FDA Guide On Approving Medical Devices

Posted on July 30, 2016. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , , , , , |

FDA Guidance On Approving Medical Devices

ImageNew 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.

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Media Inquiries: Michelle Bolek, 301-796-2973, Michelle.Bolek@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
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How Human Factors Lead to Medical Device Adverse Events

Posted on June 1, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

Medical Device Adverse Events

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.

 TROUBLING HUMAN FACTORS PROBLEMS

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.

REFERENCES
1. FDA’s Human Factors Program: Promoting safety in medical device use. http://www.fda.gov/cdrh/humanfactors/index.html. Accessed March
27, 2008.
2. Sawyer D. Do it by design: An introduction to human factors. http://www.fda.gov/cdrh/humfac/doit.html. 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). http://www.fda.gov/cdrh/maude.html. 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)

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Source ~ www.FDA.org
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Medical Device Fellowship Program

Posted on May 27, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , , , , , , , , , |

Medical Device Fellowship Program

(EEP, OCD, CDRH) 

Introduction

 

The Center for Devices and Radiological Health (CDRH) Medical Device Fellowship Program (MDFP) provides opportunities for health professionals to participate in the FDA regulatory process for medical devices. MDFP is part of External Expertise and Partnerships (EEP) in the Office of the Center Director (OCD) in CDRH.  In addition to MDFP, other components of EEP include Technology Transfer and Partnerships, and the Critical Path Initiative.

CDRH regulates a wide array of medical devices and is involved with the latest medical device cutting-edge technology areas such as genomics, proteomics, diagnostics for personalized medicine, percutaneous heart valves, artificial hearts, tissue engineered wound dressing with cells, and bone void fillers with growth factors, and many others.

To keep pace with the rapid development of new technology, and to make decisions based on the best scientific information and knowledge available, CDRH routinely consults with experts in the academic community, other government entities, clinical practice, and the military. By filling gaps in expertise for a finite period of time, EEP enhances the efficiency and effectiveness of CDRH operations. EEP is the focal point of all CDRH fellowships and interorganizational partnerships. EEP also fosters scientific innovation by helping offices form partnerships with academia, private sector organizations, and government agencies.

CDRH established MDFP to increase the range and depth of collaborations between CDRH and the outside scientific community. The MDFP offers short and long-term fellowship opportunities for individuals interested in learning about the regulatory process and sharing their knowledge and experience with medical devices from the relatively simple to the highly complex.

Physicians with clinical or surgical expertise, engineers in biomedical, mechanical, electrical and software areas, and individuals from many other scientific disciplines have participated in the fellowship program. Opportunities are available for students in many areas as well.

Career Development

Learn about the FDA approval process for medical devices:

  • medical device design
  • clinical trial design and data
  • safety and efficacy evaluation
  • materials, performance, bioeffects and standards
  • adverse events

  

Public Service

  • Join CDRH’s mission to protect the public health by ensuring that medical devices are safe and effective
  • Share your expertise on complex device issues
  • Make a difference in the lives of patients and consumers

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What Is A Medical Device?

Posted on May 21, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

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]

Definitions

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].

Classification

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.

Canada

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.

Australia

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 Australia
Classification Level of Risk
Class I Low
Class I – measuring or Class I – supplied sterile or class IIa Low – medium
Class IIb Medium – high
Class III High
Active 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

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Is There A GROUP PURCHASING ORGANIZATION (GPO) Conspiracy?

Posted on May 18, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , , , , , , , , , , |

AN ANALYSIS OF GROUP PURCHASING ORGANIZATIONS’
CONTRACTING PRACTICES UNDER THE ANTITRUST LAWS:

Group purchasing organizations (GPOs) play an important role in the provision of health care services in the United States. As hospitals and other health care providers have come under pressure to reduce expenses, they have turned increasingly to GPOs to reduce the costs of the products and services they purchase. Today, virtually every hospital in the U.S. belongs to at least one GPO. More than seventy percent of all hospital purchases are made through GPO contracts, and GPOs contract for purchases with an annual value in the range of $150 billion.

The fundamental purpose of a GPO is to allow its members to join together to leverage their purchasing strength in order to purchase goods and services at lower prices, which in turn should enable them to lower their costs and become more competitive in the provision of their own services. In its basic form, a GPO is a cooperative of buyers. Over time, however, GPOs have evolved significantly to offer other competition-enhancing programs such as networking, bench marking, and educational quality improvement programs. These functions are pro-competitive and consistent with antitrust policy – they offer GPO members increased efficiency, eliminate wasteful administrative duplication, and they increase competition between manufacturers/vendors, and within the hospital members’ own markets, which translate into lower prices and higher quality for consumers.

At a time when increasing health care costs are a major policy concern, one would expect GPOs to be seen as a major force in the health care industry for increased efficiency and cost containment. In fact, GPOs currently are under attack from several different directions. On the political front, GPOs have come under attack by some manufacturers of medical devices that claim GPO contracting practices, including “sole-source contracts,” percentage of purchase or “market share” discounts, and multi-product or “bundled” discounts, favor large established manufacturers with the result that smaller companies with “innovative” products are effectively foreclosed from selling to a large number of the nation’s hospitals. These concerns have attracted the attention of the U.S. Senate, which held hearings last year scrutinizing GPO contracting practices; the Senate may hold additional hearings on GPOs in 2003. Similarly, the Federal Trade Commission (FTC) held a workshop last fall at which GPO contracting practices were a topic of discussion, and the FTC, together with the Antitrust Division of the Department of Justice (DOJ), are holding health care hearings in 2003 at which GPO contracting practices also are being discussed. Finally, a 2002 preliminary study by the General Accounting Office (GAO) raised questions about whether GPO contracts actually save hospitals money.  GPO contracts also have been the subject of recent private litigation. In Kinetic Concepts, Inc. v. Hillenbrand Indus., Inc., a jury awarded more than $500 million in treble damages against a manufacturer of hospital beds that allegedly was using GPO contracts to exclude plaintiff, its competitor. In a suit more directly implicating GPO practices, Retractable Technologies, Inc. v. Becton Dickinson, et al., a manufacturer of safety syringes sued the two largest manufacturers of standard and safety syringes along with the two largest GPOs, alleging, among other things, a conspiracy between the GPOs and manufacturers to monopolize the needle and syringe market.

The important role GPOs play in the delivery of health care services, and the criticism that has been directed at them, raise important issues under the antitrust laws. Are GPOs the agents of efficiency they claim to be, or, as their critics charge, have GPOs become a vehicle for dominant manufacturers to achieve and/or maintain monopoly power? This article analyzes GPO contracting practices under the antitrust laws and whether these practices are likely to result in anti-competitive effects. As this analysis will show, in general, GPO contracts promote significant efficiencies and are unlikely to result in sufficient market foreclosure to injure competition. The policy implications of this conclusion are clear: instead of increasing competition, restrictions on GPO contracting practices are likely to result in less competition and higher prices for health care consumers.

I. History and Background of Group Purchasing Organizations Hospital GPOs trace their history back to the late 1800s, though the first known hospital GPO was the Hospital Bureau of New York, which appeared in 1910.  Over the next half century, the GPO concept grew slowly and by the early 1970s there were forty hospital GPOs in the United States. The next thirty years witnessed an explosion of GPOs. From 1974 to 1999,the number of GPOs grew from forty to 633.  Today, there are over 900 GPOs in the United States. While some of these are “child” GPOs that rely on contracts negotiated by larger “parent” GPOs, it is estimated that approximately 200 GPOs contract directly with suppliers, and that twenty-six of these operate on a national level.

It is not a coincidence that GPOs began to grow in popularity in the late 1970s and early 1980s. During this time, for-profit hospital chains began to expand and buy up not-for-profit hospitals, forcing not-for-profits to find ways to cut costs to remain competitive. In the early 1980s, Medicare instituted the Prospective Payment System through which hospitals were reimbursed a fixed rate based on a defined service rather than the cost to the hospital of providing that service. At the same time, growing pressure in the private sector to reduce health care costs in the form of Health Maintenance Organizations (HMOs) and other types of managed care also reduced hospital reimbursement. These external market factors made it important for hospitals to control costs. Part of this effort included forming or joining a GPO to lower the cost of goods and services that the hospitals purchased.

CONTINUE TO FULL ARTICLE WITH REFERENCES : http://www.ftc.gov/ogc/healthcarehearings/docs/030926bloch.pdf
MYTH AND REALITY©

Robert E. Bloch, Esq.
Scott P. Perlman, Esq,
Jay S. Brown, Esq.*
MAYER, BROWN, ROWE & MAW
1909 K Street, N.W.
Washington, D.C. 20006
(202) 263-3000

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The Making Of A Syringe

Posted on May 17, 2012. Filed under: Syringe Blog | Tags: , , , , , , , , |

The Making Of A Syringe

The hypodermic syringe, also known as the hypodermic needle, is a device used by medical professionals to transfer liquids into or out of the body. It is made up of a hollow needle, which is attached to a tube and a plunger. When the plunger handle is pulled back, fluids are drawn into the tube. The fluid is forced out through the needle when the handle is pushed down. The syringe was introduced in the mid 1800s and has steadily improved with the development of new materials and designs. Today, it has become such an important medical tool that it is nearly a symbol synonymous with the practicing physician.
 
History

Since the advent of pharmaceutical drugs, methods for administering those drugs have been sought. Various important developments needed to occur before injections through a hypodermic syringe could be conceived. Early nineteenth century physicians were not aware that drugs could be introduced into the body through the skin. One early experiment that demonstrated this idea, however, was performed by Francois Magendie in 1809. In his published work, he outlined a method for introducing strychnine into a dog by using a coated wooden barb. In 1825, A. J. Lesieur described another method for administering drugs through the skin, applying them directly to blisters on the skin. Expanding on results from these experiments, G. V. Lafargue developed a procedure for introducing morphine under the skin using a lancet. A drip needle was invented by F. Rynd in 1844 for the same purpose. However, he did not publish his method until 1861, eight years after the first hypodermic syringe was described.

The first true hypodermic syringe was created by Alexander Wood in 1853. He modified a regular syringe, which at that time was used for treating birthmarks, by adding a needle. He then used this new device for introducing morphine into the skin of patients who suffered from sleeping disorders. A few years later, he added a graduated scale on the barrel and a finer needle. These modifications were enough to attract the attention of the rest of the medical community, resulting in its more widespread use.

Over the years hypodermic syringes have undergone significant changes that have made them more efficient, more useful, and safer. One such improvement was the incorporation of a glass piston within the cylinder. This innovation prevented leaks and reduced the chances of infections, making the device more reliable. The technology for the mass production of hypodermic syringes was developed in the late nineteenth century. As plastics developed, they were incorporated into the design, reducing cost and further improving safety.
Background

The way in which a hypodermic needle works is simple. Fluid, such as a drug or blood, is drawn up through a hollow needle into the main tube when the plunger handle is pulled back. As long as the needle tip remains in the fluid while the plunger handle is pulled, air will not enter. The user can determine exactly how much material is in the tube by reading the measuring marks on the side of the tube. The liquid is dispensed out through the needle when the plunger handle is pushed back down.

The term hypodermic syringe comes from the Greek words hypo, meaning under, and derma, meaning skin. These terms are appropriate because they describe exactly how the device functions. The needle is used to pierce the top layer of the skin, and the material in the tube is injected in the layer below. In this subcutaneous layer, most injected materials will be readily accepted into the bloodstream and then circulated throughout the body.

A syringe is one of three primary methods for introducing a drug into the body. The others are transepidermal (through the skin) and oral. Using a hypodermic needle as the method of drug administration has some significant advantages over oral ingestion. First, the drugs are protected from the digestive system. This prevents them from being chemically altered or broken down before they can be effective. Second, since the active compounds are quickly absorbed into the bloodstream, they begin working faster. Finally, it is more difficult for the body to reject drugs that are administered by syringe. Transepidermal drug administration is a relatively new technology, and its effects are generally not as immediate as direct injection.
Design

There are many hypodermic syringe designs available. However, all of them have the same general features, including a barrel, plunger, needle, and cap. The barrel is the part of the hypodermic needle that contains the material that is injected or withdrawn. A movable plunger is contained within this tube. The width of the barrel is variable. Some manufacturers make short, wide tubes, and others make long, thin ones. The exact design will depend to some extent on how the device will be used. The end of the barrel to which the needle is attached is tapered. This ensures that only the desired amount of material will be dispensed through the needle. At the base of the barrel away from the needle attachment, two arms flare out. These pieces allow the needle user to press on the plunger with the thumb while holding the tube in place with two fingers. The other end of the barrel is tapered.

The plunger, which is responsible for creating the vacuum to draw up materials and then discharge them, is made of a long, straight piece with a handle at one end and a rubber plunger head on the other. The rubber head fits snugly against the walls of the barrel, making an airtight seal. In addition to ensuring an accurate amount of material is drawn in, the squeegee action of the plunger head keeps materials off the inner walls of the tube.

The needle is the part of the device that actually pierces the layers of the skin. Depending on how deep the injection or fluid extraction will be, the needle orifice can be thinner or wider, and its length varies. It can also be permanently affixed to the body of the syringe or interchangeable. For the latter type of system, a variety of needles would be available to use for different applications. To prevent accidental needle stick injuries, a protective cap is placed over the top of the needle when it is not in use.

Raw Materials

Since hypodermic syringes come in direct contact with the interior of the body, government regulations require that they be made from biocompatible materials which are pharmacologically inert. Additionally, they must be sterilizable and nontoxic. Many different types of materials are used to construct the wide variety of hypodermic needles available. The needles are generally made of a heat-treatable stainless steel or carbon steel. To prevent corrosion, many are nickel plated. Depending on the style of device used, the main body of the tube can be made of plastic, glass, or both. Plastics are also used to make the plunger handle and flexible synthetic rubber for the plunger head.
The Manufacturing Process

There are many manufacturers of hypodermic needles, and while each one uses a slightly different process for production, the basic steps remain the same, including needle formation, plastic component molding, piece assembly, packaging, labeling, and shipping.

Making the needle

1. The needle is produced from steel, which is first heated until it is molten and then,
Retraction of the plunger creates the vacuum to draw up materials, which can then be discharged by pushing on the plunger. Its rubber head makes an airtight seal against the walls of the barrel.  Retraction of the plunger creates the vacuum to draw up materials, which can then be discharged by pushing on the plunger. Its rubber head makes an airtight seal against the walls of the barrel, drawn through a die designed to meet the size requirements of the needle. As it moves along the production line, the steel is further formed and rolled into a continuous, hollow wire. The wire is appropriately cut to form the needle. Some needles are significantly more complex and are produced directly from a die casting. Other metal components on the needle are also produced in this manner.



Making the barrel and plunger

2. There are various ways that the syringe tube can be fashioned, depending on the design needed and the raw materials used. One method of production is extrusion molding. The plastic or glass is supplied as granules or powder and is fed into a large hopper. The extrusion process involves a large spiral screw, which forces the material through a heated chamber and makes it a thick, flowing mass. It is then forced through a die, producing a continuous tube that is cooled and cut.

     3. For pieces that have more complex shapes like the ends, the plunger, or the safety caps, injection molding is used. In this process the plastic is heated, converting it into a liquid. It is then forcibly injected into a mold that is the inverse of the desired shape. After it cools, it solidifies and maintains its shape after the die is opened. Although the head of the plunger is rubber, it can also be manufactured by injection molding. Later, the head of the plunger is attached to the plunger handle.

Assembly and packaging

4. When all of the component pieces are available, final assembly can occur. As the tubes travel down a conveyor, the plunger is inserted and held into place. The ends that cap the tube are affixed. Graduation markings may also be printed on the main tube body at this point in the manufacturing process. The machines that print these markings are specially calibrated to ensure they print measurements on accurately. Depending on the design, the needle can also be attached at this time, along with the safety cap.

5. After all of the components are in place and printing is complete, the hypodermic syringes are put into appropriate packaging. Since sterility of the device is imperative, steps are taken to ensure they are free from disease-causing agents. They are typically packaged individually in airtight plastic. Groups of syringes are packed into boxes, stacked on pallets, and shipped to distributors.

Quality Control

The quality of the components of these devices are checked during each phase of manufacture. Since thousands of parts are made daily, complete inspection is impossible. Consequently, line inspectors randomly check components at fixed time intervals to ensure they meet size, shape, and consistency specifications. These random samples give a good indication of the quality of the hypodermic syringe produced. Visual inspection is the primary test method. However, more rigorous measurements are also performed. Measuring equipment is used to check the length, width, and thickness of the component pieces. Typically, devices such as a vernier caliper, a micrometer, or a microscope are used. Each of these differ in accuracy and application. In addition to specific tests, line inspectors are stationed at various points of the production process and visually inspect the components as they are made. They check for things such as deformed needles or tubes, pieces that fit together incorrectly, or inappropriate packaging.

Hypodermic syringe production is strictly controlled by the United States government, specifically the Food and Drug Administration (FDA). They have compiled a list of specifications to which every manufacturer must comply. They perform inspections of each of these companies to ensure that they are following good manufacturing practices, handling complaints appropriately, and keeping adequate records related to design and production. Additionally, individual manufacturers have their own product requirements.

The Future

Since Alexander Wood introduced the first device, hypodermic syringe technology has greatly improved. Future research will focus on designing better devices that will be safer, more durable, more reliable, and less expensive to produce. Also, improvements in device manufacture will also continue. One example of this is the trend toward utilizing materials such as metals and plastics that have undergone a minimum of processing from their normal state. This should minimize waste, increase production speed, and reduce costs.

Where to Learn More

Books

Chicka, C. and Anthony Chimpa. Diabetic’s Jet Ejectors. Diabetic Gun for Personal Insulin Injection. H.W. Parker, 1989.

Trissel, Lawrence. Pocket Guide to Injectable Drugs: Companion to Handbook of Injectable Drugs. American Society of Health-System Pharmacists, 1994.

— Perry Romanowski

Read more: How syringe is made – material, production process, manufacture, making, history, used, processing, parts, components, procedure, steps, product, History, Design, Raw Materials http://www.madehow.com/Volume-3/Syringe.html#ixzz1v7e3O29G

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Article from Advameg, Inc.
Advameg, Inc. is a fast growing Illinois-based company. Our websites reach over 20 million unique visitors per month and are frequently referenced by the media. According to Quantcast, City-data.com is one of the top 100 largest websites in the U.S. (May 11, 2012). City-data.com’s forum gets over 15,000 posts/day. Advameg’s president is Lech Mazur. ~ http://www.advameg.com/contact-oth.php

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The Risks of the Job: Protecting Law Enforcement from Needle Stick Injuries

Posted on May 6, 2012. Filed under: Syringe Blog | Tags: , , , , , |

ImageA needlestick injury is a percutaneous piercing wound typically set by a needle point, but possibly also by other sharp instruments or objects. Commonly encountered by medical personnel and law enforcement handling needles in the medical setting and on the streets, such injuries are an occupational hazard in the professional community. These events are of concern because of the risk to transmit blood-borne diseases through the passage of the hepatitis B virus (HBV), the hepatitis C virus (HCV), and the Human Immunodeficiency Virus (HIV), the virus which causes AIDS. SEE VIDEO ~ CLICK LINK BELOW:

 

Protecting Law Enforcement from Needle Stick Injuries

 

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What is a Healthcare GPO?

Posted on April 28, 2012. Filed under: Syringe Blog | Tags: , , , , |

What is a Healthcare GPO?

Health Care GPO’s

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SHARPS INJURY PREVENTION LIST and INFORMATION

Posted on January 28, 2012. Filed under: Syringe Blog | Tags: , , , , , , |

SHARPS INJURY PREVENTION LIST and INFORMATION

In all workplaces where employees are exposed to contaminated needles or other contaminated sharps, the employer shall comply with 29CFR 1910.1030, Tennessee Code Annotated 50-3-203(e)(1)-(e)(4) and Tennessee Rule 0800-1-10 as follows:

  • Evaluate available engineered sharps injury prevention devices for all sharps
  • Solicit input from employees directly involved in patient care in the evaluation and selection of devices and document this in the Exposure Control Plan
  • Select the devices most appropriate to your procedures
  • Train employees to use the devices,
  • Require use of the safer devices and use of safer work practices when handling and passing contaminated sharps
  • Update the Exposure Control Plan at least annually or when needed to document the devices evaluated and those placed into use
  • Justify the use of any sharps without sharps injury protection & document in the Exposure Control Plan
  • Maintain a Sharps Injury Log with:
  1. Type and brand of device involved in the exposure incident
  2. Department or work area of occurrence
  3. Explanation of how it occurred

The list below is to assist employers in complying with changes in Tennessee Code Annotated Section 50-3-203 (Senate Bill 1023/House Bill 634). Inclusion of types of devices does not represent or imply any evaluation, endorsement, or approval by The Tennessee Department of Labor and Workforce Development, the Tennessee Department of Health, or any other agency. This list is not all inclusive.

Types of Devices and Engineering Controls

Injection Equipment

  • Hypodermic needles and syringes- sliding sheath/sleeve, needle guards
  • Needleless jet injection
  • Retractable needles

Medication Vial Adaptors (used to access ports of medication vials)
IV Medication Delivery Systems

  • Needle guards for pre-filled medication cartridges
  • Needleless IV access-blunted cannulas
  • Needleless valve/access ports and connectors
  • Prefilled medication cartridge with safety needles
  • Recessed/protected needle
  • Needle guards for pre-filled medication cartridges

IV Insertion Devices

  • Shielded or retracting peripheral IV catheters
  • Shielded midline IV catheters

IV Catheter Securement Devices
Epidural/Spinal Needles
Blood Collection Devices

  • Arterial blood gas syringes
  • Phlebotomy needles
  • Safety-engineered blood collection needles
  • Blood tube holders
  • Closed venous sampling systems
  • Plastic blood collection tubes
  • Butterfly blood collection needles
  • Blood Donor Plebotomy Devices

Other Catheter Equipment

  • Guidewire Introducers-for venous and arterial access
  • Central Venous Catheters
  • Peripheral Inserted Central Catheters
  • Radial Artery Catheters

Umbilical cord sampling devices
Lancets

  • Laser lancet
  • Retracting Lancet
  • Strip Lancet

Laboratory Devices

  • Hemoglobin reader
  • Mylar-wrapped glass capillary tubes
  • Plastic capillary tubes
  • Protected needles for blood culture vial access
  • Vacuum tube stopper
  • Plastic fingerstick sampling blood collection tube
  • Slide preparation devices

Surgical Devices

  • Scalpels (disposable safety, retracting, shielded)
  • Ultrasonic scalpel

Blunted Suture Needles (for internal suturing- fascia/muscles)
Surgical Glues & Adhesives
Alternative Skin Closure Devices
Surgical Sharps Protection and Other Surgical Sharps Protection

  • Hands free transfer disposable magnetic drapes
  • Sharps counting and disposal system
  • Magnetic floor sweep
  • Scalpel blade removal system

Hemodialysis and Apheresis Devices
Fluid Sampling Devices
Sharps Disposal or Destruction Containers
Irrigation Splash Shield (Eliminates use of needles in debridement procedures)
Blood Bank Devices

  • Segment sampling devices

Nuclear Medicine Devices
Cut or puncture-resistant barrier products (gloves, liners or pads)
Huber Needle and related devices
Smallpox Vaccination Needles
Vaginal Retractors
Surgical Prep Razors
Bone Marrow Collection Systems
Dental Safety Devices
To access this fact sheet online: www.state.tn.us/labor-wfd/sharpslist.pdf

The next list below contains web site resources that can be used for the purposes of information and research. The examples of effective engineering controls in this list do not include all those on the market, but are simply representative of the devices available. Neither the Tennessee Department of Labor and Workforce Development nor the Tennessee Department of Health approve, endorse, register or certify any medical devices. Inclusion on this list does not indicate approval, endorsement, registration or certification.

International Health Care Worker Safety Center, University of Virginia:
Available: Features a list of safety devices with manufacturers and specific product names: http://www.healthsystem.virginia.edu/internet/epinet/safetydevicene… and Safety in Surgery : http://healthsystem.virginia.edu/internet/safetycenter/internetsafe…

International Sharps Injury Prevention Society:
Available: http://www.isips.org/
ISIPS is an international group of medical device and pharmaceutical manufacturers, health organizations, healthcare professionals, medical waste disposal experts and others that are joining forces to provide education, information, and product knowledge that will help reduce the number of sharps injuries that occur each year. This website features a list of safety product categories with a description of the category and a list of safety products that fit under that category : http://www.isips.org/safetyproductlist.php
Food and Drug Administration (FDA) Safety Alert: Needlestick and Other Risks from Hypodermic Needles on Secondary IV Administration Sets – Piggyback and Intermittent IV: http://www.osha.gov/SLTC/bloodbornepathogens/fdaletter.html
Warns of the risk of needlestick injuries from the use of hypodermic needles as a connection between two pieces of intravenous (IV) equipment. Describes characteristics of devices which have the potential to decrease the risk.
Occupational Safety and Health Administration (OSHA) Glass Capillary Tubes: Joint Safety Advisory About Potential Risks : http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=INTER…
Describes safer alternatives to conventional glass capillary tubes.
Occupational Safety and Health Administration (OSHA) Needlestick Injuries Available: http://www.osha.gov/SLTC/bloodbornepathogens/index.html
Features recent news, recognition, evaluation, controls, compliance, and links to information on effective engineering controls.
Needle Safety http://www1.va.gov/vasafety/page.cfm?pg=119
Features needle safety information from the US Department of Veterans Affairs (VA).
Training for Development of Innovative Control Technologies (TDICT) Project Available: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIREC…
TDICT “Safety Feature Evaluation Forms” in Appendix B of this directive.
OSHA Instruction CPL 2-2.69 Enforcement procedures for the Occupational Exposure to Bloodborne Pathogens
Available: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=DIREC…
Instruction that establishes policies and provides clarification to ensure uniform inspection procedures are followed when conducting inspections to enforce the Occupational Exposure to Bloodborne Pathogens Standard (29 CFR 1910.1030).
Service Employees International Union (SEIU) Guide List
Available: http://www.seiu.org

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An Act To Amend The Public Health Law, In Relation To Hypodermic Syringes

Posted on December 5, 2011. Filed under: Syringe Blog | Tags: , , , , , |

More than 3,000 pharmacies, health care facilities and practitioners have registered with the Department of Health (DOH) to sell or furnish syringes to those age 18 and over without a prescription under the ESAP.

This program makes syringes available without a prescription and promotes the safe disposal of used syringes. Research has shown this program effectively reduces transmission of blood-borne pathogens as a result of needle sharing and reuse and may increase safe disposal of used syringes. ESAP providers sell two to three million non-prescription syringes a year and the need for unrestricted access to syringes remains high. Only two states, Delaware and New Jersey, do not allow the sale of syringes without a prescription.

In a 2003 report, the New York Academy of Medicine (NYAM) stated that ESAP “has great potential to prevent transmission of blood-borne diseases without any detrimental effect on syringe disposal, drug use or crime.” NYAM’s recommendation included: (1) enacting legislation to allow the program to continue permanently (which occurred as part of the 2009-10 enacted budget); (2) lifting the restriction on pharmacy advertising; (3) continuing education and outreach; (4) continuing safe syringe disposal education; and (5) expanding disposal options. At the time of the program’s extension through 2007, NYAM again noted the importance of syringe access, indicating that expanded syringe access “is critically important to stemming the spread of infectious disease.” Numerous studies published in peer-reviewed journals have attested to the value of ESAP in reducing syringe sharing and re-use and preventing disease transmission.

This bill would eliminate two restrictions on the sale of syringes to further the objectives of ESAP. First, the bill would remove the restriction on the number of syringes that may be sold or furnished, leaving the matter to the discretion of the individual ESAP provider. The current limit of 10 syringes per transaction was first implemented when ESAP was a demonstration project. Removing the limitation would better serve individuals who use this program by ensuring that they have enough clean syringes to prevent reusing or sharing syringes. For individuals in rural regions of the State, removing this restriction will facilitate access, particularly when it may be difficult or time-consuming to get to a pharmacy to purchase or dispose of used syringes.

Second, the bill would permit pharmacies to advertise the availability of syringes to the public. Of the 3,300 pharmacies, health care facilities and practitioners that have registered with DOH as part of ESAP, more than 97 percent are pharmacies. The public health function that they serve is compromised if potential customers are unaware of which pharmacies are registered ESAP providers. Appropriate pharmacy advertising can supplement the efforts of DOH to promote ESAP and provide consumers with access to information that they need to make informed choices.

~ S5312-2011: Relates to hypodermic syringes


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