubing and syringes to deliver medications and other substances to patients through vascular, enteral, respiratory, epidural and intrathecal delivery systems.

These delivery systems frequently employ fittings called Luer connectors to link various system components. The male and female components of Luer connectors join together to create secure yet detachable leak-proof connections. Multiple connections between medical devices and tubing are common in patient care.

Unfortunately, because Luer connectors are ubiquitous, easy-to-use and compatible between different delivery systems, clinicians can inadvertently connect wrong systems together, causing medication or other fluids to be delivered through the wrong route. Such errors have occurred in diverse clinical settings, causing serious patient injuries and deaths. The Food and Drug Administration (FDA), The Joint Commission (TJC), the Institute for Safe Medication Practices (ISMP), the United States Pharmacopeia (USP), the ECRI Institute and others have all received reports of misconnection errors. The problem is well-known and well documented. Yet despite efforts on the part of FDA and other organizations to reduce misconnections through education, protocol and monitoring, the use of Luer connectors in incompatible medical delivery systems continues to create situations where dangerous misconnections can, and do, occur.

To further reduce the occurrence of these misconnections, FDA is actively participating in an international effort to develop and implement standards for noninterchangeable connectors for small bore medical connectors. A joint working group established by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) leads this effort to develop a series of standards for incompatible connectors used in intravascular (IV), breathing systems, enteral, urethral/urinary, cuff inflation and neuraxial applications. Once implemented, these connectors will facilitate correct connections and eliminate incompatible tubing misconnections.

Until standards are completed and manufacturers design and produce products that can’t be misconnected, all interested parties must continue their efforts to keep these dangerous misconnections from happening. “Actions must be taken at the patient bedside, within all levels of health care organizations and throughout the channels of regulation, manufacturing and distribution of these devices in order to eradicate the serious problem of tubing misconnections,” said Peter B. Angood, M.D., Vice President and Chief Patient Safety Officer for The Joint Commission (TJC).

These Medical Device Safety photos are one of those efforts. These photos provided a graphic depiction of misconnection cases that have occurred, coupled with recommendations from TJC on ways to prevent these types of errors.

We hope you’ll post these Medical Device Safety photos as a reminder to staff that these errors can occur in any clinical setting. We also urge you to use the case synopses and recommendations as ongoing training materials. To that end, we have made the photos, case studies and additional resources available, free of charge, at We encourage you to visit this web site to download and make further use of these materials. Let’s continue to work together to prevent these tragic errors.

Daniel G. Schultz, M.D.
Director, Center for Devices and Radiological Health
U.S. Food and Drug Administration
 Source ~

FDA and Device Approvals

New FDA guidance on considerations used in device approval, de novo decisions
Clinical data, risks, benefits and patient risk tolerance outlined in process


The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review.


Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential unreasonable risk of illness or injury. The de novo process is available for low- and moderate-risk devices that have been found not substantially equivalent (NSE) to existing devices.


When evaluating PMA applications or de novo petitions, the FDA relies upon valid scientific evidence to assess safety and effectiveness. Both clinical and non-clinical data play a role in FDA’s benefit-risk determinations. 


The guidance includes a worksheet for device reviewers that incorporates the principal factors that influence benefit-risk determinations, such as the type, magnitude and duration of a risk or benefit, the probability that a patient will experience the risk, patient tolerance for risk, availability of alternative treatments, and the value the patient places on treatment. 


The guidance:


  • outlines the systematic approach FDA device reviewers take when making benefit-risk determinations during the premarket review process
  • provides manufacturers a helpful tool that explains the various principal factors considered by the agency during the review of PMA applications, the regulatory pathway for high-risk medical devices, and de novo petitions, a regulatory pathway available for novel, low- to moderate-risk devices
  • describes an approach that takes into account patients’ tolerance for risks and perspectives on benefits, as well as the novelty of the device.


“This guidance clarifies this process for industry, which will provide manufacturers with greater predictability, consistency and transparency in FDA decision-making while allowing manufacturers and the FDA to use a common framework for benefit-risk determinations,“ said Jeffrey Shuren, M.D., director of FDA’s Center for Devices and Radiological Health (CDRH).


The FDA will also increase the transparency of the decision-making processes by describing the worksheet analysis in the Summary of Safety and Effectiveness Data for PMAs and the decision summary review memos for de novo decisions.


“In addition to bringing clarity to our decision making for industry, this guidance will provide our reviewers with uniform and consistent guidelines to assess probable benefits and risks,” said Shuren.


CDRH will train medical officers, review staff managers and device reviewers on the guidance to assure the guidance is applied consistently to submissions and petitions.  CDRH reviewers will begin applying the guidance to incoming PMA and de novo submissions and to submissions already under review with decisions beginning on May 1.


The FDA is also developing external training modules to help industry and device sponsors understand how CRDH will apply the guidance.


For more information:
Medical Device Guidance Documents


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



Media Inquiries: Michelle Bolek, 301-796-2973,
Consumer Inquiries: 888-INFO-FDA



Is The Product A Medical Device?

A medical device is an instrument, apparatus, implant, in vitro reagent, or other similar or related article, which is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body.[1] Whereas medicinal products (also called pharmaceuticals) achieve their principal action by pharmacological, metabolic or immunological means, medical devices act by other means like physical, mechanical, thermal, physico-chemical or chemical means.

Medical devices include a wide range of products varying in complexity and application. Examples include tongue depressors, medical thermometers, and blood sugar meters.

The global market of medical devices reached roughly 209 billion US Dollar in 2006 and is expected to grow with an average annual rate of 6–9% through 2010.[2]


European Union legal framework and definition

Based on the “New Approach”, rules relating to the safety and performance of medical devices were harmonised in the EU in the 1990s. The “New Approach”, defined in a European Council Resolution of May 1985, represents an innovative way of technical harmonisation. It aims to remove technical barriers to trade and dispel the consequent uncertainty for economic operators allowing for the free movement of goods inside the EU.

The core legal framework consists of 3 directives:

  • Directive 90/385/EEC regarding active implantable medical devices;
  • Directive 93/42/EEC regarding medical devices;
  • Directive 98/79/EC regarding in vitro diagnostic medical devices.

They aim at ensuring a high level of protection of human health and safety and the good functioning of the Single Market. These 3 main directives have been supplemented over time by several modifying and implementing directives, including the last technical revision brought about by Directive 2007/47 EC.

Directive 2007/47/ec defines a medical device as: “any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings. Devices are to be used 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

This includes devices that do 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.”

The government of each Member State is required to appoint a Competent Authority responsible for medical devices. The Competent Authority (CA) is a body with authority to act on behalf of the government of the Member State to ensure that the requirements of the Medical Device Directives are transposed into National Law and are applied. The Competent Authority reports to the Minister of Health in the Member State. • The Competent Authority in one Member State does not have jurisdiction in any other Member State, but they do exchange information and try to reach common positions.

In UK the Medicines and Healthcare products Regulatory Agency (MHRA) acts as a CA, in Italy it is the Ministero Salute (Ministry of Health)[3]

Medical devices must not be mistaken with medicinal products. In the EU, all medical devices must be identified with the CE mark.

Definition in USA by the Food and Drug Administration

Medical machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory that is:

  • recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
  • intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in man or other animals, or
  • intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

»> Medical Device Definition US FDA «<

Definition in Canada by the Food and Drugs Act

The term medical devices, as defined in the Food and Drugs Act, covers a wide range of health or medical instruments used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Health Canada reviews medical devices to assess their safety, effectiveness and quality before being authorized for sale in Canada[citation needed].


The regulatory authorities recognize different classes of medical devices, based on their design complexity, their use characteristics, and their potential for harm if misused. Each country or region defines these categories in different ways. The authorities also recognize that some devices are provided in combination with drugs, and regulation of these combination products takes this factor into consideration.


The Medical Devices Bureau of Health Canada has recognized four classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device. Class I devices present the lowest potential risk and do not require a licence. Class II devices require the manufacturer’s declaration of device safety and effectiveness, whereas Class III and IV devices present a greater potential risk and are subject to in-depth scrutiny.[4] A guidance document for device classification is published by Health Canada .[5]

Canadian classes of medical devices generally correspond to the European Council Directive 93/42/EEC (MDD) devices as follows: Class IV (Canada) generally corresponds to Class III (ECD), Class III (Canada) generally corresponds to Class IIb (ECD), Class II (Canada) generally corresponds to Class IIa (ECD), and Class I (Canada) generally corresponds to Class I (ECD) .[6] Examples are surgical instruments (Class I); contact lenses, ultrasound scanners (Class II); orthopedic implants, hemodialysis machines (Class III); and cardiac pacemakers (Class IV) .[7]

United States

The Food and Drug Administration has recognized three classes of medical devices based on the level of control necessary to assure the safety and effectiveness of the device.[8] The classification procedures are described in the Code of Federal Regulations, Title 21, part 860 (usually known as 21 CFR 860).[9]

Class I: General controls

Class I devices are subject to the least regulatory control. Class I devices are subject to “General Controls” as are Class II and Class III devices.[8][10][11] General controls include provisions that relate to adulteration; misbranding; device registration and listing; premarket notification; banned devices; notification, including repair, replacement, or refund; records and reports; restricted devices; and good manufacturing practices.[11] Class I devices are not intended for use in supporting or sustaining life or to be of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury.[11] Most Class I devices are exempt from the premarket notification and/or good manufacturing practices regulation.[8][10][11] Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments.[10]

Class II: General controls with special controls

Class II devices are those for which general controls alone are insufficient to assure safety and effectiveness, and existing methods are available to provide such assurances.[8][10] In addition to complying with general controls, Class II devices are also subject to special controls.[10] A few Class II devices are exempt from the premarket notification.[10] Special controls may include special labeling requirements, mandatory performance standards and postmarket surveillance.[10] Devices in Class II are held to a higher level of assurance than Class I devices, and are designed to perform as indicated without causing injury or harm to patient or user. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes.[8][10]

Class III: General controls and premarket approval

A Class III device is one for which insufficient information exists to assure safety and effectiveness solely through the general or special controls sufficient for Class I or Class II devices.[8][10] Such a device needs premarket approval, a scientific review to ensure the device’s safety and effectiveness, in addition to the general controls of Class I.[8][10] Class III devices are usually those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.[10] Examples of Class III devices which currently require a premarket notification include implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, and endosseous implants.[10]

European Union (EU) and European Free Trade Association (EFTA)

The classification of medical devices in the European Union is outlined in Annex IX of the Council Directive 93/42/EEC. There are basically four classes, ranging from low risk to high risk.

  • Class I (including Is & Im)
  • Class IIa
  • Class IIb
  • Class III

The authorization of medical devices is guaranteed by a Declaration of Conformity. This declaration is issued by the manufacturer itself, but for products in Class Is, Im, IIa, IIb or III, it must be verified by a Certificate of Conformity issued by a Notified Body. A Notified Body is a public or private organisation that has been accredited to validate the compliance of the device to the European Directive. Medical devices that pertain to class I (on condition they do not need to be sterilised or are not used to measure a function) can be put on the market purely by self-certification.

The European classification depends on rules that involve the medical device’s duration of body contact, its invasive character, its use of an energy source, its effect on the central circulation or nervous system, its diagnostic impact or its incorporation of a medicinal product.

Certified medical devices should have the CE mark on the packaging, insert leaflets, etc.. These packagings should also show harmonised pictograms and EN standardised logos to indicate essential features such as instructions for use, expiry date, manufacturer, sterile, don’t reuse, etc.


The classification of medical devices in Australia is outlined in section 41BD of the Therapeutic Goods Act 1989 and Regulation 3.2 of the Therapeutic Goods Regulations 2002, under control of the Therapeutic Goods Administration. Similarly to the EU classification, they rank in several categories, by order of increasing risk and associated required level of control; various rules exist in the regulation which allow for the device’s category to be identified [12]

Medical Devices Categories in AustraliaClassificationLevel of RiskClass ILowClass I – measuring or Class I – supplied sterile or class IIaLow – mediumClass IIbMedium – highClass IIIHighActive implantable medical devices (AIMD)High

Radio-frequency identification

Medical devices incorporating RFID

In 2004, the FDA authorized marketing of two different types of medical devices that incorporate radio-frequency identification, or RFID. The first type is the SurgiChip tag, an external surgical marker that is intended to minimize the likelihood of wrong-site, wrong-procedure and wrong-patient surgeries. The tag consists of a label with passive transponder, along with a printer, an encoder and a RFID reader. The tag is labeled and encoded with the patient’s name and the details of the planned surgery, and then placed in the patient’s chart. On the day of surgery, the adhesive-backed tag is placed on the patient’s body near the surgical site. In the operating room the tag is scanned and the information is verified with the patient’s chart. Just before surgery, the tag is removed and placed back in the chart.

The second type of RFID medical device is the implantable radiofrequency transponder system for patient identification and health information. One example of this type of medical device is the VeriChip, which includes a passive implanted transponder, inserter and scanner. The chip stores a unique electronic identification code that can be used to access patient identification and corresponding health information in a database. The chip itself does not store health information or a patient’s name.[13]

Practical and information security considerations

Companies developing RFID-containing medical devices must consider product development issues common to other medical devices that come into contact with the body, are implanted in the body, or use computer software. For example, as part of product development, a company must implement controls and conduct testing on issues such as product performance, sterility, adverse tissue reactions, migration of the implanted transponder, electromagnetic interference, and software validation.

Medical devices that use RFID technology to store, access, and/or transfer patient information also raise significant issues regarding information security. The FDA defines “information security” as the process of preventing the modification, misuse or denial of use, or the unauthorized use of that information. At its core, this means ensuring the privacy of patient information.[13]

Four components of information security

The FDA has recommended that a company’s specifications for implantable RFID-containing medical devices address the following four components of information security: confidentiality, integrity, availability and accountability (CIAA).

  • Confidentiality means data and information are disclosed only to authorized persons, entities and processes at authorized times and in the authorized manner. This ensures that no unauthorized users have access to the information.
  • Integrity means data and information are accurate and complete, and the accuracy and completeness are preserved. This ensures that the information is correct and has not been improperly modified.
  • Availability means data, information and information systems are accessible and usable on a timely basis in the required manner. This ensures that the information will be available when needed.
  • Accountability is the application of identification and authentication to ensure that the prescribed access process is followed by an authorized user.

Although the FDA made these recommendations in the context of implantable RFID-containing medical devices, these principles are relevant to all uses of RFID in connection with pharmaceuticals and medical devices.[13]

Medical devices and technological security issues

Medical devices such as pacemakers, insulin pumps, operating room monitors, defibrillators, surgical instruments including deep-brain stimulators are being made with the ability to transmit vital health information from a patient’s body to doctors and other professionals.[14] Some of these devices can be remotely controlled by medical professionals. There has been concern about privacy and security issues around human error and technical glitches with this technology. While only a few studies have been done on the susceptibility of medical devices to hacking, there is a risk.[15] In 2008, computer scientists proved that pacemakers and defibrillators can be hacked wirelessly through the use of radio hardware, an antenna and a personal computer[16] These researchers showed that they could shut down a combination heart defibrillator and pacemaker and reprogram it to deliver potentially lethal shocks or run out its battery. Jay Radcliff, a security researcher interested in the security of medical devices, raises fears about the safety of these devices. He shared his concerns at the Black Hat security conference.[17] Radcliff fears that the devices are vulnerable and has found that a lethal attack is possible against those with insulin pumps and glucose monitors. Some medical device makers downplay the threat from such attacks and argue that the demonstrated attacks have been performed by skilled security researchers and are unlikely to occur in the real world. At the same time, other makers have asked software security experts to investigate the safety of their devices.[18] As recently as June 2011, security experts showed that by using readily available hardware and a user manual, a scientist could both tap into the information on the system of a wireless insulin pump in combination with a glucose monitor. With a PIN access code of the device, the scientist could wirelessly control the dosage of the insulin.[19] Anand Raghunathan, a researcher in this study explains that medical devices are getting smaller and lighter so that they can be easily worn. The downside is that additional security features would put an extra strain on the battery and size and drive up prices. Dr. William Maisel offered some thoughts on the motivation to engage in this activity. Motivation to do this hacking might include acquisition of private information for financial gain or competitive advantage; damage to a device manufacturer’s reputation; sabotage; intent to inflict financial or personal injury or just satisfaction for the attacker.[20] Researchers suggest a few safeguards. One would be to use rolling codes. Another solution is to use a technology called “body-coupled communication” that uses the human skin as a wave guide for wireless communication.[19]

Standardization and regulatory concerns

The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01.[21][22] The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2003 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets.[23][24][25] Further standards are IEC 60601-1, for electrical devices (mains-powered as well as battery powered) and IEC 62304 for medical software. The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H—Medical Devices.[26]

Starting in the late 1980s [27] the FDA increased its involvement in reviewing the development of medical device software. The precipitant for change was a radiation therapy device (Therac-25) that overdosed patients because of software coding errors.[28] FDA is now focused on regulatory oversight on medical device software development process and system-level testing.[29]

A 2011 study by Dr. Diana Zuckerman and Paul Brown of the National Research Center for Women and Families, and Dr. Steven Nissen of the Cleveland Clinic, published in the Archives of Internal Medicine, showed that most medical devices recalled in the last five years for “serious health problems or death” had been previously approved by the FDA using the less stringent, and cheaper, 510(k) process. In a few cases the devices had been deemed so low-risk that they did not need FDA regulation. Of the 113 devices recalled, 35 were for cardiovacular issues.[30] This may lead to a reevaluation of FDA procedures and better oversight.

Packaging standards

Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package.[31] The sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests is used to measure the ability of the package to maintain sterility. Relevant standards include: ASTM D1585 – Guide for Integrity Testing of Porous Medical Packages, ASTM F2097 – Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products, EN 868 Packaging materials and systems for medical devices which are to be sterilized. General requirements and test methods, ISO 11607 Packaging for terminally sterilized medical devices, and others.

Package testing needs to conducted and documented to ensure that packages meet regulations and all end-use requirements. Manufacturing processes need to be controlled and validated to ensure consistent performance.[32][33]

Cleanliness standards

The cleanliness of medical devices has come under greater scrutiny since 2000, when Sulzer Orthopedics recalled several thousand metal hip implants that contained a manufacturing residue.[34] Based on this event, ASTM established a new task group (F04.15.17) for established test methods, guidance documents, and other standards to address cleanliness of medical devices. This task group has issued two standards for permanent implants to date: 1. ASTM F2459: Standard test method for extracting residue from metallic medical components and quantifying via gravimetric analysis[35] 2. ASTM F2847: Standard Practice for Reporting and Assessment of Residues on Single Use Implants[36]

In addition, the cleanliness of re-usable devices has led to a series of standards, including the following: 1. ASTM E2314: Standard Test Method for Determination of Effectiveness of Cleaning Processes for Reusable Medical Instruments Using a Microbiologic Method (Simulated Use Test)[37] 2. ASTM D7225: Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors.[38]

The ASTM F04.15.17 task group is working on several new standards involving designing implants for cleaning, validation of cleanlines, and recipes for test soils to establish cleaning efficacy.[39] Additionally, the FDA is establishing new guidelines for reprocessing reusable medical devices, such as orthoscopic shavers, endoscopes, and suction tubes.[40]

Academic resources

  • Medical & Biological Engineering & Computing
  • Expert Review of Medical Devices
  • Journal of Clinical Engineering [41]

A number of specialist University-based research institutes have been established such as the Medical Devices Center (MDC) at the University of Minnesota in the US, the Strathclyde Institute Of Medical Devices (SIMD) at the University of Strathclyde in Scotland and the Medical Device Research Institute (MDRI) at Flinders University in Australia.

Source ~ Wikipedia

See also

The Ultimate Guide To Sharps Safety

Healthcare Wide Hazards
Needlestick/Sharps Injuries

Needlesticks and other sharps-related injuries which expose workers to bloodborne pathogens continue to be a significant hazard for hospital employees. OSHA estimates that 5.6 million workers in the healthcare industry and related occupations are at risk of occupational exposure to bloodborne pathogens. Bloodborne pathogens are pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include Human Immunodeficiency Virus (HIV), Hepatitis B Virus(HBV), Hepatitis C Virus (HCV), and others.

Any worker handling sharp devices or equipment such as scalpels, sutures, hypodermic needles, blood collection devices, or phlebotomy devices is at risk. Nursing staff are most frequently injured. Exposure Prevention Information Network (EPINET) data shows that needlestick injuries occur most frequently in the operating room and in patient rooms. Syringe with a Retractable Needle - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
Syringe with a Retractable Needle.

Common safety and health topics:

  • Bloodborne Pathogens
  • Needlestick/Sharps Injuries
  • Other Sharps Injury
  • Safer Needle Devices
Bloodborne Pathogens
Definitions for bloodborne pathogens, other potentially infectious materials (OPIM), and occupational exposure are found in the Bloodborne Pathogens Standard, Definitions 29 CFR 1910.1030(b).

Potential Hazard

Exposure to blood and OPIM from contaminated sharps injuries.

Possible Solutions

Follow the requirements of the Bloodborne Pathogens Standard and implement engineering and work practice controls to minimize exposure to blood and bloodborne pathogens.
  • Engineering and Work Practice Controls must be the primary means used to eliminate or minimize exposure to bloodborne pathogens. Where engineering controls will reduce employee exposure either by removing, eliminating, or isolating the hazard, they must be used, and documented in the Exposure Control Plan (ECP). [29 CFR 1910.1030(c)(1)(iv), 29 CFR 1910.1030(c)(1)(iv)(B), 29 CFR 1910.1030(d)(2)(i), OSHA Directive CPL 02-02-069 [CPL 2-2.69].

    • Engineering Controls are measures (e.g., sharps disposal containers, self-sheathing needles, safer medical devices, such as sharps injury protections and needleless systems) that isolate or remove the bloodborne pathogens hazard from the workplace [29 CFR 1910.1030(b)].

      • NOTE: The exposure control plan must document consideration and implementation of appropriate commercially available and effective engineering controls designed to eliminate or minimize exposure [OSHA Directive OSHA Directive CPL 02-02-069 [CPL 2-2.69]], and revised Standard Exposure Control Plan [29 CFR 1910.1030(c)(1)(iv)(B)].
    • Work Practice Controls are measures that reduce the likelihood of exposure by altering the manner in which a task is performed (e.g., prohibiting recapping of needles by a two-handed technique).
  • The revised Bloodborne Pathogens and NeedleStick Prevention Standard requirements (effective date April 18, 2001) include:

    • The review and update of the Exposure Control Plan must reflect changes in technology that eliminate or reduce exposure to bloodborne pathogens and document annually consideration and implementation of appropriate commercially available and effective safer medical devices designed to eliminate or minimize occupational exposure [29 CFR 1910.1030(c)(1)(iv)(A), 29 CFR 1910.1030(c)(1)(iv)(B)].

      • Employers must get input in the identification, evaluation and selection of engineering and work practice controls from employees responsible for direct patient care in [29 CFR 1910.1030(c)(1)(v)]. This input must be documented.
    • Employers must maintain a log of injuries from contaminated sharps 29 CFR 1910.1030(h)(5)(i).
  • The Recordkeeping Standard 29 CFR 1904.8 also requires needlestick injuries to be recorded on the OSHA 300 Log. This includes all work related needlestick injuries and cuts from sharp objects that are contaminated with another person’s blood or other potentially infectious materials (OPIM).

    • If this recorded employee injury is later diagnosed with an infectious bloodborne disease the OSHA 300 log must be updated.
Other Bloodborne Pathogens Standard requirements include:
  • Compliance with Universal Precautions (an infection control principle that treats all human blood and other potentially infectious materials (OPIM) as infectious) [29 CFR 1910.1030(d)(1)].
  • Personal Protective Equipment (PPE). Engineering and work practice controls shall be used to eliminate or minimize employee exposure. Where occupational exposure remains after institution of these controls, PPE shall also be used [29 CFR 1910.1030(d)(2)(i)].
  • Worker training in appropriate engineering controls and work practices, to eliminate or minimize worker exposure. [29 CFR 1910.1030(g)(2)].
  • Proper handling and containerization of sharps.
  • Hepatitis B vaccine and vaccination series made available to all employees with occupational exposure.
  • Post-exposure evaluation and follow-up, including post-exposure prophylaxis when appropriate [29 CFR 1910.1030(f)(3)].
books For additional information, see Healthcare Wide Hazards - Bloodborne Pathogens.
Needlestick/Sharps Injuries

According to the Centers for Disease Control and Prevention (CDC), about 385,000 sharps injuries occur annually to hospital employees.

Potential Hazard

Exposure to blood and other potentially infectious materials (OPIM) because of:
  • Unsafe needle devices.
  • Improper handling and disposal of needles and other sharps.
Possible Solutions
  • Use safer needle devices and needleless devices to decrease needlestick or other sharps exposures. See Safer Needle Devices.
  • Properly handle and dispose of needles and other sharps according to the Bloodborne Pathogens Standard.

    • Handling Needles/Sharps:

      • Do not bend, recap, or remove contaminated needles and other sharps unless such an act is required by a specific procedure or has no feasible alternative [29 CFR 1910.1030(d)(2)(vii)].
      • Do not shear or break contaminated sharps. (OSHA defines contaminated as the presence or the reasonably anticipated presence of blood or other potentially infectious materials on an item or surface) [29 CFR 1910.1030(d)(2)(vii)].
    • Containerization:

Needle Container

Additional Information:
  • Exposure Prevention Information Network (EPINET). International Healthcare Worker Safety Center, U.Va. Health System. Conducts epidemiological research on needlesticks and blood exposures, advocates for a safer health care workplace and provides resources:
    • Fact Sheet: Percutaneous Injuries From Suture Needles [83 KB PDF, 1 page]. (2006, June). Identifies suture needles are the main source of needlesticks to OR personnel, causing 51% of all sharps injuries in surgical settings.
    • Checklist for Sharps Injury Prevention [23 KB PDF, 2 pages].

Other Sharps Injury

“Contaminated Sharps” means any contaminated object that can penetrate the skin including, but not limited to, needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires [29 CFR 1910.1030(b)].
Potential Hazard

Exposure to blood and other potentially infectious materials (OPIM), from contaminated sharps for example:
  • Used Disposable Razors that could be contaminated with blood.
  • I.V. Connector Systems that use needles to connect I.V. setups.
Possible Solutions

Follow the requirements of the Bloodborne Pathogens Standard 1910.1030 and implement engineering and work practice controls to help prevent needlesticks or other sharps exposures.
  • Used Disposable Razors should be considered contaminated waste and disposed of properly in appropriate sharps containers.
  • I.V. connector systems: Use needleless connector systems with I.V. setups to minimize occupational exposure to needles and bloodborne pathogens. Avoid using needles where safe and effective alternatives are available.
Needleless I.V. Connector - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
(Figure 1) Needleless I.V. Connector.The FDA urges using needleless systems, or recessed needle systems to reduce the risk of needlestick injuries.

These connectors use devices other than needles to connect one I.V. to another. This example shows the plunger-type s.
Safer Needle Devices
Most needlestick injuries result from unsafe needle devices rather than carelessness by healthcare workers (JSHQ, 1998, Summer).

Safer needle devices have built-in safety control devices, such as those that use a self-sheathing needle, to help prevent injuries before, during, and after use through safer design features.

The Centers for Disease Control and Prevention (CDC) estimated in March of 2000 that 62 to 88 percent of sharps injuries in the hospital setting could be preventing by using safer medical devices.

Potential Hazard

According to the Bloodborne Pathogens Standard, employers with the help of employees, must select safer needle devices to use in work environments.

  • There are different types of safety features that are available for safer needle devices such as:
    • Needleless devices
    • Passive safety features: remain in effect before, during and after use.
      • Integrated safety design: have a safety feature that is built in as an integral part of the device and cannot be removed. This design feature is usually preferred.
    • Active devices: require the worker to activate the safety mechanism.

      • Accessory safety devices: have safety features that are external to the device and must be carried to, or be temporarily or permanently fixed to, the point of use. This design is dependent on employee compliance and according to some researchers, is less desirable.
  • Desirable Characteristics of Safety Devices include:

    • The device is needleless.
    • The safety feature is an integral part of the device.
    • The device is easy to use and practical.
    • The device performs reliably.
    • The safety feature cannot be deactivated and remains protective through disposal.
    • The devices work effectively and reliably, and are acceptable to the healthcare worker, and do not adversely affect patient care.
    • The Food and Drug Administration (FDA) is responsible for clearing medical devices for marketing in the US. It recommends safer needle devices with a fixed safety feature that:

      • Provides a barrier between the hands and the needle after use; the safety feature should allow or require the worker’s hands to remain behind the needle at all times.
      • Is an integral part of the device and not an accessory.
      • Is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety.
      • Is as simple as possible, and requires little or no training to use effectively.
  • Examples of Safety Device Designs

There are many types of safety devices. Some examples of safety device designs include:

  • Needleless Connector Systems: Needleless connectors for IV delivery systems (e.g., blunt cannula for use with pre-pierced ports and valved connectors that accept tapered or luer ends of IV tubing) (Figure 1).

  • Self-Sheathing Safety Feature: Sliding needle shields attached to disposable syringes and vacuum tube holders (Figures 2A and 2B).

    • Disposable scalpels with safety features such as a sliding blade shield (Figure 6).
  • Retractable Technology: Needles or sharps that retract into a syringe, vacuum tube holder, or back into the device.

    • Syringe with a retractable needle (Figure 3).

    • Retractable finger/heel-stick lancets (Figure 8).
  • Self Blunting Technology: Self-blunting phlebotomy and winged-steel “butterfly” needles (a blunt cannula seated inside the phlebotomy needle is advanced beyond the needle tip before the needle is withdrawn from the vein (Figure 4), (Figure 5).
  • Hinged Safety Feature: Hinged or sliding shields attached to phlebotomy needles, winged steel needles, and blood gas needles (Figure 7).

Example Devices with Safety Features
Self Re-sheathing Needles. Before Use.
(Figure 2A) Self Re-sheathing Needles. Before Use.

Self Re-sheathing Needles. After Use.
**(Figure 2B) Self Re-sheathing Needles. After Use.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only.
Self Re-sheathing Needles
As seen in this animation, initially the sleeve is located over the barrel of the syringe with the needle exposed for use.

  • After the device is used, the user slides the sleeve forward over the needle where it locks in place and provides a guard around the used needle.

Syringe with Retractable Needles - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 3) Syringe with Retractable Needles. The used needle retracts into the barrel of the syringe.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only.
Syringe with Retractable Needles
As seen in this animation, after the needle is used, an extra push on the plunger retracts the needle into the syringe, removing the hazard of needle exposure.

Blunt-Tipped Blood Drawing Needles - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 4) Blunt-Tipped Blood Drawing Needles. Blood collection tube and blood drawing syringe.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Blunt-Tipped Blood Drawing Needles
As seen in this animation, after blood is drawn, a push on the collection tube moves the blunt tip needle forward through the needle and past the sharp needle point.

The blunt point tip of this needle can be activated before it is removed from the vein or artery.

Winged Steel Needles - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 5) Winged Steel Needles. Blunt-tipped winged steel needle.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only.
Winged Steel Needles
As seen in this animation, after placement, the third wing is rotated to flat position which blunts the needle point before it is removed from the patient.
Re-sheathing Disposable Scapel - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 6) Re-sheathing Disposable Scalpels. Re-sheathing scalpel.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only.
Re-sheathing Disposable Scalpels
As seen in this animation, single-use disposable scalpels have a shield that is advanced forward over the blade after use, containing and removing the hazard.
"Add on" Safety Feature - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 7) “Add on” Safety Feature.
“Add on” sliding shield.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. "Add on" Safety Feature
As seen in this animation, hinged or sliding shields attached to phlebotomy needles, winged steel needles, and blood gas needles, act as an “add on” safety feature.
Retracting Finger Prick Lancets - Accessibility Assistance: Contact the OSHA Directorate of Technical Support and Emergency Management at 202-693-2300 for assistance accessing figures and illustrations.
**(Figure 8) Retracting Finger Prick Lancets.

**Please note these safety devices lock in place and do not reset in actual use situations. The animation resets for viewer convenience only. Retracting Finger Prick Lancets
As seen in this animation, this single use lancet retracts automatically after use, containing and removing the hazard.

(These drawings are presented for educational purposes and do not imply endorsement of a particular product).

According to NIOSH’s Preventing Needlestick Injuries in Health Care Settings the process for selecting and evaluating needle devices with safety features includes:

  • Form a multidisciplinary team that includes workers to (1) develop, implement, and evaluate a plan to reduce needlestick injuries in the institution, and (2) evaluate needle devices with safety features.
  • Identify priorities based on assessments of how needlestick injuries are occurring, patterns of device use in the institution, and local and national data on injury and disease transmission trends. Give the highest priority to needle devices with safety features that will have the greatest impact on preventing occupational infection (e.g., hollow-bore needles used in veins and arteries).
  • When selecting a safer device, identify its intended scope of use in the healthcare facility and any special technique or design factors that will influence its safety, efficiency, and user acceptability. Seek published, Internet, or other sources of data on the safety and overall performance of the device.

  • Conduct a product evaluation, making sure that the participants represent the scope of eventual product users. The following steps will contribute to a successful product evaluation:

    • Train healthcare workers in the correct use of the new device.

    • Establish clear criteria and measures to evaluate the device with regard to both healthcare worker safety and patient care. (Safety feature evaluation forms are available from the references cited earlier.)

    • Conduct onsite follow-up to obtain informal feedback, identify problems, and provide additional guidance.

  • Monitor the use of a new device after it is implemented to determine the need for additional training, solicit informal feedback on healthcare worker experience with the device (e.g., using a suggestion box), and identify possible adverse effects of the device on patient care.

OSHA Directive CPL 02-02-069 [CPL 2-2.69] provides suggested non-mandatory forms to help employers evaluate engineering controls such as safety syringes, I.V. access devices, and sharps containers.

  • The appendix includes the sample evaluation form [18 KB PDF*, 1 page] developed by the Emergency Care Research Institute (ECRI). [Appendix B, OSHA Directive CPL 02-02-069 [CPL 2-2.69].

Additional Information:

  • Bloodborne Pathogens and Needlestick Prevention. OSHA Safety and Health Topics Page.
  • Preventing Needlestick Injuries in Health Care Settings. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2000-108, (1999, November).
  • What Every Worker Should Know—How to Protect Yourself From Needlestick Injuries. US Department of Health and Human Services (DHHS), National Institute for Occupational Safety and Health (NIOSH) Publication No. 2000-135, (2000, August 11).

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DOs and DON’Ts of Proper Sharps Disposal


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  • DO immediately place used needles and other sharps in a sharps disposal container to reduce the risk of needle sticks, cuts or punctures from loose sharps.
  • DO use an FDA-cleared sharps disposal container, if possible. If an FDA-cleared container is not available, some organizations and community guidelines recommend using a heavy-duty plastic household container as an alternative.
  • DO make sure that if a household container is used, it has the basic features of a good disposal container.
  • DO carry a portable sharps disposal container for travel.
  • DO follow your community guidelines for getting rid of your sharps disposal container.
  • DO call your local trash or public health department (listed in the county and city government section of your phone book) to find out about sharps disposal programs in your area.
  • DO ask your health care provider, veterinarian, local hospital or pharmacist
    • where and how to get an FDA-cleared sharps disposal container,
    • if they can dispose of your used needles and other sharps, or
    • if they know of sharps disposal programs near you.
  • DO keep all sharps and sharps disposal containers out of reach of children and pets.
  • DO seal sharps disposal containers when disposing of them, label them properly and check your community guidelines on how to properly dispose of them.
  • DO ask your medical or prescription insurer whether they cover sharps disposal containers.
  • DO ask the manufacturer of your drug products that are used with a needle or other sharps if they provide a sharps disposal container to patients at no charge.
  • DO report a problem associated with sharps and disposal containers.
  • DON’T throw loose needles and other sharps into the trash.
  • DON’T flush needles and other sharps down the toilet.
  • DON’T put needles and other sharps in your recycling bin — they are not recyclable.
  • DON’T try to remove, bend, break, or recap needles used by another person. This can lead to accidental needle sticks, which may cause serious infections.
  • DON’T attempt to remove the needle without a needle clipper because the needle could fall, fly off, or get lost and injure someone.